A Prospective, Multi-center, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the OR3O™ Dual Mobility System Versus Conventional Single Bearing Design Total Hip System in Primary Total Hip Arthroplasty (THA) Procedures.
Phase: NA
Conditions: Degenerative Hip Joint Disease, Rheumatoid Arthritis (RA), Femoral Neck Fractures, Avascular Necrosis of Femoral Head, Osteoarthritis (OA), Hip Dislocation, Hip Fractures
Sponsor: Smith & Nephew Medical (Shanghai) Ltd

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 1 of 90 
 
 
 
A Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual Mobility 
System versus conventional single bearing design Total Hip 
System in Primary Total Hip Arthroplasty (THA) Procedures 
Protocol No： 
OR3O.2019.10 (China) 
Protocol Version and Date: 
1.0, 18AUG2020 
Investigational Product(s): 
OR3O™ - Dual Mobility System   
Management Type of 
Investigational Product： 
Category III Medical Device Requiring Clinical Trial 
Approval  Yes☐  No☒ 
Similar Products in China: 
Yes☒ No☐ 
Leading Site of Clinical 
Trial: 
The First Affiliated Hospital of Xinjiang Medical 
University 
Site of Clinical Trial: 
Peking University Third Hospital 
The Ninth People's Hospital affiliated to Shanghai Jiao 
Tong University Medical College 
The Third Hospital of Hebei Medical University 
Sponsor: 
Smith & Nephew Medical (Shanghai) Limited 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 2 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Sponsor Name and 
Address: 
SMITH & NEPHEW MEDICAL (SHANGHAI) LIMITED. 
Unit B, Floor 4, General Factory Building, 
No. 188, Ao Na Road, China (Shanghai) Pilot Free Trade Zone, 
Shanghai, PRC 
 
 
 
 
Protocol Author(s): 
Tracey Brengola, Senior Clinical Study Manager 
Babajide Olayinka, Senior Biostatistician 
Vinay Bhal, Clinical Strategy Lead (Ortho)  
Astrid Yung, Associate Director Clinical Strategy & Operations 
 
 
 
 
 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 3 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 SIGNATURES 
 
PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
This page will be returned to Smith & Nephew Medical (Shanghai) Limited and a copy retained at the 
investigational site. 
I have read the attached protocol entitled “A Prospective, Multi-center, Randomized, Controlled Study to 
Evaluate the Safety and Efficacy of the OR3O™ Dual Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip Arthroplasty (THA) Procedures”, version <1.0>, dated 
<18/AUG/2020>, and agree to abide by all provisions set forth herein. 
I agree to comply with the Investigator’s Obligations stipulated in the protocol, I agree to ensure that the 
confidential information contained in this document will not be used for any purpose other than the conduct 
of the described clinical investigation without the prior written consent of Smith & Nephew Medical 
(Shanghai) Limited. 
 
 
Name, Address,  
Professional Position 
Signature 
Date Signed 
(DD/MMM/YYYY) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 4 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
COORDINATING INVESTIGATOR APPROVAL  
I have read the attached protocol entitled “A Prospective, Multi-center, Randomized, Controlled Study to 
Evaluate the Safety and Efficacy of the OR3O™ Dual Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip Arthroplasty (THA) Procedures”, version <1.0>, dated 
<18/AUG/2020>, and agree to abide by all provisions set forth herein. 
I agree to comply with the Investigator’s Obligations stipulated in the protocol, I agree to ensure that the 
confidential information contained in this document will not be used for any purpose other than the conduct 
of the described clinical investigation without the prior written consent of Smith & Nephew Medical 
(Shanghai) Limited. 
 
 
Name, Address,  
Professional Position 
Signature 
Date Signed 
(DD/MMM/YYYY) 
 
 
 
 
 
 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 5 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
INVESTIGATOR APPROVAL  
I have read the attached protocol entitled “A Prospective, Multi-center, Randomized, Controlled Study to 
Evaluate the Safety and Efficacy of the OR3O™ Dual Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip Arthroplasty (THA) Procedures”, version <1.0>, dated 
<18/AUG/2020>, and agree to abide by all provisions set forth herein. 
I agree to comply with the Investigator’s Obligations stipulated in the protocol, I agree to ensure that the 
confidential information contained in this document will not be used for any purpose other than the conduct 
of the described clinical investigation without the prior written consent of Smith & Nephew Medical 
(Shanghai) Limited. 
 
 
Name, Address,  
Professional Position 
Signature 
Date Signed 
(DD/MMM/YYYY) 
 
 
 
 
 
 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 6 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
INVESTIGATOR APPROVAL  
I have read the attached protocol entitled “A Prospective, Multi-center, Randomized, Controlled Study to 
Evaluate the Safety and Efficacy of the OR3O™ Dual Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip Arthroplasty (THA) Procedures”, version <1.0>, dated 
<18/AUG/2020>, and agree to abide by all provisions set forth herein. 
I agree to comply with the Investigator’s Obligations stipulated in the protocol, I agree to ensure that the 
confidential information contained in this document will not be used for any purpose other than the conduct 
of the described clinical investigation without the prior written consent of Smith & Nephew Medical 
(Shanghai) Limited. 
 
 
Name, Address,  
Professional Position 
Signature 
Date Signed 
(DD/MMM/YYYY) 
 
 
 
 
 
 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 7 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
SPONSOR APPROVAL  
 
 
Name and Title 
Signature and Date / DocuSign Stamp 
Head of China Clinical 
Affairs 
Julian Yang, Director, 
China Clinical Affairs 
 
Head of Global Clinical 
Strategy 
Yancy Shaherah 
Senior Director, Global 
Clinical Strategy  
 
Head of Global 
Biostatistics 
Alan Rossington, 
Director Biostatistics 
and Data Management 
 
Medical Affairs 
Representative 
Orlandini Luca， 
Vice President Medical 
Affairs Global Clinical 
Affairs 
 
Regulatory 
Representative 
Kerry Geng, Senior 
Director, Head of 
Regulatory Affairs and 
Quality, Greater China 
 
 
 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 8 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 SYNOPSIS 
Title of Study: 
A Prospective, Multi-center, Randomized, Controlled Study to Evaluate the 
Safety and Efficacy of the OR3O™ Dual Mobility System versus 
conventional single bearing design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Study Design: 
A prospective, multi-center, randomized, controlled, 2-arm study with 
follow up to 2 years. 
Study Type: 
Pre-market study 
Study Product:  
OR3O™ Dual Mobility System is comprised of a diffusion-hardened, 
oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of 
highly cross-linked polyethylene (OR3O™ XLPE Insert).  
In this study, the OR3O™ Dual Mobility System will be used in 
combination with R3™ Acetabular Shell and a Smith & Nephew Oxinium 
(Ox) femoral head. 
Comparison Group: 
 
A conventional, single-bearing design Total Hip System comprised of R3™ 
Acetabular Shell with XLPE liner and a Smith & Nephew Oxinium (Ox) 
femoral head. 
Study Purpose: 
The purpose of this study is to compare OR3O™ Dual Mobility System to 
a conventional, single-bearing design Total Hip System in subjects who 
undergo Primary THA. Data collected in this study will be used to support 
NMPA regulatory approval of OR3O™ Dual Mobility System in China as 
well as to support and maintain product registration in global markets. 
Primary Objective: 
Assess safety and efficacy of the OR3O™ Dual Mobility System in 
Primary THA at 1 year postoperative. 
Secondary Objective(s): 
Assess safety and efficacy of the OR3O™ Dual Mobility System and 
compatible components in Primary THA up to 2 years after surgery. 
Other Objective(s): 
Assess the hip dislocation and hospital readmission up to 2 years after 
device implantation. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 9 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
Sample Size: 
Sample size calculation is based on the assumption that in order to be 
considered of comparable efficacy, Study Arm (dual mobility cohort) must 
obtain at least 90% of the efficacy in the Controlled Arm (conventional 
cohort). It is expected and further assumed that 95% of the Harris Hip Score 
at 12 months postoperative will have a rating of good or excellent (80-89, 
≥ 90), then 76 evaluable subjects per group would be required to carry out 
the hypothesis testing at 12 months postoperatively. Assuming an attrition 
rate of 10% at 1 year, 85 subjects per arm, in total of 170 subjects are 
needed.   
Number of Study Sites: 
4 study sites in China 
Inclusion Criteria: 
 
Subject is a suitable candidate for implanting the OR3O™ Dual 
Mobility System or single-bearing design Total Hip System in 
primary total hip replacement in the Investigator’s judgement. 
 
Subject is skeletally mature in the Investigator’s judgement. 
 
Subject is 18 – 80 years old (inclusive). 
 
Subject is receiving total hip replacement for the first time on the 
affected hip. 
 
Subject has any of the following conditions: 
o 
Advanced degeneration of the hip joint as a result of 
degenerative, post-traumatic, or rheumatoid arthritis(RA); 
o 
Fracture or avascular necrosis of the femoral head;  
o 
All forms of osteoarthritis(OA); 
o 
Patients with hips at risk of dislocation; 
o 
Femoral neck fracture or proximal hip joint fracture. 
 
Subject provides written informed consent for study participation 
using an Ethical Committee (EC) approved consent form before 
any study procedures are performed, including pre-operative data 
review and/or collection of data on electronic Case Report Forms 
(eCRFs). 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 10 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Subject is willing and able to participate in required follow-up 
visits and is able to complete study activities. 
 
Subjects with preoperative HHS ≤ 79 (fair or worse category). 
Exclusion Criteria: 
 
Subject has conditions that would eliminate or tend to eliminate 
adequate implant support or prevent the use of an appropriately-
sized implant, e.g.: 
o 
blood supply limitations; 
o 
insufficient quantity or quality of bone support, e.g., 
osteoporosis, metabolic disorders which may impair bone 
formation, radioactive bone disease, tumor around hip 
joint, and osteomalacia; 
o 
infections or other conditions which may lead to 
increased bone resorption. 
 
Subject has dysplasia of hip joint with CROWE Grade III, IV. 
 
Subject has weak constitution or failing to endure the surgery due 
to other diseases of the body. 
 
Subject has bodily disease(s) that may interfere with THA survival 
or outcome.  
 
Subject has life expectancy of less than 2 years.  
 
Subject has mental or neurological conditions which impair the 
subject’s ability or willingness to restrict activities that may put 
the affected limb at risk. 
 
Subject has physical conditions or activities which tend to place 
extreme loads on implants, e.g., Charcot joints, muscle 
deficiencies, multiple joint disabilities. 
 
Subject has neuromuscular dysfunctions (paralysis, myolysis and 
abductor muscle weakness) which will cause unstable hip joint or 
abnormal gait after surgery. 
 
Subject has a mental or neurological condition that would pre-
empt their ability or willingness to participate in the study 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 11 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
including mental illness, mental retardation, drug or alcohol 
abuse. 
 
Subject has an active infection – systemic or at the site of 
intended surgery. 
 
Subject has a Body Mass Index ≥ 40.0 kg/m².  
 
Subject has a known allergy to any component of the devices used 
in the study. 
 
Subject is pregnant or breast feeding. 
 
Subject is entered in another investigational drug, biologic, or 
device study within 30 days of active study participation. 
 
Subjects that are expected with poor compliance. 
 
Subjects with complications of other diseases are limited to 
participate in the research, not able to comply with the follow-up 
or have impact on scientific integrity. 
 
Subjects with preoperative HHS ≥ 80 (good to excellent 
category). 
 
Subject has other diseases or conditions that investigator 
considers not appropriate to participate in the study. 
Study Duration: 
Approximately. 36 months (3 years) 
Enrollment period: approximately. 12 months 
Follow-up period: 24 months 
Primary endpoint: 
Proportion of excellent (≥ 90) or good (80-89) HHS scores at 12 month 
postoperative. 
Secondary endpoint(s): 
Safety and efficacy evaluated in this study at baseline, 6 weeks, 3 months, 
6 months, 1 year and 2 years after surgery as measured by:  
 
Survivorship of the OR3O™ Dual Mobility System (no revision 
due to any reason) 
 
Survivorship of controlled system  
 
Harris Hip Score (HHS) 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 12 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
EuroQol(European Quality of Life) five-dimensional Five-level 
(EQ-5D-5L) score 
 
Hip Disability and Osteoarthritis Outcome Score for Joint 
Replacement (HOOS JR.) 
 
Radiographic Assessment 
o 
Implant position/Orientation 
o 
Implant subsidence/migration 
o 
Periprosthetic fractures 
o 
Heterotopic ossification 
o 
Radiolucencies  
o 
Osteolysis 
o 
Implant loosening 
o 
Stress Shielding 
Other exploratory 
endpoint(s): 
 
Dislocation percentage of the hip up to 2 years after device 
implantation. 
 
Hospital readmission percentage (cumulative) by 30, 60, 90 days 
of discharge due to any reason related to study device or study 
procedure. 
Safety Data: 
 
All adverse events (AEs) occurring from the time of subject 
enrollment until study termination or study completion including 
intra-operative adverse events.  
 
Device Deficiencies (DDs) 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 13 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
STUDY SCHEDULE  
Schedule of events  
Pre-Op 
Data 
Operative / 
Discharge 
6 Weeks 
(42 – 7/+14 
days) 
3 months  
(90 ± 30 
days) 
6 months  
(180 ± 30 
days) 
1 yr.  
(365 ± 60 
days) 
2 yr. 
 (730 ± 60 
days) 
Informed Consent 
x 
 
 
 
 
 
 
Inclusion/ Exclusion  
x 
 
 
 
 
 
 
Demographics 
x 
 
 
 
 
 
 
Medical History 
x 
 
 
 
 
 
 
Vital Signs 
x 
 
 
 
 
 
 
Preoperative Lab Examinations 
(eg. Blood Routine Examination,
Biochemical Examination, 
Coagulation Examination) (1) 
x 
 
 
 
 
 
 
Pregnancy Test(2) 
x 
 
 
 
 
 
 
Operative Data  
 
x 
 
 
 
 
 
Discharge Data  
 
x 
 
 
 
 
 
Implant status 
 
 
x 
 
x 
x 
x 
HHS 
x 
 
x 
x 
x 
x 
x 
EQ-5D-5L 
x 
 
x 
x 
x 
x 
x 
HOOS JR. 
x 
 
x 
x 
x 
x 
x 
Radiographic Assessment 
(x)3 
(x)4 
(x)4 
x 
x 
x 
x 
Concomitant Medications(5) 
 
 x 
x 
x 
x 
x 
x 
Safety Assessment (AEs, DDs) 
 
x 
x 
x 
x 
x 
x 
End of Study/ Exit 
 
x 
x 
x 
x 
x 
x 
1 
If applicable, where, for preoperative lab examinations, only those within Day 0~14 before the operation are 
acceptable. 
The Preoperative Lab Examinations required to be performed include: 
 
Blood routine examination: Haemoglobin, Platelet count, White Blood Cell count, neutrophil count, erythrocyte 
sedimentation rate 
 
Coagulation examination: Prothrombin time, activated partial thromboplastin time), thrombin time, D-dimer 
 
Biochemical examination: Urea or urea nitrogen, creatinine, AST, ALT, blood glucose 
 
Other examination: Erythrocyte sedimentation rate, C-reactive Protein 
2 
If applicable, where, the pregnancy test is only suitable for females of child-bearing potential, neither premenstrual 
females nor sterilized or postmenopausal (i.e., 12-month amenorrhea without alternative medical reasons) females. 
3 
If X-ray image has been done within 30 days before the Informed Consent Form is signed, and the data is available, 
they can be used as the data for screening before operation. 
4 
Radiographic assessment performed at discharge or 6 weeks follow-up visit only. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 14 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
5 
All combination medications associated with AEs or serious adverse events (SAEs) are reported.

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 15 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 CONTENTS  
 
TABLE OF CONTENTS 
 
Signatures .................................................................................................................................................... 3 
 
Principal Investigator Signature Page ................................................................................................. 3 
 
Coordinating Investigator Approval ................................................................................................... 4 
 
Investigator Approval ......................................................................................................................... 5 
 
Investigator Approval ......................................................................................................................... 6 
 
Sponsor Approval ............................................................................................................................... 7 
 
Synopsis....................................................................................................................................................... 8 
 
Contents ..................................................................................................................................................... 15 
 
Table of Contents.............................................................................................................................. 15 
 
List of Tables .................................................................................................................................... 18 
 
List of Figures ................................................................................................................................... 18 
 
List of Abbreviations and Definitions .............................................................................................. 19 
 
Introduction ............................................................................................................................................... 22 
 
Background ....................................................................................................................................... 22 
 
Literature Summary .......................................................................................................................... 23 
 
Study Purpose ................................................................................................................................... 24 
 
Safety Considerations ....................................................................................................................... 24 
 
Objective(s) ............................................................................................................................................... 25 
 
Primary Objective ............................................................................................................................. 25 
 
Secondary Objectives ....................................................................................................................... 25 
 
Other Objectives ............................................................................................................................... 26 
 
Investigational Products ............................................................................................................................ 26 
 
Identification ..................................................................................................................................... 26 
 
Product Use ...................................................................................................................................... 27 
 
Packaging and Labeling .................................................................................................................... 27 
 
Product Accountability Procedures .................................................................................................. 28 
 
Surgical Technique ........................................................................................................................... 29 
 
Subject Enrollment and Withdrawal .......................................................................................................... 29 
 
Subject Population ............................................................................................................................ 29 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 16 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Inclusion Criteria .............................................................................................................................. 29 
 
Exclusion Criteria ............................................................................................................................. 30 
 
Screening .......................................................................................................................................... 32 
 
Informed Consent ............................................................................................................................. 32 
 
Enrollment ........................................................................................................................................ 33 
 
Lost to Follow-Up ............................................................................................................................ 33 
 
Withdrawal ....................................................................................................................................... 34 
 
Study Design ............................................................................................................................................. 35 
 
Study Design and justification .......................................................................................................... 35 
 
Allocation and Blinding .................................................................................................................... 37 
 
Data Management ............................................................................................................................. 38 
 
Study Endpoints ................................................................................................................................ 39 
 
Methods Used to Minimize Bias and Maximize Validity ................................................................. 40 
 
Study Procedures ....................................................................................................................................... 41 
 
Visits and Examinations ................................................................................................................... 41 
 
Study Methods and Measurements ................................................................................................... 49 
 
Health Economics/Quality of Life .................................................................................................... 51 
 
Statistical Design ....................................................................................................................................... 52 
 
General ............................................................................................................................................. 52 
 
Analysis Populations ........................................................................................................................ 52 
 
Baseline Data .................................................................................................................................... 53 
 
Efficacy Analysis .............................................................................................................................. 54 
 
Safety Analyses ................................................................................................................................ 57 
 
Interim Analyses ............................................................................................................................... 58 
 
Sample Size Justification ........................................................................................................................... 58 
 
Total Sample Size ............................................................................................................................. 58 
 
Number of subjects with each disease in clinical study and reason for determination ..................... 59 
 
In multi-center clinical study, minimum and maximum number of subjects in each clinical study 
institution and justification ................................................................................................................................ 59 
 
Significance level and power of the clinical study ........................................................................... 59 
 
Expected drop-out rate ...................................................................................................................... 59 
 
Criteria for acceptability/unacceptability of clinical study result ..................................................... 59 
 
Criteria and reason for terminating the study based on the statistical consideration ........................ 60 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 17 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Statistical method of all data, together with the handling method of missing, unused and wrong data 
(including discontinuation and withdrawal) and unreasonable data .................................................................. 60 
 
Reporting procedure of deviation from original statistical plan ....................................................... 60 
 
Adverse Events and Device Deficiencies .................................................................................................. 60 
 
Definitions ........................................................................................................................................ 60 
 
Treatment for adverse events ............................................................ Error! Bookmark not defined. 
 
AE Coding Dictionary ...................................................................................................................... 64 
 
Reporting Procedures ....................................................................................................................... 64 
 
Unblinding of Investigational Product .............................................................................................. 67 
 
Follow-up of Subjects with Adverse Events ..................................................................................... 67 
 
Investigator Obligations ............................................................................................................................ 68 
 
Sponsor and Monitor Responsibilities ....................................................................................................... 68 
 
Site Qualification Visit ..................................................................................................................... 68 
 
Ethical approval and Clinical trial agreement ................................................................................... 69 
 
Site Initiation Visit............................................................................................................................ 69 
 
Interim Monitoring Visit .................................................................................................................. 69 
 
Sponsor Audits and Regulatory Inspection ...................................................................................... 69 
 
Close-out Visit .................................................................................................................................. 70 
 
Protocol Deviations ................................................................................................................................... 70 
 
Protocol Amendments ............................................................................................................................... 70 
 
Confidentiality of The Study ..................................................................................................................... 71 
 
Statements of Compliance ......................................................................................................................... 71 
 
Ehtical Consideration ................................................................................................................................ 71 
 
End of Study .............................................................................................................................................. 72 
 
Publication Policy ...................................................................................................................................... 73 
 
Publication of Study Data ................................................................................................................. 73 
 
Data Sharing ..................................................................................................................................... 73 
 
Feasibility analysis .................................................................................................................................... 73 
 
possibility analysis on success .......................................................................................................... 73 
 
possibility analysis on failure ........................................................................................................... 74 
 
References ................................................................................................................................................. 76 
 
Appendices ................................................................................................................................................ 78 
 
Protocol Amendment ........................................................................................................................ 78 
 
Instructions For Use.......................................................................................................................... 78 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 18 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Equipment and Special Instructions ................................................................................................. 78 
 
Health Economic Outcome Measures/Quality of Life measures ...................................................... 81 
 
Principal Investigator Obligation ...................................................................................................... 81 
 
LIST OF TABLES  
Table 9-1: Study Procedures by Visit ................................................................................................................... 42 
Table 12-1: Categories of Adverse Event ............................................................................................................. 61 
Table 21-1: OR3O™ Dual Mobility Liners .......................................................................................................... 78 
Table 21-2: OR3O™ Dual Mobility Inserts .......................................................................................................... 78 
Table 21-3: Acetabular Shells – R3™ non-HA Acetabular Shells ....................................................................... 79 
Table 21-4: OXINIUM Femoral Heads ................................................................................................................ 80 
Table 21-5: List of Compatible Stems .................................................................................................................. 80 
 
LIST OF FIGURES 
Figure 6-1: OR3O™ Dual Mobility Construct ..................................................................................................... 27 
Figure 8-1: Study Flowchart ................................................................................................................................. 37 
Figure 12-1: Evaluation and Reporting of AE ...................................................................................................... 66 
Figure 12-2: Evaluation and Reporting of DD ...................................................................................................... 67 
 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 19 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
LIST OF ABBREVIATIONS AND DEFINITIONS 
Abbreviation 
Definition 
ADE 
Adverse Device Effect(s) 
ADL 
Activities of Daily Living 
AE 
Adverse Event(s) 
ANCOVA 
Analysis of Covariance 
AP 
Anteroposterior 
ASADE 
Anticipated serious adverse device effect 
AVN 
Avascular Necrosis 
BMI 
Body Mass Index 
BSI 
British Standards Institute 
CE 
Conformité Européene  
CI 
Confidence Interval 
CoCr 
Cobalt Chrome 
CRA 
Clinical Research Associate 
CRC 
Clinical Research Coordinator 
CV 
Curriculum Vitae 
DD 
Device Deficiency(ies) 
DH 
Diffusion Hardened 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EQ-5D-5L 
EuroQol (European Quality of Life) five-dimensional Five-level 
FAS 
Full Analysis Set Population 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 20 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
Abbreviation 
Definition 
HA 
Hydroxyapatite  
HHS 
Harris Hip Score 
HIPAA 
Health Information Portability Accountability Act 
HSA 
Health Science Authority 
HOOS JR. 
Hip disability and Osteoarthritis Outcome Score for Joint Replacement 
HRQOL 
Health Related Quality of Life 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICMJE 
International Committee of Medical Journal Editors 
IEC 
Independent Ethics Committee 
IFU 
Instructions for Use 
IP 
Investigational Product 
IPD 
Intra-prosthetic Dislocation 
ISF 
Investigator Site File 
ITT 
Intent-to-Treat 
KM 
Kaplan-Meier 
LL 
Lower Limit 
LOCF 
Last Observation Carry Forward 
NA or N/A 
Not Applicable 
N (or n) 
Total Sample Size (or subgroup sample size) 
NDA 
Non-Disclosure Agreement 
NMPA 
National Medical Products Administration 
OA 
Osteoarthritis 
Ox 
Oxinium 
PI 
Principal Investigator 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 21 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
Abbreviation 
Definition 
PP 
Per-protocol Population 
QA 
Quality Assurance 
QC 
Quality Control 
RA 
Rheumatoid Arthritis 
S+N 
Smith & Nephew 
SADE 
Serious Adverse Device Effect(s) 
SAE 
Serious Adverse Event(s) 
SAF 
Safety population 
SAP 
Statistical Analysis Plan 
SOP 
Standard Operating Procedure 
TGA 
Therapeutic Goods Administration 
THA 
Total Hip Arthroplasty 
UL 
Upper Limit 
USADE 
Unanticipated Serious Adverse Device Effect(s) 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 22 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 INTRODUCTION 
 
BACKGROUND  
Arthritis is a clinical syndrome of joint pain accompanied by varying degrees of functional 
limitation and reduced quality of life. Two common etiologies of arthritis are degeneration of the 
joint, osteoarthritis (OA), and inappropriate inflammatory response, rheumatoid arthritis (RA). 
OA is characterized by loss of cartilage, remodeling of adjacent bone, and inflammation in the 
affected joint (2, 9). RA is a progressive inflammatory disease that eventually causes systemic 
joint damage and disability (1). 
Avascular necrosis (AVN) has several etiologies but fundamentally results from a decrease in 
blood flow to the femoral head, leading to cellular death (4, 11). 
For patients with any of these indications who have exhausted available conservative 
interventions or advanced degeneration of the joint, joint replacement is considered the most 
effective treatment. 
Total hip arthroplasty (THA) is an extremely successful intervention that significantly reduces 
pain, increases mobility, and restores function in patients with degenerative joint disease (7). It is 
most frequently employed to treat symptomatic end-stage OA (7, 12). Other indications include 
RA, AVN, femoral neck fracture, and developmental dysplasia of the hip. Hip arthroplasty device 
designs consist of a femoral component, acetabular component, and bearing surface (7). The 
materials used and fixation methods vary, allowing the surgeon to choose the most effective 
system for each case (20). Current research in THA focuses on optimizing clinical outcomes, 
reducing complications, and improving implant designs by researching materials and novel design 
advancements to mimic normal physiology (10). 
Dual-mobility hip systems incorporate two distinct articulations. These two articulations allow 
for greater range of motion, a greater head-to-neck ratio, and a more physiologic effective head 
size that increases the jump distance and hence resistance to dislocation (13, 19). 
The primary articulation is between the femoral head and the polyethylene insert, and the second 
at the interface between the convex surface of the polyethylene insert and the acetabular liner. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 23 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
The primary articulation is engaged during the majority of activities with normal range-of-motion 
requirements. The secondary articulation is engaged during activities that exceed normal range of 
motion.  
The OR3O™ Dual Mobility System provides modular dual mobility using an advanced bearing 
surface, OXINIUM DH (Diffusion Hardened) and a highly cross-linked polyethylene (XLPE). 
Dual mobility components are used with compatible Smith & Nephew (S+N) acetabular shells 
and femoral heads. 
This study is a pre-market study of imported OR3O™ Dual Mobility System as an investigational 
device. Refer to the Investigator's Brochure for comprehensive literature review, preclinical and 
clinical safety data, and risk analysis. 
 
LITERATURE SUMMARY 
Dual mobility acetabular components have been shown to provide increased stability after THA 
(6, 22). A growing body of literature reports reduced dislocation rate in primary and revision 
arthroplasty using dual-mobility (3, 5, 6, 18). The main complication associated with dual-
mobility is intra-prosthetic dislocation (IPD), which is characterized by the loss of the positive 
locking between the femoral head and the polyethylene insert; although the mechanism is not yet 
completely understood (6, 8). A systematic review of 17,908 THAs using dual mobility acetabular 
components reported that the rate of dislocation was 0.9% in primary THA and 3.0% in the 
revision THA group. The mean rate of IPD was 0.7% in primary and 1.3% in revision THAs (6).  
Wear and loosening are commonly reported complications for dual mobility systems and are 
accentuated due to larger diameter articulations with multiple surfaces (14).  
A higher rate of instability is also reported with displaced femoral neck fractures, creating 
increased utilization of dual mobility THA for these patients. A retrospective study compared the 
results of 171 bipolar hemiarthroplasty and 175 THA performed using dual mobility in patients 
with displaced femoral neck fractures. The rate of dislocation in the THA group was significantly 
lower than the bipolar hemiarthroplasty group (14.6% versus 4.6%) (16, 21). Another prospective 
multicenter study reported a short-term dislocation rate of 1.4% when THA with dual mobility 
was used in femoral neck fracture patients (16, 21).  

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 24 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
Utilization of dual mobility components have also shown promising results in other high risk 
dislocation populations such as obese patients and patients with neurological disorders (16). Dual 
mobility has also been found beneficial for young and active patients, particularly as implants 
have improved, causing wear-related complications to reduce. One study, with a 22 year follow-
up, reported the dual mobility cup survival rate of 77% in patients under 50 years of age (mean 
age: 41 years) (16).  
 
STUDY PURPOSE 
The purpose of this study is to compare OR3O™ Dual Mobility System to a conventional, single-
bearing design Total Hip System in subjects who undergo Primary THA to assess the safety and 
efficacy of the OR3O™ Dual Mobility System. Data collected in this study will be used to support 
NMPA regulatory approval of OR3O™ Dual Mobility System in China as well as to support and 
maintain product registration in global markets.  
 
SAFETY CONSIDERATIONS 
 
Intended Use 
The OR3O™ Dual Mobility System is intended for use in Primary and Revision THA in 
skeletally mature subjects.  
 
Indications 
 
Advanced degeneration of the hip joint as a result of degenerative, post-traumatic, or 
rheumatoid arthritis.  
 
Fracture or avascular necrosis of the femoral head.  
 
Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, 
hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.  
 
All forms of osteoarthritis.  
 
Patients with hips at risk of dislocation.  
 
Femoral neck fracture or proximal hip joint fracture.  
The OR3O™ Dual Mobility System is intended for single use only. The modular OR3O Dual 
Mobility Liners and Inserts are to be implanted without bone cement.  
Mating components may be indicated for use without bone cement.  

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 25 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Contraindications 
 
Do not use OR3O™ Liners with any polyethylene dual mobility insert other than Smith 
& Nephew OR3O™ XLPE Inserts of matching bearing size.  
 
Do not use OR3O™ Liners with metal or ceramic femoral heads made from materials 
such as stainless steel, CoCr, alumina, zirconia toughened alumina, OXINIUM, or 
OXINIUM DH.  
 
Conditions that would eliminate or tend to eliminate adequate implant support or 
prevent the use of an appropriately-sized implant, e.g.:  
o 
blood supply limitations;  
o 
insufficient quantity or quality of bone support, e.g., osteoporosis, or metabolic 
disorders which may impair bone formation, and osteomalacia; and  
o 
infections or other conditions which may lead to increased bone resorption.  
 
Mental or neurological conditions which may tend to impair the patient’s ability or 
willingness to restrict activities putting the affected limb at risk.  
 
Physical conditions or activities which tend to place extreme loads on implants, e.g., 
Charcot joints, muscle deficiencies, multiple joint disabilities, etc.  
 
Skeletal immaturity.  
 
Skirted femoral heads are contraindicated for use with this device. 
 OBJECTIVE(S) 
 
PRIMARY OBJECTIVE 
The primary objective of this study is to assess safety and efficacy of the OR3O™ Dual Mobility 
System in Primary THA at 1 year postoperative. 
 
SECONDARY OBJECTIVES 
The secondary objectives of this study are to assess safety and efficacy of the OR3O™ Dual 
Mobility System and compatible components in Primary THA up to 2 years after surgery.  

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 26 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
OTHER OBJECTIVES 
Other objectives of the study are to assess the hip dislocation percentage and hospital readmission 
percentage (cumulative) up to 2 years after device implantation. 
 INVESTIGATIONAL PRODUCTS  
 
IDENTIFICATION  
 
Investigational Product 
The OR3O™ Dual Mobility System (liner and insert) is an acetabular system for THA. It is 
intended for use in Primary and Revision THA in skeletally mature patients.  
OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium 
(Oxinium™) acetabular liner with a highly polished inner surface of zirconia, a machined locking 
taper and backside of Zr-2.5Nb alloy, and an insert of highly cross-linked polyethylene (XLPE).  
The OR3O™ Liner is assembled into an acetabular shell with a locking taper. The outer diameter 
of the OR3O™ XLPE Insert articulates within the OR3O™ Liner and features an inner articular 
surface, which engages with oxidized zirconium (Oxinium™) or CoCr alloy femoral heads of 
sizes 22mm (for shell sizes 48mm-52mm) and 28mm (for shell sizes 54mm-74mm). Femoral 
heads are retained within the OR3O™ XLPE Insert by means of a snap fit locking mechanism. 
The OR3O™ Dual Mobility System (liner / insert) is combined with existing commercially 
available S+N acetabular shells and femoral heads, which will be referred to as OR3O™ Dual 
Mobility Construct within this protocol. The OR3O™ Liner is designed to mate with a dedicated 
R3™ or REDAPT™ Modular Press-fit acetabular shell with outer diameter sizes of 48mm to 
74mm.  
Figure 6-1 illustrates the OR3O™ Dual Mobility Construct with an acetabular shell (with optional 
screws), an Oxinium™ DH Liner, a XLPE Insert and a femoral head. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 27 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
Figure 6-1: OR3O™ Dual Mobility Construct 
 
In this study, non-Hydroxyapatite (HA) R3™ Acetabular Shells and Oxinium femoral head will 
be used in sites in China. The use of screws to secure the acetabular shell is at the discretion of 
the surgeon. 
   
The OR3O™ Dual Mobility System will be combined with a compatible Smith & Nephew 
femoral stem.  
 
Comparator Treatment 
The comparator treatment in the study is a conventional, single-bearing design Total Hip 
System comprised of R3™ Acetabular Shell with XLPE liner and a Smith & Nephew Oxinium 
(Ox) femoral head. 
 
PRODUCT USE 
Each device is packaged with an IFU (Document ID 81104400) to ensure that the device is used 
properly and for the intended purposes. It is the Investigator’s responsibility to ensure adherence 
to this IFU as well as Investigator’s Brochure. 
 
PACKAGING AND LABELING 
Packaging and labeling will be prepared to meet China current laws and regulatory requirements. 
Package integrity and labelling should be verified prior to use of the product. 
Acetabular Shell 
OR3O™ Liner 
OR3O™ Insert 
Femoral Head 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 28 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Labeling of Investigational Product  
In China, commercially available products (acetabular shells and femoral heads) are combined 
with an investigational product (OR3O™ Dual Mobility System) to form the OR3O™ Dual 
Mobility Construct. The R3™ Acetabular Shells and Oxinium femoral head to be used in this 
study are commercial products in China and will be labeled and packed as per the standard 
commercial packaging. 
OR3O™ Dual Mobility liner and insert are investigational products in China. The standard 
commercial packaging as marketed in the US will be used for these investigational products. 
Additional labels will be included on the commercial packaging to specify that the product is for 
investigational use only in order to meet regulatory requirements for use of investigational devices 
in China. 
 
Comparator Product  
The comparator product to be used in this study are commercial products in China and will be 
labeled and packed as per the standard commercial packaging. 
 
PRODUCT ACCOUNTABILITY PROCEDURES  
No product accountability procedures will be applied for the acetabular shells, femoral heads and 
femoral stems in all study sites as these are commercially available products in China. 
The study includes the use of investigational devices in China and the following product 
accountability procedures will be applied for OR3O™ Dual Mobility liners and inserts: 
The investigational site will maintain an inventory of the investigational product (IP). The 
Sponsor or its designee will provide a log(s) to facilitate IP inventory control. The log will contain 
details of receipt, use, returns etc. of IP. All IP accountability logs must be retained in the 
Investigator Site File (ISF). These records must be available for inspection by the Sponsor, its 
designees, or by regulatory agencies at any time. IP Management Instructions will be provided 
by the Sponsor to the site detailing all additional forms that might need completion (e.g. 
confirmation of receipt) for IP control. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 29 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
The Study Monitor will ensure that the procedures and records are in place for the appropriate 
reconciliation of all IP. As part of monitoring, the Study Monitor will check that site personnel 
are following the proper procedures for accountability and completing all necessary 
documentation. 
 
SURGICAL TECHNIQUE 
All study related procedures with the OR3O™ Dual Mobility System must be performed 
according to the approved surgical technique.  
Surgical techniques are available for different OR3O™ Dual Mobility System / acetabular shell 
combinations. The appropriate surgical technique needs to be followed when using the OR3O™ 
Dual Mobility System in combination with R3™ Acetabular Shells (Document ID 71381776). 
Surgeons selected to participate in this study will be familiar with implanting Dual Mobility 
Systems and have expertise in the study procedure. 
If device replacement/reconditioning is required during the primary surgery, the investigator shall 
perform device replacement/reconditioning on the subject in accordance with conventional 
medical device replacement/reconditioning. 
 SUBJECT ENROLLMENT AND WITHDRAWAL 
 
SUBJECT POPULATION 
A total of 170 hips will be enrolled into the study at 4 study sites in China.  
Subjects may be enrolled and randomized in the study with one hip implanted with either the 
OR3O™ Dual Mobility System in combination with R3™ Acetabular Shells and a Smith & 
Nephew Oxinium femoral head or the single-bearing design Total Hip System comprised of R3™ 
Acetabular Shell with XLPE liner and a Smith & Nephew Oxinium femoral head. Therefore, 
enrollment refers to the number of subjects. 
 
INCLUSION CRITERIA 
Subjects will be considered qualified for enrollment if they meet the following criteria: 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 30 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
1. 
Subject is a suitable candidate for implanting the OR3O™ Dual Mobility System in 
primary total hip replacement in the Investigator’s judgement. 
2. 
Subject is skeletally mature in the Investigator’s judgement. 
3. 
Subject is 18 – 80 years old (inclusive). 
4. 
Subject is receiving total hip replacement for the first time on the affected hip. 
5. 
Subject has any of the following conditions: 
 
Advanced degeneration of the hip joint as a result of degenerative, post-traumatic, 
or rheumatoid arthritis(RA); 
 
Fracture or avascular necrosis of the femoral head;  
 
All forms of osteoarthritis(OA); 
 
Patients with hips at risk of dislocation; 
 
Femoral neck fracture or proximal hip joint fracture. 
6. 
Subject provides written informed consent for study participation using an Ethical 
Committee (EC) approved consent form before any study procedures are performed, 
including pre-operative data review and/or collection of data on Case Report Forms. 
7. 
Subject is willing and able to participate in required follow-up visits and is able to complete 
study activities. 
8. 
Subjects with preoperative HHS ≤ 79 (fair or worse category). 
 
 
EXCLUSION CRITERIA 
Any one (1) of the following criteria will disqualify a potential subject from participation in the 
study: 
 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 31 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
1. 
Subject has conditions that would eliminate or tend to eliminate adequate implant support 
or prevent the use of an appropriately-sized implant, e.g.: 
 blood supply limitations; 
 insufficient quantity or quality of bone support, e.g., osteoporosis, metabolic 
disorders which may impair bone formation, radioactive bone disease, tumor around 
hip joint, and osteomalacia; 
 infections or other conditions which may lead to increased bone resorption. 
2. 
Subject has dysplasia of hip joint with CROWE Grade III, IV. 
3. 
Subject has weak constitution or failing to endure the surgery due to other diseases of the 
body. 
4. 
Subject has bodily disease(s) that may interfere with THA survival or outcome 
5. 
Subject has life expectancy of less than 2 years.  
6. 
Subject has mental or neurological conditions which impair the subject’s ability or 
willingness to restrict activities that may put the affected limb at risk. 
7. 
Subject has physical conditions or activities which tend to place extreme loads on 
implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities. 
8. 
Subject has neuromuscular dysfunctions (paralysis, myolysis and abductor muscle 
weakness) which will cause unstable hip joint or abnormal gait after surgery. 
9. 
Subject has a mental or neurological condition that would pre-empt their ability or 
willingness to participate in the study including mental illness, mental retardation, drug or 
alcohol abuse. 
10. 
Subject has an active infection – systemic or at the site of intended surgery. 
11. 
Subject has a Body Mass Index ≥ 40.0 kg/m².  
12. 
Subject has a known allergy to any component of the devices used in the study. 
13. 
Subject is pregnant or breast feeding. 
14. 
Subject is entered in another investigational drug, biologic, or device study within 30 
days of active study participation. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 32 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
15. 
Subjects that are expected with poor compliance. 
16. 
Subjects with complications of other diseases are limited to participate in the research, 
not able to comply with the follow-up or have impact on scientific integrity. 
17. 
Subjects with preoperative HHS ≥ 80 (good to excellent category). 
18. 
Subject has other diseases or conditions that investigator considers not appropriate to 
participate in the study. 
 
SCREENING  
Investigators should consecutively screen all subjects undergo primary THA to determine 
whether they meet all inclusion and none of the exclusion criteria. Participating study sites are 
required to document all screened subjects considered for inclusion in this study on a Screening 
and Enrollment Log. If a subject is excluded from the study, the reasons for exclusion will be 
noted on the Screening and Enrollment Log.  
 
INFORMED CONSENT 
Investigators are responsible for obtaining and documenting the voluntary informed consent of 
the study subjects before conducting any study procedures or examinations, per International 
Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines. 
Prior to beginning the study, in obtaining the informed consent, the purpose and nature of the 
study should be explained to the subject in their native language. The subject, will then read, sign, 
and personally date the EC approved informed consent document(s) (see below for difficulties 
with reading and writing). Additionally, the individual who obtains consent from the subject will 
sign and date the informed consent document. A copy of the signed informed consent document 
will be provided to the subject, and the original appropriately filed at the investigative site. 
The informed consent process must be fully documented in the subject’s medical record. 
If the subject is unable to read, the informed consent document and associated study information 
may be read aloud to the subject in the presence of an impartial witness. If possible, the subject 
shall sign and personally date the Informed Consent Form (ICF). Where this is not possible, due 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 33 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
to difficulties in writing, the subject shall provide verbal consent to participate in the study. The 
witness shall then personally sign and date the informed consent form, attesting that the 
information was accurately explained and that the informed consent was freely given.  
The informed consent form and any other written information provided to subjects shall be 
revised whenever important new information becomes available that may be relevant to the 
subject’s continued consent. All revised informed consent forms must have written and dated 
EC approval in advance of use. 
 
ENROLLMENT 
The site initiation shall be started only after the EC has approved and the clinical trial agreement 
has signed at each site. Subjects for whom the consent process has been completed and have been 
implanted with the study product are considered enrolled. Competitive enrollment continues until 
the completion of enrolled 170 subjects. 
If the subject does not have the OR3O™ Dual Mobility System or controlled system implanted 
after signing an informed consent form, the subject will be considered to be a Screen Failure. 
Screen Failures will not count into the total number of enrolled subjects.  
 
LOST TO FOLLOW-UP 
A subject will be considered lost to follow-up if he/she does not appear for the scheduled study 
visit for 2 consecutive visits, and study personnel are unable to contact the subject. 
Some actively enrolled subjects will not return for follow-up exams on time. Study personnel 
must make a reasonable effort to contact the subject and document the following contact attempts 
before declaring a subject to be lost to follow-up: the subject has been contacted according to the 
site's policies, but no fewer than two documented phone contacts (at least one of these attempted 
phone contacts conducted by the Investigator) and one written attempt without response. The 
written attempt can either be a certified letter or an email with read confirmation dependent on 
accepted ways of communication within the study regions. Copies of all attempts to reach the 
subjects by mail or email and/or the attempts to contact the subject via other means should be 
documented, and that documentation should be kept with the subject’s source documents. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 34 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
WITHDRAWAL 
 
Withdrawal from Treatment 
Subjects may be withdrawn from having the study device implanted at a date close to surgery or 
during surgery for the following reasons: 
 
At the discretion of the Investigator due to: 
o 
A change in treatment being clinically warranted. 
o 
An adverse event. 
o 
Any other significant reason identified by the Investigator. 
Subjects who provide informed consent but do not receive the study device for any reason will be 
considered a Screen Failure. Screen Failures will not count into the total number of enrolled 
subjects. 
If at any point during the study, the study device needs to be revised for any reason the following 
will apply: Intraoperative data from the revision surgery will be collected including implant 
information used for revision THA. Subjects will terminate the study following revision surgery. 
Subjects shall be followed by the Investigator according to site´s standard of care in order to 
monitor the subject’s health status and the outcome of the revision. Data collected following the 
revision surgery will be reported as follow-up data to the adverse event. Data will not be included 
as study data but presented separately as safety data. Data collected upon the point of revision 
will be included as study data.  
 
Withdrawal from Study 
The Investigator may withdraw subjects from the study, including but not limited to the following 
reasons: 
 
Subject noncompliance (e.g., did not follow instructions for regular follow up); 
 
Subject lost to follow-up; 
 
The Investigator or the Sponsor stops the study for any reason and decides to withdraw 
subject(s) from the study; 
 
Concurrent illness; 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 35 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Adverse Events/Adverse Device Effects 
 
Any other significant reason identified by the Investigator. 
For each case, information will be recorded in the source document and the electronic Case Report 
Form (eCRF) detailing circumstances leading to the withdrawal. Data collected upon point of 
withdrawal will be included as study data. 
Subjects who drop out or are withdrawn will not be re-entered into the study at a later date. If at 
any point during the study, the total hip prosthesis needs to be revised for any reason the 
following will apply: Subjects shall continue to have follow-up visits in order to monitor the 
subject’s health status. Potential data following the revision surgery will not be included as 
study data but presented separately as safety data.  
 
Subject’s Withdrawal of Consent to Participate in Study 
Study participation is voluntary, and subjects may withdraw at any point during the study without 
giving their reason for doing so. Where subjects withdraw consent, the Investigator should make 
a reasonable effort to ascertain the reason(s), while fully respecting the subject’s privacy. The 
reason for withdrawal will be recorded in the eCRF and source documents.  
If withdrawal is after OR3O™ Dual Mobility System or controlled system implantation, then the 
Investigator should inform the subject of any recommended follow-up visits to monitor subject 
safety.   
 
Use of Data Following Withdrawal 
In cases where the subject withdraws consent, the data collected up to the point of withdrawal 
may be used, but no additional data for that subject may be collected after withdrawal of consent.  
 STUDY DESIGN 
 
STUDY DESIGN AND JUSTIFICATION 
This study is a prospective, multi-center, randomized, controlled, 2-arm study to assess safety and 
efficacy of the OR3O™ Dual Mobility System in Primary THA. Subjects meet the 
inclusion/exclusion criteria specified in the protocol will be randomized to receive implantation 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 36 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
with the investigational product or controlled system. Up to 4 sites in China will participate 
competitive enrolling a total of 170 hips, whereas the number of subjects enroll in each study site 
should be no more than 85 cases. 
The study is expected to enroll all subjects within a 12 months’ timeframe. Subjects will be 
followed-up at 6 weeks, 3, 6, 12 and 24 months after surgery.  
In this study, a summary of 1 year follow-up data will be reported to NMPA for regulatory 
approval and a 2 year follow-up will be sufficient to identify and assess the risk of any 
associated unacceptable adverse event over this time period. The study duration will be 
sufficient to allow conclusions about likely safety and efficacy of the OR3O Dual Mobility 
System in a longer term. 
Figure 8-1 details the different steps of study conduct from screening to enrollment and follow-
up. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 37 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 Figure 8-1: Study Flowchart 
 
 
Subjects may be assigned a subject ID, but then not enrolled in the study (e.g. did not receive 
the study or controlled device or decided not to participate in the study). 
 
ALLOCATION AND BLINDING 
 
Treatment Allocation 
This study is randomized. All subjects who sign the ICF and meet inclusion / exclusion criteria 
will randomly receive either the OR3O™ Dual Mobility System in combination with R3™ and a 
Smith & Nephew Oxinium femoral head, or a conventional, single-bearing design Total Hip 
System comprised of R3™ Acetabular Shell with XLPE liner and a Smith & Nephew Oxinium 
femoral head at 1:1. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 38 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Blinding 
To minimize the impact of bias associated with treatment assignment during the study, since the 
surgeon cannot be blinded to the identity of the surgical product, it is planned to appoint an 
independent evaluator in each study site, who will be blinded and responsible for completing 
study related scoring at each follow-up. 
 
DATA MANAGEMENT 
 
Source Document 
Investigators are responsible for obtaining and maintaining complete subject health information 
in the medical record for each subject (source documents). Source data is all information and 
original records of clinical findings, observations, or other activities necessary for the evaluation 
of the study. These original documents and data records include but are not limited to inpatient 
or outpatient medical records, clinical and office charts, laboratory notes, memoranda, subjects’ 
memory aids or evaluation checklists, transportation, delivery, use and recovery records of the 
device, recorded audio tapes of counseling sessions, recorded data from automated instruments, 
copies certified, microfiches, photographic negatives, microfilm or magnetic media, X-rays, and 
subjects’ files and records kept at the pharmacy, laboratories and ancillary departments involved 
in the clinical study. The AE and SAE Report Forms contain information other than medical 
records will be considered as the source document. 
 
Direct Access 
Each study site will maintain medical and study records for this study in compliance with the 
GCP for Medical Device Trials and regulatory and institutional requirements. In order to protect 
the safety, rights and interests of the subjects, to ensure the authenticity, accuracy and integrity 
of the study and data, each study site must allow Monitors, QA personnel, regulatory authorities 
and authorized representatives to have the right to access, review or verify source data or source 
documents. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 39 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Data Handling and Record Requirements 
Data quality procedures are designed to ensure the complete, accurate and timely data are 
submitted in accordance with clinical protocol requirement. The data management plan will be 
completed after the clinical protocol is finalized and before the first subject is enrolled. Data 
management plans may need to be updated and revised according to actual operations. 
 
Data Recording and Record Retention 
Study records shall be stored properly to ensure the privacy, confidentiality, security and 
accessibility of the records during and after the conduct of the study. The 
Investigator/Institution will take measures to prevent accidental or premature destruction of 
those documents. The Investigator must retain essential study documents according to the 
local/regional regulations after the latest of the following: the date the study is terminated or 
completed or the date the documents are no longer needed to support a premarket approval 
application.  
When the responsible Investigator retires, relocates, or withdraws from responsibility of keeping 
the study records, custody must be transferred to a delegated person. Smith & Nephew must be 
notified in writing of the name and address of the new custodian. Under no circumstance shall 
the Investigator relocate or dispose of any study documents before having obtained written 
approval from Smith & Nephew. 
 
STUDY ENDPOINTS 
 
Primary Endpoint 
The primary endpoint of the study is defined as proportion of excellent (≥ 90) or good (80-89) 
HHS scores at 12 month postoperative. 
 
Secondary Endpoints  
Safety and efficacy evaluated in this study at baseline, 6 weeks, 3 months, 6 months, 1 year and 
2 years after surgery as measured by: 
 
Survivorship of the OR3O™ Dual Mobility System (no revision due to any reason)  
 
Survivorship of controlled system (no revision due to any reason) 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 40 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Harris Hip Score (HHS) 
           EuroQol (European quality of life) five-dimensional Five-level (EQ-5D-5L) score 
 
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.) 
 
Radiographic Assessment 
o 
Implant position/Orientation 
o 
Implant subsidence/migration 
o 
Periprosthetic fractures 
o 
Heterotopic ossification 
o 
Radiolucencies  
o 
Osteolysis 
o 
Implant loosening 
o 
Stress Shielding 
 
Other Endpoints 
The following exploratory endpoints will be collected: 
 
Dislocation percentage of the hip up to 2 years after device implantation. 
 
Hospital readmission percentage (cumulative) within 30, 60 and 90 days of discharge 
due to any reason related to study device or study procedure. 
 
Safety Endpoints 
Safety endpoints include the collection of the following events: 
 
All adverse events (AEs) occurring from the time of subject enrollment until study 
termination or study completion including intra-operative adverse events.  
 
Device Deficiencies. 
 
METHODS USED TO MINIMIZE BIAS AND MAXIMIZE VALIDITY 
 
Multiple Sites 
Subjects will be enrolled at multiple sites, utilizing up to 4 sites in total for the study. This will 
reduce the effect of observer bias that might arise at any one study site as well as maximize the 
diversity of subjects treated. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 41 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Randomization 
Subjects meet all inclusion/exclusion criteria will be randomly allocated into any of two study 
groups (study arm or controlled arm) in a 1:1 allocation ratio. Blocked randomization to balance 
this allocation ratio by investigational site and overall will be implemented through a network-
based randomization system. A randomization number is allocated only when subjects have 
signed the Informed Consent Form and satisfy all study eligibility criteria. 
 
Prospective Enrollment 
Enrollment will be utilized to enroll subjects who meet the inclusion/exclusion criteria.  
 
Balanced Covariates 
The Inclusion/Exclusion criteria will be generalizable and applicable to the widest possible subset 
of the population satisfying the study’s eligibility criteria. This should maximize the applicability 
to as many subjects with similar baseline characteristics and help to bolster external validity. 
 
Subject Attrition  
Subject attrition for the sample size has been accounted for in the estimate of the Confidence 
Interval (CI) so as to validate the analysis and most efficiently use the available subjects. 
 
Pre-specification of Statistical Analysis 
The primary outcome measure has been pre-specified as well as the type of statistical analysis to 
be performed in order to evaluate this outcome. The details of the analysis will further be pre-
specified in the Statistical Analysis Plan (SAP) so as to minimize bias. 
 STUDY PROCEDURES 
 
VISITS AND EXAMINATIONS  
 
Summary 
For a summary of the required procedures by visit, refer to the Study Schematic Table 9-1. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 42 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
Table 9-1: Study Procedures by Visit 
Schedule of events  
Pre-
Operative 
Data 
Operative 
/ 
Discharge 
6 Weeks 
(42 – 7/+14 
days) 
3 mos  
(90 ± 30 
days) 
6 mos  
(180 ± 30 
days) 
1 yr.  
(365 ± 60 
days) 
2 yr. 
 (730 ± 60 
days) 
Informed Consent 
x 
 
 
 
 
 
 
Inclusion/ Exclusion  
x 
 
 
 
 
 
 
Demographics 
x 
 
 
 
 
 
 
Medical  History 
x 
 
 
 
 
 
 
Vital Signs 
x 
 
 
 
 
 
 
Preoperative Lab Examinations 
(eg. Blood Routine Examination, 
Biochemical Examination, 
Coagulation Examination) (1) 
x 
 
 
 
 
 
 
Pregnancy Test(2) 
x 
 
 
 
 
 
 
Operative Data  
 
x 
 
 
 
 
 
Discharge Data  
 
x 
 
 
 
 
 
Implant status 
 
 
x 
 
x 
x 
x 
HHS 
x 
 
x 
x 
x 
x 
x 
EQ-5D-5L 
x 
 
x 
x 
x 
x 
x 
HOOS JR. 
x 
 
x 
x 
x 
x 
x 
Radiographic Assessment 
(x)3 
(x)4 
(x)4 
x 
x 
x 
x 
Concomitant Medications(5) 
 
x 
x 
x 
x 
x 
x 
Safety Assessment (AEs, DDs) 
 
x 
x 
x 
x 
x 
x 
End of Study/ Exit 
 
x 
x 
x 
x 
x 
x 
1 
If applicable, where, for preoperative lab examinations, only those within Day 0~14 before the operation are 
acceptable. 
The Preoperative Lab Examinations required to be performed include: 
 
Blood routine examination: Haemoglobin, Platelet count, White Blood Cell count, neutrophil count, erythrocyte 
sedimentation rate 
 
Coagulation examination: Prothrombin time, activated partial thromboplastin time), thrombin time, D-dimer 
 
Biochemical examination: Urea or urea nitrogen, creatinine, AST, ALT, blood glucose 
 
Other examination: Erythrocyte sedimentation rate, C-reactive Protein 
2 
If applicable, where, the pregnancy test is only suitable for females of child-bearing potential, neither premenstrual 
females nor sterilized or postmenopausal (i.e., 12-month amenorrhea without alternative medical reasons) females. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled Study 
to Evaluate the Safety and Efficacy of the OR3O™ Dual 
Mobility System versus conventional single bearing 
design Total Hip System in Primary Total Hip 
Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 43 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is intended 
for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the contents be 
disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
3 
If X-ray image has been done within 30 days before the Informed Consent Form is signed, and the data is available, 
they can be used as the data for screening before operation. 
4 
Radiographic assessment performed at discharge or 6 weeks follow-up visit only. 
5 
All combination medications associated with AEs or serious adverse events (SAEs) are reported.

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 44 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Screening / Preoperative Visit  
1. 
Obtain written informed consent from the subject as detailed in Section 7.5.  
----- Do not proceed until consent has been obtained ----- 
2. 
Set up the subject in the electronic data capture system. Subject number will be assigned to 
subject. 
3. 
Finalize subject screening by verifying all inclusion/exclusion criteria. Any subject who 
signs an ICF but fails to meet the entry criteria is considered to be a Screen Failure. 
4. 
Obtain demographic information and relevant medical history, including information on 
all concomitant medications/therapies, as well as perform preoperative lab examination 
and radiology exam where applicable. 
Relevant medical history will be defined as anything that is active to include the indication 
for the THA (i.e. OA, RA, Fracture, AVN etc.), as well as anything related to the 
following conditions:  
 
Cardiovascular Disease; 
 
Pulmonary Disease;  
 
Liver Disease;  
 
Renal Disease;  
 
Gastrointestinal Disease 
 
Hematological Disease; 
 
Endocrine Disorders;  
 
Cancer;  
 
Recent surgeries (within the last year);  
 
Recent illness;  
 
Previous surgeries on the affected hip. 
 
Other pre-existing conditions that may lead to unrelated adverse events after study 
enrollment. 
6. 
Complete the HHS. 
7. 
Have the subject complete the EQ-5D-5L questionnaire. 
8. 
Have the subject complete the HOOS JR questionnaire. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 45 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
9. 
Review the pre-operative radiographic assessment as per standard of care to collect subject 
diagnosis information  
10. Instruct the subject to return for the Operation Visit on the scheduled date. 
11.  Transcribe data to the eCRF. 
 
Operation Visit (Day 0) / Discharge 
1. 
Collect information on any changes in subject general health and the use of concomitant 
medications. Update medical history as necessary. 
2. 
Perform surgery and collect intraoperative data on source documents. This includes but is 
not limited to the following information: 
 
Implant product – study arm or controlled arm 
 
Implant data 
 
Surgical data e.g. duration, surgical approach 
 
AEs, Device Deficiencies 
Any subject who signs an ICF but fails to be implanted with the study device for any 
reason is considered to be a Screen Failure. 
3. 
At time of discharge, collect discharge data on source documents. This includes but is not 
limited to the following information: 
 
Discharge Date 
 
Mobility Status 
 
Medication at discharge 
 
AEs, Device Deficiencies 
4. 
Based on standard of care at the study site, the investigator will decide whether the 
radiographic assessment will be performed prior to discharge or at the 6 weeks follow-up 
visit. Radiographic images are to be collected in anteroposterior (AP) and lateral view in 
supine position. Investigator to review the images and radiographic report, as well as 
record data in the subject´s medical record.  
5. 
Instruct the subject on follow-up procedures, including returning to the site for the 
follow-up visit in 6 weeks (42 days (- 7 days / +14 days) from the date of surgery). 
6. 
Transcribe data to the eCRF. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 46 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Follow-Up visit at 6 weeks post-surgery (42 - 7 days / + 14 days from the date of 
surgery) 
1. 
Query subject regarding any changes in general health and the use of concomitant 
medications. If any adverse events or device deficiencies are observed or reported, they 
must be recorded as instructed in Section 12 - Adverse Events and Device Deficiencies. 
2. 
Verify with subject if any revision has occurred since last visit. If any revision is 
observed or reported, it must be recorded as instructed in Section 12 - Adverse Events 
and Device Deficiencies. Revised components are to be recorded. 
3. 
Complete the HHS.  
4. 
Have the subject complete the EQ-5D-5L questionnaire.  
5. 
Have the subject complete the HOOS JR. questionnaire. 
6. 
Collect radiographic images of the affected hip in AP and lateral view in supine position 
if not performed at discharge. Investigator to review the images and record data in the 
subject´s medical record. 
7. 
Instruct the subject on returning to the site for the next follow-up visit. 
8. 
In case the follow-up visit was missed, contact the subject by telephone to collect 
information on implant status and adverse events. Collect the information on the 
appropriate source document. 
9. 
Transcribe data to the eCRF. 
 
Follow-Up visits at 3 months (90 ± 30 days), 6 months (180 ± 30 days ) and 1 year 
(365 ± 60 days ) post-surgery 
1.  Query subject regarding any changes in general health and the use of concomitant 
medications. If any adverse events or device deficiencies are observed or reported, they 
must be recorded as instructed in Section 12 - Adverse Events and Device Deficiencies. 
2. 
Verify with subject if any revision has occurred since last visit. If any revision is 
observed or reported, it must be recorded as instructed in Section 12 - Adverse Events 
and Device Deficiencies. Revised components are to be recorded. 
3. 
Complete the HHS. 
4. 
Have the subject complete the EQ-5D-5L quesionnaire.  
5. 
Have the subject complete the HOOS JR. questionnaire. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 47 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
6. 
Collect radiographic images of the affected hip in AP and lateral view in supine position. 
Investigator to review the images and radiographic report, as well as record data in the 
subject´s medical record.   
7. 
Instruct the subject on returning to the site for the next follow-up Visit. 
8. 
In case the follow-up visit was missed, contact the subject by telephone to collect 
information on implant status and adverse events. Collect the information on the 
appropriate source document. 
9. 
Transcribe data to the eCRF. 
 
End of Study Visit 2 years post-surgery (730 ± 60 days ) or upon withdrawal from 
the study 
1.  Query subject regarding any changes in general health and the use of concomitant 
medications. If any adverse events or device deficiencies are observed or reported, they 
must be recorded as instructed in Section 12 - Adverse Events and Device Deficiencies. 
2. 
Verify with subject if any revision has occurred since last visit. If any revision is observed 
or reported, it must be recorded as instructed in Section 12 - Adverse Events and Device 
Deficiencies. Revised components are to be recorded. 
3. 
Complete the HHS. 
4. 
Have the subject complete the EQ-5D-5L questionnaire.  
5. 
Have the subject complete the HOOS JR. questionnaire. 
6. 
Collect radiographic images of the affected hip in AP and lateral view in supine position. 
Investigator to review the images and radiographic report, as well as record data in the 
subject´s medical record.  
7. 
In case the follow-up visit was missed, contact the subject by telephone to collect 
information on implant status and adverse events. Collect the information on the 
appropriate source document. 
8. 
Transcribe data to the eCRF. 
9.  Complete End of Study eCRF. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 48 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Unscheduled Visits 
Unscheduled examinations may be conducted at the discretion of the Investigator with all 
obtained information recorded in the source documents. The reason for the unscheduled visit as 
well as implant status should be transcribed to the appropriate eCRF. If any adverse events or 
device deficiencies are observed or reported, they must be recorded as instructed in Section 12 - 
Adverse Events and Device Deficiencies. The subject should be scheduled to return for the next 
scheduled study visit within the acceptable time window. 
 
Concomitant Medications and Therapies 
Concomitant medications and concomitant therapies after surgery are recorded at any time from 
enrollment into the study through the subject’s last study visit.  
9.1.8.1 
Concomitant Medications 
Excluded Concomitant Medications 
There are no restrictions on concomitant medications for this study. 
Recording Concomitant Medications in the eCRF 
Only medications related to the study treatment and medications used to treat an adverse event 
related to the study device and / or study procedure and device deficiency will be recorded in the 
eCRF. Reference the eCRF Completion Guidelines for additional information.    
9.1.8.2 
Concomitant Therapies 
Therapies Prohibited During the Study  
There are no restrictions on concomitant therapies for this study. 
Recording Concomitant Therapies in the eCRF 
Only therapies related to the study treatment and therapies used to treat an adverse event related 
to the study device or study procedure and device deficiency will be recorded in the eCRF. 
Reference the eCRF Completion Guidelines for additional information.     

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 49 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Discontinued Subjects 
Discontinued subjects are those who voluntarily discontinue participation, who are lost to follow-
up or who are withdrawn from the study for any reasons (refer to section 7.7 and 7.8 for further 
details). Where possible, a full Exit Visit should be completed for all subjects who discontinue 
the study early. Where consent is withdrawn, the date and any reason given for discontinuation 
(if given by the subject) should be captured (see Section 7.8.3). 
Finally, if appropriate, the Investigator will also advise the subject of subsequent therapy and/or 
procedures necessary for their medical condition.  
 Subject Pregnancy 
Women who are pregnant or breast feeding are excluded from the study. However, if a woman 
becomes pregnant during the study, Smith+Nephew must be contacted immediately once the 
investigator is made aware of the pregnancy. All study procedures that are contraindicated 
during pregnancy and/or lactation (e.g. radiographic examinations) will not be required. A 
decision will be made regarding the continuation in the study of the pregnant woman. 
Pregnancy is not an adverse event; however, complications related to the pregnancy may be 
reportable as determined on a case-by-case basis. Pregnancy-related information will be 
collected until the end of the pregnancy. 
 
STUDY METHODS AND MEASUREMENTS 
 
Survivorship 
Survivorship of THA is defined as no revision of any of the components of the OR3O™ Dual 
Mobility System (insert, liner) or controlled product, acetabular shell, femoral head and femoral 
stem. Information on implant / component survivorship will be derived from adverse event in 
eCRFs. 
 
Harris Hip Score 
The Harris Hip Score (HHS) will be collected before surgery and at 6 weeks, 3 months, 6 months, 
1 year and 2 years after surgery.  

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 50 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain 
(1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity 
(1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) 
to 100 (best). 
 
Radiographic Assessment 
An AP and a lateral view radiograph are required to adequately assess the status of the study 
device. Radiographs are taken during the course of the study at discharge or 6 weeks, 3 months, 
6 months, 1 year and 2 years after surgery. Radiographs will be performed with the subject in a 
supine position.  
Assessments to be made from radiographs will include:  
 Implant position/Orientation 
 Implant subsidence/migration 
 Periprosthetic fractures 
 Heterotopic ossification 
 Radiolucencies  
 Osteolysis 
 Implant loosening 
 Stress Shielding  
Images taken at discharge or 6 weeks after surgery will serve as baseline for comparing 
subsequent images. Information on initial implant position will also be collected from the baseline 
images. 
In addition, pre-operative radiographs are obtained to evaluate the initial disease diagnosis. 
Images can be used that have been taken according to the methodology and timing that is standard 
of care at each site as long as the radiographs are taken within 30 days prior to surgery. 
Radiographic images and reports will be reviewed by the Investigator, data will be recorded in 
the subject´s medical chart. Subsequently information will be transcribed to the radiographic part 
in eCRFs.  

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 51 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Dislocation of the hip 
The dislocation information of the hip will be collected up to 2 years after device implantation. 
Information on dislocation of the hip will be derived from the adverse event eCRFs. 
 
Hospital readmission 
The hospital readmission information will be assessed at 30, 60 and 90 days after discharge. 
Information on hospital readmission will be derived from the adverse event eCRFs. 
 
HEALTH ECONOMICS/QUALITY OF LIFE  
 
EQ-5D-5L 
The EQ-5D-5L questionnaire will be collected before surgery, at 6 weeks, 3 months, 6 months, 1 
year and 2 years after surgery. A paper questionnaire will be provided by the Sponsor to be 
completed by the subject. Subsequently the information will be transcribed to the eCRF. 
The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ VAS. 
The descriptive system is used to describe the subject’s health state and consists of five 
dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each 
dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, 
moderate problems, severe problems and extreme problems. The subject is asked to indicate 
his/her health state by marking the most appropriate statement in each of the five areas.  
The EQ VAS records the subject’s self-rated health on a vertical visual analogue scale. The  
endpoints on the scale are labelled ‘The best health you can imagine’ and ‘The worst health you 
can imagine’. The VAS can be used as a quantitative measure of health outcome as judged by the 
individual respondents. 
 
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS 
JR.) 
The HOOS JR. questionnaire will be collected before surgery, at 6 weeks, 3 months, 6 months, 1 
year and 2 years after surgery. A paper questionnaire will be provided by the Sponsor to be 
completed by the subject. Subsequently the information will be transcribed to the eCRF. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 52 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
The HOOS JR. is a short-form survey based on the HOOS that specifically focuses on the outcome 
after THA. HOOS JR. consists of 2 areas: pain (2 items) and function, daily living (4 items). The 
last week is taken into consideration when answering the questions. Standardized answer options 
are given (5 Likert boxes – no, mild, moderate, severe, extreme) and each question gets a score 
from 0 to 4. An interval score from 0 -100 (0 indicating total hip disability and 100 indicating 
perfect hip health) is calculated (15) . 
 STATISTICAL DESIGN 
A SAP that will provide more detailed and precise information on the study’s analyses will be 
written and finalized prior to database lock.  
 
GENERAL 
Smith & Nephew’s Biostatistics group or an assigned vendor including the AOANJRR will 
conduct the statistical analysis for this study. Unless otherwise stated, all significance tests and 
hypothesis testing will be two-sided, performed at the 5% significance level. Resulting p-values 
will be quoted and 95% two-sided confidence intervals (CI) will be generated where appropriate. 
Where data summaries are specified, categorical and ordinal variables will be summarized with 
frequencies and percentages. Continuous variables will be summarized with the following 
summary statistics: number of observations, mean, median, standard deviation, minimum and 
maximum values.  
All statistical comparisons of data would describe the test statistic used as well as its distributional 
assumptions. For continuous variables, in an event of marked deviation from normality 
assumptions, a commensurate non-parametric test will be used as alternative thereby eliminating 
the possibility of violation of normality assumptions. All analyses will be performed using SAS™ 
version 9.3 (or a later version). 
 
ANALYSIS POPULATIONS 
The following section details the analysis populations: 
 
Safety (SAF) Population: This is defined as all hips who have been implanted with the 
OR3O™ Dual Mobility System or controlled system.  

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 53 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Full Analysis Set (FAS) Population: according to the basic principle of Intent-to-Treat 
(ITT) analysis, all randomly selected subjects with at least one validity evaluation will be 
included in FAS Population. 
 
Per-Protocol (PP) Population: The PP population is a subset of hips in the FAS population 
who do not have major protocol deviations and who satisfied all enrollment eligibility 
criteria. Criteria that can be regarded as major deviations will be formally classified on a 
case-by-case basis prior to the final study database lock.  
 
BASELINE DATA 
All observations available prior to the operative date will be defined as baseline data. All 
demographic and preoperative characteristics data will be summarized at baseline. All 
demographic and baseline characteristics will be summarized using the SAF, ITT and PP analysis 
populations.   
Demography and medical variables at baseline (including but not limited to, age, gender, race, 
medical history, medical history and disease diagnosis) will be used to describe subjects and 
summarize subject information. Summary statistics will be given based on the nature of 
variables (continuous or classified variables). For continuous variables, the number of 
observations, mean, standard deviation, median, minimum and maximum will be reported. For 
classified variables, the number of observations, frequency and percentage will be reported. 
A detailed list of different data set sizes in each group, case distribution of each site, total dropout 
rate comparison and reasons for not completing the study, will be provided. The demographic 
characteristics (age, height, vital signs, etc.), the medical history and the medication history of the 
patients are described, and comparison of the age, height, body weight, etc. between the two 
groups will be conducted to measure the comparability between the two groups. The outcome 
data can be accepted and reported only when the baseline of two groups is balanced; otherwise, 
the outcome data needs to be corrected and then can be reported. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 54 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
EFFICACY ANALYSIS 
 Analysis of Primary Endpoint 
The primary endpoint of this study is the proportion of excellent (≥ 90) or good (80-89) HHS 
scores at 12 month postoperative.  Hypothesis testing would be in two steps. First, testing for 
non-inferiority of P1 versus P0 and secondly if non-inferiority is demonstrated then testing for 
superiority of P1 to P0 as follows:    
H0 (null): P1 ≤ (P0-∆) versus 
Ha1 (alternate 1st stage): P1 > (P0-∆) and Ha2 (alternate 2nd stage): P1 > P0, 
Where ∆ is the margin of non-inferiority (9.5%), P1 is the proportion of good to excellent HHS 
scores at 12 months in the OR3O dual mobility system (test) and P0 is the proportion of good to 
excellent HHS scores at 12 months in the Conventional, single-bearing design (control). 
 
The null hypothesis, H0, is rejected in favor of the first alternate hypothesis, Ha1, (i.e. 
demonstration of non-inferiority) if the lower limit of the 95% Confidence interval for 
P1 > (P1-∆) otherwise, H0 will be accepted. 
 
If the null hypothesis, H0, is rejected in favor of Ha1, the test for superiority would 
additionally be performed. If the upper limit of the 95% CI for P0 is less than the lower 
limit of the 95% CI for P1, then superiority of P1 to P0 is demonstrated, i.e. acceptance 
of Ha2.. This stepwise hypothesis-testing framework would not require any adjustment 
made to α, thus strongly controlling the overall significance at 0.05. All 95% CIs 
generated for P1 and P0 would be calculated using exact methods. 
The primary endpoint will be summarized using the ITT population as the primary analysis 
population and then subsequently with the per PP population for sensitivity analysis. 
 Analysis of Secondary Endpoints 
Implant Survivorship 
 
Survivorship of the OR3O Dual Mobility System (assessed by revision for any reason) 
will be summarized using Kaplan-Meier survival tables and graphs. Time to revision will 
be the endpoint of interest, for subjects who die, are lost to follow-up or do not encounter 
the event of interest by the time of study termination would be censored on these dates. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 55 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
Survivorship of the controlled system up to 2 years after surgery (assessed by revision 
for any reason). Kaplan-Meier survival tables analogous to that specified for the OR3O 
Dual Mobility system will be implemented here as well. 
Harris Hip Score (HHS) 
 
HHS scores for each subject will further be categorized as follows: Excellent (90-100); 
Good (80-89); Fair (70-79); Poor (60-69) and; Very poor (<60). Shift tables from the 
preoperative visit to all postoperative visits using these classifications will be generated.  
 
The total HHS and the scores for each of its following subdomains: pain, function, 
absence of deformity, and range of motion will be summarized using continuous 
summary characteristics preoperatively and postoperatively at 6 weeks, 3 months, 6 
months, 1 year and 2 years (i.e. by visit). For the HHS and its subdomain scores, 
independent repeated measures Analysis of Covariance (ANCOVA) model (with visit as 
the repeated term) will be used to model the change from preoperative to postoperative 
total HHS (and its subdomain) scores as dependent variable (s). As a minimum, each 
model will contain treatment (OR3O dual mobility system i.e. Test, versus Conventional 
single-bearing design, i.e. Control) as a fixed term and a repeated specification for visit 
in the model. Preoperative prognostic and demographic variables including but not only 
restricted to type of THA procedure (primary), age, BMI, sex, and investigational site and 
any other covariate that can be ascertained to be impactful on the total HHS (or its 
subdomain scores) will be introduced as covariates in the final model. These covariates 
will be added to the model in a stepwise manner and retained in the final model if a p-
value of ≤ 0.1 is encountered.  Model based means (adjusted means or Least Square 
Means, LSMeans) and corresponding standard errors associated with the change from 
preoperative to postoperative HHS (and its subdomain) scores by treatment will be 
presented. Model based differences (and corresponding standard errors) between 
treatment as well as their corresponding 95% CIs will additionally be summarized. If the 
p-value associated with the treatment term in the model is significant (i.e. p < 0.05).    
EQ5D-5L Score 
 
The HRQoL Index score and its VAS component will be sumarized using summary 
statistics for continuous variables preoperatively and at the postoperative visits: 6 weeks, 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 56 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
3 months, 6 months, 1 year and 2 years (i.e. by visit). Model based repeated measures 
ANCOVA analysis, the type specified for the total HHS and its subdomain scores will be 
implemented. 
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.) 
 
The HOOS JR. scoring instrument that will be administered for this study has two 
dimensions (pain and function, daily living). Pain has 2 items scored and function, daily 
living has 4 items with a combined 6 total items. Each of the items within each dimension 
has a rating of 0-4 where 0 is the best outcome on the item and 4 is the worst outcome on 
the item. The maximum HOOS JR raw summed score for all dimensions combined is 24. 
The higher the combined raw scores is the worse the outcome. The raw summed scores  
are transformed to a 0-100 interval score where a score of 0 implies total hip disability 
and a score of 100 signifies perfect hip health. The scoring instructions for the 
transformation will be detailed in the SAP. Thetransformed (0-100) interval scores will 
be summarized by visit using descriptive summary characteristics for continuous 
variables preoperatively and at the postoperative visits: 6 weeks, 3 months, 6 months, 1 
year and 2 years (i.e. by visit). Changes from preoperative to postoperative follow-up 
time points will similarly be summarized. Model based repeated measures ANCOVA 
analysis, the type previously specified for the total HHS (and its subdomain scores) will 
be implemented. 
Radiographic Characteristics 
 
The radiographic characteristics of implant position, implant fixation, heterotopic 
ossification, radiolucencies, osteolysis, atrophy and hypertrophy will be summarized 
using descriptive characteristics for continuous or categorical variables as appropriate and 
relevant.  
 
All secondary endpoints will be summarized using the ITT analysis population.  
 Analysis of Other Endpoint(s) 
Survivorship of compatible components up to 2 years 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 57 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
Survivorship of acetabular shell, femoral head, and any of the femoral stems will be estimated 
by cumulative proportion of hips without revision of the respective components due to any 
reason, up to 2 years. The cumulative implant survival rates will be summarized using KM 
product limit estimates. 
Dislocation percentage of the hip up to 2 years after device implantation 
The cumulative dislocation percentage at the interim visits up to 2 years after device implantation, 
pdis,i will be compared to a literature specified percentage, pliterature. These literature-specified 
percentages will be included in the SAP created for the study. For the estimation of dislocation 
rate, a hip with multiple dislocations on-study will be counted only once. Two-sided exact 95% 
CIs will be estimated for pdis,i where i is the visit at which the cumulative dislocation will be 
estimated (i.e. at 3months, 6 months, 1 year and 2 years).  
One of the following conclusions will be made: 
 
If the lower limit (LL) of the 95% CI for pdis,i is > pliterature, then it is concluded that the 
dislocation rate on-study is significantly greater than the literature-specified rate. 
 
If the upper limit (UL) of the  95% CI for pdis,i > pliterature, then it is concluded that the 
dislocation rate on-study is significantly less than than the literature-specified rate.  
 
If (LL of 95% CI of pdis,i <= pliterature <= UL of 95% CI of pdis,i), then the dislocation 
rate on-study is comparable to that specified in literature.  
Hospital readmission percentage (cumulative) within 30, 60 and 90 days of discharge 
The readmission percentage by 30, 60 and 90 days of discharge, p30,60,90 will be descriptively 
summarized as counts (n) and percentages (%).  
 
SAFETY ANALYSES 
 
The number of adverse events will be reported both overall and by seriousness, relationship 
to study device and/or study procedure and expectedness. 
 
The number of subjects experiencing adverse events will be summarised both overall and 
by seriousness, relationship to study device and/or study procedure and expectedness. 
 
An overall AE summary table that will summarize as number (n) and percentages (%), the 
overall incidence according to subjects with at least one AE; subjects with at least one AE 
by worst severity (mild, moderate, or severe); subjects with at least one AE by worst 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 58 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
outcome (resolved, ongoing/unresolved, or death); subjects with an AE that led to study 
discontinuation and; subjects with at least one AE by worse relatedness to device. Other 
events such as SAEs, ADEs, SADEs or USADEs will also be similarly summarized using 
number (n) and percentages (%).  
 
Incidence of device- or procedure-related re-interventions that occur on-study will be 
summarized as number (n) and percentages as well as by type. 
 
A listing of device deficiencies that occur on-study will be provided. 
All safety endpoints will be summarized using the SAF analysis population. 
 
INTERIM ANALYSES 
An interim analysis is planned for after completion of all 1 year follow-up visits in order to support 
the China NMPA registration. Additional interim analyses might be performed as and when 
needed to support and maintain product registration in different markets globally. More specific 
details on the interim analyses will be included in the SAP. 
 SAMPLE SIZE JUSTIFICATION 
 
TOTAL SAMPLE SIZE 
170 subjects who need unilateral hip joint replacement should be enrolled into the study - 85 
subjects randomized per study arm. 
The primary assumptions for sample size calculation are as below: 
 
 
Type I (α) error = 0.05  
 
Type II (β) error = 0.20 (Power = 80%) 
 
Margin of non-inferiority, ∆ = -9.50%    
 
Sample size calculation is based on the assumption that in order to be considered of comparable 
efficacy, study arm (dual mobility cohort) must obtain at least 90% of the efficacy in the 
controlled arm (conventional cohort). It is expected and further assumed that 95% of the Harris 
Hip Score at 12 months postoperative will have a rating of good or excellent (80-89, ≥ 90), then 
76 evaluable subjects per group would be required to carry out the hypothesis testing at 12 months 
postoperatively. Assuming an attrition rate of 10% at 1 year, 85 subjects are needed per arm. It is 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 59 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
planned to have 4 sites enrol on average, 43 subjects per investigational site and a min. of 20 
subjects should be enrolled per site (overall subjects enrolled in the study of 170). 
 
NUMBER OF SUBJECTS WITH EACH DISEASE IN CLINICAL STUDY AND 
REASON FOR DETERMINATION 
In this clinical protocol, it is strictly required that patients should be enrolled in compliance with 
the inclusion/exclusion criteria. It can be considered that all the patients have the same type of 
disease, and are not further divided. 
 
IN MULTI-CENTER CLINICAL STUDY, MINIMUM AND MAXIMUM NUMBER 
OF SUBJECTS IN EACH CLINICAL STUDY INSTITUTION AND JUSTIFICATION 
This study will be carried out at the same time in a number of clinical study sites. In principle, 
the number of subjects enrolled in each site will be distributed as evenly as possible to ensure 
adequate site representation. However, considering the feasibility and progress of the enrolment, 
the number of subjects enrolled will be adjusted according to the actual situation to ensure that 
the enrolment scale at each site is relatively balanced, and that the final enrolment scale for a 
specific site should not exceed 50% of the total number of cases. 
 
SIGNIFICANCE LEVEL AND POWER OF THE CLINICAL STUDY 
The statistical significance level takes the two-tailed significance level of α = 5%, 80% power 
(1-β). 
 
EXPECTED DROP-OUT RATE 
Expected drop-out rate is not more than 10%. 
 
CRITERIA FOR ACCEPTABILITY/UNACCEPTABILITY OF CLINICAL STUDY 
RESULT 
Primary efficacy endpoint (the Proportion of excellent (≥ 90) or good (80-89) HHS scores at 
12 months postoperative): If the lower limit of 95% CI for the efficacy difference between two 
groups is greater than the non-inferiority margin, it is considered that the investigational product 
is non-inferior to the control product, the statistical hypothesis is valid and the result of clinical 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 60 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
trial is qualified; otherwise, the hypothesis is invalid, and the result of clinical trial is 
unacceptable. 
 
CRITERIA AND REASON FOR TERMINATING THE STUDY BASED ON THE 
STATISTICAL CONSIDERATION 
Interim analyses will be performed after completion of all 1 year follow-up visits. 
 
STATISTICAL METHOD OF ALL DATA, TOGETHER WITH THE HANDLING 
METHOD 
OF 
MISSING, 
UNUSED 
AND 
WRONG 
DATA (INCLUDING 
DISCONTINUATION AND WITHDRAWAL) AND UNREASONABLE DATA 
The statistical analysis plan will be finalized prior to the study’s database lock. The statistical 
analysis programming and logic test programming will be conducted according to the statistical 
analysis plan. Draft tables, figures and listings would be generated prior to database lock using 
dummy assigned treatment codes. A data review meeting may be convened prior to the database 
lock to determine major and minor protocol deviations.  
Missing data on the primary endpoint would be imputed using the Last Observation Carried 
Forward (LOCF) single value imputation method. 
 
REPORTING PROCEDURE OF DEVIATION FROM ORIGINAL STATISTICAL 
PLAN 
In the event of a change to the statistical analyses indicated in the clinical protocol, the change 
procedure shall be applied in advance, such as changes in the statistical plan shall be truthfully 
recorded in the statistical analysis plan, including changed position, change reasons, change 
time and other revision records. 
 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
 
DEFINITIONS 
The categories of adverse events are shown in Table 12-1. The definitions for each of these 
categories are given in the subsequent sections. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 61 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
Table 12-1: Categories of Adverse Event  
 
NOT DEVICE- 
RELATED 
DEVICE- OR PROCEDURE-RELATED 
NON-
SERIOUS 
ADVERSE EVENT  
(AE) 
ADVERSE DEVICE EFFECT  
(ADE)  
SERIOUS 
SERIOUS ADVERSE 
EVENT  
(SAE)  
SERIOUS ADVERSE DEVICE EFFECT 
(SADE) (SEE 12.1.3) 
ANTICIPATED 
UNANTICIPATED 
ANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT  
(ASADE)  
UNANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT   
(USADE)  
 Adverse Event 
An Adverse Event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical sign (including abnormal laboratory findings) in subjects, users or other 
persons, whether or not causally related to the IP/Ancillary Product and whether anticipated or 
unanticipated.   
Any events that occur newly or deteriorate in severity and frequency as compared with baseline 
conditions, or abnormal results found in the process of diagnosis, including abnormal laboratory 
findings, are included herein. 
Note 1: This definition includes events related to the IP, comparator or ancillary products.  
Note 2: This definition includes events related to the procedures involved.  
Note 3: For users or other persons, this definition is restricted to events related to the IP 
AE is used both to refer to AE which do not meet the definitions of Adverse Device Effects or 
Serious Adverse Events and as an umbrella term referring to adverse events of all classifications.  

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 62 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
An AE can be any unfavorable and unintended sign (for example, an abnormal laboratory finding), 
symptom, or disease. For reporting purposes, emphasis is placed first and foremost on whether or 
not the event constitutes an untoward medical occurrence.    
 Adverse Device Effect 
An Adverse Device Effect (ADE) is an adverse event that is related to the use of the IP.  
Note 1: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation or operation, or any malfunction of the 
investigational medical device.  
Note 2: This definition includes any event resulting from use error or from intentional misuse of 
the investigational medical device.  
Note 3: This includes “comparator” if comparator is a medical device. 
Not Related -  An AE is considered to be not related to the use of an IP or the procedure when 
the effect is DEFINITELY UNRELATED to the use of the IP or the procedure; 
Related –  An AE is considered to be related to the use of an IP or the procedure when there is 
a POSSIBLE or DEFINITE relationship between the AE and the use of the IP or 
the procedure. 
An ADE is further categorized depending on whether the criteria in section 12.1.3 and 12.1.4 are 
met. 
 Serious Adverse Events and Serious Adverse Device Effects  
An AE or ADE is considered a Serious Adverse Event (SAE) or Serious Adverse Device 
Effects (SADE) if, in the view of either the Investigator or the Sponsor, it: 
a) led to death, 
b) led to serious deterioration in the health of the subject, users, or other persons as 
defined by one or more of the following:  
1) a life-threatening illness or injury, or 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 63 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
2) a permanent impairment of a body structure or a body function including 
chronic diseases, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury, 
or permanent impairment to a body structure or a body function, 
c) led to foetal distress, foetal death or a congenital abnormality or birth defect 
including physical or mental impairment 
Note: Planned hospitalization for a pre-existing condition, or a procedure required by the study 
protocol, without serious deterioration in health, is not considered a serious adverse event. 
 Anticipated/Unanticipated Serious Adverse Device Effect 
An unanticipated Serious adverse device effect (USADE) is a serious ADE which by its nature, 
incidence, severity or outcome has not been identified in the current version of the risk analysis 
report.  
Note: anticipated serious adverse device effect (ASADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the risk analysis report. 
Guidance Regarding the Determination of Unanticipated Events: 
During causality assessment activity, clinical judgement shall be used and the relevant documents, 
such as the Instruction for Use, the Clinical Protocol or the Risk Analysis Report shall be 
consulted, as all the foreseeable serious adverse events and the potential risks are listed and 
assessed there. The presence of confounding factors, such as concomitant medication/treatment, 
the natural history of the underlying disease, other concurrent illness or risk factors shall also be 
considered. 
 Severity  
The severity of every AE will be assessed by the PI or medically qualified site staff to whom the 
responsibility has been delegated and documented on the delegation of authority log. AE should 
be classified as mild, moderate, or severe, regardless of whether or not the AE are considered to 
be serious or non-serious. The classification should be based on the following definitions: 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 64 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
Mild  
- 
 
An event is mild if the subject is aware of, but can easily tolerate the 
sign or symptom; 
Moderate - 
An event is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities; 
Severe -    
An event is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities. 
 Device Deficiency 
A Device Deficiency (DD) is an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. DD includes malfunctions, use errors and 
inadequate labeling.  
Note 1: DD includes malfunctions, use errors and inadequacy in the information supplied by the 
manufacturer including labelling. 
Note 2: This definition includes device deficiencies related to the investigational medical device 
or the comparator. 
Device deficiencies that did not lead to an adverse event but could have led to a medical 
occurrence  
a) if either suitable action had not been taken,  
b) if intervention had not been made, or  
c) if circumstances had been less fortunate,  
 
AE CODING DICTIONARY  
Coding for this study will be done per International Medical Device Regulators Forum AE 
Terminology Annex E – Clinical signs, symptoms and conditions. 
 
REPORTING PROCEDURES 
AE of any kind and DD will be recorded in the applicable eCRF and source notes. The Investigator 
will evaluate all AE for relationship to the device and procedure, seriousness, and severity. DD 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 65 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
will be evaluated for potential to cause SADE.  The following timescales should be followed for 
the AE/DD information to be entered into the eCRF and reported to the Sponsor or designee (see 
Figure 12-1): 
 
ADE and DD – without unreasonable delay 
 
SAE, SADE and DD with potential to cause SADE – immediately (i.e. within 24 hours of 
the investigator being informed about the event) 
In case the electronic data capture system using eCRFs has a system down time for any reason, 
AEs should be reported to the Sponsor via e-mail to ensure timescales given above are met. 
For ADE and DD, details of the product/procedure related to the event will be included and where 
applicable, pictures taken of the device. The deficient product should be retained for return to 
Smith & Nephew unless it is contaminated (e.g., used dressings must not be retained). Updates to 
submitted information will be recorded in the eCRF according to the timescales above. 
All adverse events will be reviewed by a medically qualified person appointed by the Sponsor to 
determine which, if any, meet criteria for expedited reporting to the regulatory authorities. 
Adverse Event review will be performed according to the Sponsor´s procedure.   
The investigator will inform the IRB/EC of adverse events according to the IRB/EC requirements.  
Depending on the nature of the adverse event, Smith & Nephew may request copies of the 
subject’s de-identified medical records, imaging, operative notes, as well as results of any relevant 
laboratory tests performed or other documentation related to the AE. If the subject was 
hospitalized, a copy of the discharge summary may be requested by S+N and should be forwarded 
as soon as it becomes available. In certain cases, Smith & Nephew also may request a letter from 
the Investigator that summarizes the events related to the case. Refer to the ISF Sponsor Contact 
Information Sheet to report SAE, SADE, USADE, and DD. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 66 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
Figure 12-1: Evaluation and Reporting of AE 
Site 
aware 
of AE
Investigator 
assesses 
seriousness 
Serious
Investigator 
assesses device 
relationship
Related 
Investigator 
assesses whether 
SADE is 
anticipated
Not Related
Serious Adverse 
Event (SAE)
unanticipated
Unanticpated 
Serious Adverse 
Device Effect 
(USADE)
Anticipated 
Serious Adverse 
Device Effect 
(ASADE)
Investigator 
assesses device 
relationship
Non-serious
Related
Adverse Device 
Effect (ADE)
Not Related
Adverse Event 
(AE)
Complete CRF 
and alert S&N 
IMMEDIATELY  
Record 
information in 
patient CRF 
according to 
usual 
timescales.
Complete CRF 
and alert S&N 
without 
unreasonable 
delay. 
Record 
details in 
subject s 
medical 
records

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 67 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
Figure 12-2: Evaluation and Reporting of DD  
Site aware 
of DD
Investigator 
assesses whether 
could have led to 
SADE 
Potential to cause SADE
No potential to cause SADE
Complete CRF and alert S&N 
IMMEDIATELY  
Record information in patient 
CRF according to usual 
timescales.
Record details in subject s 
medical records
 
 
UNBLINDING OF INVESTIGATIONAL PRODUCT 
Not applicable 
 
FOLLOW-UP OF SUBJECTS WITH ADVERSE EVENTS 
For subjects who are experiencing ongoing unresolved AE at the time of their study completion 
or early discontinuation from the study, it is recommended that the Investigator schedule an 
appropriate follow-up visit to determine the outcome of the event.  
Any additional data must be documented and available to the Sponsor who will determine whether 
the data needs to be documented in the eCRF or Clinical Study Report. 
 Ongoing Adverse Events at Study Discontinuation 
Adverse events which are related to a study procedure or S+N IP and are ongoing at the end of 
subject’s participation: The event should be followed until it is either resolved or until the event 
has become chronic and is not expected to further improve based on Investigator’s review of the 
event. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 68 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
Adverse events which are not related to a study procedure or S+N IP and are ongoing at the end 
of subject’s participation should be followed for 30 days after discontinuation or if the AE is 
resolved, whichever is sooner. 
At the time of data analysis (e.g., interim or final), an evaluation of ongoing events should take 
place and be listed as ongoing in the safety table. 
 INVESTIGATOR OBLIGATIONS 
The Principal Investigator will comply with Good Clinical Practice (GCP) and all applicable 
regulatory requirements as outlined in Appendix 24.4 of this protocol. 
In addition, the PI will ensure that the Financial Disclosure Statements will be completed by the 
PI and the Sub-Investigator upon entry into the study, at the end of the study and as any changes 
that affect their financial disclosure status occur during the course of the study and up to one year 
after study completion. 
 SPONSOR AND MONITOR RESPONSIBILITIES 
The Sponsor will designate monitors to conduct the appropriate site visits at the appropriate 
intervals. The clinical investigation will be monitored to ensure that: the rights and wellbeing of 
the subjects are protected; the reported data are accurate, complete, and verifiable from the source 
documents; and the study is conducted in compliance with the currently approved protocol and 
amendment(s), if applicable, with GCP regulations, and with applicable regulatory requirements. 
Detailed monitoring requirements will be documented in the Clinical Monitoring Plan for this 
study.  
 
SITE QUALIFICATION VISIT 
A site qualification visit may be performed by the Sponsor prior to the execution of a clinical 
agreement to ensure that all Investigators have the appropriate training, staff, facilities, and 
resources to adequately conduct the study. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 69 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
ETHICAL APPROVAL AND CLINICAL TRIAL AGREEMENT 
The clinical protocol and informed consent materials that used in the study must be approved by 
the EC. Copies of EC approval documents will be provided to Smith & Nephew. 
A CTA must be fully executed by the site and Smith & Nephew and any other appropriate 
parties. Prior to initiation of the study, all investigators who will participate in the study need to 
be authorized by the principal investigator (PI), and the authorization outlines the 
responsibilities associated with the study. Unauthorized investigators are not allowed to 
participate in the study. 
 
SITE INITIATION VISIT 
A site initiation visit to provide training on the specifics of the study, site obligations and 
expectations of study conduct will be performed by the Sponsor or qualified person designated 
by the Sponsor. 
 
INTERIM MONITORING VISIT 
Interim monitoring visits will be performed by the Sponsor or qualified person designated by the 
Sponsor on a regular basis. 
 
SPONSOR AUDITS AND REGULATORY INSPECTION 
The objective of audit is to ensure the quality, authenticity and integrity of the clinical study and 
data, to ensure the risk of the study is controllable and evaluate whether the implementation of 
the study is strictly in accordance with the clinical protocol and SOP. 
Quality Assurance auditors, whether an employee of the Sponsor or its designee, may evaluate 
study conduct at the study sites. These parties must have access to any and all study reports and 
source documentation, regardless of location and format.   
Due to the purpose of the study to support product registration, NMPA inspections of study 
conduct at clinical sites might occur. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 70 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
CLOSE-OUT VISIT 
A study close-out visit will be performed by the Sponsor or designee to retrieve and account for 
all remaining clinical data and to resolve outstanding queries. During study close-out, the monitor 
will review investigator files to ensure required documents and records are on file, review IP  
accountability documents including documentation of return of unused devices, confirm the 
disposition of any other ancillary items used for the study, and review regulatory requirements 
regarding records retention and EC reporting requirements. When no subjects have been included, 
a remote close-out visit may be conducted.  
 PROTOCOL DEVIATIONS 
An Investigator must not make any changes or deviate from this protocol, except to protect the 
life and physical well-being of a subject in an emergency. Protocol deviations reported by the 
Investigator or discovered during monitoring visits will be compiled in a Protocol / GCP 
Deviation Log (TMP-CD-31-02 Protocol/GCP Deviation Log). Significant and/or recurrent 
protocol/GCP deviations will be documented on a protocol deviation form (TMP-CD-31-01 
Protocol/GCP Deviation) including identified root cause and, as necessary, appropriate 
corrective and preventive actions will be put in place and and signed off by the study personnel. 
 PROTOCOL AMENDMENTS 
Amendments shall be made only in necessary cases once the study has started. Protocol 
amendments must be approved by the protocol signatories prior to submission to the EC. Protocol 
amendments need to be approved by the EC and Regulatory Authority(ies), according to the 
applicable requirements prior to implementation at the site. 
 
 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 71 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 CONFIDENTIALITY OF THE STUDY 
The confidentiality of this study and associated documents is governed by the terms of the 
Clinical Trial Agreement (CTA). 
 STATEMENTS OF COMPLIANCE 
This clinical study will be performed in compliance with the ethical principles of the 
Declaration of Helsinki; and Good Clinical Practice, as well as applicable national laws and 
requirements. 
This clinical study will not commence until the required approval from the IRB/EC and 
regulatory authority has been obtained. Any additional requirements imposed by the IRB/EC or 
regulatory authority will be followed.  
Public/Products Liability Insurance has been purchased by Smith & Nephew Worldwide and 
incorporates coverage for personal injury in respect of clinical studies. Smith & Nephew agrees 
to operate in good faith and in accordance with ABHI (Association of British Healthcare 
Industries) guidelines regarding compensation for injury arising in the course of clinical studies. 
 EHTICAL CONSIDERATION 
This clinical study must follow the Declaration of Helsinki, and will be carried out according to 
the GCP and regulations related to medical devices issued by International conference on 
Harmonization (ICH) and China. 
Investigators are responsible for obtaining written and dated approval from an Ethics 
Committee (EC) prior to enrolling subjects. This approval must include the protocol, the 
informed consent form, subject recruitment materials, advertising or any written information 
that will be provided to subjects. 
Investigators are also responsible for maintaining EC approval throughout the study by 
submitting progress reports (continuing review reports) at least annually and more often if 
requested by the EC. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 72 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
In any event of withdrawal of EC Approval, the Investigator will report to the Sponsor within 5 
working days if, for any reason, the EC withdraws approval to conduct the clinical study. The 
report will include a complete description of the reason(s) for which approval was withdrawn. 
Additional documents that require the Investigator obtain written and dated EC approval during 
the course of the study include: 
● 
Protocol amendments (should not be implemented prior to EC approval) 
● 
Informed consent form revisions (Sponsor reserves the right to review all revised 
informed consent forms prior to submission as they relate to the Sponsor’s obligations) 
● 
Protocol deviation report 
● 
Adverse events described in Section 12 of this protocol 
● 
All other documents as required by the EC 
 END OF STUDY 
The end of the study is defined by the last follow-up visit that occurred in the whole study 
population. Due to defined visit windows the last follow-up visit must not necessarily be of the 
last subject treated.  
Should circumstances arise which require the termination of the entire study prior to its planned 
completion (e.g., safety concerns) or circumstances arise which mean the end of the 
participation of an individual site (e.g., departure of Investigator, non-compliance), then this 
will be undertaken according to the SOPs of the Sponsor.  
The Sponsor may decide to discontinue a specific study site under the following conditions: 
 
Non-compliance to GCP or protocol 
 
Failure to enroll subjects 
 
Unsafe or unethical practices. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 73 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 PUBLICATION POLICY 
 
PUBLICATION OF STUDY DATA 
The preparation and submission for publication of manuscripts containing the study results shall 
be in accordance with a process determined by the Clinical Trial Agreements between the study 
Sponsor and participating institutions. The publication or presentation of any study results shall 
comply with all applicable privacy laws, including, but not limited to the Health Insurance 
Portability and Accountability Act of 1996. 
 
DATA SHARING 
Smith & Nephew is committed to upholding the highest ethical and legal standards involved in 
conducting clinical studies. Smith & Nephew, therefore, supports the data sharing requirements 
of The International Committee of Medical Journal Editors (ICMJE) published on the 6th June 
2017. In accordance, Smith & Nephew will consider requests to share individual (de-identified) 
participant data that underlie the results of any interventional clinical trial, as presented from the 
1st July 2018 within an ICMJE associated journal. Requests made by researchers who provide a 
methodologically sound proposal will be considered. Requests may include data that underlie 
results presented in text, tables, figures, and appendices, together with data dictionaries. 
Availability of these data will begin nine months and end 36 months after article publication. Data 
supplied may only be used by the researcher(s) named in the approved research proposal for the 
purposes of achieving the aims of the analyses specified therein. All proposals should be directed 
to datasharing.gcs@smith-nephew.com. To gain access, data requestors will need to sign a data 
access agreement. 
 FEASIBILITY ANALYSIS 
 
POSSIBILITY ANALYSIS ON SUCCESS 
Smith & Nephew is a leading medical product enterprise and has a complete research and 
development (R&D), production and quality control (QC) system. The OR3O™ Dual Mobility 
System and similar products developed by Smith & Nephew have been marketed and used in 
foreign countries.  

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 74 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
The material and design of the investigational product in this study meets the technical 
requirements of national registration and testing, the product has passed the testing of Quality 
Supervision and Inspection Center for Medical Devices successfully, and all the performance 
indicators are qualified. 
The design of this clinical protocol is in accordance with Guidance for Clinical Trial Design of 
Medical Devices, and is repeatedly discussed and demonstrated by clinical experts, clinical 
study sites, statisticians and internal experts of Smith & Nephew. 
The clinical sites that undertake this study have complete instruments, equipment and technical 
resources, and have passed the national certification for qualifications of clinical study sites. 
The investigators are outstanding academic leaders in the field of domestic sports medicine, 
with rich experience in clinical study, and can guarantee the smooth progress of clinical study. 
 
POSSIBILITY ANALYSIS ON FAILURE 
In the previous similar studies, most of the subjects were older patients. During the early follow-
up of the study, due to the limitation of functional recovery of patients after surgery, there was a 
phenomenon of loss to follow-up. In view of this problem, according to the Guidance for 
Clinical Trial Design of Medical Devices, the follow-up time is arranged scientifically, which 
not only ensures that the early recovery data of subjects can be collected completely in the 
study, but also fully considers the convenience of subjects' actions. In order to avoid the loss to 
follow-up of subjects, in the informed consent process, the investigator’s team will fully 
emphasize the necessity for follow-up and the importance of protocol compliance with the 
subjects, allowing the subjects to fully understand the study procedures, and ensure the integrity 
of the adverse event collection of subjects during the study, at the same time repeatedly confirm 
and remind the follow-up arrangements of subjects in advance, and give compensation for the 
transportation cost from an ethical perspective. 
Rating scale is a subjective evaluation index; in order to ensure consistency, each site will 
delegated individual evaluator, who are given consistency training according to scoring criteria. 
The grasp of inclusion and exclusion criteria is the key to the success of the study. Smith & 
Nephew will provide sufficient training and the reminder cards to the investigators at the 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 75 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
beginning of the study. After the first subject is enrolled in each site, the Study Monitor will 
conduct a visit to the study site to verify the process are in line with the protocol requirements. 
 
 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 76 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 REFERENCES 
1. 
Arora S, Rafiq A, Jolly M. Management of rheumatoid arthritis: Review of current 
guidelines. Journal of Arthroscopy and Joint Surgery. 2016;3(2):45-50. 
2. 
Balmaceda CM. Evolving guidelines in the use of topical nonsteroidal anti-inflammatory 
drugs in the treatment of osteoarthritis. BMC Musculoskelet Disord. 2014;15:27. 
3. 
Batailler C, Fary C, Verdier R, Aslanian T, Caton J, Lustig S. The evolution of outcomes 
and indications for the dual-mobility cup: a systematic review. Int Orthop. 
2017;41(3):645-59. 
4. 
Chughtai M, Piuzzi NS, Khlopas A, Jones LC, Goodman SB, Mont MA. An evidence-
based guide to the treatment of osteonecrosis of the femoral head. Bone Joint J. 2017;99-
B(10):1267-79. 
5. 
Darrith B, Courtney PM, Della Valle CJ. Outcomes of dual mobility components in total 
hip arthroplasty: a systematic review of the literature. Bone Joint J. 2018;100-B(1):11-9. 
6. 
De Martino I, D'Apolito R, Soranoglou VG, Poultsides LA, Sculco PK, Sculco TP. 
Dislocation following total hip arthroplasty using dual mobility acetabular components: 
a systematic review. Bone Joint J. 2017;99-B(ASuppl1):18-24. 
7. 
Dvorzhinskiy A, Bostrom MPG. Options for Primary Hip Arthroplasty.  In: Aaron R (eds) 
Diagnosis and Management of Hip Disease. Cham: Springer; 2015. 
8. 
Fabry C, Langlois J, Hamadouche M, Bader R. Intra-prosthetic dislocation of dual-
mobility cups after total hip arthroplasty: potential causes from a clinical and 
biomechanical perspective. Int Orthop. 2016;40(5):901-6. 
9. 
Ferreira de Meneses S, Rannous F, Hunter DJ. Osteoarthritis guidelines: Barriers to 
implementation and solutions. Annals of Physical and Rehabilitation Medicine. 
2016;59(3):170-3. 
10. 
Grieco PW, Pascal S, Newman JM, Shah NV, Stroud SG, Sheth NP, et al. New alternate 
bearing surfaces in total hip arthroplasty: A review of the current literature. J Clin Orthop 
Trauma. 2018;9(1):7-16. 
11. 
Hernigou P, Trousselier M, Roubineau F, Bouthors C, Chevallier N, Rouard H, et al. 
Stem Cell Therapy for the Treatment of Hip Osteonecrosis: A 30-Year Review of 
Progress. Clin Orthop Surg. 2016;8(1):1-8. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 77 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
12. 
Keurentjes J.C., Pijls B.G., Van Tol F.R., Mentink J.F., Mes S.D., Schoones J.W., et al. 
Which implant should we use for primary total hip replacement? A systematic review and 
meta-analysis. The Journal of Bone and Joint Surgery. 2014;96(Supplement 1):79–97. 
13. 
Konan S, Duncan CP, Garbuz DS, Masri BA. The Role of Dual-mobility Cups in Total 
Hip Arthroplasty. Instr Course Lect. 2015;64:347-57. 
14. 
Laura AD, Hothi H, Battisti C, Cerquiglini A, Henckel J, Skinner J, et al. Wear of dual-
mobility cups: a review article. Int Orthop. 2017;41(3):625-33. 
15. 
Lyman S, Lee YY, Franklin PD, Li W, Mayman DJ, Padgett DE. Validation of the HOOS, 
JR: A Short-form Hip Replacement Survey. Clin Orthop Relat Res. 2016;474(6):1472-
82. 
16. 
Neri T, Philippot R, Klasan A, Putnis S, Leie M, Boyer B, et al. Dual mobility acetabular 
cups for total hip arthroplasty: advantages and drawbacks. Expert Rev Med Devices. 
2018;15(11):835-45. 
17. 
NICE. Total hip replacement and resurfacing arthroplasty for end-stage arthritis of the 
hip. Technology appraisal guidance: National Institute for Health and Care Excellence 
2014. 
18. 
Pituckanotai K, Arirachakaran A, Tuchinda H, Putananon C, Nualsalee N, Setrkraising 
K, et al. Risk of revision and dislocation in single, dual mobility and large femoral head 
total hip arthroplasty: systematic review and network meta-analysis. Eur J Orthop Surg 
Traumatol. 2018;28(3):445-55. 
19. 
Plummer DR, Haughom BD, Della Valle CJ. Dual mobility in total hip arthroplasty. 
Orthop Clin North Am. 2014;45(1):1-8. 
20. 
Si HB, Zeng Y, Cao F, Pei FX, Shen B. Is a ceramic-on-ceramic bearing really superior 
to ceramic-on-polyethylene for primary total hip arthroplasty? A systematic review and 
meta-analysis of randomised controlled trials. Hip Int. 2015;25(3):191-8. 
21. 
Vahedi H, Makhdom AM, Parvizi J. Dual mobility acetabular cup for total hip 
arthroplasty: use with caution. Expert Rev Med Devices. 2017;14(3):237-43. 
22. 
Zagra L, Caboni E. Total hip arthroplasty instability treatment without dual mobility cups: 
brief overview and experience of other options. Int Orthop. 2017;41(3):661-8. 
 
 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 78 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 APPENDICES 
 
PROTOCOL AMENDMENT  
Not applicable; this protocol has not been amended.  
 
INSTRUCTIONS FOR USE 
Instructions for Use (IFU) are made available for these implants. Refer to the most recent IFU 
for more information. 
Instruction for Use Document ID 81104400 
 
EQUIPMENT AND SPECIAL INSTRUCTIONS 
The following section provides a list of components that are allowed to be used within the study: 
Table 24-1: OR3O™ Dual Mobility Liners 
Catalog Item # 
Catalog Item Description 
71358251 
OR3O™ Dual Mobility Liner 32/44 
71358252 
OR3O™ Dual Mobility Liner 34/46 
71358201  
OR3O™ Dual Mobility Liner 36/48  
71358202  
OR3O™ Dual Mobility Liner 38/50  
71358203  
OR3O™ Dual Mobility Liner 40/52  
71358204  
OR3O™ Dual Mobility Liner 42/54  
71358205  
OR3O™ Dual Mobility Liner 44/56  
71358206  
OR3O™ Dual Mobility Liner 44/58  
71358207  
OR3O™ Dual Mobility Liner 46/60  
71358208  
OR3O™ Dual Mobility Liner 48/62  
71358209  
OR3O™ Dual Mobility Liner 50/64  
71358211  
OR3O™ Dual Mobility Liner 52/66-70  
71358212 
OR3O™ Dual Mobility Liner 54/72-74 
Table 24-2: OR3O™ Dual Mobility Inserts 
Catalog Item # 
Catalog Item Description 
71358253 
OR3O™ Dual Mobility XLPE Insert 22/32 
71358254 
OR3O™ Dual Mobility XLPE Insert 22/34 
71358213  
OR3O™ Dual Mobility XLPE Insert 22/36  
71358214  
OR3O™ Dual Mobility XLPE Insert 22/38  
71358215 
OR3O™ DUAL MOBILITY XLPE INSERT 28/38 
71358216  
OR3O™ Dual Mobility XLPE Insert 22/40  
71358217   
OR3O™ Dual Mobility XLPE Insert 28/40 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 79 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
Catalog Item # 
Catalog Item Description 
71358218  
OR3O™ Dual Mobility XLPE Insert 28/42  
71358219  
OR3O™ Dual Mobility XLPE Insert 28/44  
71358221  
OR3O™ Dual Mobility XLPE Insert 28/46  
71358222  
OR3O™ Dual Mobility XLPE Insert 28/48  
71358223  
OR3O™ Dual Mobility XLPE Insert 28/50  
71358224  
OR3O™ Dual Mobility XLPE Insert 28/52  
71358225  
OR3O™ Dual Mobility XLPE Insert 28/54  
Table 24-3: Acetabular Shells – R3™ non-HA Acetabular Shells  
Catalog Item # 
Catalog Item Description* 
71331848  
R3™ No-Hole Acetabular Shell 48mm OD  
71331850  
R3™ No-Hole Acetabular Shell 50mm OD  
71331852  
R3™ No-Hole Acetabular Shell 52mm OD  
71331854  
R3™ No-Hole Acetabular Shell 54mm OD  
71331856  
R3™ No-Hole Acetabular Shell 56mm OD  
71331858  
R3™ No-Hole Acetabular Shell 58mm OD  
71331860  
R3™ No-Hole Acetabular Shell 60mm OD  
71331862  
R3™ No-Hole Acetabular Shell 62mm OD  
71331864  
R3™ No-Hole Acetabular Shell 64mm OD  
71331866  
R3™ No-Hole Acetabular Shell 66mm OD  
71331868  
R3™ No-Hole Acetabular Shell 68mm OD  
71335548  
R3™ Three Hole Acetabular Shell 48mm OD  
71335550  
R3™ Three Hole Acetabular Shell 50mm OD  
71335552  
R3™ Three Hole Acetabular Shell 52mm OD  
71335554  
R3™ Three Hole Acetabular Shell 54mm OD  
71335556  
R3™ Three Hole Acetabular Shell 56mm OD  
71335558  
R3™ Three Hole Acetabular Shell 58mm OD  
71335560  
R3™ Three Hole Acetabular Shell 60mm OD  
71335562  
R3™ Three Hole Acetabular Shell 62mm OD  
71335564  
R3™ Three Hole Acetabular Shell 64mm OD  
71335566  
R3™ Three Hole Acetabular Shell 66mm OD  
71335568  
R3™ Three Hole Acetabular Shell 68mm OD  
71338663  
R3™ Multi Hole Acetabular Shell 48mm OD  
71338664  
R3™ Multi Hole Acetabular Shell 50mm OD  
71338665  
R3™ Multi Hole Acetabular Shell 52mm OD  
71338666  
R3™ Multi Hole Acetabular Shell 54mm OD  
71338667  
R3™ Multi Hole Acetabular Shell 56mm OD  
71338668  
R3™ Multi Hole Acetabular Shell 58mm OD  
71338669  
R3™ Multi Hole Acetabular Shell 60mm OD  
71338671  
R3™ Multi Hole Acetabular Shell 62mm OD  
71338672  
R3™ Multi Hole Acetabular Shell 64mm OD  
71338673  
R3™ Multi Hole Acetabular Shell 66mm OD  
71338674  
R3™ Multi Hole Acetabular Shell 68mm OD  
71338675  
R3™ Multi Hole Acetabular Shell 70mm OD  
71338676  
R3™ Multi Hole Acetabular Shell 72mm OD  
71338677  
R3™ Multi Hole Acetabular Shell 74mm OD  

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 80 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
*Variants of R3™ non-HA Acetabular Shells that are commercially available vary per region. Only 
commercially available R3™ non-HA Acetabular Shells can be used in the study. 
Table 24-4: OXINIUM Femoral Heads 
Catalog Item # 
Catalog Item Description 
71342200  
12/14 Taper Femoral Head 22mm O.D. +0  
71342204  
12/14 Taper Femoral Head 22mm O.D. +4  
71342208 
12/14 Taper Femoral Head 22mm O.D. +8  
71342803  
12/14 Taper Femoral Head 28mm O.D. -3  
71342800  
12/14 Taper Femoral Head 28mm O.D. +0  
71342804  
12/14 Taper Femoral Head 28mm O.D. +4  
71342808  
12/14 Taper Femoral Head 28mm O.D. +8  
Table 24-5: List of Compatible Stems 
Product Name 
SMF™ Hip Stem 
Synergy™ Hip Stem 
Anthology™ Hip Stem 
Spectron™ Hip Stem *(not for this clinical trial) 
POLARSTEM™ 
SL-PLUS™ Hip Stem 
SLR-PLUS™ Hip Stem  *(not for this clinical trial) 
SL-PLUS™ (S-Version) Hip Stem 
SL-PLUS MIA™ Stem 
SLR-PLUS™ (S-Version) Hip Stem  *(not for this clinical trial) 
POLARSTEM™ collared and noncollared (Standard and Lateral) and Valgus Femoral Stem with 
Ti/Ha   *(not for this clinical trial) 
Anthology™ AFIT Hip Stem   *(not for this clinical trial) 
ECHELON™ Hip Stem  *(not for this clinical trial) 
REDAPT Hip Stem  *(not for this clinical trial) 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 81 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
 
HEALTH ECONOMIC OUTCOME MEASURES/QUALITY OF LIFE MEASURES 
For more information on EQ-5D-5L and HOOS JR scores, please refer to the eCRF table. 
 
PRINCIPAL INVESTIGATOR OBLIGATION 
 Responsibilities of Clinical Trial Institutions and Investigators (Decree No. 25) 
Article 59 Before accepting clinical trial, clinical trial institutions shall evaluate relevant 
resources in accordance with the characteristics of investigational medical devices to decide 
whether to accept this clinical trial.  
Article 60 Clinical trial institutions shall properly keep clinical trial records and basic 
documents according to the agreement with the sponsor.  
Article 61 Investigators who are in charge of the clinical trial shall:  
(I) Have professional title and qualification above associate level, such as associate chief 
physician, associate professor and associate researcher in the clinical trial institutions;  
(II) Have professional knowledge and experience required for investigational medical devices 
and pass relevant trainings if necessary;  
(III) Be familiar with clinical trial requirements provided by sponsor, and the data and 
literatures related to clinical trial;  
(IV) Be able to coordinate, allocate and assign personnel and devices of this trial, and to handle 
the adverse events and other correlating events related to investigational medical devices;  
(V) Be familiar with relevant national laws, regulations and this Provision.  
Article 62 Prior to a clinical trial, the medical device clinical trial administrative department of 
clinical trial institutions shall coordinate sponsor to file applications to the ethics committee and 
submit relevant documents in accordance with relevant provisions. 
Article 63 Investigators shall ensure that the staff member participating in the trial are familiar 
with the principles, indications, product performance, operating methods, installation 
requirements and technical specifications of investigational medical devices, understand 
preclinical research data and safety data of investigational medical devices, and master 
precautions and emergency treatment for possible risks in clinical trial.  

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 82 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
Article 64 Investigators shall ensure all participants of clinical trial fully understand the clinical 
trial protocol, relevant provisions, characteristics of investigational medical devices and relevant 
responsibilities of clinical trial, make sure that enough subjects meeting inclusion criteria in 
clinical trial protocol can be enrolled into clinical trial, ensure enough time in the agreed trial 
period, to implement and complete clinical trial safely according relevant regulations.  
Article 65 The investigator shall ensure that the investigational medical devices are only used 
for subjects of the clinical trial, and used for free. 
Article 66 Investigators shall strictly comply with clinical trial protocol. Without consent of 
sponsor and ethics committee or approval of China Food and Drug Administration in 
accordance with regulations, investigators shall not deviate the protocol or substantially change 
the protocol. However, in case of an emergency that subjects face direct danger that needs to be 
eliminated immediately, it can be reported in writing afterwards.  
Article 67 Investigators shall be responsible for recruiting subjects and talking with subjects or 
their guardians. Investigators are responsible to specify the details relating to investigational 
medical devices and clinical trial for subjects, inform subjects of possible benefits and known 
and foreseeable risks, and obtain the signed and dated informed consent form from subjects and 
their guardians.  
Article 68 Investigators and other personnel participated in the trial shall not force or induce 
subjects in improper way to take part in the trial.  
Article 69 In case of finding unanticipated adverse events of investigational medical devices 
during clinical trial, investigators shall revise relevant content of informed consent form 
together with the sponsor. After being reviewed and approved by ethics committee in 
accordance with relevant working procedure, the affected subjects and their guardians shall 
resign the revised informed consent form for confirmation. 
Article 70 Investigators shall be responsible for making decisions relating to clinical trial. In 
case of adverse events relating to clinical trial, clinical trial institutions and investigators shall 
provide sufficient and timely treatment and management to subjects. In case subjects have 
complications and need treatment and management, investigators shall timely notify subjects.  

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 83 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
Article 71 In case of serious adverse events during clinical trial, investigators shall take proper 
treatment measures for subjects immediately, then report to medical device clinical trial 
administrative departments of clinical trial institutions where they belong to, and notify sponsor 
in writing through them. Clinical trial administrative departments of medical devices shall 
report to corresponding ethics committee and Food and Drug Administration of province, 
autonomous region or municipality and the Health and Family Planning Commission where the 
clinical trial institution is located in written form within 24 hours. For lethal events, clinical trial 
institutions and investigators shall provide all necessary data to ethics committee and sponsor.  
Article 72 Investigators shall record all adverse events and device deficiency that occur during 
the process of clinical trial, analyze event cases together with sponsor, draft written analysis 
report, put forward opinions of continuing, suspending or terminating the trial, and report to 
ethics committee for review through medical device clinical trial administrative departments of 
clinical trial institutions.  
Article 73 Investigators shall ensure that clinical trial data are filled in case report forms 
accurately, completely, clearly and timely. Case report forms shall be signed by investigators. 
Any change of data shall be signed and dated by investigator, original records should be kept, 
clear and recognizable.  
Article 74 Clinical trial institutions and investigators shall ensure authenticity, accuracy, clarity 
and safety of data and documents generated in clinical trial. 
Article 75 Clinical trial institutions and investigators shall accept the monitoring and audit of 
sponsor as well as supervision of ethics committee, and provide all required records relating to 
the trial. In case Food and Drug Administration and Health and Family Planning Commission 
send inspectors to implement inspection, clinical trial institutions and investigators shall 
cooperate with them. 
Article 76 In case clinical trial institutions and investigators identify risks overweighting 
possible benefits, or have obtained the results that is sufficient to judge the safety and efficacy 
of investigational medical devices, thus need to suspend or terminate clinical trial, it is required 
to notify subjects and ensure subjects to obtain proper treatment and follow-up, report in 
accordance with regulations and provide detailed written explanation at the same time. If 
necessary, report to the Food and Drug Administration of province, autonomous region or 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 84 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
municipality where it locates. In case of receiving the notification of sponsor or ethics 
committee on the need of suspending or terminating clinical trial, investigators shall timely 
notify subjects and ensure subjects to obtain proper treatment and follow-up.  
Article 77 In case the sponsor violates relevant regulations or request to change the trial data 
and conclusion, clinical trial institutions and investigators shall report to Food and Drug 
Administration of province, autonomous region or municipality where the sponsor is located or 
report to the China Food and Drug Administration.  
Article 78 At the end of a clinical trial, the investigator shall ensure the completion of all 
records and reports. Meanwhile, the investigator shall ensure the quantity of received 
investigational medical devices is consistent with the used, discarded or returned devices, and 
ensure that the rest investigational medical devices are disposed properly and recorded for 
filing.  
Article 79 Investigators can authorize corresponding personnel to recruit subjects, continuously 
communicate with subjects, record the clinical trial data, and manage investigational medical 
devices in accordance with the needs of clinical trial. Investigators shall implement relevant 
training for the authorized personnel and document accordingly. 
 Principal Investigator Obligations (ISO14155:2011) 
1. General: 
a. The role of the PI is to implement and manage the day-to-day conduct of the clinical 
investigation as well as ensure data integrity and the rights, safety, and well-being of 
the subjects involved in the clinical investigation. 
2. Qualification of the PI. The PI shall: 
a. be qualified by education, training, and experience to assume responsibility for the 
proper conduct of the clinical investigation in accordance with this International 
Standard; evidence of such qualifications of the PI and key members of the 
investigation site team shall be provided to the Sponsor through up-to-date Curriculum 
Vitae (CV) or other relevant documentation, 
b. be experienced in the field of application and trained in the use of the investigational 
device under consideration, 
c. disclose potential conflicts of interest, including financial, that interfere with the 
conduct of the clinical investigation or interpretation of results, and 
d. be knowledgeable with the method of obtaining informed consent. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 85 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
3. Qualification of investigation site. The PI shall be able to demonstrate that the proposed 
investigation site: 
a. has the required number of eligible subjects needed within the agreed recruitment 
period, and 
b. has one or more qualified investigators, a qualified investigation site team and adequate 
facilities for the foreseen duration of the clinical investigation. 
4. Communication with the IEC. The PI shall: 
a. provide the Sponsor with copies of any clinical-investigation-related communications 
between the PI and the IEC, 
b. comply with the requirements described in 4.5 of ISO 14155:2011. 
i. 
Submit to the IEC the following information, any amendments and any 
additional documentation required by the IEC: the Protocol; IB or equivalent; 
informed consent form and any other written information provided to subjects; 
procedures for recruiting subjects and advertising materials, if any; a copy of the 
CV of the PI(s) for with the IEC has oversight. 
ii. Provide documentation of the IECs approval/favorable opinion, identifying the 
documents and amendments on which the opinion was based, to the Sponsor, 
prior to commencing the clinical investigation. 
iii. Submit the following to the IEC if required by national regulations, the protocol 
or IEC, whichever is more stringent: 
1. SAEs 
2. Requests for deviations, and reports of deviations, if the deviation affects 
subject’s rights, safety, and well-being, or the scientific integrity of the 
clinical investigation. Document and report to the Sponsor and IEC a report 
of deviations made to protect the rights, safety, and well-being of human 
subjects under emergency circumstances. 
3. Progress reports, including safety summary and deviations 
4. Amendments to any documents already approved by the IEC. 
5. If applicable, notifications of suspension or premature termination 
6. If applicable, justification and request for resuming the clinical 
investigation after suspension. 
7. Clinical investigation report or summary. 
iv. As a minimum, during the clinical investigation, the following information shall 
be obtained in writing from the IEC prior to implementation: 
1. Approval/favorable opinion of amendments 
2. Approval of the request for deviations that can affect the subject’s rights, 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 86 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
safety, and well-being or scientific integrity of the clinical investigation 
3. Approval for resumption of a suspended clinical investigation if applicable. 
c. obtain the written and dated approval/favorable opinion of the IEC for the clinical 
investigation before recruiting subjects and implementing all subsequent amendments, 
if required, 
d. promptly report any deviations from the protocol that affect the rights, safety or well-
being of the subject or the scientific integrity of the clinical investigation, including 
those which occur under emergency circumstances, if required by the IEC, protocol or 
national regulations. In particular circumstances, the communication with the IEC can 
be performed by the Sponsor, partly or in full, in which case the Sponsor shall keep 
the Principal Investigator informed. 
5. Informed consent process. The PI shall: 
a. General: 
i. 
Informed consent shall be obtained in writing from the subject and the process 
shall be documented before any procedure specific to the clinical investigation 
is applied to the subject; except when special circumstances for emergency 
treatments apply (see below) 
b. Process of obtaining informed consent. The general process for obtaining informed 
consent shall be documented in the protocol and shall comply with the following. 
These requirements also apply with respect to informed consent obtained from a 
subject’s legally authorized representative: 
i. 
Ensure that the PI or his/her authorized designee conducts the informed consent 
process 
ii. Include all aspects of the clinical investigation that are relevant to the subject’s 
decision to participate throughout the clinical investigation 
iii. Avoid any coercion or undue improper influence on, or inducement of, the 
subject to participate 
iv. Not waive or appear to waive the subject’s legal rights 
v. Use native non-technical language that is understandable to the subject 
vi. Provide ample time for the subject to read and understand the informed consent 
form and to consider participation in the clinical investigation 
vii. Include personally dated signatures and the PI or an authorized designee 
responsible for conducting the informed consent process 
viii. 
Show how informed consent will be obtained in special circumstances 
(see below) where the subject is unable to provide him or herself, and 
ix. Ensure important new information is provided to new and existing subjects 
throughout the clinical investigation. 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 87 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
c. Special circumstances for informed consent (the following provisions are subject to 
national regulations): 
i. 
Subject needing legally authorized representatives: informed consent may be 
given by the legally authorized representative only if a subject is unable to make 
the decision to participate in a clinical investigation (e.g., infant, child, or 
juvenile, seriously ill or unconscious subject, mentally ill person, mentally 
handicapped person). In such cases, the subject shall also be informed about the 
clinical investigation within his/her ability to understand. 
ii. Subject unable to read or write: informed consent shall be obtained through a 
supervised oral process if a subject or legally authorized representative is unable 
to read or write. An independent witness shall be present throughout the process. 
The written informed consent form and any other information shall be read aloud 
and explained to the prospective subject or his/her legally authorized 
representative and, whenever possible, either shall sign and personally date the 
informed consent form. The witness also signs and personally dates the informed 
consent for attesting that the information was accurately explained and that the 
informed consent was freely given. 
iii. Emergency treatments: 
1. For clinical investigations involving emergency treatments, when prior 
informed consent of the subject is not possible because of the subject’s 
medical condition, the informed consent of the subject’s legally authorized 
representative, if present, shall be requested. 
2. When it is not possible to obtain prior informed consent from the subject, 
and the subject’s legally authorized representative, is not available, the 
subject may still be enrolled if a specific process has been described in the 
protocol. 
3. Arrangements shall be made to inform the subject or legally authorized 
representative, as soon as possible, about the subject’s inclusion in the 
clinical investigation and about all aspects of the clinical investigation. 
4. The subject shall be asked to provide informed consent for continued 
participation as soon as his/her medical condition allows. 
d. The Principal Investigator may not enroll a subject without obtaining informed consent 
of the subject or his/her legally authorized representative only when the following 
conditions are fulfilled: the prospective subject fulfils the emergency conditions and is 
obviously in a life-threatening situation; no sufficient clinical benefits are anticipated 
from the currently available treatment; there is a fair possibility that the life-threatening 
risk to the prospective subject can be avoided if the investigational device is used; 
anticipated risks are outweighed by the potential benefits of applying the 
investigational device ; the legally authorized representative cannot be promptly 
reached and informed. 
e. Information provided to the subject. All information pertinent to the clinical 
investigation, including at least the following, shall be provided in writing and in native, 
non-technical language that is understandable to the subject (or the subject’s legally 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 88 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
authorized representative): 
i. 
Description and purpose 
ii. Potential benefits 
iii. Risks and inconveniences or the subject and, when applicable, for any embryo, 
fetus or nursing infant 
iv. Alternative procedures 
v. Confidentiality 
vi. Compensation 
vii. Anticipated expenses, if any, to be borne by the subject for participating in the 
clinical investigation 
viii. 
Information on the role of Sponsor’s representative in the clinical 
investigation 
ix. Contact persons 
x. Statement declaring that new findings or the reasons for any amendment to the 
protocol that affect the subject’s continued participation shall be made available 
to the subject. 
xi. Statement indicating that, upon the subject’s approval, the subject’s personal 
physician will be informed of the subject’s participation in the clinical 
investigation 
xii. Termination procedures 
f. 
Informed consent signature shall contain the following: 
i. 
The voluntary agreement to participate in the clinical investigation and follow 
the investigator’s instructions 
ii. A statement declaring that refusal of participation incurs no penalty for the 
subject 
iii. A statement declaring that discontinuation at any time incurs no penalty for the 
subject 
iv. A statement with regard to the possible consequences of withdrawal 
v. An acknowledgment of the information provided and confirmation that all the 
subject’s questions were answered 
vi. A statement confirming that the subject or his/her legally authorized 
representative agrees to the use of the subject’s relevant personal data for the 
purpose of the clinical investigation 
vii. A statement confirming that the subject or his/her legally authorized 
representative agrees that Sponsor’s representatives, regulatory authorities and 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 89 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
IEC representatives will be granted direct access to the subject’s medical records. 
g. New information: if new information becomes available that can significantly affect a 
subject’s future health and medical care, that information shall be provided to the 
subject(s) affected in written form. If relevant, all affected subjects shall be asked to 
confirm their continuing consent in writing. 
h. ensure compliance with the applicable regulatory requirements and ethical principles 
for the process of obtaining informed consent, and 
i. 
ensure and document appropriate training if an authorized designee is appointed to 
conduct the informed consent process. 
6. Compliance with the protocol. The Principal Investigator shall: 
a. indicate his/her acceptance of the protocol in writing, 
b. conduct the clinical investigation in compliance with the protocol, 
c. create and maintain source documents throughout the clinical investigation and make 
them available as requested during monitoring visits or audits, 
d. ensure that the investigational device is used solely by authorized users as specified in 
6.2, and in accordance with the protocol and instructions for use, 
e. propose to the Sponsor any appropriate modification(s) of the protocol or 
investigational device or of the use of the investigational device, 
f. 
refrain from implementing any modifications to the protocol without agreement from 
the Sponsor, IEC and regulatory authorities, if required, 
g. document and explain any deviation from the approved protocol that occurred during 
the course of the clinical investigation, 
h. ensure that an adequate investigation site team and facilities exist and are maintained 
and documented during the clinical investigation, 
i. 
ensure that maintenance and calibration of the equipment relevant for the assessment 
of the clinical investigation is appropriately performed and documented, where 
applicable, 
j. 
ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
Sponsor in the CRF and in all required reports, 
k. maintain the device accountability records, 
l. 
allow and support the Sponsor to perform monitoring and auditing activities, 
m. be accessible to the monitor and respond to questions during monitoring visits, 
n. allow and support regulatory authorities and the IEC when performing auditing 
activities, 
o. ensure that all clinical-investigation-related records are retained as required taking 
measures to prevent accidental or premature destruction, and review and sign the 

 
Clinical Protocol 
Study Number: OR3O.2019.10 (China) 
Prospective, Multi-center, Randomized, Controlled 
Study to Evaluate the Safety and Efficacy of the 
OR3O™ Dual Mobility System versus conventional 
single bearing design Total Hip System in Primary 
Total Hip Arthroplasty (THA) Procedures 
Version: 1.0, 18Aug2020 
Page: 90 of 90 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall 
the contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it 
that is contrary to the expressed or implied wishes of Smith & Nephew. 
TMP-CD-05-01 – Clinical Protocol-Device – Revision B; SOP-CD-05 Clinical Protocols 
clinical investigation report, as applicable. 
7. Medical care of subjects. The Principal Investigator shall 
a. provide adequate medical care to a subject during and after a subject's participation in 
a clinical investigation in the case of adverse events, 
b. inform the subject of the nature and possible cause of any adverse events experienced, 
c. provide the subject with the necessary instructions on proper use, handling, storage, 
and return of the investigational device, when it is used or operated by the subject, 
d. inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required, 
e. provide the subject with well-defined procedures for possible emergency situations 
related to the clinical investigation, and make the necessary arrangements for 
emergency treatment, including decoding procedures for blinded/masked clinical 
investigations, as needed, 
f. 
ensure that clinical records are clearly marked to indicate that the subject is enrolled in 
a particular clinical investigation, 
g. if appropriate, subjects enrolled in the clinical investigation shall be provided with 
some means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures 
(contact address and telephone numbers shall be provided), 
h. inform, with the subject's approval or when required by national regulations, the 
subject's personal physician about the subject's participation in the clinical 
investigation, and 
i. 
make all reasonable efforts to ascertain the reason(s) for a subject's premature 
withdrawal from the clinical investigation while fully respecting the subject's rights. 
8. Safety reporting. The Principal Investigator shall: 
a. record every adverse event and observed device deficiency, together with an 
assessment, 
b. report to the Sponsor, without unjustified delay, all serious adverse events and device 
deficiencies that could have led to a serious adverse device effect; this information 
shall be promptly followed by detailed written reports, as specified in the protocol, 
c. c) report to the IEC serious adverse events and device deficiencies that could have led 
to a serious adverse device effect, if required by the national regulations or protocol or 
by the IEC, 
d. report to regulatory authorities, serious adverse events and device deficiencies that 
could have led to a serious adverse device effect, as required by the national regulations, 
and supply the Sponsor, upon Sponsor's request, with any additional information 
related to the safety reporting of a particular event.