A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of CONQUEST FN for the Treatment of Intracapsular Femoral Neck Fractures
Phase: NA
Conditions: Femoral Neck Fractures
Sponsor: Smith & Nephew, Inc.

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 1 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
 SIGNATURES 
1.1 
PROTOCOL SIGNATURE PAGE 
This page will be returned to Smith & Nephew Inc. and a copy retained at the study site. 
I have read the attached protocol entitled “A Multicenter, Post Market, Prospective Study 
Evaluating Safety and Efficacy of CONQUEST FNTM for the Treatment of Intracapsular Femoral 
Neck Fractures”, version 2.0, dated 30-Nov-2018, and agree to abide by all provisions set forth 
herein. 
I agree to comply with the Investigator’s Obligations stipulated in Section 20.3 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.  
Role 
Name 
Signature* 
Date Signed*
(DD-MMM-YYYY)
Principal Investigator  
 
 
 
 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 2 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
1.2 
SPONSOR APPROVAL 
 
 
Role 
Approver Name 
Approver Signature 
Head of Global Clinical 
Operations 
Andy Weymann 
 
Head of Global Clinical 
Strategy 
Beate Hanson 
 
Head of Global 
Biostatistics & Global 
Data Sciences 
Alan Rossington 
 
Head of Global Medical 
Affairs 
Luca Orlandini 
 
SIGN

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 3 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
 SYNOPSIS 
Title of Study: 
A Multicenter, Post Market, Prospective Study Evaluating Safety and 
Efficacy of CONQUEST FN™ for the Treatment of Intracapsular 
Femoral Neck Fractures 
 
Study Design: 
Prospective, single arm, multi-center study of subjects who are to be 
implanted with the CONQUEST FN™ Femoral Neck Fracture System 
for treatment of a trauma related femoral neck fracture.   
Study Type: 
Post-Market Clinical Follow-Up (PMCF) 
Study Product:  
The CONQUEST FN™ Femoral Neck Fracture System  
Study Purpose: 
A post-market, prospective study to evaluate the reoperation rate of 
displaced and nondisplaced femoral neck fractures treated with the 
CONQUEST FN™ system. 
Primary Objective: 
The primary objective of this study is to evaluate the reoperation rate 
for any reason of displaced and non-displaced femoral neck fractures 
treated with the CONQUEST FN™ Femoral Neck Fracture System at 
one year post-operation. 
Secondary Objective(s): The secondary objective of this study is to generate safety and 
performance evidence for the CONQUEST FN™ Femoral Neck 
Fracture System via the collection  
of functional outcomes, quality of life, and safety data.  
Statistical Rationale:  
A total minimum sample size of 90 subjects with a minimum of 45 
subjects for displaced and 45 subjects for non-displaced femoral neck 
fractures. Since the primary and secondary endpoints are the same for 
all fractures, overall results will be reported as well. 
Sample Size: 
A minimum of 90 Subjects (minimum of 45 displaced and 45 non-
displaced femoral neck fractures) 
Number of Study Sites: Approximately 10 sites 
Targeted Global 
Regions: 
United States  
Inclusion Criteria: 
1. The subject must provide written informed consent (reference 
section 7.4). 
 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 4 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
2. The subject must be eighteen (18) years of age or older. 
 
3. The subject must be willing and able to make all required study 
visits including one (1) year post-operative follow-up. 
 
4. The subject must be able to follow instructions. 
 
5. Subject has experienced displaced or non-displaced intracapsular 
femoral neck fracture and are scheduled for repair using the 
CONQUEST FN™ Femoral Neck Fracture System. 
 
Exclusion Criteria: 
1. Contraindications or hypersensitivity to the use of the CONQUEST 
FN™ Femoral Neck Fracture System or its components (316L
stainless steel). 
 
2. Subject with fracture occurring more than 7 days prior to 
implantation of the CONQUEST FN™ Femoral Neck System. 
 
3. Subject has more than one fracture on target hip. 
 
4. Subject is obese as defined by a Body Mass Index (BMI) > 40 at 
the time of surgery. 
 
5. Subject, in the opinion of the Investigator, has an emotional or 
neurological condition that precludes cooperation and compliance 
with the rehabilitation regimen. 
 
6. Therapy with another investigational agent within thirty (30) days 
of Screening or planned therapy with another investigational 
agent during the course of the study.  
 
7. Subject has a physical condition that, in the opinion of the 
Investigator, would preclude adequate implant support or impede
healing (e.g. blood supply impairment, insufficient bone quality or 
quantity, or an active, local or systemic infection). If this is identified 
at the time of surgery, the subject will be screen failed. 
 
8. Subject has undergone previous surgery on the target hip. 
 
9. Subject has severe bow of the target hip or gross distortion of the 
femur. 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 5 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
 
10. Subjects who have participated previously in this clinical trial and 
who have healed or been withdrawn. 
 
11. Current systemic therapy with cytotoxic drugs.  
 
12. Subjects with a history of poor compliance with medical 
treatment.  
 
13. Subjects with a medical or physical condition that, in the opinion of 
the Investigator, would preclude safe subject participation in the 
study. 
Study Duration: 
Approximately 30 months (18 month recruitment period, 12 month 
follow-up) 
Primary endpoint: 
Reoperation rate for any reason of displaced and non-displaced 
femoral neck fractures treated with the Conquest FN™ at one year 
post-operation.   
Secondary endpoint(s): The secondary endpoints of this study include generation of safety, 
performance, and health economic evidence supporting the use of the 
CONQUEST FN™ Femoral Neck Fracture System per the endpoints 
listed below: 
 
Intraoperative complications 
 
Radiographic outcomes including quality of fracture reduction 
 
Construct failure past typical femoral neck fracture healing 
period (past 6 months) 
 
Visual analogue scale (VAS) relating to pain at the fracture site
 
Quality of Life (EQ-5D-5L) 
 
Time to return to full weight-bearing  
 
Ambulatory status from pre-injury to study completion  
 
Timed Up & Go  
 
Length of hospital stay 
 
Hospital readmissions for any reason 
 
Device- and surgery-related adverse events  
 
Active straight leg raise (ASLR) assessment 
Safety Data 
Adverse Events will be collected and 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. All events, based on these 
categorizations, will be reported to appropriate regulatory authorities 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 6 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
per ISO 14155: Clinical investigation of medical devices – Good Clinical 
Practice and ICH-E6. 
 
STUDY SCHEMATIC  
Schedule of 
events  
Pre-
Operative 
Data 
(Day -7 to 
Day 0) 
Operative/ 
Discharge 
Data1 
(Day 1) 
6 weeks 
(Day 42 ± 
7 days) 
 
3 months 
(Day 90 ± 
7 days) 
 
6 months 
(Day 180 ± 
14 days) 
 
12 months 
(Day 365 ± 
30 days) 
 
Informed Consent 
 
 
 
 
 
 
Inclusion/Exclusion  
 
 
 
 
 
 
Demographics/ 
Medical  History 
 
 
 
 
 
 
Operative Data 
Collection 
 
 
 
 
 
 
Discharge Data 
Collection1 
 
 
 
 
 
 
VAS (pain score) 
 
 
 
 
 
 
Timed Up & Go 
 
 
 
 
 
 
EQ-5D-5L 
 
 
 
 
 
 
X-Ray 
 
AP 

Lateral
 
 
 
 
 
 
Active Straight Leg 
Raise 
 
 
 
 
 
 
Adverse Event 
Assessment 
 
 
 
 
 
 
End of Study/Exit   
 
 
 
 
 
 
1 Discharge data to be collected at time of discharge which will be dependent on subject recovery. 
 
 
 
 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 7 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
 TABLE OF CONTENTS 
 
Signatures .......................................................................................................................................... 1 
1.1 
Protocol Signature Page ............................................................................................................ 1 
1.2 
Sponsor Approval ...................................................................................................................... 2 
 
Synopsis ............................................................................................................................................ 3 
 
Table of Contents .............................................................................................................................. 7 
3.1 
Table of Tables .......................................................................................................................... 9 
3.2 
Table of Figures ......................................................................................................................... 9 
3.3 
List of Abbreviations ................................................................................................................ 10 
 
Introduction ...................................................................................................................................... 12 
4.1 
Background.............................................................................................................................. 12 
4.2 
Study Purpose ......................................................................................................................... 13 
4.3 
Safety Considerations ............................................................................................................. 13 
 
Objective(s) ...................................................................................................................................... 14 
5.1 
Primary Objective .................................................................................................................... 14 
5.2 
Secondary Objective(s) ........................................................................................................... 14 
 
Study Device(S) ............................................................................................................................... 15 
6.1 
Identification............................................................................................................................. 15 
6.2 
Product Use ............................................................................................................................. 17 
6.3 
Packaging and Labeling .......................................................................................................... 17 
6.4 
Study device/ Ancillary Products and Study Supplies Accountability Procedures .................. 17 
6.5 
Surgical Technique .................................................................................................................. 17 
 
Subject Enrollment and Withdrawal ................................................................................................. 18 
7.1 
Inclusion Criteria ...................................................................................................................... 18 
7.2 
Exclusion Criteria ..................................................................................................................... 18 
7.3 
Screening ................................................................................................................................. 19 
7.4 
Informed Consent .................................................................................................................... 20 
7.5 
Enrollment ................................................................................................................................ 20 
7.6 
Lost to Follow-Up ..................................................................................................................... 20 
7.7 
Withdrawal ............................................................................................................................... 21 
 
Study Design ................................................................................................................................... 22 
8.1 
Study Design ........................................................................................................................... 22 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 8 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
8.2 
Allocation and Blinding ............................................................................................................ 22 
This study is not randomized. ................................................................................................................. 22 
8.3 
Study Endpoints ...................................................................................................................... 22 
8.4 
Visits and Examinations .......................................................................................................... 24 
8.5 
Study Methods and Measurements ......................................................................................... 30 
 
Statistical Design ............................................................................................................................. 32 
9.1 
General .................................................................................................................................... 32 
9.2 
Analysis Populations ............................................................................................................... 33 
9.3 
Baseline Data .......................................................................................................................... 33 
9.4 
Efficacy Analysis ...................................................................................................................... 33 
9.5 
Safety Analyses ....................................................................................................................... 34 
9.6 
Interim Analyses ...................................................................................................................... 35 
 
Sample Size Justification ................................................................................................................. 35 
 
Adverse Events and Device Deficiencies ........................................................................................ 35 
11.1 
Definitions ................................................................................................................................ 35 
11.2 
Reporting Procedures .............................................................................................................. 38 
11.3 
Follow-up of Subjects with Adverse Events ............................................................................ 40 
 
Investigator Obligations ................................................................................................................... 41 
 
Sponsor and Monitor Responsibilities ............................................................................................. 41 
13.1 
Site Qualification Visit .............................................................................................................. 42 
13.2 
Site Initiation Visit .................................................................................................................... 42 
13.3 
Sponsor Audits and Regulatory Inspection ............................................................................. 42 
13.4 
Close-out Visit.......................................................................................................................... 42 
 
Protocol Amendments ..................................................................................................................... 42 
 
Confidentiality of the Study .............................................................................................................. 43 
 
Statements of Compliance............................................................................................................... 43 
 
End of Study .................................................................................................................................... 43 
 
Publication Policy ............................................................................................................................. 43 
18.1 
Publication of Study Data ........................................................................................................ 44 
18.2 
Data Sharing ............................................................................................................................ 44 
 
References ...................................................................................................................................... 45 
 
Appendices ...................................................................................................................................... 47 
20.1 
Protocol Amendment ............................................................................................................... 47 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 9 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
2. Synopsis – Exclusion Criteria ................................................................................................................. 47 
2. Synopsis – Exclusion Criteria ................................................................................................................. 48 
2. Synopsis – Exclusion Criteria ................................................................................................................. 48 
7.2 Exclusion Criteria .................................................................................................................................. 52 
7.2 Exclusion Criteria .................................................................................................................................. 52 
8.4.2 Screening/Preoperative Visit .............................................................................................................. 52 
8.4.3 Baseline/Operation Visit (Day 1) ........................................................................................................ 52 
8.4.3 Baseline/Operation Visit (Day 1) ........................................................................................................ 53 
8.4.4 Follow-up Visits .................................................................................................................................. 53 
Entire document .......................................................................................................................................... 54 
20.2 
Instructions For Use ................................................................................................................ 54 
20.3 
Principal Investigator Obligations (ISO14155) ........................................................................ 55 
3.1 
TABLE OF TABLES  
Table 8.4.1-1: Study Procedures by Visit .................................................................................................... 25 
Table 12.1-1: Categories of Adverse Event ................................................................................................ 36 
3.2 
TABLE OF FIGURES 
Figure 12.2-1: Evaluation and Reporting of AE and DevD ......................................................................... 40 
 
 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 10 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
3.3 
LIST OF ABBREVIATIONS  
Abbreviation
Definition
ASLR 
Active Straight Leg Raise 
ADE 
Adverse Device Effect(s) 
AE 
Adverse Event(s) 
AP 
Anteroposterior 
CRF 
Case Report Form(s) 
CV 
Curriculum Vitae 
DevD 
Device Deficiency(ies) 
FAS 
Full Analysis Set Population 
FU 
Follow-up 
GCP 
Good Clinical Practice 
ICH 
International Conference on Harmonisation  
IEC 
Independent Ethics Committee 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
ITT 
Intention to Treat population 
MedDRA 
Medical Dictionary for Regulatory Activities  
NA or N/A 
Not Applicable 
N (or n) 
Total Sample Size (or subgroup sample size) 
PI 
Principal Investigator 
PP 
Per-protocol Population 
S&N 
Smith & Nephew Inc. 
SADE 
Serious Adverse Device Effect(s) 
SAE 
Serious Adverse Event(s) 
SAF 
Safety population 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
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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-110 – Clinical Protocol - Devices  
 
Abbreviation
Definition
SAP 
Statistical Analysis Plan 
TUG 
Timed Up and Go 
USADE 
Unanticipated Serious Adverse Device Effect(s) 
VAS 
Visual Analog Scale 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 12 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
 
INTRODUCTION 
4.1 
BACKGROUND  
Femoral neck fractures are major surgical challenges with high complication rates in young (<60 
years), young elderly (60-70 years) and elderly adults (>70 years). Relevant literature has 
reported complication rates ranging from 15–64%1,2 and 0-36%3,4 for displaced and non-
displaced femoral neck fractures, respectively. Complications typically manifest as avascular 
necrosis, fracture non-union with implant failure and concomitant loss of fracture reduction.5, 6, 7  
In many cases, the onset of these complications necessitates re-operation.8 The function and 
anatomy of the proximal femur, including the high regional variability in local load/strain 
distribution, vascular supply and lack of periosteal fracture response, all contribute in making 
femoral neck fractures challenging to manage clinically.9,10,11 
 
Conservative care for high (i.e. traumatic) or low (i.e. fragility) energy femoral neck fractures is 
rarely a therapeutic option, and so a higher risk surgical intervention is usually the only 
management choice.12 Fixation has historically been accomplished using multiple cannulated 
screws or compressions hip screws with or without anti-rotation screws, which act to reduce the 
fracture and confer compression across the fracture site to allow healing.13  For high-energy 
injuries resulting in displaced femoral neck fractures, the quality of fracture reduction is of 
significant importance, as poorly reduced fractures have been associated with high non-union 
rates and the need for repeat surgical intervention.14  While various permutations of these 
fixation strategies have been utilized clinically, current data to not conclusively support the 
superiority of a single fixation system or approach for the treatment of intracapsular femoral 
neck fractures and high complication rates persist.15,16 
 
The CONQUEST FN™ represents the next generation femoral neck fracture system designed 
to offer better intra-operative reduction control with the assurance of eliminating device failure 
modes.  This system is dedicated to treating both non-displaced and displaced intracapsular 
fractures of the femoral neck. It is a dynamic locked implant system that provides multiple points 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 13 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
of fixed angle support with continuous compression across the fracture site, ensuring bone-on-
bone contact during the fracture union process. The continuous fracture site compression and 
post-operative reduction maintenance is accomplished with the incorporation of telescoping 
compression screw technology. The novel system empowers surgeons to address the current 
surgical challenges and often unfavorable patient outcomes and high re-operation rate 
associated with the current treatment options for intracapsular femoral neck fractures.    
 
The CONQUEST FN™ Femoral Neck Fracture System obtained 510(k) clearance from FDA on 
17Mar2016. To date, it is being used in clinical practice by several institutions in the United 
States with approximately sixty (60) cases in which the system has been implanted.  Clinical 
studies on the system are needed to provide evidence to assess overall safety and efficacy. A 
summary of known and potential risks and benefits to humans of the Study Device can be found 
in the Instructions for Use (IFU).  
4.2 
STUDY PURPOSE 
A post-market, prospective study to evaluate the reoperation rate of displaced and 
nondisplaced femoral neck fractures treated with the CONQUEST FN™ system.Safety 
Considerations 
Reference the current Instructions for Use (IFU) for a comprehensive list on known 
contraindications and safety considerations.  
 
 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 14 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
 
OBJECTIVE(S) 
5.1 
PRIMARY OBJECTIVE 
The primary objective of this study is to evaluate the re-operation rate for any reason of 
displaced and non-displaced femoral neck fractures treated with the CONQUEST FN™ Femoral 
Neck Fracture System at one year post-operation.  
5.2 
SECONDARY OBJECTIVE(S) 
The secondary objective of this study is to generate safety and performance evidence for the 
CONQUEST FN™ Femoral Neck Fracture System via the collection of functional outcomes, 
quality of life, and safety data. 
 
 
 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 15 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
 
STUDY DEVICE(S) 
6.1 
IDENTIFICATION  
6.1.1 Study Product 
Intended Use 
The CONQUEST FN™ Femoral Neck Fracture System is indicated for use in displaced and 
non-displaced intracapsular femoral neck fractures. The present study aims to evaluate the use 
of CONQUEST FN™ in adults (≥ 18 years of age) who have suffered a femoral neck fracture 
due to trauma but are otherwise active individuals. 
 
Device description 
The CONQUEST FN™ is a dynamic locking plate system that includes a proximal femoral 
locking plate, telescoping compression screws, and reduction maintenance instrumentation. The 
proximal femoral locking plate is available in three sizes (left and right) (see figure 6.1.1-1), all of 
which are comprised of 316L Stainless Steel with a neck angle of 124 degrees and anteversion 
of 14 degrees. The telescoping compression screws are available in two (2) circumference 
sizes, 7.5mm and 8.5mm, which are also comprised of 316L Stainless Steel with lengths 
ranging from 75mm-130mm (5mm increments).  
 
Manufacturer  
CONQUEST FN™ is manufactured by Smith & Nephew, Inc., 1450 Brooks Road, Memphis, TN 
38116. 
 
 
 
 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 16 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
Figure 6.1.1-1 CONQUEST FN™ Femoral Neck Fracture System (Not Actual Size) 
 
 
 
 
 
 
 
 
 
 
 
6.1.2 IP-Control and Comparator Treatment 
There will be no comparator products used in this study.  
6.1.3 Ancillary Products 
No ancillary products are to be provided for this study.  
CONQUEST FN Locking Plates 60mm
Set No. 7181-1401 
Cat. No.
Description 
Quantity 
7580-7001L 
CONQUEST FN Locking Plate 1H Left 60mm 
1 
7580-7001R 
CONQUEST FN Locking Plate 1H Right 60mm 
1 
CONQUEST FN Locking Plates 85mm
Set No. 7181-1401 
Cat. No.
Description 
Quantity 
7580-8002L 
CONQUEST FN Locking Plate 2H Left 85mm 
1 
7580-8002R 
CONQUEST FN Locking Plate 2H Right 85mm 
1 
CONQUEST FN™ Locking Plates 127mm
Set No. 7181-1401 
Cat. No.
Description 
Quantity 
7580-7003L 
CONQUEST FN Locking Plate 3H Left 127mm 
1 
7580-7003R 
CONQUEST FN Locking Plate 3H Right 127mm 
1 
1 Hole – 60mm length 
2 Hole – 85mm length 
3 Hole – 127mm length 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 17 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
6.2 
PRODUCT USE 
Refer to IFU and Surgical Technique educational brochure for full instructions. 
Study center personnel with responsibilities for the medical care of subjects and/or the 
implantation of the study device (CONQUEST FN™) will be trained on the use and surgical 
techniques of CONQUEST FN™ prior to enrolling subjects in the study.  
6.3 
PACKAGING AND LABELING 
Packaging and labelling will be prepared to meet regulatory requirements. 
6.3.1 Study Device Labeling    
Smith & Nephew will not supply the site with study devices due to the various size options 
available for use.  Standard device procurement and management will be used per site 
processes.  
6.4 
STUDY DEVICE/ ANCILLARY PRODUCTS AND STUDY SUPPLIES ACCOUNTABILITY 
PROCEDURES  
No Study device/Ancillary Products and Study Supplies are supplied for the study and the 
Sponsor accountability will not be required. 
6.5 
SURGICAL TECHNIQUE 
All study-related procedures conducted at the study site must be performed according to the 
recommended surgical technique described in the labeling and instructions for use (IFU).  
 
Surgeons selected to participate in this study will be required to have completed two (2) 
surgeries using the CONQUEST FN™ Femoral Neck Fracture System and have written 
evidence of training and expertise in the study procedure. 
 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 18 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
 
SUBJECT ENROLLMENT AND WITHDRAWAL 
 Subject Population 
A minimum of 90 subjects (18 years of age or older) with a confirmed displaced or non-
displaced intracapsular femoral neck fracture who are scheduled for repair using CONQUEST 
FN™ will be recruited at approximately 10 study sites in the United States. Additional sites may 
be added, if necessary, to meet recruitment goals. A minimum of 45 displaced and 45 non-
displaced fractures are required.  
7.1 
  INCLUSION CRITERIA 
Subjects will be considered qualified for enrollment if they meet the following criteria: 
1.
The subject must provide written informed consent (reference section 7.4). 
2.
The subject must be eighteen (18) years of age or older. 
3.
The subject must be willing and able to make all required study visits including one (1) 
year post-operative follow-up.  
4.
The subject must be able to follow instructions. 
5. Subject has experienced displaced or non-displaced intracapsular femoral neck fracture 
and is scheduled for repair using the CONQUEST FN™ Femoral Neck Fracture System. 
7.2 
EXCLUSION CRITERIA 
Any one (1) of the following criteria will disqualify a potential subject from participation in the 
study: 
1. Contraindications or hypersensitivity to the use of the CONQUEST FN™ Femoral 
Neck Fracture System or its components (e.g. stainless steel). 
2. Subject with fracture occurring more than 7 days prior to implantation of the 
CONQUEST FN™ Femoral Neck System. 
3. Subject has more than one fracture on target hip.  
4. Subject is obese as defined by a Body Mass Index (BMI) > 40 at the time of surgery. 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 19 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
5. Subject, in the opinion of the Investigator, has an emotional or neurological condition 
that preludes cooperation and compliance with the rehabilitation regimen.  
6. Therapy with another investigational agent within thirty (30) days of Screening or 
planned therapy with another investigational agent during the course of the study.  
 
7. Subject has a physical condition that, in the opinion of the Investigator, would 
preclude adequate implant support or impede healing (e.g. blood supply impairment, 
insufficient bone quality or quantity, or an active, local or systemic infection). If this is 
identified at the time of surgery, the subject will be screen failed. 
8. Subject has undergone previous surgery on the target hip.  
9. Subject has a severe bow of the target hip or gross distortion of the femur.  
10. Subjects who have participated previously in this clinical trial and who have healed or 
been withdrawn. 
11. Current systemic therapy with cytotoxic drugs. 
12. Subjects with a history of poor compliance with medical treatment. 
13. Subjects with a medical or physical condition that, in the opinion of the Investigator, 
would preclude safe subject participation in the study. 
7.3 
SCREENING  
Participating study sites are required to document all screened subjects. 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.  
Part of the screening process will include documentation of women’s childbearing potential. If 
the woman is not of child bearing potential this should be documented in the medical history 
(e.g. surgically postmenopausal, postmenopausal [i.e. at least 1 year without menses]). For 
women of childbearing potential their method of birth control should be documented in the 
source.  

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 20 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
7.4 
INFORMED CONSENT 
Before conducting any study procedures or examinations, the purpose and nature of the study 
will be explained to the subject in their native language. Informed Consent Forms (ICF) requiring 
translation from English to a subject’s native language will be translated by a certified third party 
vendor of the Sponsor’s choosing. The translated ICF will then be submitted to the site’s 
Institutional Review Board (IRB) for review and approval prior to distributing to potential 
subjects.  The subject will then read, sign, and personally date the IRB -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 documentation will be provided to the subject 
and the original kept on site. Any additional requirements required by the IRB will be followed.  
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. 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 ICF, attesting that the information 
was accurately explained and that the informed consent was freely given. 
7.5 
ENROLLMENT 
Enrollment in this study shall occur once the subject has successfully completed the informed 
consent process and successfully completed the Operative Visit (Day 1). A subject number will 
be assigned at the time of the Screening visit.  
7.6 
LOST TO FOLLOW-UP 
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 prior to declaring a subject to be lost to follow-up: the subject has been contacted 
according to the site's policies, but no fewer than 2 documented phone contacts and 1 certified 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 21 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
letter without response. Copies of all attempts to reach the subjects per regular mail or email 
and/or the attempts to contact the subject via other means should be documented and that 
documentation should be kept with the subject’s source documents. 
7.7 
WITHDRAWAL 
7.7.1 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 
 
in the event any component of the original hardware is revised/exchanged  
 
Replacement Policy 
Subjects who dropout before being enrolled (i.e. during Screening) will be replaced. Subjects 
who drop out of the study after being enrolled, for whatever reason, will not be replaced. Any 
subject who drops out after randomization will not be permitted to re-enroll into the study at a 
later date.  
For each case, information will be obtained in the source document and the End of Study Case 
Report Form (CRF), detailing circumstances leading to the withdrawal.  
7.7.2 Subject’s Withdrawal of Consent to Participate in Study 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 22 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
Study participation is voluntary and subjects may withdraw at any point during the study without 
giving their reason for doing so. Where subjects withdraw consent, the Investigator should make 
a reasonable effort to ascertain the reason(s), while fully respecting the subject’s privacy. The 
reason for withdrawal will be recorded in the CRF and in source documents. 
7.7.3 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.  
 
STUDY DESIGN 
8.1 
STUDY DESIGN 
This is a multi-center, post-marketing, prospective study. Subjects will be stratified by fracture 
type (minimum of 45 displaced and 45 non-displaced fractures) for a minimum total of 90 
enrolled subjects.  
 
Data from eligible subjects who have provided a signed ICF will be evaluated at the pre-
operative, operative/discharge, 6-weeks, 3-month, 6-month and 12-month follow-up visits.   
 
The total study duration will include approximately 18 months for enrollment and one year of 
follow-up at approximately 10 sites in the United States. 
8.2 
ALLOCATION AND BLINDING 
This study is not randomized. 
8.3 
STUDY ENDPOINTS 
8.3.1 Primary Endpoint 
The primary endpoint of this study is the re-operation rate for any reason of displaced and non-
displaced femoral neck fractures treated with CONQUEST FN™ at one year post-operation.    

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 23 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
8.3.2 Secondary Endpoints  
The secondary endpoints of this study include generation of safety, performance, and health 
economic evidence supporting the use of the CONQUEST FN™ Femoral Neck Fracture System 
per the endpoints listed below: 
 
Intraoperative complications 
 
Radiographic outcomes including quality of fracture reduction 
 
Construct failure past typical femoral neck fracture healing period (past 6 months) 
 
Visual analogue scale (VAS) relating to pain at the fracture site 
 
Quality of Life (EQ-5D-5L) 
 
Time to return to full weight-bearing  
 
Ambulatory status from pre-injury to study completion 
 
Timed Up & Go 
 
Length of hospital stay 
 
Hospital readmission for any reason 
 
Device- and surgery-related adverse events 
 
Active straight leg raise (ASLR) assessment  
 
 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 24 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
8.3.3 Safety Endpoints 
Device- and surgery-related adverse events (AE), as indicated by the Investigator. 
8.3.4 Other Endpoints 
The re-operation rate in older patients vs. younger patients for a given fracture type for both the 
displaced and non-displaced fracture types. 
8.4 
VISITS AND EXAMINATIONS  
8.4.1 Summary 
For a summary of the required procedures by visit, refer to Table 8.4.1-1: Study Procedures by 
Visit. 
 
 
 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
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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-110 – Clinical Protocol - Devices  
 
Table 8.4.1-1: Study Procedures by Visit 
Schedule of 
events  
Pre-
Operative 
Data  
(Day -7 to 
Day 0) 
Operative/
Discharge 
Data1 
(Day 1) 
6 weeks
(Day 42 ± 
7 days) 
 
3 months
(Day 90 ± 
7 days) 
 
6 months
(Day 180 ± 
14 days) 
 
12 months
(Day 365 ± 
30 days) 
 
Informed Consent 
 
 
 
 
 
 
Inclusion/Exclusion  
 
 
 
 
 
 
Demographics/ 
Medical  History 
 
 
 
 
 
 
Operative Data 
Collection 
 
 
 
 
 
 
Discharge Data 
Collection1 
 
 
 
 
 
 
VAS (pain score) 
 
 
 
 
 
 
Timed Up & Go 
 
 
 
 
 
 
EQ-5D-5L 
 
 
 
 
 
 
X-Ray 
 
AP 

Lateral
 
 
 
 
 
 
Active Straight Leg 
Raise 
 
 
 
 
 
 
Adverse Event 
Assessment 
 
 
 
 
 
 
End of Study/Exit   
 
 
 
 
 
 
1 Discharge data to be collected at time of discharge which will be dependent on subject recovery. 
 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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Version: 2.0, 30Nov2018
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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-110 – Clinical Protocol - Devices  
 
8.4.2 Screening/Preoperative Visit  
NOTE: Any subject who signs an informed consent but fails to meet the required entry criteria is 
considered to be a Screen Failure. Screen Failure subjects will be assigned subject numbers 
and their demographic information will be captured in the appropriate CRF with the reason for 
screen failure specified. 
 
1.  
Obtain written informed consent from the subject as detailed in Section 7.4 
----- Do not proceed until consent has been obtained ----- 
2.  
Obtain demographic information and medical history, including information on all 
concomitant medications/therapies and pre-injury ambulatory status.  
3.  
Screen the subject for protocol inclusion/exclusion criteria. 
4.  
If subject meets protocol inclusion/exclusion criteria, assign a subject number using 
format SS-NNN (SS = site number, NNN subject number at site). The subject 
number will be assigned in sequential order starting with 001. Screened subject 
numbers will NOT be reused by qualifying subjects. 
5.  
Perform radiology imaging collecting both anteroposterior (AP) and lateral images 
of the target hip. 
6.  
Assess level of pain from the target hip within the previous 24 hours using the 
Visual Analog Scale (VAS). 
7.  
Instruct the subject to complete the health outcome questionnaire, EQ-5D-5L. 
8.  
Instruct the subject on treatment procedures.  
9. Subjects will return to the treatment facility, if applicable, for the Baseline 
/Operation Visit no longer than 7 days post-fracture. 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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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-110 – Clinical Protocol - Devices  
 
8.4.3 Baseline/Operation Visit (Day 1) 
NOTE: If the Investigator decides a subject should not receive the Study Device for any reason 
at the time of surgery, the subject will be considered a Screen Failure and the reason for non-
enrollment will be clearly documented in the subject’s source documents.   
1. Query subject regarding any changes in general health and the use of concomitant 
medications. 
2. If any adverse device effects or device deficiencies are observed or reported, they 
must be recorded as instructed in Section 11, adverse events and device deficiencies.
3. Perform surgery per current CONQUEST FN™ Instructions for Use (IFU).  
4. Collect study-specific operative data.  
5. Perform radiology imaging collecting both anteroposterior (AP) and lateral images of 
the target hip to ensure the CONQUEST FN™ is properly implanted.  
6. Collect study-specific discharge data. 
7. Instruct the subject on proper postoperative care documenting the prescribed 
rehabilitation plan in the subject’s source document. 
8. Instruct the subject on follow-up procedures, including returning to the office for 
Follow-up (FU) Visit 1 in 42 (± 7) days. 
8.4.4 Follow-up Visits: 6 Weeks (Day 42 ± 7 days), 3 Months (Day 90 ± 7 days), 6 Months 
(Day 180 ± 14 days) 
1. 
Assess level of pain from the target hip within the previous 24 hours using the VAS. 
2. 
Instruct the subject to complete the health outcome questionnaire, EQ-5D-5L. 
3. 
Complete active straight leg raise (ASLR) test as instructed in Section 8.5, Study 
Methods and Measurements.  
4. 
Complete Timed Up and Go (TUG) test as instructed in Section 8.5, Study Methods 
and Measurements.  

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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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-110 – Clinical Protocol - Devices  
 
5. 
Query subject regarding any changes in general health, the use of concomitant 
medications, and ambulatory status 
6. 
If any adverse device effects or device deficiencies are observed or reported, they 
must be recorded as instructed in Section 11, adverse events and device deficiencies.
7. 
Perform radiology imaging collecting both anteroposterior (AP) and lateral images of 
the target hip. 
8. 
Instruct the subject on proper postoperative care documenting continued instructions 
in the subject’s source document.  
9. 
Instruct the subject on follow-up procedures, including returning to the office for FU 
Visit 2 in 90 (± 7) days and Visit 3 in 180 (± 14) days 
8.4.5 Exit Visit: 12 months (Day 365 ± 30 days) 
1. Assess level of pain from the target hip within the previous 24 hours using the VAS. 
2. Instruct the subject to complete the health outcome questionnaire, EQ-5D-5L. 
3. Complete ASLR test as instructed in Section 8.5, Study Methods and Measurements.  
4. Complete TUG test as instructed in Section 8.5, Study Methods and Measurements. 
5. Query subject regarding any changes in general health, the use of concomitant 
medications, and ambulatory status 
6. If any adverse device effects or device deficiencies are observed or reported, they 
must be recorded as instructed in Section 11, adverse events and device deficiencies.
7. Perform radiology imaging collecting both AP and lateral images of the target hip. 
8. Complete Exit Visit CRF 
8.4.6 Unscheduled Visits  
Unscheduled examinations may be conducted at the discretion of the Investigator with all 
obtained information recorded in the source documents and on the appropriate CRF. 
8.4.7 Concomitant Medications and Therapies 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
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TMP-110 – Clinical Protocol - Devices  
 
A concomitant medication (e.g. drug, substance) and a concomitant therapy (e.g. physical 
therapy, TENS Unit, massage) are recorded pre-operatively and at each visit   through the 
subject’s last study visit. The subject’s ambulatory status will be documented pre-operatively 
and at each follow-up through the last study visit. 
8.4.7.1 
Concomitant Medications 
8.4.7.1.1 
Excluded Concomitant Medications 
There are no excluded concomitant medications for this study.  
8.4.7.1.2 
Recording Concomitant Medications in the CRF 
Only medications related to the IP implanted and medications used to treat an AE/ADE related 
to the IP will be recorded in the CRF. Reference the CRF Completion Guidelines for how 
medications are recorded.  
9.1.8 Discontinued Subjects 
Discontinued subjects are those who voluntarily discontinue participation, who are withdrawn for 
reasons of safety or use of prohibited concomitant treatments, or who are lost to follow-up. 
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 7.7.1). 
Any changes to medical health and/or the use of concomitant medications will be captured. If 
any SAE, SADE, or DevD were observed since the previous visit, they must be recorded (refer 
to section 11, Adverse Events and Device Deficiencies, for instructions on reporting and 
evaluation procedures).  Finally, if appropriate, the Investigator will also advise the subject of 
subsequent therapy and/or procedures necessary for their medical condition.  
8.4.8 Subject Pregnancy 
Women of childbearing potential are not excluded from the study as long as adequate birth 
control methods are being used by the subject.However, if a woman becomes pregnant during 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110 – Clinical Protocol - Devices  
 
the study, S&N must be contacted immediately once the Investigator is made aware of the 
pregnancy. Pregnancy is not reportable as 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. 
8.5 
STUDY METHODS AND MEASUREMENTS 
All questionnaires should be completed prior to any other procedure at the time of the 
scheduled visit.  The dates of all assessments should be recorded. 
 
8.5.1 Visual Analogue Scale (VAS) for Pain 
The Visual Analogue Scale is simply a line of fixed length, on which the subject marks their 
experience of pain with a single stroke of a pen.  
 
 
 
 
At each specified visit, the subject will be asked to indicate their average level of pain from the 
operated hip over the prior 24 hours using a visual analog scale (VAS). The subject will record 
their level of pain on a 100 mm visual analog scale, similar to the one illustrated above. The 
scale will be marked ‘no pain’ on the left side of the scale and ‘severe pain’ at the right end of 
the scale. The subject will be instructed to place a vertical mark on the scale, using an ink pen. 
The Investigator, or designee, will measure the distance (in millimeters) from the left end of the 
VAS scale to the vertical line drawn by the subject. This value will be entered in the subject’s 
CRF as a measure of the pain associated with the operated hip. 
  8.5.2 EQ-5D-5L 
The EuroQol EQ-5D-5L is a standardized instrument for use as a measurement of health 
outcome.  It consists of a descriptive system with 5 dimensions (mobility, self-care, usual 
 No pain 
 Severe 
   pain

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110 – Clinical Protocol - Devices  
 
activities, pain/discomfort and anxiety/depression), which are each assigned five levels (no 
problems, slight problems, moderate problems, severe problems and extreme problems), as 
well as, a Visual Analogue Scale where subjects indicate a numerical value from 1-100 where 0 
is the worst imaginable health state and 100 is the best imaginable health state. 
The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box 
against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-
digit number expressing the level selected for that dimension. The digits for 5 dimensions can 
be combined in a 5-digit number describing the respondent’s health state.  
 
8.5.3Timed Up and Go (TUG) 
The Timed Up and Go Test assesses mobility, balance, walking ability, and fall risk in adults by 
measuring time, in seconds, that it takes the individual to stand from a chair, walk a distance of 
10 feet, walk back to the chair, and sit down. The subject will perform the test in their everyday 
footwear with their walking aid (cane, walker), if applicable.17 The site will follow the guidelines 
provided by the Centers for Disease Control and Prevention recording the results on the form 
provided by the Sponsor.18 
  8.5.4 Assessment of Quality of Fracture Reduction 
The quality of the final fracture reduction will be defined using the criteria described by 
Upadhyay et el.14 Appropriate reduction will be defined as the principal compressive trabeculae 
measuring >160° in the AP view and <5° of posterior angulation in the lateral view.  If reduction 
is acceptable in both views, it will be classified as grade I. Grade II will be indicative of one 
plane of malreduction, and grade III will be indicative of malreduction in both radiographic views.  
Pre-operative radiographs will be reviewed and classified as displaced (e.g. Garden III & IV) or 
non-displaced (e.g. Garden I & II) femoral neck fractures by the Investigator at each site. Quality 
of fracture reduction will also be assessed post-operatively by the Investigator at each site.  
  8.4.5 Active Straight Leg Raise (ASLR) Assessment 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-110 – Clinical Protocol - Devices  
 
The ALSR assessment provides information about the ability of load transfer and motor control 
strategies in the lumbo/pelvic/hip complex. ASLR will be performed with the subject in a relaxed 
supine position with legs straight and feet apart.  Subjects will be instructed to raise their 
operated leg 20cm above the examination table without bending the knee and without pelvic 
movement relative to the trunk.  A score will be provided by the subject for the operated limb on 
a six-point Likert scale (0 = not difficult at all, 1 = minimally difficult; 2 = somewhat able to do, 3 
= fairly difficult, 4 = very difficult, 5 = unable to do). 
 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. The SAP will be more 
detailed and account for all analyses.  All analyses will be conducted with statistical software 
SAS Version 9.4 or later.  
9.1 
GENERAL 
The subject data will be described and summarised using the baseline demographic and medical 
variables, which include, but are not limited to, age, gender, ethnicity, medical and medication 
history, diagnostic factors as well as study process variables (e.g. AE and withdrawal(s)). Summary 
statistics will be given according to the nature of the variable, continuous or categorical. For 
continuous variables, the number of observations, mean, standard deviation, median, minimum, and 
maximum will be presented, while for categorical variables the number of observations, frequency, 
and percentages will be reported.  
 
Primary, secondary, and exploratory outcome variables and derived variables will also be 
summarised accordingly. Parametric statistical tests will be used if the data are normally 
distributed and corresponding non-parametric tests will be considered if the data are not. Where 
necessary, suitable regression techniques will be used to adjust for confounding variables since 
the study is non-randomised. The results will be reported at 5% significance level and where 
appropriate 95% confidence intervals will be given. 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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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-110 – Clinical Protocol - Devices  
 
9.2 
ANALYSIS POPULATIONS 
 
Intention to Treat population (ITT), including all subjects randomized into the study. 
 
Full analysis set population (FAS), following Intention to Treat principle including all 
subjects who were randomized into the study and attended at least one post-baseline 
assessment  
 
Safety Population (SAF), including all subjects who have received the IP or the control 
devices. 
 
Per-Protocol Population (PP), including all subjects in the full analysis set who have 
no significant protocol deviations and met the inclusion/exclusion criteria. 
Statistical analysis will be performed using each of the patient populations as follows. Analysis 
of the primary, secondary and exploratory efficacy objectives will be performed separately using 
both the Full Analysis Set and the Per Protocol Population. All safety analyses will utilize the 
Safety Population. 
9.3 
BASELINE DATA 
The subjects will be described and summarised using the baseline demographic and medical 
variables, which include, but are not limited to, age, gender, ethnicity, medical and medication 
history, diagnostic factors. Summary statistics will be given according to the nature of the 
variable, continuous or categorical. For continuous variables, the number of observations, 
mean, standard deviation, median, minimum, and maximum will be presented, while for 
categorical variables the number of observations, frequency, and percentages will be reported. 
A complete accountability report, along with the explanation for lost-to-follow-up, death, revision, 
and withdrawn subjects will be provided with the methods being detailed in the SAP. 
9.4 
EFFICACY ANALYSIS 
The study is non-comparative and non-randomized, single cohort, post-marketing, multicenter 
prospective study to evaluate the clinical outcomes of the CONQUEST FN™ Femoral Neck 
Fracture System. A minimum total of 90 subjects will be enrolled in the study, which includes a 
5% estimate for subjects lost to follow-up at 1 year. 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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Version: 2.0, 30Nov2018
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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 
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TMP-110 – Clinical Protocol - Devices  
 
9.4.1 Analysis of Primary Endpoint 
A two-sided confidence interval will be provided for the proportion of re-operation (i.e. re-
operation rate) for any reason of displaced and non-displaced femoral neck fractures treated 
with CONQUEST FN™ at one-year post-operation. 
9.4.2 Analysis of Secondary Endpoint(s) 
The rate or mean of the following outcomes at 1 year post-operation will be reported: 
 
Intraoperative complications 
 
Radiographic outcomes including quality of fracture reduction 
 
Construct failure past typical femoral neck fracture healing period (past 6 months) 
 
Visual analogue scale (VAS) relating to pain at the fracture site 
 
Quality of Life (EQ-5D-5L) 
 
Time to return to full weight-bearing  
 
Ambulatory status from pre-injury to study completion 
 
Timed Up & Go 
 
 Length of hospital stay 
 
Hospital readmission for any reason 
 
Device and surgery related adverse events  
 
Active straight leg raise (ASLR) assessment 
9.4.3 Analysis of Other Endpoint(s) 
Provide the re-operation rate in older patients vs. younger patients for both the displaced and 
non-displaced fracture types. 
9.5 
SAFETY ANALYSES 
All safety analyses will be conducted using the safety population. The number of incidences and 
number of subjects reporting all adverse events will be summarized both overall and by 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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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-110 – Clinical Protocol - Devices  
 
seriousness, severity, relationship to study device and outcome. Incidences and number of 
subjects reporting device deficiencies will also be summarized. Further summaries of safety 
data may be described in the SAP. 
9.6 
INTERIM ANALYSES 
Once the last subject passes 6 Months, an interim analysis composed of summarizing the 
outcome and safety data will be performed. Additional unscheduled interim analyses may be 
performed during the conduct of this study to support requests from regulatory authorities and 
scientific publications. 
 SAMPLE SIZE JUSTIFICATION 
 Precision Analysis was used to assess the overall proportion of re-operation rate for any reason 
of displaced and non-displaced femoral neck fractures treated with the CONQUEST FN™ 
Femoral Neck Fracture System at one-year post-operation. Assuming a 5% lost to follow-up 
rate after the first year, a minimum of 90 subjects will be enrolled (based on the 
inclusion/exclusion criteria) in order to complete 80 evaluable subjects. The 90 subjects will be 
enrolled to allow a minimum of 45 subjects with each of the following indications to be recruited: 
displaced or non-displaced femoral neck fractures. For the displaced group this number of 
subjects is sufficient to estimate the proportion of success rate to within 12% by use of the two-
sided 95% confidence interval (assuming an overall success rate of 87%). And for the non-
displaced group this number of subjects is sufficient to estimate the proportion of success rate 
to within 10% use of the two-sided 95% confidence interval (assuming an overall success rate 
of 93%). 
 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
11.1 
DEFINITIONS 
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 (see reference within the table). 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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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-110 – Clinical Protocol - Devices  
 
 
Table 12.1-1: Categories of Adverse Event 
 
NOT DEVICE-
RELATED 
DEVICE- OR PROCEDURE-RELATED 
NON-
SERIOUS
ADVERSE EVENT  
(AE) (SEE 12.1.1) 
ADVERSE DEVICE EFFECT  
(ADE) (SEE 12.1.2) 
SERIOUS
SERIOUS ADVERSE 
EVENT  
(SAE)  
(SEE 12.1.3) 
SERIOUS ADVERSE DEVICE EFFECT 
(SADE) (SEE 12.1.3)
ANTICIPATED
UNANTICIPATED
ANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT  
(ASADE) (SEE 12.1.4) 
UNANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT  
(USADE) (SEE 12.1.4) 
11.1.1 Adverse Event 
An Adverse Event (AE) is any untoward medical occurrence temporally associated with the use 
of a study device, whether or not considered causally related to that study device.  
AE is used both to refer to AE which are non-serious non-study device or procedure-related 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.19 
11.1.2 Adverse Device Effect 
An Adverse Device Effect (ADE) is an adverse event that, in the opinion of the Investigator, is 
related to the study device or the procedure.  

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
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TMP-110 – Clinical Protocol - Devices  
 
Not Related -  An AE is considered to be not related to the use of a study device or the 
procedure when the effect is DEFINITELY UNRELATED or UNLIKELY to have 
any relationship to the use of the study device or the procedure; 
Related –  An AE is considered to be related to the use of an study device or the procedure 
when there is a POSSIBLE, PROBABLE, or DEFINITE relationship between the AE 
and the use of the study device or the procedure. 
An ADE is further categorized depending on whether the criteria in section 12.1.3 and 12.1.4 
are met. 
11.1.3 Serious Adverse Events and Serious Adverse Device Effects  
An AE or ADE is considered a Serious Adverse Event (SAE) or Serious Adverse Device 
Effects (SADE) if, in the view of either the Investigator or the Sponsor, it: 
 
a) led to death, 
 
b) led to serious deterioration in the health of the subject, that either resulted in 
o 
1) a life-threatening illness or injury, or 
o 
2) a permanent impairment of a body structure or a body function, or 
o 
3) in-patient or prolonged hospitalization, or 
o 
4) medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function, 
 
c) led to foetal distress, foetal death or a congenital abnormality or birth defect 
Note 1 to entry: Planned hospitalization for a pre-existing condition, or a procedure required by the 
CIP, without serious deterioration in health, is not considered a serious adverse event. 19 
 
Medical and scientific judgment should be exercised in deciding whether other situations should 
be considered serious such as important medical events that might not be immediately life-
threatening or result in death or hospitalization but might jeopardize the subject or might require 
intervention to prevent one of the other outcomes listed in the definition above. 19 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
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TMP-110 – Clinical Protocol - Devices  
 
11.1.4 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 analysis 
report.19 
Note 1 to entry: Anticipated serious adverse device effect (ASADE) is an effect which by its 
nature, incidence, severity or outcome has been identified in the risk analysis report. 19 
11.1.5 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 to cause interference with the subject’s usual activities; 
Severe -   
An event is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities. 
11.1.6 Device Deficiency 
A Device Deficiency (DevD) is an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. DevD includes malfunctions, use errors and 
inadequate labelling. 19  
11.2 
REPORTING PROCEDURES 
AE of any kind and DevD will be recorded in the applicable CRF and source notes. The 
Investigator will evaluate all AE for relationship to the device and procedure, if applicable, 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
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TMP-110 – Clinical Protocol - Devices  
 
seriousness, and severity. ADE, SAE, and DevD will be entered into the CRF and reported to 
the Sponsor within 24 hours of the investigator being informed about the event (Figure 12.2-1). 
For ADE and DevD, 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 within 24 hours of the information being 
available to the investigator. 
All adverse events, including SAE and ADE, 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.  
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 may request copies of the subject’s 
medical records, Imaging, Operative notes, as well as results of any relevant laboratory tests 
performed or other documentation related to the AE. If the subject was hospitalized, a copy of 
the discharge summary may be requested by S&N and should be forwarded as soon as it 
becomes available. In certain cases, S&N also may request a letter from the Investigator that 
summarizes the events related to the case. 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
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TMP-110 – Clinical Protocol - Devices  
 
Figure 11.2-1: Evaluation and Reporting of AE and DevD  
Site aware 
of AE
Investigator assesses Seriousness 
and Relationship to Device or 
Procedure
Complete CRF 
within usual 
time period
Complete CRF 
and alert S&N 
within 24 hours
U ADE/SADE
ADE 
Unanticipated or 
Anticipated?
Site aware 
of DevD
Anticipated 
SADE
Anticipated 
ADE
Record in 
Source
Unanticipated
Anticipated
 ADE: Serious or 
Not?
Anticipated
Serious
Not
Serious
SAE
Device- or 
Procedure-Related
NOT Serious AND 
NOT Device- or 
Procedure-Related
 
 
11.3 
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 in order to determine the outcome of the event.  

 
Study Protocol—Device 
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TMP-110 – Clinical Protocol - Devices  
 
Any additional data must be documented and available to the Sponsor who will determine 
whether the data need to be documented within the CRF. 
11.3.1 Ongoing Adverse Events at Study Discontinuation 
Adverse events which are related to a study procedure or S&N study device and are ongoing at 
end of subject’s participation: The event should be followed until it is either resolved or until the 
event has become chronic and is not expected to further improve based on Investigator’s review 
of the event. 
Adverse events which are not related to a study procedure or S&N study device and are 
ongoing at end of subject’s participation should be followed for 30 days after discontinuation or if 
the AE is resolved, whichever is sooner. 
At the time of data analysis (e.g. interim or final), an evaluation of ongoing events should take 
place and be listed as ongoing in the safety table. 
 INVESTIGATOR OBLIGATIONS 
The Principal Investigator will comply with Good Clinical Practice (GCP), and all applicable 
regulatory requirements as outlined in Appendix 20.3 of this protocol. 
 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, with GCP regulations, and with applicable regulatory requirements. 
Detailed monitoring requirements will be documented within the Clinical Monitoring Plan for this 
study.  

 
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TMP-110 – Clinical Protocol - Devices  
 
13.1 
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. 
13.2 
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 approval.  
13.3 
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.  
13.4 
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 regarding records retention and IRB/IEC reporting requirements.  
 PROTOCOL AMENDMENTS 
Amendments should be made only in exceptional cases once the study has started. Protocol 
amendments must be approved by the protocol signatories prior to submission to the IRB. 
Protocol amendments need to be approved by the IRB and Regulatory Authority(ies), as 
applicable prior to implementation at the site 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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Version: 2.0, 30Nov2018
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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-110 – Clinical Protocol - Devices  
 
 CONFIDENTIALITY OF THE STUDY 
The confidentiality of this study and associated documents is governed by the terms of the 
Clinical Trial Agreement (CTA). 
 STATEMENTS OF COMPLIANCE 
This clinical study will be performed in compliance with the ethical principles of the Declaration 
of Helsinki; ISO 14155: Clinical investigation of medical devices – Good Clinical Practice; ICH-
E6, and the US regulatory authority.  
This clinical study will not commence until the required approval/favorable opinion from the IRB 
or regulatory authority has been obtained. Any additional requirements imposed by the IRB or 
regulatory authority will be followed.  
Public/Products Liability Insurance has been purchased by Smith & Nephew plc. Worldwide and 
incorporates coverage for personal injury in respect of clinical studies.  
 END OF STUDY 
The end of study is defined as the date of the last subject, last visit.  No additional care for 
subjects will be provided under the protocol once their participation in the study has ended.  
 
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.  
 
Reasonable efforts should be made to retain enrolled subjects for the 12-month post-operative 
follow-up of this study.  A study termination CRF will need to be completed for any subject that 
does not complete the study and reason for termination must be documented.  
 PUBLICATION POLICY 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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Version: 2.0, 30Nov2018
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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-110 – Clinical Protocol - Devices  
 
18.1 
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. 
18.2 
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 (deidentified) 
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 9 months and end 36 months after article publication. Data 
supplied may only be used by the researcher(s) named in the approved research proposal for 
the purposes of achieving the aims of the analyses specified therein. All proposals should be 
directed to datasharing.gcs@smith-nephew.com. To gain access, data requestors will need to 
sign a data access agreement.20 
 
 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
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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-110 – Clinical Protocol - Devices  
 
 REFERENCES 
1. Kenan, S., et al., Long Term Outcomes Following Reduction and Fixation of Displaced 
Subcapital Hip Fractures in the Young Elderly. IMAJ, 2015. 17: p. 341;345 
2. Han, S., et al., Risk stratification for avascular necrosis of the femoral head after internal 
fixation of femoral neck fractures by post3operative bone SPECT/CT. Nucl Med Mol Imaging, 
2017. 51: p.49;57. 
3. Farooq, M.A., et al., Intracapsular fractures of the femoral neck in younger patients. Ir J Med 
Sci, 2005. 174(4): p. 42;5. 
4. Campenfeldt, P., et al., Good functional outcome but not regained health related quality of life 
in the majority of 20369 years old patients with femoral neck fracture treated with internal 
fixation: A prospective 23 year follow-up study of 182 patients. Injury, 2017. 48(12): p. 
2744;2753. 
5. Sprague, S., et al., Young femoral neck fractures: are we measuring outcomes that matter? 
Injury, 2015. 46(3): p. 507;14. 
6. Griffin, J., et al., What is the impact of age on reoperation rates for femoral neck fractures 
treated with internal fixation and hemiarthroplasty? A comparison of hip fracture outcomes in the 
very elderly population. J Orthop, 2016. 13(1): p. 33;9. 
7. Kenan, S., et al., Long3Term Outcomes Following Reduction and Fixation of Displaced 
Subcapital Hip Fractures in the Young Elderly. IMAJ, 2015. 17: p. 341;345 
8. Slobogean, G.P., et al., Complications following young femoral neck fractures. Injury, 2015. 
46(3): p. 484;91. 
9. Lotz, J.C., E.J. Cheal, and W.C. Hayes, Stress Distributions within the Proximal Femur during 
Gait and Falls: Implications for Osteoporotic Fracture. Osteoporosis Int, 1995. 5: p. 252;261. 
10. Nawathe, S., et al., Cortical and trabecular load sharing in the human femoral neck. J 
Biomech, 2015. 48(5): p. 816;22. 
11. Yuan, H.F., et al., Predictive value of single photon emission computerized tomography and 
computerized tomography in osteonecrosis after femoral neck fracture: a prospective study. Int 
Orthop, 2015. 39(7): p. 1417;22. 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 46 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
12. Goudie, E., A. Duckworth, and T. White, Hip fractures in young adults. Orthopaedics and 
Trauma, 2017. 31(2): p. 76;85. 
13. Slobogean, G.P., et al., Management of young femoral neck fractures: is there a 
consensus? Injury, 2015. 46(3): p. 435;40. 
14. Upadhyay A. , et al., Delayed internal fixation of fractures of the neck of the femur in young 
adults: A PROSPECTIVE, RANDOMISED STUDY COMPARING CLOSED AND OPEN 
REDUCTION. J Bone Joint Surg [Br] 2004. 86:B(7): p. 1035;1040. 
15. Bhandari M, et al., Optimal Internal Fixation for Femoral Neck Fractures: Multiple Screws or 
Sliding Hip Screws? J Orthop Trauma, 2009. 23(6): p. 403;407. 
16. Hoshino, C.M. and R.V. O'Toole, Fixed angle devices versus multiple cancellous screws: 
what does the evidence tell us? Injury, 2015. 46(3): p. 474;7. 
17. Lysack, C. L., Household and Neighborhood Safety, Mobility. Handbook of Assessment in 
Clinical Gerontology. p. 619-646. 
18. Center for Disease Control and Prevention: Stopping Elderly Accidents, Deaths, & Injuries. 
https://www.cdc.gov/steadi 
19. ISO 14155:2011 Clinical investigation of medical devices for human subjects – good clinical 
practice.  
20. Taichman, DB, et al. Data Sharing Statements for Clinical Trials: A Requirement of the 
International Committee of Medical Journal Editors. Ann Intern Med. 2017. 6th June. 
doi:10.7326/M17-1028 
 
 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 47 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
 APPENDICES 
20.1 
PROTOCOL AMENDMENT  
Section 
Current Text 04Jun2018 
Version 1 
 
Revised Text 30Nov2018 Version 
2.0 
 
2. Synopsis – 
Secondary Objective 
To 
generate 
safety 
and 
performance evidence for the 
CONQUEST 
FN™ 
Femoral 
Neck Fracture System via the 
collection  
of functional outcomes, quality of 
life, and safety data. 
The secondary objective of this 
study is to generate safety and 
performance evidence for the 
CONQUEST FN™ Femoral Neck 
Fracture System via the collection  
of functional outcomes, quality of 
life, and safety data.  
2. Synopsis – 
Statistical Rationale  
A total sample size of 90 
subjects with a minimum of 45 
subjects for displaced and non-
displaced femoral neck 
fractures. Since the primary and 
secondary endpoints are the 
same for all fractures, overall 
results will be reported as well. 
 
A total minimum sample size of 90 
subjects with a minimum of 45 
subjects for displaced and 45 
subjects for non-displaced femoral 
neck fractures. Since the primary 
and secondary endpoints are the 
same for all fractures, overall results 
will be reported as well. 
 
2. Synopsis – Inclusion 
Criteria 
1. 
Provide 
IRB 
approved 
informed consent, which will 
consist of reading, signing, and 
dating the informed consent 
document after the Investigator, 
sub-Investigator, 
or 
other 
designated study staff member 
has 
explained 
the 
study 
procedures, risks, and contact 
information.  
 
1. The subject must provide written 
informed consent (reference section 
7.4). 
 
2. Synopsis – 
Exclusion Criteria 
N/A - Inadvertently left this 
exclusion criteria out of this 
section. 
3. Subject has more than one 
fracture on target hip. 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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Version: 2.0, 30Nov2018
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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-110 – Clinical Protocol - Devices  
 
2. Synopsis – 
Exclusion Criteria 
5. Therapy with another 
investigational agent within thirty 
(30) days of Screening.  
 
6. Therapy with another 
investigational agent within thirty 
(30) days of Screening or or 
planned therapy with another 
investigational agent during the 
course of the study. 
 
2. Synopsis – 
Exclusion Criteria 
N/A - Inadvertently left this 
exclusion criteria out of this 
section. 
12. Subjects with a history of poor 
compliance with medical treatment.  
 
2. Synopsis – 
Secondary endpoint(s) 
 
Intraoperative 
complications 
 
Radiographic outcomes 
including quality of 
fracture reduction 
 
Construct failure past 
typical femoral neck 
fracture healing period 
(past 6 months) 
 
Pain (VAS) 
 
EQ-5D-5L 
 
Time to return to full 
weight-bearing  
 
Ambulatory status from 
pre-injury to study 
completion  
 
Timed Up & Go  
 
Length of hospital stay 
 
Readmissions for any 
reason 
 
Device- and surgery-
related adverse events  
 
Active straight leg raise 
(ASLR) assessment 
 
The secondary endpoints of this 
study include generation of safety, 
performance, and health economic 
evidence supporting the use of the 
CONQUEST FN™ Femoral Neck 
Fracture System per the endpoints 
listed below: 
 
Intraoperative complications 
 
Radiographic outcomes 
including quality of fracture 
reduction 
 
Construct failure past typical 
femoral neck fracture healing 
period (past 6 months) 
 
Visual analogue scale (VAS) 
relating to pain at the 
fracture site 
 
Quality of Life (EQ-5D-5L) 
 
Time to return to full weight-
bearing  
 
Ambulatory status from pre-
injury to study completion  
 
Timed Up & Go  
 
Length of hospital stay 
 
Hospital readmissions for 
any reason 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
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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-110 – Clinical Protocol - Devices  
 
 
Device- and surgery-related 
adverse events  
 
Active straight leg raise 
(ASLR) assessment 
 
2. Synopsis – Study 
Schematic  
Pre-Operative Data 
Pre-Operative Data (Day -7 to Day 
0) 
3.3 List of 
Abbreviations 
N/A - Inadvertently left out of 
table 
FU - Follow-up 
3.3 List of 
Abbreviations 
N/A - Inadvertently left out of 
table 
TUG – Timed Up and Go 
4.2 Study Purpose 
The purpose of this study is to 
evaluate the re-operation rate for 
any reason of the CONQUEST 
FN™ Femoral Neck Fracture 
System one year post operation.
A post-market, prospective study to 
evaluate the reoperation rate of 
displaced and nondisplaced femoral 
neck fractures treated with the 
CONQUEST FN™ system. 
5.2 Secondary 
Objective(s) 
The secondary objective of this 
study is to generate safety and 
performance evidence for the 
CONQUEST FN™ Femoral 
Neck Fracture System via the 
collection of functional 
outcomes, quality of life, and 
safety data 
The secondary objective of this 
study is to generate safety and 
performance evidence for the 
CONQUEST FN™ Femoral Neck 
Fracture System via the collection of 
functional outcomes, quality of life, 
and safety data including the 
following: 
1. Intraoperative complications 
2. Radiographic outcomes 
including quality of fracture 
reduction  

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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Version: 2.0, 30Nov2018
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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-110 – Clinical Protocol - Devices  
 
3. Construct failure past typical 
femoral neck fracture healing 
period (past 6 months) 
 
4. Pain (VAS) 
5. EQ-5D-5L 
6. Time to return to full weight-
bearing  
7. Ambulatory status from pre-
injury to study completion  
8. Timed Up & Go  
9. Length of hospital stay 
10. Readmissions for any 
reason 
11. Device and surgery related 
adverse events 
12. Active straight leg raise 
(ASLR) 
 
6.5 Surgical Technique All study-related procedures 
conducted at the investigational 
site must be performed 
according to the recommended 
surgical technique described in 
the labeling and instructions for 
use (IFU).  
 
All study-related procedures 
conducted at the study site must be 
performed according to the 
recommended surgical technique 
described in the labeling and 
instructions for use (IFU).  
 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 51 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
6.5 Surgial Technique 
Surgeons selected to participate 
in this study will be required to 
have completed three (3) 
surgeries using the CONQUEST 
FN™ Femoral Neck Fracture 
System and have written 
evidence of training and 
expertise in the study procedure.
Surgeons selected to participate in 
this study will be required to have 
completed two (2) surgeries using 
the CONQUEST FN™ Femoral 
Neck Fracture System and have 
written evidence of training and 
expertise in the study procedure. 
 
Subject Enrollment and 
Withdrawal – Subject 
Population 
Approximately 90 subjects (18 
years of age or older) with a 
confirmed displaced or non-
displaced intracapsular femoral 
neck fracture who are scheduled 
for repair using CONQUEST 
FN™ will be recruited at 
approximately 10 investigational 
centers in the United States. 
Additional sites may be added, if 
necessary, to meet recruitment 
goals. A minimum of 45 
displaced and 45 non-displaced 
fractures are required.  
 
A minimum of 90 subjects (18 years 
of age or older) with a confirmed 
displaced or non-displaced 
intracapsular femoral neck fracture 
who are scheduled for repair using 
CONQUEST FN™ will be recruited 
at approximately 10 study sites in 
the United States. Additional sites 
may be added, if necessary, to meet 
recruitment goals. A minimum of 45 
displaced and 45 non-displaced 
fractures are required.  
 
7.1 Inclusion Criteria 
1. The subject must provide 
written informed consent 
(reference section 7.5). 
1. The subject must provide written 
informed consent (reference section 
7.4). 
7.2 Exclusion Criteria 
6. Therapy with another 
investigational agent within thirty 
6. Therapy with another 
investigational agent within thirty 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
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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-110 – Clinical Protocol - Devices  
 
(30) days of Screening or during 
the course of the study.  
(30) days of Screening or planned 
therapy with another investigational 
agent during the course of the study
7.2 Exclusion Criteria 
7. Subject has a physical 
condition that, in the opinion of 
the Investigator,  would preclude 
adequate implant support or 
impede healing (e.g. blood 
supply impairment, insufficient 
bone quality or quantity, or an 
active, local or systemic 
infection). 
7. Subject has a physical condition 
that, in the opinion of the 
Investigator, would preclude 
adequate implant support or impede 
healing (e.g. blood supply 
impairment, insufficient bone quality 
or quantity, or an active, local or 
systemic infection). If this is 
identified at the time of surgery, the 
subject will be screen failed. 
7.2 Exclusion Criteria 
N/A - Inadvertently left this 
exclusion criteria out of this 
section. 
11. Current systemic therapy with 
cytotoxic drugs. 
7.5 Enrollment 
A subject ID will be assigned at 
the time of the Screening visit. 
A subject number will be assigned 
at the time of the Screening visit. 
8.1 Study Design  
Subjects will be stratified by 
fracture type (45 displaced and 
45 non-displaced fractures) for a 
total of approximately 90 
enrolled subjects.  
Subjects will be stratified by fracture 
type (minimum of 45 displaced and 
45 non-displaced fractures) for a 
minimum total of 90 enrolled 
subjects.  
Table 8.4.1-1 Study 
Procedures by Visit 
Pre-Operative Data 
Pre-Operative Data (Day -7 to Day 
0) 
8.4.2 
Screening/Preoperative 
Visit 
N/A - Inadvertently left this out of 
this section. 
5. Perform radiology imaging 
collecting both anteroposterior (AP) 
and lateral images of the target hip. 
8.4.3 
Baseline/Operation 
Visit (Day 1) 
N/A - Inadvertently left this out of 
this section. 
3. Perform surgery per CONQUEST 
FN™ surgical technique guide.  

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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Version: 2.0, 30Nov2018
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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-110 – Clinical Protocol - Devices  
 
8.4.3 
Baseline/Operation 
Visit (Day 1) 
N/A - Inadvertently left this out of 
this section. 
5. Perform radiology imaging 
collecting both anteroposterior (AP) 
and lateral images of the target hip 
to ensure the CONQUEST FN™ is 
properly implanted.  
8.4.4 Follow-up Visits 
Number 5 listed twice. 
Previously numbers 1-8 
Renumbered to remove duplicate 
numbering. Now numbered 1-9 
8.4.5 Exit Visit 
Exit Visit (Day 365 ± 30 days) 
8.4.5 Exit Visit: 12 months (Day 365 
± 30 days) 
8.4.7 Concomitant 
Medications and 
Therapies 
A concomitant medication (e.g. 
drug, substance) and a 
concomitant therapy (e.g. 
physical therapy, TENS Unit, 
massage) are recorded at any 
time from enrolment into the 
study through the subject’s last 
study visit. 
A concomitant medication (e.g. 
drug, substance) and a concomitant 
therapy (e.g. physical therapy, 
TENS Unit, massage) are recorded 
pre-operatively and at each visit   
through the subject’s last study visit.
8.4.8 Subject 
Pregnancy 
Women of childbearing potential 
are not excluded from the study 
as long as adequate birth control 
methods are being used by the 
subject as outlined in the 
protocol’s inclusion criteria.  
Women of childbearing potential are 
not excluded from the study as long 
as adequate birth control methods 
are being used by the subject. 
9.4 Efficacy Analysis 
A total of 90 subjects will be 
enrolled in the study, which 
includes a 5% estimate for 
subjects lost to follow-up at 1 
year. 
A minimum total of 90 subjects will 
be enrolled in the study, which 
includes a 5% estimate for subjects 
lost to follow-up at 1 year. 
10. Sample Size 
Justification 
Assuming a 5% lost to follow-up 
rate after the first year, 90 
subjects will be enrolled (based 
on the inclusion/exclusion 
criteria) in order to complete 80 
Assuming a 5% lost to follow-up rate 
after the first year, a minimum of 90 
subjects will be enrolled (based on 
the inclusion/exclusion criteria) in 
order to complete 80 evaluable 
subjects. The 90 subjects will be 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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Version: 2.0, 30Nov2018
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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-110 – Clinical Protocol - Devices  
 
evaluable subjects. The 90 
subjects will be enrolled to allow 
a minimum of 40 subjects with 
each of the following indications 
to be recruited: displaced or 
non-displaced femoral neck 
fractures 
enrolled to allow a minimum of 45 
subjects with each of the following 
indications to be recruited: displaced
or non-displaced femoral neck 
fractures 
12. Investigator 
Obligations 
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. 
 
Removed.  
Entire document 
Spelling errors 
Corrected all spelling errors 
 
20.2 INSTRUCTIONS FOR USE 
Refer to Instructions for Use (IFU) supplied by the Sponsor.  
 
 

 
Study Protocol—Device 
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CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
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Page: Page 55 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
20.3 PRINCIPAL INVESTIGATOR OBLIGATIONS (ISO14155) 
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: 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 56 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
i. 
Submit to the IEC the following information, any amendments and any additional 
documentation required by the IEC: the Protocol; IB or equivalent; informed 
consent form and any other written information provided to subjects; procedures 
for recruiting subjects and advertising materials, if any; a copy of the CV of the 
PI(s) for with the IEC has oversight. 
ii. 
Provide documentation of the IECs approval/favorable opinion, identifying the 
documents and amendments on which the opinion was based, to the Sponsor, 
prior to commencing the clinical investigation.  
iii. 
Submit the following to the IEC if required by national regulations, the protocol or 
IEC, whichever is more stringent: 
1. 
SAEs 
2. 
Requests for deviations, and reports of deviations, if the deviation affects 
subject’s rights, safety, and well-being, or the scientific integrity of the clinical 
investigation. Document and report to the Sponsor and IEC a report of 
deviations made to protect the rights, safety, and well-being of human 
subjects under emergency circumstances.  
3. 
Progress reports, including safety summary and deviations 
4. 
Amendments to any documents already approved by the IEC.  
5. 
If applicable, notifications of suspension or premature termination 
6. 
If applicable, justification and request for resuming the clinical investigation 
after suspension.  
7. 
Clinical investigation report or summary. 
iv. 
As a minimum, during the clinical investigation, the following information shall be 
obtained in writing from the IEC prior to implementation: 
1. 
Approval/favorable opinion of amendments 
2. 
Approval of the request for deviations that can affect the subject’s rights, 
safety, and well-being or scientific integrity of the clinical investigation 
3. 
Approval for resumption of a suspended clinical investigation if applicable.  

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 57 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
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) 
ii. 
The informed consent form consists of an information form and informed consent 
signature form. These two forms can either be combined in one document or 
separated into two documents 
b. 
Process of obtaining informed consent. The general process for obtaining informed 
consent shall be documented in the protocol and shall comply with the following. These 
requirements also apply with respect to informed consent obtained from a subject’s 
legally authorized representative:  
i. 
Ensure that the PI or his/her authorized designee conducts the informed consent 
process 
ii. 
Include all aspects of the clinical investigation that are relevant to the subject’s 
decision to participate throughout the clinical investigation 
iii. 
Avoid any coercion or undue improper influence on, or inducement of, the subject 
to participate 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 58 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
iv. 
Not waive or appear to waive the subject’s legal rights 
v. 
Use native non-technical language that is understandable to the subject 
vi. 
Provide ample time for the subject to read and understand the informed consent 
form and to consider participation in the clinical investigation 
vii. 
Include personally dated signatures and the PI or an authorized designee 
responsible for conducting the informed consent process 
viii. 
Show how informed consent will be obtained in special circumstances (see 
below) where the subject is unable to provide him or herself, and  
ix. 
Ensure important new information is provided to new and existing subjects 
throughout the clinical investigation.  
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:  

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 59 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
1. 
For clinical investigations involving emergency treatments, when prior 
informed consent of the subject is not possible because of the subject’s 
medical condition, the informed consent of the subject’s legally authorized 
representative, if present, shall be requested.  
2. 
When it is not possible to obtain prior informed consent from the subject, and 
the subject’s legally authorized representative, is not available, the subject 
may still be enrolled if a specific process has been described in the protocol.  
3. 
Arrangements shall be made to inform the subject or legally authorized 
representative, as soon as possible, about the subject’s inclusion in the 
clinical investigation and about all aspects of the clinical investigation.  
4. 
The subject shall be asked to provide informed consent for continued 
participation as soon as his/her medical condition allows.  
d. 
The Principal Investigator may not enroll a subject without obtaining informed consent 
of the subject or his/her legally authorized representative only when the following 
conditions are fulfilled: the prospective subject fulfils the emergency conditions and is 
obviously in a life-threatening situation; no sufficient clinical benefits are anticipated 
from the currently available treatment; there is a fair possibility that the life-threatening 
risk to the prospective subject can be avoided if the investigational device is used; 
anticipated risks are outweighed by the potential benefits of applying the investigational 
device ; the legally authorized representative cannot be promptly reached and 
informed.  
e. 
Information provided to the subject. All information pertinent to the clinical investigation, 
including at least the following, shall be provided in writing and in native, non-technical 
language that is understandable to the subject (or the subject’s legally authorized 
representative): 
i. 
Description and purpose 
ii. 
Potential benefits 
iii. 
Risks and inconveniences or the subject and, when applicable, for any embryo, 
foetus or nursing infant 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 60 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
iv. 
Alternative procedures 
v. 
Confidentiality 
vi. 
Compensation 
vii. 
Anticipated expenses, if any, to be borne by the subject for participating in the 
clinical investigation 
viii. 
Information on the role of Sponsor’s representative in the clinical investigation 
ix. 
Contact persons 
x. 
Statement declaring that new findings or the reasons for any amendment to the 
protocol that affect the subject’s continued participation shall be made available 
to the subject.  
xi. 
Statement indicating that, upon the subject’s approval, the subject’s personal 
physician will be informed of the subject’s participation in the clinical investigation 
xii. 
Termination procedures 
f. 
Informed consent signature shall contain the following:  
i. 
The voluntary agreement to participate in the clinical investigation and follow the 
investigator’s instructions 
ii. 
A statement declaring that refusal of participation incurs no penalty for the subject 
iii. 
A statement declaring that discontinuation at any time incurs no penalty for the 
subject 
iv. 
A statement with regard to the possible consequences of withdrawal 
v. 
An acknowledgement of the information provided and confirmation that all the 
subject’s questions were answered 
vi. 
A statement confirming that the subject or his/her legally authorized 
representative agrees to the use of the subject’s relevant personal data for the 
purpose of the clinical investigation 
vii. 
A statement confirming that the subject or his/her legally authorized 
representative agrees that Sponsor’s representatives, regulatory authorities and 
IEC representatives will be granted direct access to the subject’s medical 
records.  

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 61 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
g. 
New information: if new information becomes available that can significantly affect a 
subject’s future health and medical care, that information shall be provided to the 
subject(s) affected in written form. If relevant, all affected subjects shall be asked to 
confirm their continuing consent in writing.  
h. 
ensure compliance with the applicable regulatory requirements and ethical principles 
for the process of obtaining informed consent, and 
i. 
ensure and document appropriate training if an authorized designee is appointed to 
conduct the informed consent process. 
6. Compliance with the protocol. The Principal Investigator shall: 
a. 
indicate his/her acceptance of the protocol in writing, 
b. 
conduct the clinical investigation in compliance with the protocol, 
c. 
create and maintain source documents throughout the clinical investigation and make 
them available as requested during monitoring visits or audits, 
d. 
ensure that the investigational device is used solely by authorized users as specified in 
6.2, and in accordance with the protocol and instructions for use, 
e. 
propose to the Sponsor any appropriate modification(s) of the protocol or 
investigational device or of the use of the investigational device, 
f. 
refrain from implementing any modifications to the protocol without agreement from the 
Sponsor, IEC and regulatory authorities, if required, 
g. 
document and explain any deviation from the approved protocol that occurred during 
the course of the clinical investigation, 
h. 
ensure that an adequate investigation site team and facilities exist and are maintained 
and documented during the clinical investigation, 
i. 
ensure that maintenance and calibration of the equipment relevant for the assessment 
of the clinical investigation is appropriately performed and documented, where 
applicable, 
j. 
ensure the accuracy, completeness, legibility and timeliness of the data reported to the 
Sponsor in the CRF and in all required reports, 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 62 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
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), 

 
Study Protocol—Device 
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of 
CONQUEST FNTM for the Treatment of Intracapsular Femoral Neck Fractures 
Number: 18-3047-02
Version: 2.0, 30Nov2018
Page: Page 63 of 63 
 
 
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-110 – Clinical Protocol - Devices  
 
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.