Prospective, Multi-Center, Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair
Conditions: Rotator Cuff
Sponsor: Smith & Nephew, Inc.

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 1 of 74   
 
 
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, Inc. 150 Minuteman Road, Andover, MA 
01810 
Investigational Product(s) 
HEALICOIL  Knotless Suture Anchor 
HEALICOIL Knotless PEEK Self-Tapping  
HEALICOIL Knotless PEEK Non-Self Tapping 
HEALICOIL Knotless REGENESORB  Self-Tapping 
HEALICOIL Knotless REGENESORB Non-Self Tapping 
Single Identification Number of 
Clinical Investigation 
Not applicable   
Protocol Author(s): 
Rob Bedford, Senior Clinical Study Manager 
Michelle Foster, Senior Biostatistician  
Stephan Mangin, Director, Clinical Strategy, Sports 
Med/ENT 
 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 2 of 74   
 
 
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 SIGNATURES 
1.1  Principal Investigator Signature Page 
This page will be returned to Smith + Nephew, Inc. and a copy retained at the investigational site. 
I have read the attached protocol entitled Prospective, Multi-Center, Post-Market Clinical 
Follow-up Study to Evaluate Safety and Performance of the HEALICOIL  Knotless Suture Anchor in 
Shoulder Rotator Cuff Tendon Repair  version 3.0, dated 25Feb2021 and agree to abide by all 
provisions set forth herein. 
I agree to comply 
Section 22.5 of 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, Inc. 
Name, Address, Professional Position 
Signature and Date / DocuSign Stamp 
 
 
 
 

Clinical Protocol - Device
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair
Version: 3.0 25Feb2021
Page: 3 of 74
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
1.2 Coordinating Investigator Approval
I have read the attached protocol entitled Prospective, Multi-Center, Post-Market Clinical 
Follow-up Study to Evaluate Safety and Performance of the HEALICOIL Knotless Suture 
Anchor in Shoulder Rotator Cuff Tendon Repair
version 3.0, dated 25Feb2021, and agree to 
abide by all provisions set forth therein.
Name, Address, Professional Position
Signature and Date / DocuSign Stamp

Clinical Protocol - Device
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair
Version: 3.0 25Feb2021
Page: 4 of 74
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
1.3 Sponsor Approval
Name and Title
Signature and Date / DocuSign Stamp
Head of Global Clinical 
Operations
Rachael Winter 
Head of Global Clinical Strategy
Stephan Mangin 
Head of Global Data Analytics
Alan Rossington 
Medical Affairs Representative
Luca Orlandini

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 5 of 74   
 
 
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 SYNOPSIS 
Title of Study: 
Prospective, Multi-Center, Post-Market Clinical Follow-up Study to 
Evaluate Safety and Performance of the HEALICOIL  Knotless Suture 
Anchor in Shoulder Rotator Cuff Tendon Repair 
Study Design: 
Prospective, multi-center, non-randomized clinical trial  
 
160 subjects at up to 6 sites 
 
2 groups: HEALICOIL Knotless PEEK and HEALICOIL 
Knotless REGENESORB  
 
Follow up: 6 and 12 months for HEALICOIL Knotless PEEK Self-
Tapping, HEALICOIL Knotless PEEK Non-Self Tapping, and 
HEALICOIL Knotless REGENESORB Self-Tapping subgroups and 
6, 12, and 24 months for HEALICOIL Knotless REGENESORB Non 
Self-Tapping subgroup 
Study Type: 
Observational, prospective, multi-center, non-randomized clinical 
follow-up study 
Study Product:  
HEALICOIL Knotless Suture Anchor: 
SKU 72205138 HEALICOIL Knotless PEEK Self-Tapping (ST) 
SKU 72205137 HEALICOIL Knotless PEEK Non-Self Tapping (NST) 
SKU 72205136 HEALICOIL Knotless REGENESORB (RG) ST  
SKU 72205135 HEALICOIL Knotless RG NST 
Comparison Group(s)*: 
(*if applicable) 
No comparator treatment will be used for this study 
Study Purpose: 
The purpose of this study is to assess safety and performance by 
product variant of HEALICOIL Knotless Suture Anchor. 
Primary Objective: 
The primary objective of this study is to assess repair failure rate 
defined as the need for a second repair procedure at 6 months. 
 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 6 of 74   
 
 
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 
Secondary Objective(s): 
The secondary objectives are: 
 
Assess post-operative repair failure rates defined as the need for a 
second repair procedure  
 
Access clinical performance with patient-reported outcomes  
 
To characterize tendon thickening and REGENESORB material 
resorption at 6 months and 24 months in the HEALICOIL Knotless 
REGENESORB NST subgroup 
 
To characterize the MRI tendon re-tear rates at 6 months and 24 
months in the HEALICOIL Knotless REGENESORB NST subgroup 
Sample Size: 
The sample size for this study is determined based on the feasibility of 
recruitment, enrollment and follow-up considerations. The study is 
therefore not powered for any statistical hypothesis testing but will be 
able to estimate a clinical success rate of 91% with a 95% confidence 
interval of 80% to 100%. Enrolling between 60 and 80 subjects per 
variant would provide probability greater than 90%.  
 
HEALICOIL Knotless PEEK patients: Minimum N=60, Maximum N=80 
HEALICOIL Knotless REGENESORB 
patients: Minimum N=60, Maximum 
N=80Enrollment distribution will ensure 
that all variants are represented in the 
patient population:HEALICOILKnotless 
Suture Anchor 
Minimum
Maximum 
HEALICOIL Knotless PEEK Self-Tapping  
30 
40 
HEALICOIL Knotless PEEK NST 
30 
40 
HEALICOIL Knotless RG Self -Tapping 
30 
40 
HEALICOIL Knotless RG NST 
30 
40 
The statistical plan will provide a detailed approach of the statistical 
analysis that will be conducted on two independent subgroups: the 
HEALICOIL Knotless PEEK anchor group (2 variants, 60-80 patients) 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 7 of 74   
 
 
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 
and the HEALICOIL Knotless REGENESORB anchor group (2 variants, 
60-80 patients). 
Number of Study Sites: 
Up to 6 study sites 
Targeted Global Regions: United States / Canada (*) 
(*) Participation of Canada sites will be contingent on timeline for Health Canada 
approval
Inclusion Criteria: 
Subjects will be considered qualified for enrolment if they meet the 
following criteria: 
1. Requires reattachment of soft tissue to bone for the following 
shoulder indications: 
a. Rotator Cuff Tendon repair: 
i. Single or double row rotator cuff repair using 
HEALICOIL Knotless PEEK NST, HEALICOIL Knotless 
PEEK Self-Tapping, or HEALICOIL Knotless RG Self-
Tapping; OR 
ii. Double row rotator cuff repair using HEALICOIL 
Knotless RG NST in lateral row (existing HEALICOIL 
RG device to be used in medial row of the repair); 
AND/OR 
b. Biceps tenodesis   
i. In conjunction with Rotator Cuff Tendon repair using 
HEALICOIL Knotless PEEK NST, HEALICOIL Knotless 
PEEK Self-Tapping, HEALICOIL Knotless RG NST or 
HEALICOIL Knotless RG Self-Tapping OR 
ii. As a stand-alone procedure for HEALICOIL Knotless 
PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, 
or HEALICOIL Knotless RG Self-Tapping (not 
HEALICOIL Knotless RG NST 
 
 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 8 of 74   
 
 
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. Has a pre-operative MRI collected within 6 months of surgery 
which meets one of the following criteria:  
a. MRI collected as standard-of-care has been submitted to 
external imaging vendor and confirmed as acceptable OR 
b. If standard-of-care images are unavailable or considered 
unacceptable by external imaging vendor, subject must 
undergo an additional study-specific pre-operative MRI, 
confirmed as acceptable by external imaging vendor OR 
c. MRI not required; subject not in HEALICOIL Knotless 
RG NST subgroup 
3. Has consented to participate in the study by signing the IRB/IEC 
approved informed consent form. 
4. Requires only one variant of the HEALICOIL Knotless Suture 
Anchor 
5. 
 
6. Willing and able to make all required study visits    
7. Able to follow instructions (Approved translated documents 
supplied upon request) 
Exclusion Criteria: 
Any one (1) of the following criteria will disqualify a potential subject 
from participation in the study: 
1. Known hypersensitivity to the implant material. Where material 
sensitivity is suspected, appropriate tests should be made and 
sensitivity ruled out prior to implantation. 
2. Pathological conditions of bone, such as cystic changes or severe 
osteopenia, which would compromise secure anchor fixation. 
3. Pathological conditions in the soft tissues to be attached that 
would impair secure fixation by suture. 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 9 of 74   
 
 
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 
4. Comminuted bone surface, which would compromise secure 
anchor fixation. 
5. Physical conditions which would eliminate, or tend to eliminate, 
adequate anchor support or retard healing. 
6. The presence of infection. 
7. 
restrict activities or follow directions during the healing period. 
8. Concurrent bilateral surgery. 
9. Participation in the treatment period of another clinical trial within 
thirty (30) days of Visit 1, or during the study. 
10.Women who are pregnant.  
11.Prior ipsilateral surgeries performed on the joint space. 
12.Subjects with a medical or physical condition that, in the opinion 
of the Investigator, would preclude safe subject participation in 
the study. 
Study Duration: 
Total study timeline: 36 months  
Enrollment period: 12 months 
Follow-up period: 6 and 12 months for HEALICOIL Knotless PEEK Self-
Tapping, HEALICOIL Knotless PEEK NST, and HEALICOIL Knotless RG 
Self-Tapping subgroups and 6, 12, and 24 months for HEALICOIL 
Knotless RG NST subgroup 
Primary endpoint: 
Assess repair failure rate defined as the need for a second repair 
procedure at 6 months 
Secondary endpoint(s): 
All endpoints to be collected and analyzed on all subjects: 
 
Repair failure rate at 12 months (and 24 months for the HEALICOIL 
Knotless RG NST subgroup). Repair failure rate is defined as the 
need for a second repair procedure. 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 10 of 74   
 
 
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 
 
Constant-Murley Score at 6 months and 12 months (24 months for 
the HEALICOIL Knotless RG NST subgroup) 
 
American Shoulder and Elbow Surgeons (ASES) scale at 6 months 
and 12 months (24 months for the HEALICOIL Knotless RG NST 
subgroup) 
 
ASES Visual Analog Scale (VAS) pain score at 6 months and 12 
months (24 months for the HEALICOIL Knotless RG NST subgroup) 
 
Single Assessment Numeric Evaluation (SANE) Shoulder scale at 6 
months and 12 months (24 months for the HEALICOIL Knotless RG 
NST) 
 
EQ-5D-3L at 6 months and 12 months (24 months for the 
HEALICOIL Knotless RG NST) 
 
Only for the HEALICOIL Knotless RG NST subgroup -  MRI to 
determine tendon thickening and anchor absorption/replacement by 
bone at 6 months and 24 months 
 
Only for the HEALICOIL Knotless RG NST subgroup -  MRI to 
determine tendon re-tear rate at 6 months and 24 months 
Other exploratory 
endpoint(s): 
Not applicable  
Safety Data 
 
All adverse events (AEs) and complications occurring from the time 
of surgical implantation until study termination or study completion 
including intra-operative adverse events and complications 
 
Device Deficiencies  
 
 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 11 of 74   
 
 
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  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Visit Type/name 
Frequency/Time point 
Pre-Operative 
 
Operative through Discharge/Visit 2  
Day 0 - Surgery 
Follow-up/ Visit 3 
6 months (± 30 days) post-surgery 
Follow-up/Visit 4  
12 months (± 30 days) post-surgery 
Follow-up/Visit 5 for 30-40 HEALICOIL 
Knotless RG NST subjects
24 months (± 60 days) post-surgery 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 12 of 74   
 
 
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 CONTENTS  
3.1 Table of Contents 
1 SIGNATURES .................................................................................................................. 2 
1.1 Principal Investigator Signature Page .......................................................................... 2 
1.2 Coordinating Investigator Approval ............................................................................. 3 
1.3 Sponsor Approval ...................................................................................................... 4 
2 SYNOPSIS ...................................................................................................................... 5 
3 CONTENTS ................................................................................................................... 12 
3.1 Table of Contents .................................................................................................... 12 
3.2 List of Tables .......................................................................................................... 15 
3.3 List of Figures ......................................................................................................... 15 
3.4 List of Abbreviations and Definitions .......................................................................... 15 
4 INTRODUCTION ............................................................................................................ 17 
4.1 Background ............................................................................................................ 17 
4.2 Literature Summary ................................................................................................ 18 
4.3 Study Purpose ........................................................................................................ 20 
4.4 Safety Consideration ............................................................................................... 21 
5 OBJECTIVE(S) ............................................................................................................... 21 
5.1 Primary Objective ................................................................................................... 21 
5.2 Secondary Objective(s)............................................................................................ 21 
5.3 Claims ................................................................................................................... 22 
6 INVESTIGATIONAL PRODUCT(S) ..................................................................................... 22 
6.1 Identification .......................................................................................................... 22 
6.2 Product Use ............................................................................................................ 27 
6.3 Packaging and Labelling ........................................................................................... 27 
6.4 Product Accountability Procedures ............................................................................. 28 
6.5 Surgical Technique .................................................................................................. 28 
7 SUBJECT ENROLLMENT AND WITHDRAWAL ...................................................................... 28 
7.1 Subject Population .................................................................................................. 28 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 13 of 74   
 
 
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 
7.2 Inclusion Criteria .................................................................................................... 29 
7.3 Exclusion Criteria .................................................................................................... 30 
7.4 Screening .............................................................................................................. 31 
7.5 Informed Consent ................................................................................................... 31 
7.6 Enrollment ............................................................................................................. 32 
7.7 Lost to Follow-up .................................................................................................... 32 
7.8 Withdrawal ............................................................................................................. 33 
8 STUDY DESIGN ............................................................................................................. 34 
8.1 Study Design .......................................................................................................... 34 
8.2 Allocation and Blinding ............................................................................................ 35 
8.3 Data Management ................................................................................................... 35 
8.4 Study Endpoints ..................................................................................................... 35 
8.5 Methods Used to Minimize Bias and Maximize Validity .................................................. 36 
9 STUDY PROCEDURES ..................................................................................................... 37 
9.1 Visits and Examinations ........................................................................................... 37 
9.2 Study Methods and Measurements ............................................................................ 44 
9.3 Health Economics/Quality of Life ............................................................................... 45 
10 STATISTICAL DESIGN .................................................................................................. 46 
10.1 General ................................................................................................................ 46 
10.2 Analysis Populations .............................................................................................. 46 
10.3 Baseline Data ....................................................................................................... 46 
10.4 Efficacy Analysis ................................................................................................... 46 
10.5 Safety Analyses .................................................................................................... 47 
10.6 Interim Analyses ................................................................................................... 48 
11 SAMPLE SIZE JUSTIFICATION ....................................................................................... 48 
12 ADVERSE EVENTS AND DEVICE DEFICIENCIES ............................................................... 49 
12.1 Definitions (ISO/DIS 14155:2018) .......................................................................... 49 
12.2 AE Coding Dictionary ............................................................................................. 53 
12.3 Reporting procedures ............................................................................................ 53 
12.4 Unblinding of Investigational Product ....................................................................... 56 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 14 of 74   
 
 
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 
12.5 Follow-up of Subjects with Adverse Events ............................................................... 56 
13 INVESTIGATOR OBLIGATIONS ...................................................................................... 57 
14 SPONSOR AND MONITOR RESPONSIBILITIES ................................................................. 57 
14.1 Contract Research Organization .............................................................................. 57 
14.2 Site Qualification Visit ............................................................................................ 58 
14.3 Site Initiation Visit ................................................................................................. 58 
14.4 Interim Monitoring Visit ......................................................................................... 58 
14.5 Sponsor Audits and Regulatory Inspection ................................................................ 58 
14.6 Close-Out Visit ...................................................................................................... 58 
15 PROTOCOL DEVIATIONS ............................................................................................... 59 
16 PROTOCOL AMENDMENTS ............................................................................................ 59 
17 CONFIDENTIALITY OF THE STUDY ................................................................................. 59 
18 STATEMENTS OF COMPLIANCE ...................................................................................... 59 
19 END OF STUDY ............................................................................................................ 60 
20 PUBLICATION POLICY .................................................................................................. 60 
20.1 Publication of Study Data ....................................................................................... 60 
20.2 Data Sharing ........................................................................................................ 60 
21 REFERENCES .............................................................................................................. 61 
22 APPENDICES ............................................................................................................... 63 
22.1 Protocol Amendment 2 ........................................................................................... 63 
22.2 Instructions for Use ............................................................................................... 68 
22.3 Equipment and Special Instructions ......................................................................... 68 
22.4 Health Economic Outcome Measures/Quality of Life measures .................................... 68 
22.5 Principal Investigator Obligations (ISO14155:2011) .................................................. 69 
 
 
 
 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 15 of 74   
 
 
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 
3.2 List of Tables 
Table 9.1.1-1: Study Procedures by Visit ............................................................................................. 38
Table 11-1: Enrollment Distribution .................................................................................................... 48
Table 12.1-1: Categories of Adverse Event .......................................................................................... 49
 
3.3  List of Figures 
Figure 4.2-1 T2-weighted coronal image at the midpoint (anteroposterior) of the supraspinatus fossa. dMTJ, 
distance from MTJ to glenoid face; GFL, glenoid face line; MTJ, musculotendinous junction; TL, tendon 
length; TR, tendon retraction. ............................................................................................................ 19
Figure 6.1.1-1: Product Description .................................................................................................... 23
Figure 6.1.1-2: Investigational Product ............................................................................................... 25
Figure 12.3-1: Evaluation and Reporting of AE ..................................................................................... 55
Figure 12.3-2: Evaluation and Reporting of DD .................................................................................... 56
 
3.4  List of Abbreviations and Definitions 
Abbreviation 
Definition 
ADE 
Adverse Device Effect(s) 
AE
Adverse Event(s) 
ASES                          
American Shoulder and Elbow Surgeons 
BSI
British Standards Institute 
CER
Clinical Evaluation Report 
CMS
Constant-Murley Shoulder 
CRF 
Case Report Form(s) 
CRO
Contract Research Organization 
DD 
Device Deficiency(ies) 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 16 of 74   
 
 
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 
FAS
Full Analysis Set Population 
FDA
Food and Drug Administration 
FU 
Follow-Up 
GCP 
Good Clinical Practice 
HIPAA 
Health Information Portability Accountability Act 
IB 
 
ICH
International Conference on Harmonisation  
IEC
Independent Ethics Committee 
IFU 
Instructions for Use 
IP 
Investigational Product  
IRB 
Institutional Review Board 
ISF
Investigator Site File 
MRI  
Magnetic Resonance Imaging   
NA or N/A 
Not Applicable 
N (or n) 
Total Sample Size (or subgroup sample size) 
NST 
Non Self-Tapping  
PI 
Principal Investigator 
PT 
Physical Therapy  
S+N 
Smith + Nephew, Inc. 
SADE 
Serious Adverse Device Effect(s) 
SAE 
Serious Adverse Event(s) 
SAF
Safety population 
SANE 
Single Assessment Numeric Evaluation 
SAP 
Statistical Analysis Plan 
ST                                     Self-Tapping  
TX  
Treatment  
USADE 
Unanticipated Serious Adverse Device Effect(s) 
VAS 
Visual Analog Scale  

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 17 of 74   
 
 
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 
4 INTRODUCTION 
 
4.1 Background 
Disease/Medical Condition State: Rotator Cuff tears 
The shoulder is a ball and socket joint that is subject to repeated overhead movement common to 
routine and sports activities. Rotator cuff tears are injuries to the tendons involved in shoulder joint 
motion. The integrity of the rotator cuff repair site after surgical treatment of full-thickness rotator 
cuff tears has been shown to correlate with clinical improvement, particularly the return of 
strength. Therefore, rotator cuff tears should be fully repaired. After arthroscopic rotator cuff 
repair, numerous studies have reported excellent clinical outcomes. However, long-term restoration 
of a functional, completely healed rotator cuff may not be always attainable in primary rotator cuff 
repair, and retears occur frequently after arthroscopic repairs. The causes for retears vary and 
include poor quality of tendon tissue, pullout of suture anchor, suture breakage, and inappropriate 
rehabilitation. The commonly cited mechanism of failure of suture anchor-based rotator cuff repairs 
in most reports was failure of the repair construct, leading to repair site gapping. In an effort to 
improve the biomechanics of rotator cuff repair constructs, advances in repair techniques are 
needed to optimize the healing environment after repair to facilitate restoration of function.2 
Current Treatment 
Rotator Cuff Repair 
Treatments for rotator cuff surgery can vary depending on the size of the tear, duration of 
symptoms, failure/duration of nonoperative treatment, nocturnal pain, history of trauma, and 
limitation of daily activities.2  Patient activity level and patient expectations are important 
considerations when recommending treatment for rotator cuff tears.14  
Several non-operative treatments exist and are considered effective such as physical therapy (PT), 
anti-inflammatory medications, and cortisone injections.9 Non-operative treatment has shown to be 
effective in 75% of full-thickness atraumatic rotator cuff tears.2 The patients who fail nonoperative 
treatment usually fail within the first 12 weeks of their PT program.2 A 6-12 week structure physical 
therapy program should be generally prescribed prior to surgery for patients with atraumatic, 
symptomatic, full thickness rotator cuff tears. While conservative treatment is a good option for some 
patients, it is difficult to speculate which patients, or which tears will respond best to conservative 
treatment alone. 9 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 18 of 74   
 
 
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 
Rotator cuff repair techniques can vary depending on the type of tear and the tendon(s) affected: 
supraspinatus, infraspinatus, subscapularis, and teres. Techniques used include single row or double 
row repair. Recent studies on structural healing after double row repair show superior biomechanical 
characteristics and lower rate (11%-17%) of recurrent tears.2 
Biceps Tenodesis 
Indications for tenodesis of the biceps tendon include pain associated with significant tenosynovitis, 
pre-rupture of the tendon, subluxation, and dislocation. This treatment typically also is implemented 
-
2 Biceps tenodesis can be performed either in an open or 
arthroscopic technique. The patient should be positioned in either the lateral decubitus or beach chair 
position, however the beach chair position allows for easier control of the shoulder and elbow flexion 
and rotation during the procedure. The biceps tendon is exteriorized anteriorly, doubled on itself, and 
then inserted into a humeral socket, which is drilled at the top of the bicipital groove and fixed with 
an implant.1 Interference screws or suture anchors can be used for the procedure. There are several 
techniques options, one difference is to either push or pull the biceps tendon long head into the 
humeral socket.  
 
Typically, in patients treated for biceps tenodesis, full passive and active elbow flexion, extension, 
supination and pronation are allowed on the same day as surgery, with no immobilization. Elbow 
activities under stress or resistance are restricted for 6 weeks after the tenodesis procedure.1 
4.2 Literature Summary 
HEALICOIL Knotless PEEK and REGENESORB suture anchors are new products and there is no 
literature available for these devices. This study will provide evidence for all indications support CE 
marking of the project under MDR. In addition to that, this study will provide evidence related to 
clinical literature on Arthroscopic Rotator Cuff Repair: the general question often asked in the 
literature is: Is the Repair Integrity Actually Maintained?2 Recently, arthroscopic repair has been 
widely accepted for treatment of rotator cuff tears, with equal or better results than those from 
open repair reported. With recent arthroscopic instrument development and wide surgical 
experience, most symptomatic tears of the rotator cuff can be managed successfully by an 
arthroscopic approach. However, technical advances to optimize the healing at a repaired rotator 
cuff insertion are needed for improving the outcome.2 Retears may occur after arthroscopic rotator 
cuff repair with a retear rate as high as 94%.6 In an effort to prevent retears, new operative 
techniques and new devices (such as the HEALICOIL Knotless Suture Anchor System) have evolved 
with time. Re-tear Type will be graded in accordance with the following definitions, adapted from 
Ellman et al.: Intact (No evidence of tendon tear), Low-grade Partial-Thickness Tear (covering 
<50% of the tendon thickness), Bursal or Articular, High-grade Partial-Thickness Tear (covering 
) and finally Full-Thickness Tear (Complete tear of the tendon) with 
this study focusing on the last category.4 Finally, there is some literature (albeit more limited) on 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 19 of 74   
 
 
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 
pre-operative tendon retraction and position of the Musculotendinous Junction (MTJ) of the 
supraspinatus tendon after initial repair: this study will contribute to the published evidence that 
suggests those factors impact greatly the clinical success outcome of the repair.13 
Figure 4.2-1 T2-weighted coronal image at the midpoint (anteroposterior) of the 
supraspinatus fossa. dMTJ, distance from MTJ to glenoid face; GFL, glenoid face line; 
MTJ, musculotendinous junction; TL, tendon length; TR, tendon retraction. 
 
 
Finally, there are well known factors that predispose patients to a failed rotator cuff repair: those 
are muscle fatty degeneration or fatty infiltration as well as muscle atrophy.5,7,8 The overall quality 
of the rotator cuff repair will also rely on the well published literature on the Sugaya tendon repair 
classification.12 
 
 
 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 20 of 74   
 
 
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 
4.3 Study Purpose 
The purpose of this post-market study is to assess safety and performance by product variant of 
HEALICOIL Knotless Suture Anchor.This study will be conducted to obtain the Conformité 
Européene (CE) Mark and will submitted to the EU for consideration.  
The study has two main purposes: 
-
To meet EU pre-market and PMCF requirements for the HEALICOIL Knotless Suture Anchor 
product: the data on PEEK variants (NST and ST) will be considered PMCF data since those 
are already CE-marked by self-certification. The data on REGENESORB are critical to support 
an EU submission and are to be reviewed by the notified body BSI prior to CE marking 
approval. 
-
To support marketing claims on double row tendon repair performed with the HEALICOIL RG 
NST variant. Claims will be supported by collecting MRI imaging data on early tendon repair 
healing and anchor material resorption with new bone formation (6 months and 24 months) 
 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 21 of 74   
 
 
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 
4.4 Safety Consideration 
The following clinical performance and benefits are anticipated with the HEALICOIL Knotless Suture 
Anchor: 
The  HEALICOIL  Knotless  Suture  Anchor  functions  to  restore  the  rotator  cuff  and  biceps  
anatomy and allow healing of the tendon back onto the tendon-bone footprint 
The  HEALICOIL  Knotless  Suture  Anchor  result  in  improved  patient  reported  outcomes  
following RC repair or biceps tenodesis procedures 
The HEALICOIL  Knotless  Suture  Anchor  (REGENESORB  only) resorb over time and allow 
for easy revision in repeat procedures 
The open architecture of the HEALICOIL Knotless Suture Anchor results in accelerated tendon 
healing and thickening at 6 months post-operatively 
During causality assessment activity (assessment of Unanticipated vs Anticipated), clinical 
judgement shall be used and relevant documents, such as the Instructions for Use (IFU) shall be 
consulted, as foreseeable serious adverse events and the potential risks are summarized 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. 
 
5 OBJECTIVE(S) 
The primary, secondary, and safety objectives of this study are listed as follows. 
5.1 Primary Objective 
The primary objective of this study is to assess repair failure rate defined as the need for a second 
repair procedure at 6 months. 
5.2  Secondary Objective(s) 
The secondary objectives are to: 
Assess post-operative repair failure rates defined as the need for a second repair procedure 
Access clinical performance as assessed with patient-reported outcomes  

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 22 of 74   
 
 
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 characterize tendon thickening and REGENESORB material resorption at 6 months and 24 
months in the HEALICOIL Knotless REGENESORB NST subgroup  
To characterize the MRI tendon re-tear rates at 6 months and 24 months in the HEALICOIL 
Knotless REGENESORB NST subgroup 
 
5.3  Claims 
1. Improved tendon healing with HEALICOIL REGENESORB and HEALICOIL Knotless REGENESORB 
a. Captured by looking at tendon thickness at the 6 month mark and other MRI imaging 
endpoints such as Sugaya repair healing classification, tendon footprint coverage and other 
tendon morphological features 
2. Complete or near complete absorption for the REGENESORB material  
b. Captured via MRI at 6 months and 24 months as well as capturing under MRI new bone 
formation, bone in-growth and absence of osteolysis      
6 INVESTIGATIONAL PRODUCT(S) 
HEALICOIL Knotless REGENESORB Suture Anchor and HEALICOIL Knotless PEEK Suture Anchors 
are expressly used for reattachment of soft tissue to bone for either rotator cuff tendon repair or 
biceps tenodesis.  
6.1  Identification 
6.1.1  Investigational Product(s) 
HEALICOIL Knotless PEEK Suture Anchor Non Self-Tapping and Self-Tapping  
 
The HEALICOIL Knotless Suture Anchor consists of an anchor on an inserter fitted with a suture 
threader and insertion accessory instrument. The device consists of the following components: a 

Clinical Protocol - Device
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair
Version: 3.0 25Feb2021
Page: 23 of 74
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
proximal implant composed of PEEK, a distal implant (PEEK or Titanium), and a non-absorbable 
internal PEEK plug. 
The anchor is preloaded on a stainless steel inserter. This device is to be used with Smith & 
Nephew ULTRABRAID, ULTRAPE, and MINITAPE Sutures.
HEALICOIL Knotless REGENESORB Suture Anchor Non-Self-Tapping and Self-Tapping 
The HEALICOIL Knotless REGENESORB Suture Anchor is a fixation device intended to provide 
secure reattachment of soft tissue to bone. The device consists of a knotless suture anchor 
assembled on to an insertion device. The device is to be used with Smith & Nephew ULTRABRAID, 
ULTRATAPE, and MINITAPE Sutures. This device is provided sterile, for single use only.
HEALICOIL Knotless REGENESORB is made from PLGA (poly (lacticcoglycolic acid)), ß-TCP (beta 
tricalcium phosphate), and calcium sulfate.
Figure 6.1.1-1: Product Description
Refer to the HEALICOIL Knotless Suture Anchor Instructions for Use for more information.
Contraindications for use include the following:

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 24 of 74   
 
 
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 
 
Known hypersensitivity to the implant material. Where material sensitivity is suspected, 
appropriate tests should be made and sensitivity ruled out prior to implantation. 
 
Pathological conditions of bone, such as cystic changes or severe osteopenia, which would 
compromise secure anchor fixation.  
 
 
 
 

Clinical Protocol - Device
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair
Version: 3.0 25Feb2021
Page: 25 of 74
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 6.1.1-2: Investigational Product
Refer to the HEALICOIL Knotless Suture Anchor Instructions for Use for more information.
Contraindications for use include the following:
Known hypersensitivity to the implant material. Where material sensitivity is suspected, 
appropriate tests should be made and sensitivity ruled out prior to implantation.

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 26 of 74   
 
 
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 
 
Pathological conditions of bone, such as cystic changes or severe osteopenia, which would 
compromise secure anchor fixation.  
 
Pathological conditions in the soft tissues to be attached that would impair secure fixation by 
suture.  
 
Comminuted bone surface, which would compromise secure anchor fixation.  
 
Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or 
retard healing.  
 
The presence of infection. 
 
lingness to restrict activities or follow 
direction during the healing period.  
 
Contraindications may be relative or absolute and must be carefully weighed against the 
 
 
The legal manufacturer for the HEALICOIL Knotless device is: 
 
Smith + Nephew, Inc. 
150 Minuteman Rd. 
Andover, MA 01810 
6.1.2 Comparator Treatment 
No comparator treatment will be used for this study.  
6.1.3 Ancillary Product 
There are two ancillary products provided for the conduct of this study. All sites will be provided 
with at least one Manual Muscle Tester (MMT), often referred to as a dynamometer, packaged in a 
Pelican type storage case. MMTs are ergonomic devices used to objectively quantify muscle 
strength. Additionally, all sites will be provided with at least one long-arm isometric goniometer 
which is used to measure joint range of motion. Both devices are required to complete the 
Constant-Murley score at the pre-op and follow-up visits.   
 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 27 of 74   
 
 
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 
6.2 Product Use 
Refer to the HEALICOIL Knotless Suture Anchor Instructions for Use (IFU) for detailed information 
on contraindications, warnings, adverse reactions and precautions.  
Sites that are familiar with the use of the study device will be selected or will receive training prior 
to enrolling any subjects per standard Smith + Nephew procedures if not familiar; no additional 
training is required. 
6.3  Packaging and Labelling 
Packaging and labeling will be as per commercially available and will meet regulatory requirements. 
6.3.1 Labelling of Investigational Product 
The HEALICOIL Knotless Suture Anchors have received 510k clearance in the United States. All 
devices used in this study will be procured in standard commercial packaging, ordered via normal 
and customary Smith + Nephew procedures and managed per study site processes. 
The HEALICOIL Knotless Suture Anchors contain the following information:  
Lot number  
Catalog Number 
Unique Device Identifier 
Package contents 
Use by Date 
Date of Manufacture 
Distributor information: Smith + Nephew, Inc. 
Manufacturer name and address 
Product name and cartridge size 
Customer service contact information 
Product sale restriction 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 28 of 74   
 
 
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 
6.4 Product Accountability Procedures 
As this is a post-market study, the sites will be responsible for obtaining and maintaining an 
inventory of HEALICOIL Knotless Suture Anchors. Sites will document the device that was used in a 
subject on a Case Report Form (CRF) that will include batch, lot, and UDI numbers. The CRFs will 
also document any device deficiencies, including if any products were wasted or returned to the 
Sponsor. All records must be available for inspection by the Sponsor, its designees, or by 
regulatory agencies at any time. As part of monitoring, the Study Monitor will check that site 
personnel are following the proper procedures for completing all necessary documentation.  
6.5 Surgical Technique 
All study related procedures with the HEALICOIL Knotless Suture Anchor must be performed 
according to the recommended surgical technique described in the IFU.  
Surgeons selected to participate in this study will be familiar with implanting HEALICOIL Knotless 
Suture Anchors and have written evidence of training and expertise in the study procedure. Sites 
not familiar with this product will receive and show evidence of training prior to activation per S+N 
procedures.  
 
7 SUBJECT ENROLLMENT AND WITHDRAWAL 
 
7.1  Subject Population 
This study will enroll a minimum of 30 and a maximum of 40 subjects for each variant of the 
HEALICOIL Knotless Suture Anchor treated for either rotator cuff repair and/or biceps tenodesis.  
Ethnic minorities are classed as vulnerable subjects according to ISO 14155:2011; however they 
will be included providing they meet other inclusion criteria and there are informed consent 
documents and personnel to lead the consent process in a language that is fully understood by the 
potential subject.  

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 29 of 74   
 
 
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 
7.2 Inclusion Criteria 
Subjects will be considered qualified for enrollment if they meet the following criteria: 
1.
Requires reattachment of soft tissue to bone for the following shoulder indications: 
a. Rotator Cuff Tendon repair: 
i. Single or double row rotator cuff repair using HEALICOIL Knotless PEEK 
NST, HEALICOIL Knotless PEEK Self-Tapping, or HEALICOIL Knotless RG 
Self-Tapping; OR 
ii. Double row rotator cuff repair using HEALICOIL Knotless RG NST in lateral 
row (existing HEALICOIL RG device to be used in medial row of the 
repair); AND/OR 
b. Biceps tenodesis  
i. In conjunction with Rotator Cuff Tendon repair using HEALICOIL Knotless 
PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, HEALICOIL Knotless 
RG NST or HEALICOIL Knotless RG Self-Tapping OR 
ii. As a stand-alone procedure for HEALICOIL Knotless PEEK NST, HEALICOIL 
Knotless PEEK Self-Tapping, or HEALICOIL Knotless RG Self-Tapping (not 
HEALICOIL Knotless RG NST 
2.
Has a pre-operative MRI collected within 6 months of surgery which meets one of the 
following criteria:  
a. MRI collected as standard-of-care has been submitted to external imaging 
vendor and confirmed as acceptable OR 
b. If standard-of-care images are unavailable or considered unacceptable by 
external imaging vendor, subject must undergo an additional study-specific pre-
operative MRI, confirmed as acceptable by external imaging vendor OR 
c. MRI not required; subject not in HEALICOIL Knotless RG NST subgroup 
 
3.
Has consented to participate in the study by signing the IRB/IEC approved informed consent 
form. 
4.
Requires only one variant of the HEALICOIL Knotless Suture Anchor 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 30 of 74   
 
 
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.
 
6.
Willing and able to make all required study visits    
7.
Able to follow instructions (Approved translated documents supplied upon request) 
7.3 Exclusion Criteria 
Any one (1) of the following criteria will disqualify a potential subject from participation in the 
study: 
1.
Known hypersensitivity to the implant material. Where material sensitivity is suspected, 
appropriate tests should be made and sensitivity ruled out prior to implantation. 
2.
Pathological conditions of bone, such as cystic changes or severe osteopenia, which would 
compromise secure anchor fixation. 
3.
Pathological conditions in the soft tissues to be attached that would impair secure fixation by 
suture. 
4.
Comminuted bone surface, which would compromise secure anchor fixation. 
5.
Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or 
retard healing 
6.
The presence of infection. 
7.
directions during the healing period. 
8.
Concurrent bilateral surgery. 
9.
Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, 
or during the study. 
10.
Women who are pregnant. 
11.
Prior ipsilateral surgeries performed on the joint space.  

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 31 of 74   
 
 
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.
Subjects with a medical or physical condition that, in the opinion of the Investigator, would 
preclude safe subject participation in the study. 
7.4 Screening 
Subjects will be recruited for the study through the clinical practices of the Investigators.  
Of the total 120-160 subjects, a minimum of 60 subjects and a maximum of 80 subjects will be in 
the HEALICOIL Knotless PEEK Suture Anchor group (to include 30-40 of the Self-Tapping and 30-40 
of the NST variants) and a minimum of 60 subjects and a maximum of 80 subjects will be in 
HEALICOIL Knotless REGENESORB group (to include 30-40 of the Self-Tapping and 30-40 of the 
NST variants).  Subjects will be enrolled as they meet eligibility, consent to the study, and are 
treated with the study product. Therefore, once a variant has met the 30-40 subjects, screening 
will stop within that group, and screening and enrollment will continue only in the other variants 
until all 120-160 subjects are enrolled.  
Participating study sites are required to document all screened subjects considered for inclusion in 
this study. If a subject is excluded from the study, the reasons for exclusion will be documented in 
the subject's source documents and noted on the Screening and Enrollment Log. All screening 
activities that occur prior to consent shall be referred to as pre-screening.  
woman is not of childbearing potential this should be documented in the medical history (e.g., 
surgically postmenopausal, postmenopausal [i.e., at least one year without menses]). For women 
of childbearing potential, their method of birth control should be documented in the source. 
Acceptable birth control methods include abstinence, condoms, birth control pills, IUDs, and other 
hormonal or physical methods.  
7.5 Informed Consent 
Before conducting any study procedures or examinations, the purpose and nature of the study 
should be explained to the subject in their native language. The subject, or their legally authorized 
representative, will then read, sign, and personally date the IRB/IEC-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, a copy will be placed in the 
or chart as required by the site, with the original filed in the Investigator Site File 
(ISF). 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 32 of 74   
 
 
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 
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 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. 
authorized representative (parent or legal guardian). If the legally authorized representative is 
unable to read/write, a witness signature is required as described previously.  
For sites in the United States, as required by the IRB and the site, all Health Information Portability 
Accountability Act (HIPAA) regulations and documentation will be followed.  
7.6 Enrollment 
Subjects for whom the consent process has been completed and have been treated with the study 
product are considered enrolled. 
Subjects will be assigned a Subject ID at the time of consent. Subjects with bilateral rotator cuff 
tear repairs and/or bicep tenodesis will not be enrolled.  
7.7 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 does not return for a final visit, 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 and one certified letter without 
response. 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 
 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 33 of 74   
 
 
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 
7.8  Withdrawal 
Subjects may be withdrawn from the study per the reasons listed below.  
7.8.1 Withdrawal from Study 
The Investigator may withdraw subjects from the study for many reasons, including but not limited 
to the following: 
Subject noncompliance (e.g., did not follow instructions, took disallowed medications) 
Subject lost to follow-up 
If the Investigator or the Sponsor stops the study for any reason and decides to withdraw 
subject(s) from the study 
Concurrent illness 
Adverse Events/Adverse Device Effects 
Any other significant reason identified by the Investigator 
If a subject receives a revision surgery of the study shoulder, or experiences an AE/SAE/DD, the 
subject shall continue to have follow-
any adverse events/adverse device events are resolved, is lost to follow-up, or until 12 months 
post-surgery for subjects enrolled in the HEALICOIL Knotless PEEK ST and NST and HEALICOIL 
Knotless REGENESORB Self- tapping subgroups and 24 months for the subjects enrolled in the 
HEALICOIL Knotless  REGENESORB NST subgroup. Potential data following the revision surgery will 
not be included as study data but presented separately as safety data. Revision subjects will not be 
replaced. 
For each case, information will be obtained in the source document and entered on the End of 
Study CRF detailing circumstances leading to the withdrawal. 
Subjects who drop out or are withdrawn following enrollment (i.e., treatment with study device) 
will be re-entered into the study at a later date if he or she returns to the site for a subsequent 
follow-up visit, has not received a revision surgery of the study shoulder or was withdrawn for a 
medical reason that is resolved, and the Principal Investigator (PI) agrees to re-entry in the study. 
Subjects who are withdrawn after consent, but prior to enrollment will be replaced. Subjects who 
are withdrawn following enrollment from the study will not be replaced. 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 34 of 74   
 
 
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 
7.8.2 
 
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 
for withdrawal will be recorded in the CRF and source documents. 
If a subject withdrawals following enrollment (i.e., treatment with study device), he/she will not be 
replaced.    
7.8.3 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 except for subjects who have 
consented and have an adverse event that is being followed to resolution or receive a revision 
surgery of the study shoulder as detailed in section 7.8.1 above (until the end of the study).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.  
8 STUDY DESIGN 
8.1  Study Design 
This is a prospective, multi-center, non-randomized clinical trial. The study is divided in to 2 
groups: HEALICOIL Knotless PEEK and HEALICOIL Knotless REGENESORB.  
 
Follow up: 6 and 12 months for HEALICOIL PEEK Self-Tapping, HEALICOIL PEEK Non-Self Tapping, 
and HEALICOIL REGENESORB Self-Tapping subgroups and 6, 12, and 24 months for HEALCOIL 
REGENESORB Non Self-Tapping subgroup.  
 
The study will enroll at up to 6 clinical sites in the United States/ Canada (*) Participation of Canada 
sites will be contingent on timeline for Health Canada approval 
 
The study is expected to be 36 months in duration, but will depend on enrollment rate. This 
includes: 
12 months enrollment 
12 months follow up (HEALICOIL Knotless PEEK ST and NST and REGENESORB ST sub-
groups) 
24 months follow up  (HEALICOIL Knotless REGENESORB  NST sub-group) 
 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 35 of 74   
 
 
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 
This study was designed as a prospective, multi-center, non-randomized study of rotator cuff 
repairs and biceps tenodesis. No formal hypotheses testing will be done. 
 
8.2 Allocation and Blinding 
8.2.1 Treatment Allocation 
This study is not randomized. Selection of the surgical approach (repair using HEALICOIL Knotless 
PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, HEALICOIL Knotless RG NST, or HEALICOIL 
Knotless RG Self-Tapping) will be at the discretion of the Investigator, in consultation with the 
subject, as appropriate. Treatment allocation must follow requirements of inclusion criteria 1 and 4.
To ensure an equal number of subjects are enrolled into each treatment sub-group, the Sponsor 
will continuously monitor enrollment and will close enrollment into the faster enrolling sub-group 
once the targeted enrollment has been reached.  Enrollment into the slower enrolling sub-group will 
continue until the study is fully enrolled.  
8.2.2 Blinding 
This study is not blinded. 
8.3 Data Management 
The study uses an electronic data capture system. Data will be transcribed from the data source to 
an electronic Case Report Form (eCRF). 
8.4 Study Endpoints 
8.4.1 Primary Endpoint 
The primary endpoint of this study is to assess repair failure rate defined as the need for a second 
repair procedure at 6 months. 
8.4.2 Secondary Endpoints 
Following are the secondary endpoints for this study:  
All endpoints to be collected and analyzed on all subjects: 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 36 of 74   
 
 
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 
 
Repair failure rate at 12 months (and 24 months for the HEALICOIL Knotless RG NST 
subgroup). Repair failure rate is defined as the need for a second repair procedure. 
 
Constant-Murley Shoulder scale at 6 months and 12 months (24 months for the HEALICOIL  
Knotless RG NST subgroup) 
 
ASES  scale at 6 months and 12 months (24 months for the HEALICOIL REGENESORB NST 
subgroup) 
 
ASES Visual Analog Scale (VAS) pain score at 6 months and 12 months (24 months for the 
HEALICOIL Knotless RG NST subgroup) 
 
SANE Shoulder scale at 6 months and 12 months (24 months for the HEALICOIL Knotless RG 
NST subgroup) 
 
EQ-5D-3L at 6 months and 12 months (24 months for the HEALICOIL Knotless RG NST) 
 
Only for the HEALICOIL Knotless RG NST subgroup -  MRI to determine tendon thickening 
and anchor absorption/replacement by bone at 6 months and 24 months.  
 
Only for the HEALICOIL Knotless RG NST subgroup -  MRI to determine tendon re-tear rate 
at 6 months and 24 months 
8.4.3 Safety Endpoints 
Following are the safety endpoints for this study:  
 
All adverse events (AEs) and complications occurring from the time of surgical implantation 
until study termination or study completion including intra-operative adverse events and 
complications.  
 
Device Deficiencies 
 
All safety events will be documented on the appropriate CRF and followed either until resolution or 
marked as unresolved at the end of study. All AEs will be categorized in terms of seriousness and 
relatedness to the study device or to the surgical procedure. All Serious Adverse Device Effects will 
be further categorized as Anticipated or Unanticipated. The definitions for each of these categories 
are based on ISO 14155:2020. 
8.5 Methods Used to Minimize Bias and Maximize Validity 
Balanced Covariates 
The inclusion/exclusion criteria will be generalizable and applicable to the widest possible subset of 
the population needing Rotator Cuff Tendon repair and/or Bicep tenodesis procedures. These 
criteria will be uniformly applied so as to enroll a cohort of subjects with similar symptoms and 
clinical requirements. This should maximise the applicability to as many subjects with similar 
baseline characteristics and help to bolster external validity.  

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 37 of 74   
 
 
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 Attrition 
Subject attrition due to reduction in sample size required for precision analysis has been accounted 
for in the sample size calculation so that the estimate of the confidence interval (CI) to be obtained 
will still be valid through the most efficient use of 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 to evaluate repair failure rate so as to minimize reporting bias. The precision analysis 
planned for the study includes construction of confidence intervals for the outcome summaries and 
a pre-defined range in which the 95% CI for the primary outcome are expected to fall within are 
designed to maximize the validity of the study results. 
 
More detailed information on analyses to be carried out will be incorporated in the Statistical 
Analysis Plan (SAP) so as to minimize any threats to external validity in order to yield clinically 
relevant estimates of effects and precision. 
9 STUDY PROCEDURES 
9.1 Visits and Examinations 
9.1.1 Summary 
For a summary of the required procedures by visit, refer to the Study Schematic Table 
9.1.1-1: Study Procedures by Visit

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 38 of 74   
 
 
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 9.1.1-1: Study Procedures by Visit 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Unscheduled 
visit 
Schedule of events 
Pre-
Operative
Days of 
Visit 2 
Operative 
through 
Discharge
Day 0 
Follow Up 6 
Months 
(± 30 days)
Follow 
Up 
12Months
(± 30 
days) 
Follow Up 
(RG NST 
ONLY) 
24 Months 
(± 60 days) 
Unscheduled 
Visit 
Informed Consent 
 
 
 
 
 
Inclusion/Exclusion  
 
 
 
 
 
Demographics/ 
Medical History 
 
 
 
 
 
 
Surgical Summary 
 
 
 
 
 
Post-op Repair Failure
 
 
ASES
 
 
 
 
Constant-Murley   
 
 
 
 
 
SANE Score 
 
 
 
 
 
EQ-5D-3L  
 
 
 
 
 
MRI 
*** 
 
*** 
 
*** 
 
Adverse Event 
Assessment 
 
 
 
 
 
 
Concomitant 
medications/therapies
 
 
 
 
 
 
End of Study/Exit   
** 
** 
** 
** 
** 
** 
** If necessary 
***Required only for 30-40 HEALICOIL Knotless REGENESORB NST subjects. Pre-operative MRI must meet 
criteria per inclusion criterion #2. 
(+/- tolerances are relative to surgery date) 
 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 39 of 74   
 
 
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 
9.1.2 Screening/Preoperative Visit 
 
NOTE: All subjects who sign an informed consent form must be assigned a study number and have 
demographic information recorded. Consented subjects who fail to meet all inclusion and exclusion 
criteria will be considered a screen fail and an End of Study CRF must be completed. The 
inclusion/exclusion CRF must also be updated to indicate which criterion has not been met. 
Subjects who are consented but have not received one of the study devices are not considered 
enrolled.  
1.
Obtain written informed consent from the subject as detailed in Section 7.5 
----- Do not proceed until consent has been obtained ----- 
2.
Add new subject into EDC to assign an ID 
3.
Screen the subject for protocol inclusion/exclusion criteria 
4.
Obtain demographic information and medical history. Record height, weight, smoking status 
and history of diabetes. 
5. 
Compete the Screening and Enrollment Log  
6. 
Obtain baseline Patient Reported Outcomes (PROs): ASES, Constant-Murley, SANE, EQ-5D-3L 
7.
Collect pre-operative standard of care MRI and submit to imaging vendor for qualification.  If 
images are not available or submitted images are unacceptable perform an additional study 
specific pre-operative MRI; see Image Acquisition Protocol for sequences to be used (For 
HEALICOIL Knotless REGENESORB NST subjects ONLY). 
8.
Complete Pre-Operative Visit CRFs 
9.
Subjects will be instructed to return to the treatment facility for the Treatment/Operation Visit 
 
10.
Complete End of Study form, if applicable 
9.1.3 Operative Visit (Day 0)  
1.
Query subject regarding any changes in general health and the use of concomitant 
medications. 
2.
Commence treatment/operation  

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 40 of 74   
 
 
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. 
Update information in the Screening and Enrollment Log 
4.
If any adverse events, adverse device effects or device deficiencies are observed or 
reported, they must be recorded as instructed in Section 12, adverse events and device 
deficiencies. Also record concomitant medications/therapies used to treat AEs. 
5.
Record device identification information for the anchors (e.g., Unique Device Identifier, Lot 
Number, Serial Number, Catalogue Number), suture type used with HEALICOIL Knotless 
PEEK and HEALICOIL Knotless REGENESORB anchors, and position of anchors. 
6.
Instruct the subject on proper postoperative care/procedures 
7.
Instruct the subject on follow-up procedures, including returning to the treatment facility in 
6 months (± 30 days) for follow-up visit 
8.
Complete Operation and Discharge Visit CRFs. 
9.
Complete End of Study form, if applicable 
9.1.4 Follow-up 6months (+/- 30 days) 
1.
Query subject regarding any changes in general health and the use of concomitant 
medications. 
2.
Record post-op repair failure, if any. (Post-op failure are AEs that need to be recorded on 
the AE CRFs.) 
3.
Obtain subject PROs: ASES, Constant-Murley, SANE, EQ-5D-3L 
4.
Perform MRI according to Imaging Protocol. (For HEALICOIL Knotless REGENESORB NST 
subjects). 
5. 
If any adverse device effects or device deficiencies are observed or reported, they must be 
recorded as instructed in Section 12, Adverse Events and Device Deficiencies. Also record 
concomitant medications/therapies used to treat AEs 
6. 
Instruct the subject on follow-up procedures, including returning to the treatment facility at 
12 months post-operative (± 30 days) for follow-up visit.  
7.
Complete 6-Month Follow-up Visit (Visit 3) and/or End of Study CRFs, if applicable. 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 41 of 74   
 
 
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 
9.1.5 Follow-up 12months (+/-30 days) 
1.
Query subject regarding any changes in general health and the use of concomitant 
medications. 
2.
Record post-op repair failure, if any. (Post-op failure are AEs that need to be recorded on 
the AE CRFs.) 
3.
Obtain subject PROs: ASES, Constant-Murley, SANE, EQ-5D-3L 
4. 
If any adverse device effects or device deficiencies are observed or reported, they must be 
recorded as instructed in Section 12, Adverse Events and Device Deficiencies. Also record 
concomitant medications/therapies used to treat AEs 
5. 
Complete End of Study Visit (Visit 4) CRFs for HEALICOIL Knotless REGENESORB Self-
Tapping and HEALICOIL Knotless PEEK Self-Tapping and Non Self-Tapping subjects 
6.
Instruct HEALICOIL Knotless REGENESORB NST subjects on follow-up procedures, including 
returning the treatment facility at 24 months post-operative (± 60 days) for follow-up visit. 
9.1.6 Follow-up 24 months HEALICOIL Knotless REGENESORB NST     
(+/-60 days)                    
1.
Query subject regarding any changes in general health and the use of concomitant 
medications. 
2.
Record post-op repair failure, if any. (Post-op failure are AEs that need to be recorded on 
the AE CRFs.) 
3.
Obtain subject PROs: ASES, Constant-Murley, SANE, EQ-5D-3L 
4. 
Perform MRI according to Imaging Protocol. 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 42 of 74   
 
 
CONFIDENTIAL AND PROPRIETARY 
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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. 
If any adverse device effects or device deficiencies are observed or reported, they must be 
recorded as instructed in Section 12, Adverse Events and Device Deficiencies. Also record 
concomitant medications/therapies used to treat AEs 
6. 
 
9.1.7 Unscheduled Visit 
An unscheduled visit is an in-office visit that occurs between the scheduled study visits and is 
conducted to assess subjects who are deemed to be symptomatic or require evaluation for AEs 
or DDs. Unscheduled examinations may be conducted at the discretion of the Investigator. All 
information obtained during an unscheduled visit should be recorded in the source documents 
and on the appropriate CRF 
 
1. 
Query subject regarding any changes in general health and the use of concomitant 
medications. 
2. 
Record post-op repair failure, if any. (Post-op failure are AEs that need to be recorded on 
the AE CRFs.) 
3. 
Obtain subject PROs: ASES, Constant-Murley, SANE, EQ-5D-3L 
4.  
If any adverse device effects or device deficiencies are observed or reported, they must be 
recorded as instructed in Section 12 Adverse Events and Device Deficiencies. Also record 
concomitant medications/therapies used to treat AEs 
5.  
Complete End of Study (Visit 5) CRFs, if applicable 
 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 43 of 74   
 
 
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 
9.1.8 Concomitant Medications and Therapies 
Concomitant medications and concomitant therapies are recorded at any time from enrollment into 
visit. 
Concomitant Medication 
Excluded Concomitant Medications 
For this study there are no restrictions on concomitant medications. Concomitant medications 
used to treat AEs should be recorded on the designated CRF.         
Recording Concomitant Medications in CRF 
All medications that the subject is on will be recorded in the CRF. The CRF Completion Guidelines 
will stipulate how medications should be recorded in the CRF.  
Concomitant Therapies 
Therapies Prohibited During the Study 
For this study there are no restrictions on concomitant therapies. Concomitant therapies used to 
treat AEs should be recorded on the designated CRF. 
Recording Concomitant Therapies in the CRF 
Concomitant therapies should be recorded on the designated CRF. Reference the CRF Completion 
Guidelines for how concomitant therapies are recorded.  
9.1.9 Discontinued Subjects 
Discontinued subjects are those who: voluntarily discontinue participation; are withdrawn for 
reasons of safety; are lost to follow-up; have missed 2 study visits;   undergo a surgical procedure 
not listed in the protocol; or receive non-study devices or study devices in an incompatible 
combination as listed in the inclusion criteria. . 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 should be captured, at a minimum (see Section 7.8). 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 44 of 74   
 
 
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 
Finally, if appropriate, the Investigator will also advise the subject of subsequent therapy and/or 
procedures necessary for their medical condition. Medical care will not be provided to the subject 
after the clinical investigation is completed, other than the standard care provided by the site, 
which is not considered a study visit(s). 
9.1.10 Subject Pregnancy 
Women of child-bearing potential are not excluded from the study as long as adequate birth control 
woman becomes pregnant during the study, S+N must be contacted immediately once the 
investigator is made aware of the pregnancy and 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. 
9.2 Study Methods and Measurements 
The investigational device failure will be assessed by the surgeon during surgery, at 6 months post-
operative and at 12 months post-operative visits (and 24 months for the HEALICOIL Knotless 
REGENESORB NST subgroup). Criteria used for assessment of device failure and/or re-intervention 
will be provided by the surgeon on the designated case report form (CRF).  
All subjects: 
American Shoulder and Elbow Surgeons (ASES): The ASES instrument is composed of 2 sections 
containing participant self-reported and clinician assessments.  The ASES score is a 0 to 100-point 
rating based solely on participant responses and is a combination of the pa
 shoulder pain 
rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs).10 
ASES scores will be recorded pre-operatively, at 6 and 12 months for HEALICOIL Knotless PEEK ST 
and NST and REGENESORB ST subgroups and at 6, 12 and 24 months for the HEALICOIL Knotless 
REGENESORB NST subgroup.  
 
Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology; 
two subjective: pain and activities of daily living (ADL) and two objective: range of motion (ROM) 
and strength. The subjective components can receive up to 35 points and the objective 65, 
resulting in a possible maximum total score of 100 points (best function). Pain and ADL are 
answered by the subject; ROM and strength require a physical evaluation and are answered by 
the orthopaedic surgeon or the physiotherapist.11 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 45 of 74   
 
 
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 
CMS scores will be recorded pre-operatively, at 6 and 12 months for HEALICOIL Knotless PEEK ST 
and NST and REGENESORB ST subgroups and at 6, 12 and 24 months for the HEALICOIL Knotless 
REGENESORB NST subgroup. 
Single Assessment Numeric Evaluation (SANE): The SANE is a simple, single-question, patient-
 is popular because of its 
simplicity and ability to be applied to a wide variety of clinical situations. It has not been validated 
and no minimal clinically important difference has been reported.15 SANE scores will be recorded 
pre-operatively, at 6 and 12 months for HEALICOIL PEEK ST and NST AND REGENESORB ST 
subgroups and at 6, 12 and 24 months for the HEALICOIL REGENESORB NST subgroup. 
 
Magnetic Resonance Imaging (MRI) will be used to determine tendon thickening and anchor 
absorption/replacement by bone at 6 and 24 months in the RG NST variant only. MRI will be used 
to determine tendon re-tear rate at 6 months and 24 months. Refer to Imaging Protocol for 
assessment details.  
 standard of care pre-operative MRI will be collected to determine their baseline. If a 
pre-operative standard-of-care MRI is available it must be submitted to the study imaging vendor 
for qualification. The vendor will provide a response to sites within 3 business days confirming if the 
images are: acceptable, suboptimal or unacceptable. If MRI is unavailable or considered 
unacceptable an additional study-specific MRI must be performed. Only subjects with an acceptable 
pre-operative MRI will be able to proceed with surgery and receive a Healicoil Knotless Regensorb 
NST device. 6 month and 24 month MRI images must be obtained using the post-operative 
sequences listed in the Image Acquisition Protocol. 
9.3 Health Economics/Quality of Life 
Using the EQ-5D-3L questionnaire the following secondary outcomes will be collected: 
Mobility 
Self-care 
Activities 
Pain/discomfort 
Anxiety/depression 
EQ-5D-3L scores will be recorded pre-operatively, at 6 and 12 months for HEALICOIL Knotless 
PEEK ST and NST and REGENESORB ST subgroups and at 6, 12 and 24 months for the HEALICOIL 
Knotless REGENESORB NST subgroup. 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 46 of 74   
 
 
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 
10 STATISTICAL DESIGN 
A Statistical Analysis Plan (SAP) will be written and finalized prior to database lock. The following is 
a brief description of the analyses to be described in this plan.  
10.1 General 
nee will conduct the statistical analysis for this 
study. Unless otherwise stated, all significance tests will be two-sided, performed at the 5% 
significance level. Resulting p-values will be quoted. Point estimates and their corresponding 95% 
two-sided confidence intervals will be generated where appropriate. Where data summaries are 
specified, categorical or 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 analyses will 
be performed in SAS 9.4 (or later).  
10.2 Analysis Populations 
The following analysis populations will be used for this study: 
Full Analysis Set (FAS), following Intention to Treat principle including all subjects who were 
recruited into the study and attended at least one post-surgery assessment.  
Safety Population (SAF), including all subjects who have received the study device. 
Per-Protocol Population (PP), including all subjects in the full analysis set who have no 
significant protocol deviations and met the inclusion/exclusion criteria. 
10.3 Baseline Data 
Data to be summarized at baseline includes, but is not limited to, all collected demographic 
variables such as age, gender, race, ethnicity, primary diagnosis and medical history. The baseline 
variables will be used to describe the outcome data where necessary. 
10.4 Efficacy Analysis 
10.4.1 Analysis of Primary Endpoint 
Repair failure rate will be summarized by the number and percentage of patients that have had a 
second repair procedure by their 6 month visit. A 95% exact confidence interval for the proportion 
will be presented using the Clopper-Pearson method.3 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 47 of 74   
 
 
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 
Repair failure rate will be presented by group (PEEK or REGENESORB) and by primary diagnosis 
(rotator cuff repair or biceps tenodesis).  Analysis of Secondary Endpoint(s) 
All summaries will be provided overall by group (PEEK or REGENESORB), and will be further broken 
down for each sub-group (PEEK ST, PEEK NST, REGENESORB ST, REGENESORB NST) as 
appropriate (all 24 month summaries will only be for the REGENESORB NST sub-group specifically). 
Tables will be split by primary diagnosis (rotator cuff repair or biceps tenodesis) where necessary.  
 
Repair failure rate at 12 and 24 months will be summarized cumulatively by the number and 
proportion of patients that have had a second repair procedure up to that respective time point. 
Percentages will be based on the number of available patients at each time point (e.g. excluding 
any lost-to-follow-up patients as we will not know their outcome). A 95% exact confidence interval 
for the proportion will be presented using the Clopper-Pearson method.3 
 
The Constant-Murley Shoulder score, ASES Shoulder score, SANE and EQ-5D-3L will be derived for 
each patient at each visit and summary statistics will be presented. Change from baseline score to 
each post-operative visit (6, 12 and 24 months) will also be presented. The number and proportion 
of subjects, together with a 95% confidence interval, meeting the Minimal Clinically Important 
Differences (MCID) from baseline to each post-operative visit will be presented.    
 
Separate summary statistics will be provided for the ASES VAS pain score for each visit, and for the 
change from baseline to each post-operative visit.    
 
Endpoints determined by MRI include tendon thickening, anchor absorption/replacement by bone 
and tendon re-tear rates at 6 months and 24 months. These will be summarized appropriately for 
categorical or continuous variables. 
10.5 Safety Analyses 
All safety endpoints will be summarized using the safety population. 
 
Adverse Events 
The number of subjects reporting: adverse events, serious adverse events, device-related adverse 
events, serious device-related adverse events, unanticipated adverse events, and serious 
unanticipated adverse events will be summarized. In addition, for each adverse event, the following 
will be summarized: severity, the relationship to the investigational device, outcome and duration 
of the resolved adverse events and the duration of the adverse events at trial discontinuation. 
 
Device deficiencies 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 48 of 74   
 
 
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 total number of device deficiencies and the number of patients reporting a device deficiency 
will be summarized and presented. The number of intra-operative device deficiencies will also be 
summarized.   
 
Additional summaries of safety endpoints, if applicable, will be described in the SAP. 
 
10.6 Interim Analyses 
An interim analysis will be done on all HEALICOIL Knotless REGENESORB NST and HEALICOIL 
Knotless REGENSORB ST patients that have completed their 6 month follow up.  
11 SAMPLE SIZE JUSTIFICATION 
The sample size for this study is precision based and not based on statistical power considerations, 
thus no formal statistical hypothesis is formulated. With an estimated clinical success rate of 91% 
for each HEALICOIL Knotless variant and a corresponding 95% confidence interval between 80% 
and 100%, enrolling between 60 and 80 subjects per variant would provide probability greater than 
90%. Enrolling between 60 and 80 subjects per variant would provide probability greater than 
90%.  
HEALICOIL Knotless PEEK patients: Minimum N=60, Maximum N=80 
HEALICOIL Knotless REGENESORB patients: Minimum N=60, Maximum N=80 
 
Enrollment distribution will ensure that all variants are represented in the patient population: 
Table 11-1: Enrollment Distribution 
HEALICOIL Knotless Suture 
Anchor 
Minimum 
Maximum 
HEALICOIL Knotless PEEK ST  
30 
40 
HEALICOIL Knotless PEEK NST 
30 
40 
HEALICOIL Knotless RG ST 
30 
40 
HEALICOIL Knotless RG NST 
30 
40 
 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 49 of 74   
 
 
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 statistical plan will provide a detailed approach of the statistical analysis that will be conducted 
on two independent groups: the HEALICOIL Knotless PEEK anchor group (2 variants, 60-80 
patients) and the HEALICOIL Knotless REGNESORB anchor group (2 variants, 60-80 patients). 
Furthermore, the 30-40 HEALICOIL Knotless RG NST variant patients will undergo double row 
repair and will be followed up for a longer duration (24 months) to support claims on long-term 
resorption of the REGENESORB material. 
12 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
12.1 Definitions (ISO/DIS 14155:2018) 
The categories of adverse events are shown in table 12.1-1. The definitions for each of these 
categories are given in the subsequent sections. 
 
Table 12.1-1: 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) 
12.1.1 Adverse Event 
An Adverse Event (AE) is any untoward medical occurrence, unintended disease or injury or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, 
whether or not related to the investigational medical device and whether anticipated or 
unanticipated..   
Note 1: This definition includes events related to the investigational medical device or the 
comparator.  

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 50 of 74   
 
 
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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 
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 use of 
investigational medical devices. 
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.  
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. 
12.1.2 Adverse Device Effect 
An Adverse Device Effect (ADE) is an adverse event related to the use of an investigational medical 
device.  
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 the 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 have any relationship 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.

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 51 of 74   
 
 
CONFIDENTIAL AND PROPRIETARY 
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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 
12.1.3 Related 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, it led to any of the following: 
a) death, 
b) 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 
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) fetal distress, fetal death or a congenital abnormality or birth defect including physical or 
mental impairment 
Note 1: 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. 
12.1.4 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 
assessment.  
Note 1: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the risk assessment.  
Potential Adverse Effects listed in the HEALICOIL Knotless IFUs include: 
Loss of fixation or pull out of suture anchors can occur  
Mild inflammatory reaction 
Foreign body reaction 
Infection, both deep and superficial 
Allergic reaction 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 52 of 74   
 
 
CONFIDENTIAL AND PROPRIETARY 
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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 
This list is not exhaustive. Please check Instructions For Use for a full list of adverse effects which 
are known to occur (anticipated) with HEALICOIL Knotless devices. Adverse Effects, including those 
listed above, are only ASADEs if the event is considered serious, as outlined in 11.1.3. 
 
For HEALICOIL Knotless Self-Tapping devices: titanium alloys contain elements that may stimulate 
allergic hypersensitive response by the immune system. These elements are titanium, aluminium, 
and vanadium (Ti, Al, and V). When sensitivity is anticipated, appropriate preoperative testing should 
be conducted.  
 
12.1.5 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: 
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 
 
Severe -  
inability to work or engage in their usual activities. 
12.1.6 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. 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
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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 
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, 
are considered Device Deficiencies with potential to cause SADE and shall be reported as 
specified in section 12.3. 
12.2 AE Coding Dictionary 
Coding for this study will be done per International Medical Device Regulators Forum (IMDRF) AE 
Terminology Annex E  Clinical signs, symptoms and conditions. 
12.3 Reporting procedures 
AE of any kind and DD will be recorded in the applicable CRF and source notes. The Investigator 
will evaluate all AE for relationship to the device and procedure, seriousness, and severity (if 
applicable). DD will be evaluated for potential to cause SADE.  The following timescales should be 
followed for the AE/DD information to be submitted/entered into the CRF and reported to the 
Sponsor or designee (see figure 12.3-1 and 12.3-2): 
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) 
All other events  according to usual timescales 
In addition to inputting SAE and SADE information within 24 hours of being aware of the event, the 
investigator should email Clinical.safety@Smith-nephew.com to alert the safety representative of 
the events existence and to clarify details if necessary. 
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 S+N 
unless it is contaminated (e.g., used dressings must not be retained). Updates to submitted 
information will be recorded in the CRF 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.  

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 54 of 74   
 
 
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 investigator will inform the IRB/IEC of adverse events according to the IRB/IEC requirements.  
Depending on the nature of the adverse event, S+N 
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, S+N 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, 
unanticipated SADE, anticipated SADE, and DD. 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 55 of 74   
 
 
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 12.3-1: Evaluation and Reporting of AE 
 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 56 of 74   
 
 
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 
Figure12.3-2: Evaluation and Reporting of DD 
 
 
12.4 Unblinding of Investigational Product 
Not Applicable  
12.5 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 need to be documented in the CRF/Clinical Study Report. 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 57 of 74   
 
 
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 
12.5.1 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 
Adverse events which are not related to a study procedure or S+N IP and are ongoing at the end 
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. 
13 INVESTIGATOR OBLIGATIONS 
The Principal Investigator will comply with the commitments outlined in the in the Statement of 
Investigator, provided by the Sponsor/within the Clinical Trial Agreement, and with Good Clinical 
Practice (GCP), and all applicable regulatory requirements as outlined in Appendix 22.5 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 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. 
14 SPONSOR AND MONITOR RESPONSIBILITIES 
The Sponsor will designate a monitor 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.  
14.1 Contract Research Organization  
S+N will use Medical Metrics Inc (MMI) to conduct an independent evaluation of the imaging to 
assess treatment performance and outcomes to include: 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 58 of 74   
 
 
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 
Characterize tendon thickening and REGENESORB material resorption at 6 months and 24 
months in the HEALICOIL Knotless REGENESORB NST subgroup  
To characterize the MRI tendon re-tear rates at 6 months and 24 months in the HEALICOIL 
Knotless REGENESORB NST subgroup 
 
14.2 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. 
14.3 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 following the execution of the CTA and documented IRB/IEC approval.  
14.4 Interim Monitoring Visit 
Regular interim monitoring visits will be performed by the Sponsor or qualified person designated 
by the Sponsor. 
14.5 Sponsor Audits and Regulatory Inspection 
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.   
14.6 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, confirm the 
disposition of any other ancillary items used for the study, and review regulatory requirements 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 59 of 74   
 
 
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 
regarding records retention and IRB/IEC reporting requirements.  When no subjects have been 
included, a remote close-out visit may be conducted.  
15 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 signed off by the study personnel. 
It is not allowed to use waivers to allow planned deviation of the study protocol. 
16 PROTOCOL AMENDMENTS 
Amendments should 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 IRB/IEC. 
Protocol amendments need to be approved by the IRB/IEC, according to the applicable 
requirements prior to implementation at the site. 
17 CONFIDENTIALITY OF THE STUDY 
The confidentiality of this study and associated documents is governed by the terms of the Clinical 
Trial Agreement (CTA). 
18 STATEMENTS OF COMPLIANCE 
This clinical study will be performed in compliance with the ethical principles of the Declaration of 
Helsinki; and ISO 14155: Clinical investigation of medical devices  Good Clinical Practice; and any 
local regulations.  
This clinical study will not commence until the required approval/favorable opinion from the 
IRB/IEC or regulatory authority has been obtained. Any additional requirements imposed by the 
IRB/IEC or regulatory authority will be followed.  

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 60 of 74   
 
 
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 
19 END OF STUDY 
The end of study is considered the last visit of the last subject undergoing treatment in the study. 
It is expected to last 36 months.   
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.  
 An End of Study CRF needs to be completed for all subjects including any subject that does not 
complete the study, to document the reason for termination.  
The entire study may be terminated if deemed necessary by the Sponsor (e.g. the product is 
determined to not be safe). Sites may be terminated for reasons that include, but are not limited to 
non-compliance to the protocol, ethical violations, or inability to recruit subjects. 
20 PUBLICATION POLICY 
20.1 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. 
20.2 Data Sharing 
Smith+Nephew is committed to upholding the highest ethical and legal standards involved in 
conducting clinical trials. 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 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 61 of 74   
 
 
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 
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. 
21 REFERENCES 
1. 
Boileau P, Krishnan SG, Walch G. Arthroscopic Biceps Tenodesis. In: Shoulder 
Arthroscopy. New York, NY: Springer New York; 2003:71-80 
2.
Cho, N. S., Lee, B. G., & Rhee, Y. G. (2011). Arthroscopic Rotator Cuff Repair Using a 
Suture Bridge Technique: Is the Repair Integrity Actually Maintained? The American Journal 
of Sports Medicine, 39(10), 2108 2116.   
3.      Clopper, CJ, Pearson ES. In: Biometrika. The use of confidence or fiducial limits 
illustrated in the case of the binomial. 1934, 26 p. 404 413. 
4.
Ellman H. Diagnosis and treatment of incomplete rotator cuff tears. Clin Orthop Relat Res 
1990; 254:64 74. 
5. 
Fuchs B, Weishaupt D, Zanetti M, et al. Fatty degeneration of the muscles of the rotator 
cuff: Assessment by computed tomography versus magnetic resonance imaging. J Shoulder 
Elbow Surg. 1999; 8:599-605. 
6. 
Galatz LM, Ball CM, Teefey SA, Middleton WD, Yamaguchi K. The outcome and repair 
integrity of completely arthroscopically repaired large and massive rotator cuff tears. J Bone 
Joint Surg Am. 2004;86:219-224. 
7. 
Goutallier D, Postel JM, Bernageau J, Lavau L, Voisin MC. Fatty muscle degeneration in 
cuff ruptures. Pre-and postoperative evaluation by CT scan. Clin Orthop Relat Res. 1994: 
(304)78-83. 
8. 
Lim HK, Hong SH, Yoo HJ, et al. Visual MRI grading system to evaluate atrophy of the 
supraspinatus muscle. Korean J Radiol. 2014; 15(4):501-7.  
9. 
Marx RG, Koulouvaris P, Chu SK, Levy BA. Indications for Surgery in Clinical Outcome 
Studies of Rotator Cuff Repair. Clinical Orthopaedics and Related Research. 
2009;467(2):450-456. 
10.  
Richards RR, An KN, Bigliani LU, et al. A standardized method for the assessment of 
shoulder function. J Shoulder Elbow Surg. 1994 Nov;3(6):347-52. 
11.  
Smith MV CR, Vahlberg T, Joukainen A, Aaerimaa V. Upper Extremity-Specific Measures 
of Disability and Outcomes in Orthopaedic Surgery The Journal of Bone & Joint Surgery. 
2012;94(3):277-285. 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 62 of 74   
 
 
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.  
Sugaya H, Maeda K, Matsuki K, Moriishi J. Functional and structural outcome after 
arthroscopic full-thickness rotator cuff repair: single-row versus dual-row fixation. 
Arthroscopy. 2005; 21(11):1307-1316. 
13.  
Tashjian RZ, Erickson GA, Robins RJ, et al. Influence of preoperative musculotendinous 
junction position on rotator cuff healing after double-row repair. Arthroscopy. 2017; 
33(6):1159-1166. 
14.  
Westermann RW, Wolf BR. Indications for Repair: Who Really Needs Surgery? In: Kelly Iv 
JD, ed. Elite Techniques in Shoulder Arthroscopy: New Frontiers in Shoulder Preservation. 
Cham: Springer International Publishing; 2016:181-192. 
15.  
Williams GN, Gangel TJ, Arciero RA, et al. Comparison of the Single Assessment Numeric 
Evaluation method and two shoulder rating scales. Outcomes measures after shoulder 
surgery. Am J Sports Med. 1999 Mar-Apr;27(2):214-21. 
 
 
 
 
 
 
 
 
 
 
 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 63 of 74   
 
 
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 
22 APPENDICES 
22.1 Protocol Amendment 2 
 
22.1.1 General Purpose 
Version 2.0 of the protocol was amended to 3.0 primarily to reflect a simplification of the pre-
operative imaging requirements for subjects in the Regenesorb NST cohort. Clarifications were also 
made to the process of enrolling subjects and entering their data into EDC. Details of ancillary 
products were added. Height, weight, smoking status and diabetes status have been added to the 
required data to be collected.  
22.1.2 Rationale 
Version 2.0 of the protocol required investigators to take on the responsibility for confirming that 
the pre-operative MRIs for RG NST subjects met the sequence requirements listed in inclusion 
criterion #2. Investigators expressed some concern that they were not imaging experts and did not 
feel confident confirming MRIs met inclusion criteria. In protocol version 3.0 this was addressed so 
that an external imaging vendor would make these pre-operative image eligibility decisions. Sites 
are now required to submit pre-operative images to an imaging vendor who will return a response 
within 3 business days, either accepting or rejecting images. Furthermore, the list of acceptable 
pre-operative sequences has been expanded so that more MRIs will make it through the eligibility 
assessment. Acceptable sequences are listed in the Image Acquisition Protocol. 
Protocol v2.0 was not clear on whether screened subjects should be assigned a study ID number. 
Version 3.0 addresses this by confirming that all subjects who sign a consent form must be entered 
into the database and given a study ID. This will allow the sponsor to capture details of screen 
failure should subjects fail to meet eligibility prior to surgery or intraoperatively. 
22.1.3 Effect on Study Status 
At the time of the amendment, only one patient has been consented. The impact is therefore likely 
to be positive and will make the screening and enrollment process simpler and more expedient for 
patients in the RG NST group. 
The update to the screening and subject ID assignment workflow should not impact the study; it 
should make the enrollment process simpler and allow for more fulsome oversight. 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 64 of 74   
 
 
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 
22.1.4 Details 
Section 
Current Text 02/Oct/2020 
Version 2.0  
Revised Text 25/Feb/2020 Version 
3.0  
Section 2, Synopsis 
Has a pre-operative standard of care MRI within 
6 months of surgery containing the following 
sequences:  
a. Sat T2 FS: Oblique Sag T2-weighted Fat 
Saturation Spin Echo (oriented perpendicular to 
the scapula), with TE > 70 ms, AND  
b. Cor T2 FS: Oblique Cor T2-weighted Fat 
Saturation Spin  
 
Echo (oriented parallel to the scapula), with TE > 
70 ms,  
AND  
c. Sag T1: Oblique Sag T1-weighted Spin Echo 
(oriented perpendicular to the scapula); OR  
d. Willing and able to undergo an additional 
study specific pre-operative MRI according to the 
study Imaging Protocol if the above criteria is 
not met OR  
e. MRI not required; subject not in 
HEALICOIL RG NST subgroup  
 
2. 
Has a pre-operative MRI collected within 
6 months of surgery which meets one of the 
following criteria:  
a. 
MRI collected as standard-of-care has 
been submitted to external imaging vendor and 
confirmed as acceptable OR 
b. 
If standard-of-care images are 
unavailable or considered unacceptable by 
external imaging vendor, subject must undergo 
an additional study-specific pre-operative MRI, 
confirmed as acceptable by external imaging 
vendor OR 
c. 
MRI not required; subject not in 
HEALICOIL Knotless RG NST subgroup 
Section 4.4 moved to 
Section 12.1.4 
Potential Adverse Effects listed in the IFUs 
include: 
anchors can occur 
Rotator Cuff Tendon Repair 
 
 
deep and superficial 
 
For HEALICOIL Knotless Self-Tapping 
devices: titanium alloys contain elements 
that may stimulate allergic hypersensitive 
response by the immune system. These 
elements are titanium, aluminium, and 
vanadium 
 
Potential Adverse Effects listed in the IFUs 
include: 
can occur 
Rotator Cuff Tendon Repair 
 
 
 
 
For HEALICOIL Knotless Self-Tapping devices: 
titanium alloys contain elements that may 
stimulate allergic hypersensitive response by 
the immune system. These elements are 
titanium, aluminium, and vanadium 
 
This list is not exhaustive. Please check 
Instructions For Use for a full list of adverse 
effects which are known to occur (anticipated) 
with HEALICOIL Knotless devices. Adverse 
Effects, including those listed above, are only 
ASADEs if the event is considered serious, as 
outlined in 11.1.3. 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 65 of 74   
 
 
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 
 
Section 6.1.3 
No ancillary products will be provided. 
There are two ancillary products provided for 
the conduct of this study. All sites will be 
provided with at least one Manual Muscle Tester 
(MMT), often referred to as a dynamometer, 
packaged in  a Pelican type storage case. MMTs 
are ergonomic devices used to objectively 
quantify muscle strength. Additionally, all sites 
will be provided with at least one long-arm 
isometric goniometer which is used to measure 
joint range of motion. Both devices are required 
to complete the Constant-Murley score at the 
pre-op and follow-up visits.   
 
There are required ancillary products for the 
conduct of the study, which are a hand-held 
Manual 
Muscle Tester (MMT) with a Pelican Type 
Storage Case and a 
goniometer. The MMT is an ergonomic device 
used to objectively quantify muscle 
strength (Lafayette Hand-held Dynamometer 
User Instructions, page 2). The device is 
provided to 
the sites in a sturdy case for device protection 
during shipping and storage. A long-arm 
isometric 
goniometer is required. These instruments allow 
for the precise measurements of angels, which 
helps the clinician to measure joint range of 
motion. 
Section 9.1.2 
NOTE: Any subject who signs an informed 
consent/assent but fails to meet the 
required entry criteria is considered to be a 
Screen Failure. Screen Failure subjects 
should not be assigned subject numbers, 
but their demographic information must be 
captured in the appropriate CRF with the 
reason for screen failure specified. 
 
NOTE: All subjects who sign an informed 
consent form must be assigned a study number 
and have demographic information recorded. 
Consented subjects who fail to meet all 
inclusion and exclusion criteria will be 
considered a screen fail and an End of Study 
CRF must be completed. The inclusion/exclusion 
CRF must also be updated to indicate which 
criterion has not been met. Subjects who are 
consented but have not received one of the 
study devices are not considered enrolled. 
Section 9.1.2 
 Obtain written informed consent from the 
subject as detailed in Section 7.5 
----- Do not proceed until consent has been 
obtained ----- 
p.42, section 8.1.2/3 
1. Obtain written informed consent from the 
subject as detailed in Section 6.5 
----- Do not proceed until consent has been 
obtained ----- 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 66 of 74   
 
 
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. Screen the subject for protocol 
inclusion/exclusion criteria 
3. Obtain demographic information and 
medical history, including information on all 
concomitant medications/therapies 
4. Assign the subject a study number and 
instruct the subject on treatment 
procedures. 
5. Compete the Screening and Enrollment 
Log 
6. Obtain baseline Patient Reported 
Outcomes (PROs): ASES, Constant-Murley, 
SANE, EQ-5D-3L 
7. Collect pre-operative standard of care 
MRI or perform an additional study specific 
pre-operative MRI according to the study 
Imaging Protocol per inclusion criterion #2. 
(For HEALICOIL Knotless REGENESORB 
NST subjects). 
8. Complete Pre-Operative Visit CRFs 
9. Subjects will be instructed to return to 
the treatment facility for the 
Treatment/Operation Visit 2 in 
 60 days. 
2. Add new subject into EDC into assign an 
ID 
3. Screen the subject for protocol 
inclusion/exclusion criteria 
4. Obtain demographic information and 
medical history. Record height, weight, 
smoking status and history of diabetes 
5. Compete the Screening and Enrollment Log  
6. Obtain baseline Patient Reported Outcomes 
(PROs): ASES, Constant-Murley, SANE, EQ-5D-
3L 
7. Collect pre-operative standard of care 
MRI and submit to imaging vendor for 
qualification.  If images are not available 
or submitted images are unacceptable 
perform an additional study specific pre-
operative MRI; see Image Acquisition 
Protocol for sequences to be used (For 
HEALICOIL Knotless REGENESORB NST 
subjects ONLY ). 
8. Complete Pre-Operative Visit CRFs 
9. Subjects will be instructed to return to the 
treatment facility for the Treatment/Operation 
Visit 2 in 
 60 days. 
10. Complete End of Study form, if 
applicable 
Section 9.1.3 
Record device identification information for 
the anchors (e.g., Unique Device Identifier, 
Lot Number, Serial Number, Catalogue 
Number), suture type used with HEALICOIL 
Knotless PEEK and HEALICOIL Knotless 
REGENESORB anchors, and position of 
anchors. 
Record device identification information for the 
anchors (e.g., Unique Device Identifier, Lot 
Number, Serial Number, Catalogue Number), 
suture type used with HEALICOIL Knotless PEEK 
and HEALICOIL Knotless REGENESORB anchors, 
and position of anchors. 
Section 9.1.9 
Discontinued subjects are those who 
voluntarily discontinue participation, who 
are withdrawn for reasons of safety or use 
of prohibited concomitant treatments, who 
are lost to follow-up, or who have missed 2 
study visits or fail to complete the 
complete the procedure at baseline so are 
ineligible for further participation, refer to 
section 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 should be captured, at a 
minimum (see Section 7.8.2). 
Discontinued subjects are those who: 
voluntarily discontinue participation; are 
withdrawn for reasons of safety; are lost to 
follow-up; have missed 2 study visits; undergo 
a surgical procedure not listed in the protocol; 
or receive non-study devices or study devices in 
an incompatible combination as listed in the 
inclusion criteria. 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 should be captured, at a 
minimum (see Section 6.8). 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 67 of 74   
 
 
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 
Section 9.2 
Magnetic Resonance Imaging (MRI) will be 
used to determine tendon thickening and 
anchor absorption/replacement by bone at 
6 and 24 months. MRI will was be used to 
determine tendon retear rate at 6 months 
and 24 months. Refer to Imaging Protocol 
for assessment details. 
-
operative MRI will be collected to 
determine their baseline. The pre-operative 
MRI must be within 6 months of surgery 
and contain the following sequences: 
-weighted Fat 
Saturation Spin Echo (oriented 
perpendicular to the scapula), with TE > 70 
ms, AND 
-weighted Fat 
Saturation Spin Echo (oriented parallel to 
the scapula), with TE > 70 ms, AND 
-weighted Spin 
Echo (oriented perpendicular to the 
scapula). 
-operative MRI does not 
meet the above criteria then an additional 
study specific pre-operative MRI will be 
performed according the study Imaging 
Protocol and collected to determine their 
baseline. 
 Magnetic Resonance Imaging (MRI) will be 
used to determine tendon thickening and 
anchor absorption/replacement by bone at 6 
and 24 months in the RG NST variant only. MRI 
will be used to determine tendon re-tear rate at 
6 months and 24 months. Refer to Imaging 
Protocol for assessment details.  
-operative 
MRI will be collected to determine their 
baseline. If a pre-operative standard-of-care 
MRI is available it must be submitted to the 
study imaging vendor for qualification. The 
vendor will provide a response to sites within 3 
days confirming if the images are: acceptable, 
suboptimal or unacceptable. If MRI is 
unavailable or considered unacceptable an 
additional study-specific MRI must be 
performed. Only subjects with an acceptable 
pre-operative MRI will be able to proceed with 
surgery and receive a Healicoil Knotless 
Regensorb NST device. 6 month and 24 month 
MRI images must be obtained using the post-
operative sequences listed in the Image 
Acquisition Protocol 
Section 22.3 
[none]  new section created in v3.0 
Sites will be provided with a dynamometer for 
use in the Constant-Murley assessment. This 
has been labelled by Smith & Nephew and 
calibrated by the supplier. Dynamometers must 
be calibrated once per year and sites should 
work with the sponsor to return devise 
approaching calibration expiry. Calibrated 
replacement devices will be provided. 
Figures 
Figure 8.1-1 
This figure has been deleted as it is an exact 
copy of 9.1-1. It is therefore redundant and 
likely to cause confusion. 
Other 
Figure 9.1-1, Sections 9.1.2 & 9.1.3 
The option to complete an end-of-study form 
was entered for these visits as it is possible 
subjects may screen fail at these time points. 
Other 
Section numbering 
Due to formatting issues many of the section 
numbers and references to sections or tables 
were incorrect. These have been fixed. 
 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 68 of 74   
 
 
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 
22.1.5 Approval/Notification 
The redlined amended protocol 3.0 will be submitted to central and local IRBs for approval 
depending on site requirements.  
22.2 Instructions for Use 
Refer to the Instruction for Use supplied with this product. 
22.3 Equipment and Special Instructions 
Sites will be provided with a dynamometer for use in the Constant-Murley assessment. This has 
been labelled by Smith & Nephew and calibrated by the supplier. Dynamometers must be calibrated 
once per year and sites should work with the sponsor to return devise approaching calibration 
expiry. Calibrated replacement devices will be provided. 
 
22.4 Health Economic Outcome Measures/Quality of Life 
measures 
Using the EQ-5D-3L questionnaire the following secondary outcomes will be collected: 
 
Mobility 
 
Self-care 
 
Activities 
 
Pain/discomfort 
 
Anxiety/depression 
EQ-5D-3L scores will be recorded pre-operatively, at 6 and 12 months for HEALICOIL Knotless 
PEEK ST and NST and REGENESORB ST subgroups and at 6, 12 and 24 months for the HEALICOIL 
Knotless REGENESORB NST subgroup. 
 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 69 of 74   
 
 
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 
22.5 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. 
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 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 70 of 74   
 
 
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. 
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. 
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 a
authorized representative:  

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 71 of 74   
 
 
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 
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 
decision to participate throughout the clinical investigation 
iii. 
Avoid any coercion or undue improper influence on, or inducement of, the subject to 
participate 
iv. 
 
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.  
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 
shall be requested.  

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 72 of 74   
 
 
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. When it is not possible to obtain prior informed consent from the subject, and the 
enrolled if a specific process has been described in the protocol.  
3. Arrangements shall be made to inform the subject or legally authorized 
representative
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 
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. 
 
ix. 
Contact persons 
x. 
Statement declaring that new findings or the reasons for any amendment to the 
subject.  
xi. 
articipation in the clinical investigation 
xii. 
Termination procedures 
f. 
Informed consent signature shall contain the following:  

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 73 of 74   
 
 
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 
i. 
The voluntary agreement to participate in the clinical investigation and follow the 
 
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 i
questions were answered 
vi. 
A statement confirming that the subject or his/her legally authorized representative 
al 
investigation 
vii. 
A statement confirming that the subject or his/her legally authorized representative 
 
g. New information: if new information becomes available that can significantly affect a 
care that information shall be provided to the subject 
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, 

 
Clinical Protocol - Device 
Study Number: 
HEALICOIL.KNOTLESS.2019.12
Prospective, Multi-Center, Post-Market Clinical Follow-up Study 
to Evaluate Safety and Performance of the HEALICOIL Knotless 
Suture Anchor in Shoulder Rotator Cuff Tendon Repair 
Version:  3.0 25Feb2021 
Page: 74 of 74   
 
 
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 
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 
p. review and sign the 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 
e.
supply the Sponsor, upon Sponsor's request, with any additional information related to the 
safety reporting of a particular event. 

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Clinical Sr. Director
Smith & Nephew
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FC872951-AC1C-4261-B85E-C7A7CD09ACDC
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Sent: 03-Mar-2021 | 17:35
Viewed: 03-Mar-2021 | 20:58 
Signed: 03-Mar-2021 | 20:59
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Rachael Winter
rachael.winter@smith-nephew.com
Clinical Sr. Director
Smith & Nephew
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A32F12A8-0F1B-4490-986E-80ACCB7471CB
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Sent: 03-Mar-2021 | 17:35
Viewed: 04-Mar-2021 | 11:44 
Signed: 04-Mar-2021 | 11:45
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Stephan Mangin
Stephan.Mangin@smith-nephew.com
Clinical Director
Smith & Nephew
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77573411-150E-4841-B3F0-3589FBBD3EAD
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Sent: 03-Mar-2021 | 17:35
Viewed: 03-Mar-2021 | 19:47 
Signed: 03-Mar-2021 | 19:47
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04-Mar-2021 | 12:05
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Certificate Of Completion
Envelope Id: 304DE11989C64D37BE7A449313F216E5
Status: Completed
Subject: Please DocuSign: Please_DocuSign_HEALICOIL.KNOTLESS.2019.12__ (2).pdf
Source Envelope: 
Document Pages: 76
Signatures: 1
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Certificate Pages: 5
Initials: 0
Rob Bedford
AutoNav: Enabled
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Time Zone: (UTC) Dublin, Edinburgh, Lisbon, London
7135 Goodlett Farms
Cordova, TN  38016
Robert.Bedford@smith-nephew.com
IP Address: 216.222.214.6
Record Tracking
Status: Original
             22-Mar-2021 | 14:30
Holder: Rob Bedford
             Robert.Bedford@smith-nephew.com
Location: DocuSign
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Dr Jonathan Bravman
JONATHAN.BRAVMAN@CUANSCHUTZ.EDU
University of Colorado School of Medicine
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EBE7DB12-9024-445A-8271-8F3ED0504951
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Sent: 22-Mar-2021 | 14:38
Viewed: 22-Mar-2021 | 16:29 
Signed: 22-Mar-2021 | 16:29
Electronic Record and Signature Disclosure: 
      Accepted: 15-Sep-2020 | 00:04
      ID: 213a3f50-34cd-47b9-841d-4c75c11ee01e
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22-Mar-2021 | 16:29
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22-Mar-2021 | 16:29
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22-Mar-2021 | 16:29
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