A Prospective Study Evaluating Trochanteric Fixation Nail Advanced (TFNA) in a Chinese Patient Population
Phase: NA
Conditions: Femur Fractures
Sponsor: Synthes GmbH

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
Confidential 
 
Page 1 of 74 
 
 
 
 
 
 
 
 
 
 
 
 
A Prospective Study Evaluating Trochanteric Fixation Nail Advanced 
(TFNA) in a Chinese Patient Population 
 
SHORT TITLE:  The CHINA TFNA Study   
 
 
Name of device 
Proximal femoral nailing system 
Model 
See appendix C and D 
Protocol number 
DPS201502 
Version 
C 
Version Date 
8 Jan 2019 
Study type 
Clinical trial 
Leading site 
Beijing JiShuitan Hospital 
sponsor 
Johnson & Johnson Medical Shanghai 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
Confidential 
 
Page 2 of 74 
 
The Approval Sheet： 
 
Short title： 
China TFNA Study 
Protocol number：DPS-201502 
Version date：8 Jan 2019 
 
The signature of the following team indicates the protocol, including the 
study design, statistical method, study procedure, regulation requirement, 
quality control and so on, have been internally approved within Johnson & 
Johnson before submission to ethics committees. 
Title    
Name 
Signature 
Date 
The protocol writer  
Li Shaonan 
 
 
Department of Medical Affairs 
Johnson & Johnson Medical 
(Shanghai) Ltd. 
Li Wan 
 
 
Department of Medical Affairs 
Johnson & Johnson Medical 
(Shanghai) Ltd. 
Liu Fenghua 
 
 
Department of Regulatory Affairs 
Johnson & Johnson Medical 
(Shanghai) Ltd. 
Zhang Na 
 
 
Biostatistician DePuy Synthes 
James Lesko  
 
 
Medical Monitor 
Li Shaonan 
 
 
 
 
 
 
 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
Confidential 
 
Page 3 of 74 
 
CHANGE LOG 
 
 
Version No. 
  
Version Date 
Description of Change 
 
C 
8 Jan 2019 
According to hospital actual practice, the required 
visit window for visit 3 has been changed：from 4-
14 days changed to 1-14 days after surgery 
B 
10 Apr 2018 
Augmentation removed per CMDE request in CTA 
letter 
A 
3 Feb 2016 
 Original Version 
 
 
 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
Confidential 
 
Page 4 of 74 
 
The information contained in this protocol is confidential and is intended for the use of clinical investigators. It is the 
property of Johnson & Johnson Medical. No unpublished information contained herein may be disclosed without prior 
written approval from Johnson & Johnson Medical. Access to this document must be restricted to relevant parties. 
 
  Investigator Signature Page： 
 
Study Title： 
The CHINA TFNA Study 
Project No.: 
DPS 2015-02 
Version Date: 
8 Jan 2019 
 
 
I have read this protocol and/or amendment and appendices and agree to 
adhere to the requirements. I will provide copies of this protocol and all 
pertinent information to the study personnel under my supervision. I will 
discuss this material with them and ensure they are fully informed regarding 
the device and the conduct of the study. 
I will implement the study in compliance with the protocol, GCP, the ethical 
principles outlined in Declaration of Helsinki and all applicable laws and 
regulations. 
 
 
 
 
 
 
<Name>Investigator 
 
<Date> 
 
 
 
 
 
 
<Institution>  
 
 
 
 
 
 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
Confidential 
 
Page 5 of 74 
 
 
Table of Contents 
 
1.0. INTRODUCTION ......................................................................................... 14 
1.1. Background and Rationale .................................................................... 14 
1.2. Investigational Device Description ........................................................ 15 
1.2.1 TFNA .................................................................................................. 15 
1.2.2 Comparison of TFNA and PFNA-II ..................................................... 16 
1.3. Summary of Available Clinical Data ...................................................... 16 
1.3.1 Intramedullary nails as treatment for extracapsular hip fractures ........ 16 
1.3.3 Summary of PFNA-II as treatment for extracapsular hip fractures ...... 18 
2.0 Benefits/Risks ............................................................................................. 19 
2.1. Benefits ................................................................................................. 19 
2.2. Risks ..................................................................................................... 19 
3.0 Study Objectives ......................................................................................... 21 
3.1. Intended Use and Indication ................................................................. 21 
3.2. Objective ............................................................................................... 22 
4.0 Study Design ............................................................................................... 22 
5.0 Endpoints ..................................................................................................... 22 
5.1. Primary Endpoint .................................................................................. 22 
5.2. Secondary Endpoints ............................................................................ 23 
5.3 Safety..................................................................................................... 23 
6.0 Study Population ........................................................................................ 23 
6.1. Subject Selection .................................................................................. 23 
6.2. Inclusion Criteria ................................................................................... 23 
6.3 Exclusion Criteria ................................................................................... 24 
7.0 STUDY PROCEDURES................................................................................ 25 
7.1. Screening and Baseline Period ............................................................. 25 
7.1.1. Patient Screening .............................................................................. 25 
7.1.2. Informed Consent .............................................................................. 25 
7.1.3. Screening and Baseline Assessments ............................................... 25 
7.1.4. Patient Enrollment.............................................................................. 25 
7.1.5. Randomization and Treatment Assignment ....................................... 26 
7.2. Procedure ............................................................................................. 26 
7.2.1. Instructions for Use ............................................................................ 26 
7.3. Post-Procedure ..................................................................................... 26 
7.4. Follow-up Period ................................................................................... 27 
7.5. Blinding Procedures .............................................................................. 29 
8.0 ADVERSE EVENT REPORTING ................................................................. 30 
8.1. Anticipated Adverse Events .................................................................. 30 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
Confidential 
 
Page 6 of 74 
 
8.2 Adverse Events ...................................................................................... 30 
8.3 Serious Adverse Events......................................................................... 30 
8.4. Duration of Follow-up after Adverse Events .......................................... 31 
8.5. Reporting an Adverse Event ................................................................. 31 
9.0 EARLY DISCONTINUATION ....................................................................... 32 
9.1 Reasons for Early Discontinuation ......................................................... 32 
9.2. Subject Early Discontinuation ............................................................... 33 
9.3. Study Early Discontinuation .................................................................. 33 
10.0 STATISTICAL methods section ............................................................... 34 
10.1. Study Design ...................................................................................... 34 
10.2. Treatment Assignment ........................................................................ 34 
10.3. Levels of Significance ......................................................................... 34 
10.4. Interval Windows ................................................................................ 34 
10.5. Handling of Missing Data .................................................................... 34 
10.6. Primary and Secondary Endpoints ..................................................... 35 
10.7. Hypotheses ......................................................................................... 35 
10.8. Analysis Sets ...................................................................................... 35 
10.9. Sample Size Justification .................................................................... 38 
10.10. Analysis Plan .................................................................................... 38 
10.10.1 General Consideration .................................................................... 38 
10.10.2 Subject Disposition ......................................................................... 38 
10.10.3 Data Management .......................................................................... 38 
10.10.4 Demographic Characteristics/Pre-Operative Profile ....................... 39 
10.10.5 Analysis of the primary endpoint ..................................................... 39 
10.10.6 Analysis of secondary endpoints .................................................... 39 
10.11. Plans for Interim Analysis ................................................................. 40 
10.12. Reporting .......................................................................................... 40 
11.0 STUDY MANAGEMENT AND ADMINISTRATION .................................... 40 
11.1. Investigator and Sponsor Responsibility ............................................. 40 
11.1.1. Investigator Responsibility ............................................................... 40 
11.1.2. Sponsor Responsibility .................................................................... 41 
11.2 Selection, Monitoring and Close-out .................................................... 41 
11.2.1. Selection .......................................................................................... 41 
11.2.2. Monitoring ........................................................................................ 41 
11.2.3. Close-out ......................................................................................... 42 
11.3. Required Documents .......................................................................... 42 
11.3.1. Source Documents .......................................................................... 43 
11.3.2. Source Data Verification .................................................................. 43 
11.3.4. Archiving and Data Retention .......................................................... 44 
11.3.5. Audit and Inspection ........................................................................ 44 
12. ETHICS AND REGULATORY REQUIREMENTS ........................................ 45 
12.1. Ethics Committees .............................................................................. 45 
12.2. Informed consent ................................................................................ 45 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
Confidential 
 
Page 7 of 74 
 
12.3. Subject Confidentiality ........................................................................ 45 
12.4. Protocol Amendments......................................................................... 45 
13. DEVICES ...................................................................................................... 46 
13.1. Investigational Device Accountability .................................................. 46 
13.2. Return of Study Devices ..................................................................... 47 
13.3. Device Complaint ................................................................................ 47 
APPENDIX A:  Definitions ............................................................................... 48 
APPENDIX B:  Referenced Published Literature and Joint Registries ....... 51 
APPENDIX C:  Device Part codes and Specifications – TFNA .................... 53 
APPENDIX D: DEVICE PART CODES AND SPECIFICATIONS – PFNA-II ..... 64 
APPENDIX E: ABBREVIATIONS ...................................................................... 73 
 
 
 
 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
Confidential 
 
Page 8 of 74 
 
 
Synopsis 
Study Title  
A Prospective Study Evaluating Trochanteric Fixation Nail 
Advanced (TFNA) in a Chinese Patient Population 
Study 
objective: 
The primary objective of this study is to evaluate whether fracture 
union rate, evaluated 24 weeks after proximal femur fracture, for 
the investigational TFNA intramedullary nail is non-inferior to that 
for currently available control product PFNA-II in patients with 
proximal femur fractures. 
Country 
China 
No. of clinical 
sites 
Up to 15 
No. of Patients 
188 patients enrolled 
Duration of 
subject 
participation 
Enrollment of 188 subjects is anticipated to require approximately 
8-10 months. Each subject will undergo six months of clinical and 
radiographic follow-up. Total study duration is approximately 16 
months. 
Study Design 
The Trochanteric Fixation Nail Advanced (TFNA) is an implant 
designed to treat proximal femur fractures and is currently in use in 
several regions worldwide (e.g., US, Europe). TFNA is 
manufactured using a titanium-molybdenum alloy (TiMo) that has 
not been used for a similar clinical application within China. The 
purpose of this study is to evaluate TFNA to support registration of 
the product in China. The study is a prospective, multicenter, 
controlled, two-arm, randomized, non-inferiority study comparing 
the 24-week fracture union rate for proximal femur fractures treated 
with intramedullary nails using investigational devices (TFNA) 
compared to control devices (Proximal Femoral Nail Antirotation, 
PFNA-II), under a 10% non-inferiority margin. 
The study population will include 188 patients with proximal femur 
fracture undergoing internal fixation using an intramedullary nail. 
Subjects will be randomized in a 1:1 ratio to receive either the 
investigational TFNA devices (n=94) or to the control PFNA-II 
devices (n=94).  
The primary endpoint (fracture union) will be assessed by clinical 
and radiographic follow-up at 24 weeks. An independent reviewer 
will evaluate radiographs for evidence of fracture healing and 
implant integrity. Secondary endpoints will include safety and 
efficacy outcomes, radiographic outcomes and adverse events. 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
Confidential 
 
Page 9 of 74 
 
Study 
Components 
• 
TFNA as the investigational product for this study, including: 
o Short nails available in various diameters (Ø9, Ø10, 
Ø 11, Ø12 mm), lengths (170, 200, or 235 mm) and 
CCD angle (125°, 130° and 135°). The 235 mm short 
nail is available for left and right sides. 
o Long nails available in various diameters (Ø9, Ø10, 
Ø 11, Ø12, Ø14mm), lengths (260-480mm in 20mm 
increments) and CCD angle (125°, 130° and 135°). 
All long nails are available for left and right sides. 
o Head elements are available in blade and screw 
(both are 70-130 mm in length, available in 5mm 
increments) 
o Locking screws (4.2mm diameter and available in 
lengths from 26-80mm (2mm increments) or 80-
100mm (5mm increments) 
o End caps available in 0, 5, 10 and 15mm lengths 
 
• 
PFNA-II as control product for this study, including: 
o Short nails available in various diameters (Ø9, Ø10, 
Ø 11, Ø12 mm), lengths (170, 200, or 240 mm) and 
CCD angle (125° and 130°). The 240 mm short nail 
is available for left and right sides. 
o Long nails available in various diameters (Ø9 and 
Ø10mm), lengths (260-340mm in 20mm increments 
and 340-420mm in 40mm increments) and CCD 
angle (125° and 130°). All long nails are available for 
left and right sides. 
o Head elements are available in blade (70-120 mm in 
length, available in 5mm increments) 
o Locking screws (4mm diameter and available in 
lengths from 16-60mm (2mm increments), 60-80mm 
(4mm increments) or 80-100mm (5mm increments) 
o End caps available in 0, 5, 10 and 15mm lengths 
Study Period  
2018-2021 
Inclusion 
Criteria 
Subjects will be included if ALL of the following inclusion 
criteria apply:  
1) Age ≥18 years 
2) Patients with unilateral proximal femur fractures that will be 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
Confidential 
 
Page 10 of 74 
 
treated with intramedullary nail internal fixation 
3) According to AO fracture classification, subjects with 
following fracture types: 
a. Pertrochanteric (31-A1 and 31-A2) 
b. Intertrochanteric (31-A3) 
c. Trochanteric area (31-A1/A2/A3) with diaphyseal 
extension 
4) Subject must be comfortable with speaking and 
understanding questions and responses in an available 
translated language for patient reported outcomes (PROs) 
Exclusion 
Criteria:  
Subjects will be excluded if ANY of the following exclusion 
criteria apply:  
1) Subject does not provide voluntary consent to participate in 
the study 
2) The subject is a woman who is pregnant or lactating 
3) Fractures where the operative treatment will occur more 
than three weeks after the primary injury 
4) Patients with femoral head fractures and femoral neck 
fractures (AO classification 31-B and 31-C) 
5) Pathological fracture (e.g., primary or metastatic tumor) 
6) Serious soft tissue injury, judged by the investigator, will 
impact the union of the fracture, combined vascular injury, 
and combined osteofascial compartment syndrome 
7) Multiple systemic injuries judged by researchers not suitable 
for enrollment, or orthopaedic fractures in other bones at 
three or more sites  
8) Revision surgeries (for example, due to malunion, nonunion 
or infection) 
9) Concurrent medical conditions judged by researchers not 
suitable for enrollment, such as: diabetes, metabolic bone 
disease, post-polio syndrome, poor bone quality, prior 
history of poor fracture healing, etc 
10) Patients with anaesthetic and surgical contraindications 
11) Patients known to be allergic to implant components 
12) Patients who are currently using chemotherapeutics or 
accepting radiotherapy, use systematically corticosteroid 
hormone or growth factor, or long-term use sedative 
hypnotics (continuous use over 3 months) or non-steroidal 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
Confidential 
 
Page 11 of 74 
 
anti-inflammatory drugs (continuous use over 3 months) 
13) Intemperance judged by researchers not suitable for 
enrollment (e.g., excessive daily drinking or smoking, drug 
abuse);  
14) Patients participated into other clinical trial in the previous 3 
months;  
15) Patients with bad compliance judged by researchers and 
cannot complete the test according to test scheme, such as 
schizophrenia and dementia. 
Endpoints 
Primary Endpoint:  
The primary endpoint is fracture union at 24 weeks postoperatively. 
Fracture union success is a composite endpoint; in order for an 
individual subject’s surgery implanted with TFNA or PFNA-II to be 
considered successful he/she must satisfy all of the following 
criteria: 
1. No focal tenderness or lengthwise percussion pain, or 
abnormal movement 
2. The frontal/lateral X-ray examination shows the vague or no 
fracture gap, or the continuous callus passing across the 
fracture line 
3. No deformation or breakage is found in the test product 
The fracture union rate for the investigational group will be shown 
to be non-inferior to the fracture union rate of the control group 
using a 10% non-inferiority margin and a one-sided 2.5% alpha. 
The sample size has been established to provide 80% power to 
demonstrate non-inferiority if the fracture union rates in the patient 
population are greater than 95%, and approximately the same 
when treated with TFNA or PFNA-II.  
Secondary Endpoints:  
• 
Adverse events (type and frequency) for all adverse events will 
be compared for the investigational and control groups 
• 
24-week revision rate where revision is defined as removal of 
any component for any reason. 
• 
24-week reoperation rate is defined as secondary surgery at 
the fracture site(s) for any reason  
• 
Clinical Outcomes 
◼ 
SF-12 
◼ 
Harris Hip Score 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
Confidential 
 
Page 12 of 74 
 
 
 
 
◼ 
EQ-5D 
• 
Radiographs: incidence of complications such as loosening or 
cut-out that require reoperation or revision 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 13 of 74 
 
TIME AND EVENT SCHEDULE 
Enrollment 
Follow-up 
Event/Visit 
FU1: Pre-
Op 
FU2: 
Surgery 
FU3:  
1 week 
FU4:  
6 weeks 
FU5:  
12 weeks 
FU6:  
24 weeks 
Required Timing 
-90 to 0 
days from 
day of 
surgery 
0 
1 to 14 
days 
after 
surgery 
±2 
weeks 
±2 weeks 
±4 weeks 
The signing of the informed 
consent form 
X 
 
 
 
 
 
Inclusion/Exclusion criteria 
X 
 
 
 
 
 
Demographic data and medical 
history enquiry 
X 
 
 
 
 
 
Concise patient self-rated health 
measurement scale (SF-12v2)  
X 
 
 
 
X 
X 
EQ5D 
X 
 
 
 
X 
X 
Harris Hip Score 
 
 
 
 
X 
X 
Subject history 
X 
 
 
 
 
 
Urine pregnancy test1 
X 
 
 
 
 
 
Frontal and lateral X-ray of 
fracture sites  
X 
 
X 
X 
X 
X 
Surgical reduction and 
intramedullary nail fixation 
 
X 
 
 
 
 
Surgeon’s evaluation on product 
operability during operation 
 
X 
 
 
 
 
Wound healing assessment 2 
 
 
X 
 
 
 
Local physical examination 
X 
 
X 
X 
X 
X 
Concomitant drugs3 
X 
X 
X 
X 
X 
X 
Adverse event 
 
X4 
X 
X 
X 
X 
Serious adverse event 
 
X4 
X 
X 
X 
X 
Blood chemistry 
X 
X5 
 
 
 
 
1. Urine pregnancy tests: women of childbearing age only. 
2. Wound healing condition is assessed until wound healing. 
3. Concomitant Drug Table should include only pain killers and anti-osteoporosis drugs. 
4. Adverse events and serious adverse events should be recorded starting at the time of 
patient randomization.  
5.Second Laboratory Test analyses performed during post-op recovery phase per site 
standard of care. The results closer to the time of surgery will be recorded. 
 
 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 14 of 74 
 
1.0. INTRODUCTION 
1.1. Background and Rationale 
Proximal femoral fractures are common where the incidence is increasing with possible 
correlation to the aging population [1]. Trochanteric fractures make up 55% of proximal 
femoral fractures and occur predominantly in elderly patients [2]. Trochanteric fractures 
most commonly are caused by low-energy trauma, usually in combination with 
osteoporosis [1]. Due to the patients’ high age and comorbidities, fractures of the proximal 
femur are often life-threatening. In the first postoperative year, mortality rates account for 
11% to 30% of cases [1, 3]. In young patients on the other hand, trochanteric fractures are 
typically associated with high-energy trauma and/or other injuries [2]. 
 
Trochanteric fractures by definition are extracapsular where the vascularity of the femoral 
head is rarely compromised [2]. Although various fracture classification systems exist [4], 
the Müller AO Classification of Fracture is one of the most commonly used fracture 
classification system. It divides trochanteric fractures (31-A) into three groups: 31-A1 are 
simple and stable pertrochanteric fractures, 31-A2 are unstable pertrochanteric fractures 
with medial comminution including a fractured lesser trochanter, and 31-A3 are unstable 
intertrochanteric fractures with or without medial comminution (reverse oblique fracture 
type) [2, 4]. In general, instability is determined by the presence of a zone of comminution 
of the medial cortex and posterolateral instability [4]. 
 
Operative treatment is the standard of care in trochanteric fractures (31-A), leading to 
good clinical results in the majority of cases [2]. Trochanteric fractures are often treated 
with intramedullary devices such as trochanteric nails [1]. The classical surgical approach 
is a straight lateral incision, splitting the iliotibial tract, and gently elevating the vastus 
lateralis muscle [2]. The entry point is located in the area of the tip of the greater trochanter. 
Nail insertion and locking of the nail is a well-known procedure that is standard for most 
medullary nailing systems. After internal fixation, mobilization of a compliant and otherwise 
healthy patient starts on the first postoperative day using a walking frame or crutches [2]. 
Fracture healing of the proximal femur should then be completed within three months [2]; 
for patients with ipsilateral femoral shaft fractures healing times may be longer [5]. 
 
Intramedullary implants have proven clinical outcomes based on the results of global 
studies conducted outside of China. The data is reflective of many patients worldwide. 
Both the investigational (TFNA) and control devices (PFNA-II) currently are used clinically 
worldwide including regions such as North America and Europe. PFNA-II currently is 
available for clinical use in China. The investigational device (TFNA) is manufactured 
using a titanium-molybdenum alloy (TiMo) that has not been used for a similar clinical 
application (i.e., intramedullary nail) within China. In order to meet Chinese registration 
requirements, the purpose of this study will be to examine the clinical results of TFNA 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 15 of 74 
 
compared to a device manufactured from titanium aluminum nitride (TAN) that is already 
approved and used clinically in China (PFNA-II). A comparative study inside China also 
could account for possible differences in patient population, surgical technique, and/or 
rehabilitation practices (if any).  In summary, the purpose of this study is to conduct a 
randomized controlled trial of Chinese patients with proximal femur fractures who are 
treated with TFNA versus PFNA-II.  
 
1.2. Investigational Device Description  
1.2.1 TFNA 
The investigational device is the Trochanteric Fixation Nail Advanced (TFNA; see Figure 
1). 
 
Figure 1. Synthes Trochanteric Fixation Nail Advanced (TFNA) 
 
 
 
The TFNA nails are cannulated for insertion over a guide wire. A proximal bend of 5° 
towards lateral allows for an insertion point close to the tip of the greater trochanter. The 
nail is inserted through the standard lateral surgical approach, which is a straight lateral 
incision, splitting the iliotibial tract, and gently elevating the vastus lateralis muscle [2]. 
The entry point is located in the area of the tip of the greater trochanter. Nail insertion 
and locking of the nail is a well-known procedure that is standard for most medullary 
nailing systems. 
 
Due to the anatomy of the femur, all nails except for the shortest two lengths are specific 
for left and right use. The nails are curved in the sagittal plane. The radius of the TFNA 
follows the anteroposterior curvature of the femur. The TFNA nails are available in 
different diameters and lengths to match the geometry of the medullary canal. They 
involve three different caput-collum-diaphyseal (CCD) angles to match the patients’ 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 16 of 74 
 
anatomy. Moreover, the nails are tapered distally to reduce potential stress risers at the 
distal end of the nail, as secondary fracture around the implant is a typical complication 
of trochanteric nailing [6, 7]. 
 
Distal locking options include one oval locking hole for short nails and three distal locking 
options for long nails (proximal & distal round locking hole, middle oval locking hole). 
Both short and long nails incorporate an oval hole allowing for static and dynamic 
locking. Secondary dynamization is a well-known procedure that reduces the stress 
exerted by the locking nail [8], leads to greater contact pressure at the fracture site [8], 
and shortens mean time to union [9]. The method therefore is suitable for fractures with 
a high risk of delayed healing [2]. 
 
An internal locking mechanism prevents the head element from rotating. Sliding may be 
locked as an option. Highly comminuted fractures may be a good candidate for locked 
fixation. As an option, the proximal fragment can be re-approximated with a specific 
intraoperative compression feature, which is a standard feature seen in many proximal 
femoral nailing devices (e.g. PFNA or Stryker Gamma3). 
 
The head elements for TFNA are available as a helical blade or femoral neck screw; 
each has potential advantages that may be beneficial in the individual clinical case. For 
example, the helical blade leads to bone compaction around the implant [2, 10], which 
could biomechanically improve implant anchorage and fixation [11, 12]. The femoral 
neck screw may have a positive influence on intraoperative reduction by diminishing the 
postoperative fracture gap providing compression of the bone fragments [13].Both types 
of head elements are within the state of art (e.g., PFNA or Stryker Gamma 3), where 
preferably the surgeon selects the head element for the individual clinical case.  
 
1.2.2 Comparison of TFNA and PFNA-II 
The control device is Proximal Femoral Nail Antirotation II (PFNA-II). PFNA-II and TFNA 
have the same indications and can be used for treatment of pertrochanteric, 
intertrochanteric, high subtrochanteric fractures (Type 31-A). Both implants are 
contraindicated for treatment of femoral neck fractures. The overall design of both 
implants is that same in that they include a head element (TFNA: helical blade or screw; 
PFNA-II: screw) and distal locking screws. Both are manufactured from titanium alloys 
(TFNA: Titanium Molybdenum alloy; PFNA-II: Titanium Aluminum Niobium alloy).  
1.3. Summary of Available Clinical Data 
1.3.1 Intramedullary nails as treatment for extracapsular hip fractures 
Recent meta-analyses show good clinical outcomes for intramedullary nail fixation of 
proximal femur fractures. For example, Queally et al. [14] evaluated 17 randomized trials 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 17 of 74 
 
comparing different cephalocondylic nail designs. The trials involved a total of 2,130 adults 
(predominantly female and older people) and mainly unstable trochanteric fractures. Key 
findings are described below. 
Queally et al. [14] summarized 10 studies that included mortality outcomes with one year 
of follow up. In these trials, mortality after implantation of an intramedullary nail in patients 
with extracapsular fractures ranged from 0% to 24%. 
Fracture union rate also was evaluated by Queally et al. [14], where they reported 12 
studies that included summaries of fracture union rate. The number of subjects ranged 
from 15 to 213 subjects, and all studies included intramedullary nails. Fracture union rate 
ranged from 90% to 100% in these studies. This was in alignment with a recent book 
chapter that summarized fracture union rates from select studies using reamed or 
unreamed antegrade or retrograde nails, where the fracture union rate ranged from 92% 
to 100% [15]. It is noted that the method for determining fracture union was rarely reported. 
Queally et al. [14] summarized Harris Hip Scores (HHS) reported in eight RCTs with a 
minimum of 12 months follow up. Mean HHS ranged from 65 to 96 points in these studies. 
 
Potential complications associated with implantation of intramedullary nails also were 
reviewed by Queally et al. [14], summarized in Table 2.  
 
Table 2. Summary of fracture healing complications included in a recent meta-analysis [14] evaluating 
intramedullary nails used as treatment for extracapsular hip fractures. 
Complication 
No. 
studies 
No. 
subjects 
Range of 
complication 
rates 
Cut out 
17 
2099 
0.0% - 7.5% 
Distal interlocking problem 
1 
113 
3.5% - 3.6% 
Failure of distal locking 
1 
215 
0.9% - 3.8% 
Femoral shaft fracture 
2 
295 
0.0% - 5.0% 
Fixation failure 
2 
173 
3.3% - 22.6% 
Implant breakage 
5 
895 
0.0% - 3.3% 
Infection (deep) 
9 
1236 
0.0% - 6.5% 
Infection (superficial) 
8 
1157 
0.0% - 10.0% 
Infection (unspecified) 
4 
473 
0.0% - 5.9% 
Joint penetration 
1 
215 
0.0% - 2.9% 
Later femur fracture 
8 
1197 
0.0% - 3.2% 
Lateral greater trochanter fracture 
1 
113 
1.8% - 10.5% 
Migration 
4 
903 
0.0% - 9.1% 
Nail breakage 
1 
215 
0.9% - 1.0% 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 18 of 74 
 
Nonunion / pseudoarthrosis 
13 
1587 
0.0% - 9.7% 
Operative fracture of femur 
9 
1334 
0.0% - 3.6% 
Periprosthetic fracture 
2 
295 
0.0% - 2.5% 
Proximal end of nail penetrating trochanter 
1 
113 
1.8% - 7.1% 
Reoperation 
15 
1934 
0.0% - 47.1% 
Technical complications of fixation 
2 
160 
2.4% - 7.5% 
 
The available data from the meta-analysis support the use of intramedullary nails to treat 
extracapsular, proximal femur fractures. In these studies, intramedullary nails made from 
different materials and by various manufacturers performed similarly in trials conducted 
globally. These data provide a good reference for estimating the performance of TFNA 
and PFNA-II in the study described here.  
 
1.3.3 Summary of PFNA-II as treatment for extracapsular hip fractures 
A recent literature review that included peer-reviewed literature published between 2007 
and 2015, nine English language articles were identified that summarized clinical results 
for PFNA-II, the control device for this clinical study. The level of evidence included one 
RCT, one case controlled study, six uncontrolled case series, and one case report (Table 
3). A total of 880 subjects were represented in these nine studies. 
Table 3: summary of level of evidence for PFNA-II papers 
Level of  
evidence 
Type of study 
Reference(s) 
Number of 
PFNA-II 
subjects 
1 
Randomized controlled trial 
[16] 
47 
4 
Case control 
[17] 
50 
4 
Uncontrolled case series 
[18] 
[19] 
[20] 
[21] 
[22] 
[23] 
127 
158 
40 
118 
163 
176 
4 
Case report 
[24] 
1 
Fracture union rate was reported in three of the studies, where satisfactory fracture union 
was achieved in all 389 subjects [17, 22, 23]. It is noted that the method for determining 
fracture union was rarely reported. Harris Hip Score (HHS) was reported in two studies 
[21, 22], which was 85.6 ± 17.5  after 15 months follow up in 163 subjects and 86.19 ± 6.53  
after 12 months follow up in 118 subjects, respectively.  
Complications for PFNA-II in the reported literature were similar to those reported for other 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 19 of 74 
 
intramedullary nails. Table 4 summarizes the complications reported by Zhang et al. [16] 
during the RCT of patients with extracapsular hip fractures treated with PFNA-II and the 
InterTan nail. 
Table 4. Complication rates reported by Zhang et al. 2013 [16] for intramedullary nail fixation of proximal femur 
fracture (also summarized by Queally et al. 2014 [14]). 
Complication 
InterTan Nail 
PFNA-II 
Cut out 
0.0% 
4.3% 
Distal interlocking problem 
3.5% 
3.6% 
Infection (deep) 
4.3% 
2.2% 
Infection (superficial) 
6.4% 
4.3% 
Later femur fracture 
0.0% 
2.2% 
Lateral greater trochanter fracture 
10.5% 
1.8% 
Migration 
0.0% 
8.7% 
Operative fracture of femur 
1.8% 
3.6% 
Proximal end of nail penetrating trochanter 
1.8% 
7.1% 
Reoperation 
4.3% 
6.5% 
 
2.0 BENEFITS/RISKS 
 
Intramedullary nails are widely accepted as state of the art for treatment of extracapsular 
proximal femur fractures (for example, [2, 25]). The below sections describe the expected 
benefits and risks of the investigational device (TFNA). Overall, the risk-benefit ratio for 
TFNA is expected to be similar compared to that for the control device (PFNA-II). 
 
2.1. Benefits 
The TFNA implant system is intended for the treatment of proximal femur and 
combinations of proximal and shaft fractures of the femur. Compared to conservative e 
care, operative treatment of hip fractures is more likely to result in fracture healing without 
leg shortening, a shorter hospital stay and possible increase in return of patients back to 
their original residence [26]. In this study, study subjects will be monitored closely during 
the 24-week follow-up period by the investigators who will use radiographic, functional and 
patient reported evaluations. The knowledge gained from the data produced in this study 
may benefit future patients.  
 
2.2. Risks 
Any surgical procedure poses a potential risk and the procedures undertaken as part of 
this clinical investigation are no exception. There are known risks associated with the 
method of anesthesia (general, epidural, local). In addition to these there are risks 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 20 of 74 
 
associated with a surgical procedure that involves a device. The risks that are associated 
with the study devices are similar to those of any intramedullary nail. The following 
complications have been reported and are consistent with the IFU. Please refer to the 
device Instructions for Use (IFU) which are included in the implant packaging and are also 
available upon request. The adverse events identified below are to be reported as AEs.  
 
Compared with PFNA-II, there is no additional risk associated with the investigational 
device (TFNA). The following is a summary of the most commonly reported adverse 
events and complications in intramedullary nail fixation of proximal femur fractures1: 
• 
Damage to vital organs: Damage to vital organs may occur when a guide wire is 
accidentally advanced during implant insertion, when the opening instrument 
modifies the placement of the guide wire, or when the guide wire is captured by 
the drill cannulation and advanced inadvertently. 
• 
Embolism: Bony and fat embolism may e.g. occur due to increased medullary 
pressure with improper nail insertion technique, like using an oversized nail. Air 
embolism may occur when the cannula is inadvertently filled with air.  
• 
Soft tissue damage: Major soft tissue damage may result from a variety of different 
conditions: Accidental static locking of the head element when dynamic locking is 
required, improper measurement technique for head element due to user error, 
incorrect final placement of head element, etc. 
• 
Malunion / nonunion: Malunion / nonunion may occur due to implant breakage 
because of inappropriate strain by the patient. 
• 
Neurovascular damage: Major neurovascular damage may be consequence of 
blocking at the blade / impactor interface leading to displacement of the blade in 
the femoral head. 
• 
Postoperative bone fracture: Major postoperative bone fracture may be 
consequence of undesired position of the head element in the femoral head.  
• 
Adverse soft tissue reaction: Major adverse soft tissue reaction may be a 
consequence of the use of materials with unknown biocompatibility in conjunction 
with implant and instrument materials.  
                                                             
1 Cement augmentation will not be made available for this clinical study. Therefore, any risks related to the 
augmentation procedure or cement are not captured in this list. 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 21 of 74 
 
• 
Injury to user: Injury to user may be associated with the risks associated with 
cleaning and sterilization of instruments. 
 
• 
Surgical delay: Moderate surgical delay may be associated with a variety of 
different conditions which may include: Distal locking screw targeting and insertion; 
General instrument breakage; General technique guide comprehension; Head 
element removal for example the risk of having cement in the implant-instrument 
interface of the head element; Head element targeting and insertion; Nail insertion 
and Nail removal. 
• 
Pain: Pain may be associated with the risk of implant stiffness or end cap 
protruding above the cortex. 
• 
Poor joint mechanics: Poor joint mechanics may be associated with the risk of 
guide wire penetrating joint surface during insertion. 
• 
Infection: Infection may be associated with the risk of sterilization process does not 
adequately sterilize device or packaging does not provide adequate protection for 
the device 
 
3.0 STUDY OBJECTIVES  
3.1. Intended Use and Indication  
The intended use for TFNA is the following: 
 
Intended Use: intended for the treatment of proximal femur and combinations of proximal 
and shaft fractures of the femur. 
 
The indications of the TFNA are: 
 
Short Nails (lengths 170 mm, 200 mm, 235 mm) 
- 
Pertrochanteric fractures (31-A1 and 31-A2) 
- 
Intertrochanteric fractures (31-A3) 
- 
235 mm nails are additionally indicated for high subtrochanteric fractures 
 
Long Nails (lengths 260 mm – 480 mm) 
- 
Pertrochanteric fractures (31-A1 and 31-A2) 
- 
Intertrochanteric fractures (31-A3) 
- 
Fractures of the trochanteric area (31-A1/A2/A3) with diaphyseal extension 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 22 of 74 
 
- 
Combined fractures of the trochanteric area (31-A1/A2/A3) and the femoral shaft 
(32-A/B/C) 
- 
Pathological fractures, including prophylactic use 
- 
Malunions 
- 
Nonunions 
 
3.2. Objective 
The primary objective of this study is to evaluate whether fracture union rate, evaluated 
24 weeks after proximal femur fracture, for the investigational TFNA intramedullary nail is 
non-inferior to that for currently available control product PFNA-II in patients with proximal 
femur fractures. 
 
4.0 STUDY DESIGN 
This is a prospective, multicenter, randomized, controlled, two-arm, non-inferiority study 
which will be conducted in China, comparing the safety and the effectiveness of two 
intramedullary nails (the investigational group is TFNA and the control group is PFNA-II). 
Patients enrolled at each site will be randomized in a ratio of 1:1, i.e. one patient assigned 
to surgery implanted with TFNA for each patient assigned to PFNA-II. Separate block 
randomization schedules within each site will be used to ensure equal distribution of 
treatment and control patients. Up to 15 centers will be approved to participate in this study. 
 
Patient will be clinically followed after surgery at 1, 6, 12 and 24 weeks. The data up to 
and including 24 week follow up visit will be used in determining the primary safety and 
effectiveness of the TFNA. 
 
5.0 ENDPOINTS 
5.1. Primary Endpoint 
The primary endpoint is fracture union at 24 weeks postoperatively. Fracture union 
success is a composite endpoint; in order for an individual subject’s surgery implanted 
with TFNA or PFNA-II to be considered successful he/she must satisfy all of the 
following criteria at 24 weeks: 
1. No focal tenderness or lengthwise percussion pain, or abnormal movement 
2. The frontal/lateral X-ray examination shows the vague or no fracture gap, or the 
continuous callus passing across the fracture line 
3. No deformation or breakage is found in the test product 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 23 of 74 
 
The primary endpoint analysis will be to demonstrate that the investigational device (TFNA) 
is non-inferior to the control device (PFNA-II) based the fracture union rate at the 24 week 
follow-up visit. Non-inferiority test will be conducted based on a one-sided 97.5% 
confidence interval for the difference in the fracture union rates at 24 weeks between the 
investigational and control groups.  
 
5.2. Secondary Endpoints 
The following secondary endpoints will be evaluated: 
• 
Adverse events (type and frequency) for all adverse events will be compared for 
the investigational and control groups 
• 
24-week revision rate where revision is defined as removal of any component for 
any reason. 
• 
24-week reoperation rate is defined as secondary surgery at the fracture site(s) for 
any reason 
• 
Clinical Outcomes 
o SF-12 
o Harris Hip Score 
o EQ-5D  
• 
Radiographs: incidence of complications such as loosening or cut-out that require 
reoperation or revision 
 
 
5.3 Safety 
 
An overall summary of adverse events (AE) will be provided, including for each group the 
number and the percent of subjects with all AE, all serious AE, all related AE, and all AE 
by severity. In addition, all adverse events, serious, and non-serious adverse events will 
be summarized and tabulated by preferred term, both overall and by severity, by time 
period of onset, and by operative site    
 
6.0 STUDY POPULATION 
6.1. Subject Selection 
The study will include 188 subjects with proximal femur fracture on a single limb requiring 
intervention that meet eligibility criteria and agree to participate in the study.  
Subjects must meet ALL inclusion criteria and NO exclusion criteria. 
 
6.2. Inclusion Criteria 
 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 24 of 74 
 
Subjects will be included if ALL of the following inclusion criteria apply: 
 
1) Age ≥18 years 
 
2) Patients with unilateral proximal femur fractures that will be treated with intramedullary 
nail internal fixation  
 
3) According to AO fracture classification, subjects with following fracture type: 
a. 
Pertrochanteric (31-A1 and 31-A2) 
b. 
Intertrochanteric (31-A3) 
c. 
Trochanteric area (31-A1/A2/A3) with diaphyseal extension 
 
4) Subject must be comfortable with speaking and understanding questions and 
responses in an available translated language for patient reported outcomes (PROs) 
6.3 Exclusion Criteria 
Subjects will be excluded if ANY of the following exclusion criteria apply:  
1) Subject does not provide voluntary consent to participate in the study 
2) The subject is a woman who is pregnant or lactating 
3) Fractures where the operative treatment will occur more than three weeks after the 
primary injury 
4) Patients with femoral head fractures and femoral neck fractures (AO classification 
31-B and 31-C) 
5) Pathological fracture (e.g., primary or metastatic tumor) 
6) Serious soft tissue injury, judged by the investigator, will impact the union of the 
fracture, combined vascular injury, and combined osteofascial compartment syndrome 
7) Multiple systemic injuries judged by researchers not suitable for enrollment, or 
orthopaedic fractures in other bones at three or more sites 
8) Revision surgeries (for example, due to malunion, nonunion or infection) 
9) Concurrent medical conditions judged by researchers not suitable for enrollment, 
such as: diabetes, metabolic bone disease, post-polio syndrome, poor bone quality, prior 
history of poor fracture healing, etc 
10) Patients with anaesthetic and surgical contraindications 
11) Patients known to be allergic to implant components 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 25 of 74 
 
12) Patients who are currently using chemotherapeutics or accepting radiotherapy, use 
systematically corticosteroid hormone or growth factor, or long-term use sedative 
hypnotics (continuous use over 3 months) or non-steroidal anti-inflammatory drugs 
(continuous use over 3 months) 
13) Intemperance judged by researchers not suitable for enrollment (e.g., excessive 
daily drinking or smoking, drug abuse);  
14) Patients participated into other clinical trial in the previous 3 months;  
15) Patients with bad compliance judged by researchers and cannot complete the test 
according to test scheme, such as schizophrenia and dementia. 
7.0 STUDY PROCEDURES 
 
7.1. Screening and Baseline Period 
7.1.1. Patient Screening 
A qualified member of the Institution’s research team assigned to the study team will 
review the patient’s medical history to screen for study eligibility. All patients meeting all 
inclusion criteria and no exclusion criteria will be invited to participate in the study.  
7.1.2. Informed Consent 
All potential patients must be consented prior to performing any study specific procedures. 
Once the Investigator has determined the patient’s eligibility for the study, the background 
of the proposed study and the benefits and risks of the procedures and study must be 
explained to the patient. Only those patients who sign the site’s Ethics Committee (EC) 
approved informed consent prior to participation are eligible to be in the study. Failure to 
provide written informed consent renders the patient ineligible for the study. 
 
7.1.3. Screening and Baseline Assessments 
To be performed for all patients prior to the procedure to ascertain eligibility: 
1. 
Medical history 
2. 
Inclusion and exclusion criteria 
3. 
Physical Exam 
 
7.1.4. Patient Enrollment 
Sites will be required to maintain a record of patients screened for the study meeting 
general inclusion criteria who have signed the approved informed consent document. 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 26 of 74 
 
Randomization will occur if the patient meets all inclusion criteria and does not meet any 
exclusion criteria.  
Subjects who do not continue to meet eligibility criteria at this point are considered 
screening failures. The Investigator will document screening failures on the screening 
failure log, including reasons for failures. Once randomization is complete and a treatment 
arm is assigned, crossover between treatment arms will be considered as a major protocol 
violation.   
If for some reason an enrolled subject does not receive a study device during their surgery 
he/she will be withdrawn postoperatively. This will be noted upon the end of study form. 
Thus, patients will be considered enrolled into the study after: 
1. 
The patient has met all of the inclusion and none of the exclusion criteria, and 
2. 
Signed informed consent has been obtained. 
 
7.1.5. Randomization and Treatment Assignment 
Each patient will be assigned a unique patient identification number at screening that will 
be used to identify the patient throughout the study. Eligible patients will be randomized to 
study treatment or control group using a centralized computer-generated randomization 
system. 
 
The study will be comprised of two (2) treatment groups: an investigational group (TFNA) 
and a control group (PFNA-II). Enrolled patients who meet inclusion and exclusion criteria 
will be randomized prior to the study procedure. Individual subjects will be randomized to 
one of two groups (TFNA or PFNA-II) in a 1:1 ratio. The plan is to accrue 94 subjects for 
each of the two groups.  
7.2. Procedure 
7.2.1. Instructions for Use 
Preparation, handling and the implantation procedure must be performed in accordance 
with the Instructions for Use (IFU) provided within the implant packaging. An 
instrumentation system will be available for both investigational and control treatments. 
The surgeon should refer to the appropriate surgical technique manual for details on the 
use of the instrument system and implantation of the devices.  
7.3. Post-Procedure 
Subjects should be managed in accordance with institutional standards following the 
enrollment procedure including in-hospital and physiotherapy. Blood chemistry also will 
be documented. All adverse events (serious and non-serious) occurring during post-

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 27 of 74 
 
operative hospitalization will be reported. Concomitant medications (prescription and 
non-prescription) will be collected. 
7.4. Follow-up Period 
For each clinic visit there is a required timeline for the visit, as shown in the Time & Events 
Table.  For each of these visits, the data described in Table 8 must be collected. 
 
 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 28 of 74 
 
Table 8. Time and events schedule 
Enrollment 
Follow-up 
Event/Visit 
FU 1: 
Pre-Op 
FU2: 
Surgery 
FU3: 
1 week 
FU4:  
6 weeks 
FU5: 
12 weeks 
FU6: 
24 weeks 
Required Timing 
-90 to 0 
days from 
day of 
surgery 
0 
1 to 14 
days 
after 
surgery 
±2 
weeks 
±2 weeks 
±4 weeks 
The signing of the informed 
consent form 
X 
 
 
 
 
 
Inclusion/Exclusion criteria 
X 
 
 
 
 
 
Demographic data and medical 
history enquiry 
X 
 
 
 
 
 
Concise patient self-rated health 
measurement scale (SF-12v2)  
X 
 
 
 
X 
X 
EQ5D 
X 
 
 
 
X 
X 
Harris Hip Score 
 
 
 
 
X 
X 
Subject history 
X 
 
 
 
 
 
Urine pregnancy test1 
X 
 
 
 
 
 
Frontal and lateral X-ray of 
fracture sites  
X 
 
X 
X 
X 
X 
Surgical reduction and 
intramedullary nail fixation 
 
X 
 
 
 
 
Surgeon’s evaluation on product 
operability during operation 
 
X 
 
 
 
 
Wound healing assessment 2 
 
 
X 
 
 
 
Local physical examination 
X 
 
X 
X 
X 
X 
Concomitant drugs3 
X 
X 
X 
X 
X 
X 
Adverse event 
 
X4 
X 
X 
X 
X 
Serious adverse event 
 
X4 
X 
X 
X 
X 
Blood chemistry 
X 
X5 
 
 
 
 
1. Urine pregnancy tests: women of childbearing age only. 
2. Wound healing condition is assessed until wound healing. 
3. Concomitant Drug Table should include only pain killers and anti-osteoporosis drugs. 
4. Adverse events and serious adverse events should be recorded starting at the time of 
patient randomization. 
5. Second Laboratory Test analyses performed during post-op recovery phase per site 
standard of care. The results closer to the time of surgery will be recorded. 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 29 of 74 
 
Unscheduled Visits 
If in between protocol required visits/telephone contacts, the site study team learns of any 
interventional treatment that a subject has undergone or study-related reportable adverse 
events, as defined in Section 8.0, the relevant information will be captured on the 
appropriate CRFs. All diagnostic radiographic films will be reviewed by the independent 
radiographic reviewer. All relevant source documentation required to assess the event will 
be maintained in the subject files and all relevant documentation required for event 
adjudication will be provided as requested by the Sponsor. 
Clinical follow-up 
The Investigator will be required to document clinical assessment in the medical and 
research source documents.  
7.5. Blinding Procedures 
Many medical records (source documents) documenting the patient’s operative procedure, 
hospital stay and follow-up visits will not be blinded because implant labels identifying the 
implanted stems will be provided. As is common in device trials, it will not be possible to 
blind surgeon investigators or study staff because each group will be implanted with a 
different implant system, each of which is easily distinguished and has its own instrument 
set. Blinding of the independent radiographic reviewers and study staff also is not feasible 
because of small differences in design features that may be distinguished postoperatively 
(e.g., radiographs). 
Blinding practices for this study will include the following: 
Patients: Patients will be informed of the 1:1 randomization between the two devices, but 
will remain blinded as to which implant they actually received until after they have 
completed all study follow-up. 
Implanting surgeon: It is not possible to blind the implanting physician due to his/her 
contact with the product labeling and IFU.   
Independent Radiographic Reviewer (IRR):  The IRR will not be blinded to the device 
implanted due to small differences that may be apparent in the radiographic images. 
Medical Records: All medical records (source documents) documenting the implant 
procedure through hospital discharge and all follow-ups will not be blinded because 
implant labels identifying the implanted stems will be provided.  
Monitors: Monitors will not be blinded because the detachable labels provided with the 
product identify the product and may be used in the study device accountability records 
and patient research file for the purpose of device accountability and source document 
validation.  
 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 30 of 74 
 
8.0 ADVERSE EVENT REPORTING 
Adverse events are reported using two case report forms: Adverse Event and Serious 
Adverse Event. Adverse events will be collected starting at the time the patient is 
randomized and throughout the study, including during the hospital stay, any follow up 
visits and during any unscheduled patient contact or visits. The definitions and details are 
provided in the following sections. 
 
 Data Collection Requirements 
Adverse Event Type 
Adverse Event Form 
Serious Adverse Event Form 
Non-Serious Adverse Event 
Complete entire form 
DO NOT COMPLETE 
Serious Adverse Event 
DO NOT COMPLETE 
Complete entire form 
 
8.1. Anticipated Adverse Events  
There are immediate post-operative events that are changes from the baseline condition 
of the Subject, but are expected events resulting from the surgery. If these events occur, 
they should be recorded in the Subject’s medical record and reported forward as AEs to 
the study sponsor. 
 
8.2 Adverse Events  
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, 
or untoward clinical signs (including abnormal laboratory findings) in subjects, users or 
other persons, whether or not related to the investigational medical device. 
At each evaluation of the subject enrolled in a clinical investigation, the investigator 
determines whether any adverse events (AE) have occurred, and determines their 
relationship to the study devices or procedure. 
All adverse events, study device malfunctions and other product issues must be recorded 
in the medical records and entered into CRFs.  
8.3 Serious Adverse Events 
Serious Adverse Events (SAEs) are defined as any adverse event that: 
a) led to death, 
b) led to serious deterioration in the health of the subject, that either resulted in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury or permanent 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 31 of 74 
 
impairment to a body structure or a body function, 
c) led to foetal distress, foetal death or a congenital abnormality or birth defect 
NOTE 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. 
The investigator must submit to sponsor and CFDA (or designee) any Unanticipated 
Adverse Device Effects (UADE) and SAEs occurring during the study within 24 hours after 
being notified of the event and provide additional information if required by sponsor. 
All SAEs need to be followed until the event is resolved (with or without sequelae). The 
medical monitor of this study will decide if more follow-up information is needed in case 
the event is not resolved or stable at study completion. 
The investigator notifies his/her EC of all SAEs and UADEs occurred at his/her site (and 
any additional information as required by Ethics Committee). The investigator notifies 
competent authority of all SAEs and UADEs that occurred at his/her site in accordance 
with local regulation requirements. 
The sponsor will report to all participating clinical investigators all UADEs and deaths 
within 5 working days after the sponsor first receives notice of the effect and/or event. The 
sponsor will submit every year (unless otherwise indicated by the Ethics Committee or 
recommended by the local regulations to all participating clinical investigators an update 
of all study devices related, site reported and adjudicated SAEs. A letter summarizing the 
study status, enrollment figures, any safety concerns as well as any recommendation from 
the steering committee will accompany the updates. 
Event reporting to relevant competent authorities will occur by the sponsor in a manner 
and timing in accordance with local regulation requirements. 
8.4. Duration of Follow-up after Adverse Events 
The Investigator should ensure that adequate medical care is provided to any subject for 
any adverse events, including clinically significant laboratory values, related to the study. 
All adverse events related to the subject’s participation in the study should be followed 
until the condition has resolved, or in the case of permanent impairment until the condition 
stabilizes and clinical outcome has been ascertained.  
8.5. Reporting an Adverse Event 
Adverse events are reported from the start time of the index procedure until the subject’s 
study participation has ended (i.e. revision, completion of study or withdrawal of consent). 
All AEs must be followed until the AE has resolved, stabilized, or the study has been 
completed. 
The Investigator will record the nature, severity, treatment and outcome of the AE, and will 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 32 of 74 
 
determine the relationship to the investigational products, medications or any protocol 
mandated procedures involved in the clinical study. 
The following categories of adverse event severity are to be used: 
 
Mild: 
Awareness of sign or symptom that does not interfere with the subject’s 
usual activity or is transient, resolved without treatment and with no 
sequelae, 
Moderate: 
Interferes, but does not hinder, the subject’s usual activity and may 
require treatment, 
Severe 
Symptom(s) causing severe discomfort and significant impact on the 
subject’s usual activity and requires treatment or intervention. 
 
The causal relationship should be rated as follows: 
 
Unrelated: The event is definitely not associated with product application 
Unlikely: 
The temporal sequence between product application and the event is 
such that the relationship is unlikely, 
Possible: 
The temporal sequence between product application and the event is 
such that the relationship is not unlikely or the subject’s condition or 
concomitant therapy could have caused the AE, 
Probable: 
The temporal sequence is relevant or the event abates upon product 
application completion or the event cannot be reasonably explained by 
the patient’s condition, 
Related: 
The temporal sequence is relevant and the event abates upon product 
application completion or reappearance of the event on repeat product 
application (re-challenge). 
 
 
Adverse events will be reported by the investigator to the Sponsor via the CRF.  
 
9.0 EARLY DISCONTINUATION 
9.1 Reasons for Early Discontinuation 
Possible reasons for early discontinuation may include, but are not limited to the following: 
• 
Withdrawal of consent: Subject decides to withdraw from the study. This decision 
must be an “independent decision” that is documented in the patient study files; 
• 
Physician discretion: The Investigator may choose to withdraw a subject from the 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 33 of 74 
 
study if there are safety concerns; 
• 
Adverse event: Adverse event or serious adverse event may not lead to subject 
discontinuation from the study. When the investigator decided to discontinue the 
subject, subject must be followed until the adverse event resolves or until a stable 
clinical endpoint is reached; 
• 
Death; 
• 
Early study termination: The sponsor can decide to discontinue the study prematurely 
for various reasons. 
• 
Lost to follow-up: All subjects should be encouraged to return for all scheduled clinical 
follow-ups, and to provide appropriate contact information to accommodate 
completion of required telephone follow-ups. If a subject is unable to return for 
mandatory clinical visits, 3 separate telephone calls should be made to attempt to 
bring the subject back into the clinic and/or obtain safety information and assess 
implant status. All attempts at contact should be documented in the source documents. 
If the subject does not respond to 3 telephone calls, the Investigator must send a 
registered letter to the subject. If the subject does not respond to the registered letter 
and further contact is not made, then the subject will be considered to have missed 
the scheduled visit. If the aforementioned contact efforts are unsuccessful over two 
study intervals the subject will be considered lost to follow-up and an End of Study 
case report form (CRF 9) must be completed. 
9.2. Subject Early Discontinuation 
Every subject should be encouraged to remain in the study until they have completed the 
protocol-required 24-week follow-up period. If the subject discontinues prematurely from 
the study, the reason for discontinuation must be documented in the source documents 
and site files, and submitted via CRF. 
Subjects who have discontinued prematurely will be included in the analysis of results; 
however new subjects may not be enrolled to replace these subjects.   
9.3. Study Early Discontinuation 
The sponsor reserves the right to temporarily suspend or prematurely discontinue this 
study either at a single site, multiple sites, or at all sites at any time for reasons including, 
but not limited to, safety or ethical issues, inaccurate or incomplete data recording, non-
compliance, or unsatisfactory enrollment with respect to quality or quantity 
If the study is prematurely terminated or suspended, the sponsor or its representatives will 
inform the investigators/institutions, and the regulatory authority(ies) of the termination or 
suspension and the reason(s) for the termination or suspension, in accordance with 
applicable regulatory requirement(s). The EC should also be informed and provided with 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 34 of 74 
 
reason(s) for the termination or suspension by the sponsor or by the investigator/institution, 
as specified by the applicable regulatory requirement(s). In addition, arrangements will be 
made for the return of all unused investigational products and other material in accordance 
with sponsor procedure for the study. 
 
10.0 STATISTICAL METHODS SECTION 
10.1. Study Design 
See section 4.0. 
10.2. Treatment Assignment 
See section 7.1.5. 
10.3. Levels of Significance 
A two-sided alpha of 0.05 will be used for statistical testing and confidence intervals unless 
otherwise stated. There will be no adjustment to p-values or alpha levels for testing the 
primary and the secondary endpoints.  
10.4. Interval Windows 
The required visit windows are presented in Table 8 of Section 7.4, Time and Event 
Schedule. The required pre-operative window will be from 90 days prior to surgery and 
day of the surgery, and 1 week, 6 weeks, 12 weeks and 24 week required post-operative 
intervals are defined as follows for analysis purposes: 
 
 
 
 
 
10.5. Handling of Missing Data 
All primary and secondary efficacy endpoint analyses will utilize actual subject data which 
are collected during the course of study. No data will be imputed during analysis of the 
primary endpoint.  
To evaluate the potential effects of missing data, sensitivity analyses of the primary 
endpoint will be conducted based on the Per Protocol population, which is defined in 
Section 10.8.  The effect of missing data will be evaluated using a last observation carried 
forward (LOCF) approach for all subjects, i.e. to replace missing values with the last 
 
Study interval windows (days or weeks, as 
indicated) 
Pre-Op 
Day of 
surgery 
1 week 
6 week 
12 week 
24 week 
-90 to 0 days 
Day 0 
1 to 14 
days 
after 
surgery 
±2 weeks 
±2 weeks 
±4 weeks 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 35 of 74 
 
observed values. In this LOCF sensitivity analysis, the last observed value will be non-
union unless it was definitively determined to be a successful union. 
10.6. Primary and Secondary Endpoints 
See sections 5.1 and 5.2. 
 
10.7. Hypotheses 
The primary endpoint analysis will be to demonstrate that the investigational device (TFNA) 
is non-inferior to the control device (PFNA-II) based on the fracture union rates at the 24 
week follow-up visit. Non-inferiority test will be conducted based on a one-sided 97.5% 
confidence interval for the difference in the fracture union rate at 24 weeks between the 
investigational and control groups.  
 
The primary hypothesis is that, at 24 weeks after surgery, the investigational device (TFNA) 
is non-inferior to the control device (PFNA-II) based on the individual patient fracture union 
rate. Non-inferiority is defined by a test with a two sided 5% type I error and a 10% “margin 
of non-inferiority”.  
 
The study’s null and alternative hypotheses are as follows: 
10%
P
-
P :
10%
P
-
P :
TFNA
II
-
PFNA
TFNA
II
-
PFNA


a
o
H
H
 
where 
II
-
PFNA
P
 represents the fracture union rate among those receiving PFNA-II implant 
and 
TFNA
P
denotes the fracture union rate among the recipients of TFNA.  
Decision Criterion: The decision will be made to reject the null hypothesis
o
H  and 
conclude the alternative hypothesis 
a
H if the one-sided 97.5% confidence interval for the 
difference in the fracture union rates between the investigational and the control groups is 
less than the margin of non-inferiority, 10%.  
10.8. Analysis Sets 
All subjects who met the inclusion and exclusion criteria will be eligible for enrollment and 
will be randomized to either the investigational (TFNA) or the control (PFNA-II) group. The 
following two analysis sets have been defined for this study:  
 
1) Intent-to-Treat (ITT) Population 
This analysis set includes all subjects randomized and implanted with a protocol specified 
implant, TFNA or PFNA-II. It includes the patients who were treated and withdrew prior to 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 36 of 74 
 
week 24 due to various reasons. If a patient is randomized to one treatment group, but 
receives the other group for any reasons, the patient is considered to be part of the 
treatment group as received. This analysis set will be the primary one for the secondary 
safety analysis. 
 
2) 
Per Protocol Population 
The Per Protocol Population will consist of the subset of the ITT Population who complete 
24 weeks of follow-up with no major protocol deviations (including but not limited to: failure 
to satisfy all inclusion/exclusion criteria, failure to adhere to all protocol-required 
restrictions and prohibitions, receipt of prohibited concomitant procedures or therapies, 
and non-compliance to protocol-specific procedures) as determined by a review of subject 
data.  
 
This PP population will be the analysis set for conducting the primary and secondary 
effectiveness endpoint analyses. 
 
Separately from these two populations, any subjects who are enrolled into the study but 
who do not receive one of the study devices will be summarized separately. This summary 
will include demographics and reasons for not receiving a study device.  
 
 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 37 of 74 
 
  
The figure below illustrates these populations: 
 
Figure 2: Analysis Set Flow Diagram 
 
 
Surgery Not Performed (N=) 
Non-study Device Implanted (N=) 
Major Protocol Violations 
(N=) 
List subject numbers, and reasons 
Intent-to-Treat Population 
N1 = Control  N2 = Investigational 
minus 
Per Protocol Population 
N3 = Control  N4 = Investigational 
All Enrolled Population 
N= (Total Sample Size) 
minus 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 38 of 74 
 
10.9. Sample Size Justification 
The sample size calculation is determined based on the primary endpoint using PROC 
POWER in SAS software version 9.3. It assumes that the fracture union rate at 24 weeks 
after surgery in the TFNA group would be equivalent to that of the PFNA-II group, and a 
common fracture union rate is approximately 95% or greater based on the literature review 
(see Section 1. 3.1). With a non-inferiority margin of 0.10 and a power of 80%, this implies 
a sample size of 75 for the TFNA and of 75 for PFNA-II surgery groups, respectively. The 
sample size will be increased to 188 (94 per group) to accommodate potential 20% attrition 
(see Section 1.3).   
 
The sample size applies to patients enrolled, randomized, and actually treated. Some 
patients who enroll in a study and are randomized may not be ultimately treated for various 
reasons. Patient enrollment and randomization will continue until the proposed sample 
size for treated patients is complete. 
 
10.10. Analysis Plan  
10.10.1 General Consideration  
All statistical processing will be performed using SAS® Version 9.3 or higher, unless 
otherwise noted. 
 
Summary tables will be provided for subject demographics and baseline variables for the 
Intent-to-Treat (ITT) and Per Protocol (PP) Population. The outcomes of the primary 
effectiveness endpoint will be summarized based on pooled data from all sites for the PP 
population. In addition, the primary endpoint data will be presented by investigator/site.  
 
Descriptive statistics for continuous variables will include number of subjects, mean, 
standard deviation, median, minimum, and maximum. Descriptive statistics for 
dichotomous/categorical variables will include number and percent of subjects.   
 
A 2-sided alpha of 0.05 will be used for statistical testing and confidence intervals unless 
otherwise noted.  Detail on the level of significance for testing the primary endpoint 
analysis is addressed in Section 10.3 (Levels of Significance).   
 
10.10.2 Subject Disposition 
All Subjects who are screened or enrolled (consented) into the study will be accounted for 
in Subject Disposition, overall and by study site.  
10.10.3 Data Management 
Individual subject data which are collected during the course of this trial will be entered 
into an appropriate database. A data management team will be assigned to review the 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 39 of 74 
 
data as it is being collected and any unexpected or missing data points will generate 
queries which will be forwarded to the site for resolution. The study will be closed and the 
data will be analyzed after all subjects have had an opportunity to complete their 24 week 
follow-up evaluation.   
10.10.4 Demographic Characteristics/Pre-Operative Profile 
Demographics and operative summaries will be presented and compared between the 
two treatment groups for the ITT and PP population. The two-sample T test and Fisher’s 
Exact test will be used to determine the comparability of baseline characteristics between 
the two treatment groups (TFNA vs PFNA-II). 
10.10.5 Analysis of the primary endpoint 
In accordance with ICH guidance E9(2)the primary endpoint analysis will be based on the 
Per-Protocol set of patients for a comparison of the fracture union rates at Week 24 
between TFNA and PFNA-II. Only patients in this analysis set with a known outcome for 
the primary endpoint will be analyzed. 
 
The null hypothesis (TFNA is inferior to PFNA-II) will be rejected, and TFNA will be 
considered non-inferior to PFNA-II if the exact 97.5% upper one-sided confidence bound 
for the difference in fracture union rates between PFNA-II and TFNA at 24 weeks is less 
than non-inferiority margin, 10.0%.  
 
Two sub-components of the primary endpoint at 24 weeks (radiographic outcome, and no 
deformation or breakage) will be compared between the two treatment groups.  
 
Radiographic outcome, i.e. front/lateral X-ray films, will be assessed by the independent 
radiographic reviewer to determine if there are vague or fracture gap or continuous callus 
passing across the fracture line. The radiographic outcome will be summarized and 
compared at each follow up visit between the two treatment groups using Fishers exact 
test.  
 
Similarly, the independent radiographic reviewer will also determine whether deformation 
or breakage of the implant has occurred. This outcome will be summarized between the 
two treatment groups at each follow up visit, as well. 
 
10.10.6 Analysis of secondary endpoints 
 
The outcomes of the secondary efficacy endpoints will be summarized for the two 
                                                             
2  E9 Statistical principles for clinical trials. International Conference on harmonization of Technical 
Requirements for Registration of Pharmaceutical for Human use, 1998. 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 40 of 74 
 
treatment groups. SF-12 scores will be summarized for both treatment groups at baseline 
and each follow up visit. In addition, the change from baseline to each follow-up visit will 
be summarized by treatment group. Similarly, Harris Hip score and the change from 
baseline to each follow up visit will be summarized for the two treatment groups.  
 
Furthermore, comparison of EQ-5D Scores in each of the five dimensions between the 
two treatment groups at 24 weeks will be conducted using a chi-square test. Finally, the 
incidence of complications such as loosening or cut-out in radiographic outcome will be 
summarized at each follow up visit between the two treatment groups. 
  
Adverse events (type and frequency) will be compared between the investigational and 
the control groups. Moreover, the revision rates for 24 weeks will be summarized between 
two groups.  
 
A two-sample t-test will used to compare the continuous variables at each follow up visit 
between the two treatment groups, a paired t-test will be used to compare the difference 
in continuous secondary endpoints between baseline and each follow up visit within a 
treatment group. Fishers exact test will be utilized for the categorical variable comparisons.  
 
The primary endpoint and the secondary efficacy analysis will be conducted based on PP 
population. Sensitivity analysis for the primary endpoint will be conducted on the PP 
population. Secondary safety endpoint analyses will be conducted on the ITT population. 
 
 
10.11. Plans for Interim Analysis 
No interim analysis is planned for this study for the purpose of stopping the study early. 
10.12. Reporting 
After all subjects have completed the primary endpoint (24 week follow-up visit), a clinical 
study report will be provided to CFDA for review.  
 
11.0 STUDY MANAGEMENT AND ADMINISTRATION 
 
11.1. Investigator and Sponsor Responsibility 
 
11.1.1. Investigator Responsibility 
The investigator shall ensure that all work and services described herein, or incidental to 
those described herein, shall be conducted in accordance with the highest standards of 
medical and clinical research practice. The investigator shall perform his/her 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 41 of 74 
 
responsibilities as outlined in ISO 14155-1, ICH-GCP (E6) and the Declaration of Helsinki. 
The investigator will provide current copies of the study protocol to all sub-investigators or 
other site personnel responsible for study conduct and assure that all study personnel are 
qualified and trained to perform their duties. 
The investigator will provide any interim progress reports, safety reports as required by 
local or country specific regulations as well as end of study notification in the required 
timelines to the EC.  
The investigator will provide the sponsor or designee with copies of all EC actions 
regarding the study. 
11.1.2. Sponsor Responsibility 
The sponsor has the overall responsibility for the conduct of the study, including assurance 
that the study meets the regulatory requirements of international regulatory agencies 
governing the conduct of the study in all countries where participating centers are located. 
The sponsor will ensure compliance to Chinese and international regulations and 
guidelines including ISO 14155-1, ICH-GCP and the Declaration of Helsinki in the conduct 
of the study. 
The sponsor is responsible for ensuring EC and regulatory authority approvals are 
obtained prior to the shipping of devices, ensuring proper clinical site monitoring, ensuring 
subject informed consent is obtained, providing quality data that satisfies regulations and 
informing the investigators, ECs and regulatory authorities of unanticipated adverse 
device effects, withdrawal of EC or other regulatory approval, current investigators list 
(where required) and relevant safety issues in accordance with international and local 
guidelines, and deviations from the protocol as appropriate. The sponsor will prepare 
written safety reports, progress reports and a final clinical study report. 
Required insurance coverage will be handled by the sponsor according to local regulations. 
11.2 Selection, Monitoring and Close-out 
11.2.1. Selection 
The primary requirements of site and investigator selection and continued participation in 
this study are adequate experience in the relevant field of study and all study procedures, 
commitment to safety, consistency in adherence to the protocol, and subject volume 
consistent with protocol timeline. The sponsor and its designees will select qualified 
investigators, ship investigational devices only to participating investigators, obtain signed 
study agreements, and provide the investigators with the information necessary to conduct 
the study, and any amendments or updates to study information specific to the conduct of 
the study. 
11.2.2. Monitoring 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 42 of 74 
 
The monitoring for this study will be conducted by sponsor or sponsor designee in all 
centers. The study will be monitored to assure the following: 
• 
The rights and well-being of subjects are protected; 
• 
The study is conducted according to Good Clinical Practices (ICH-GCP), ISO 14155-
1, the Declaration of Helsinki and country specific regulations; 
• 
The protocol and applicable amendments are followed; 
• 
The data recorded are accurately represented according to source document 
verification. 
Periodic monitoring visits will be performed at all active investigational sites throughout 
the clinical study to assure that the investigator obligations are fulfilled. These visits will 
assure that the facilities are still acceptable; the study protocol and any amendments are 
being followed, the EC has been notified of protocol changes as required, complete 
records are being maintained, appropriate and timely reports have been made to the 
sponsor and the EC, device and device inventory are controlled and the investigator is 
carrying out all agreed activities. 
11.2.3. Close-out 
Upon completion of the clinical study (when all subjects enrolled have completed the 
follow-up visits and the CRFs and queries have been completed), the sponsor or designee 
will notify the site of closeout and a study closeout visit will be performed. 
During the close-out visit, all unused study materials will be collected and returned to the 
sponsor or destroyed on site. The monitor and the investigator will ensure that the 
investigator’s site files are up to date and complete, and that any outstanding issues from 
previous visits have been resolved. Other issues which will be reviewed at this visit include: 
discussing retention of study files, possibility of site audits, publication policy, and notifying 
the EC of study closure. 
A study close-out visit may be scheduled prior to completion of the clinical study if for any 
reason the site has not enrolled any subjects and is terminated from further participation 
in the study by the sponsor. In this case the sponsor will provide instructions to the 
investigator regarding EC notification of status of site participation in the study and final 
documentation required by the sponsor. 
11.3. Required Documents 
The following documents must be minimally submitted to the sponsor, or designee prior 
to subject enrollment: 
• 
Confidentiality Agreement; 
• 
Signed Protocol Signature page; 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 43 of 74 
 
• 
A recent signed and dated Curriculum Vitae (CV) for the Principal and sub-
investigator(s). This CV should clearly show the site study staff’s qualifications and 
experience; 
• 
A copy of the written confirmation of the EC regarding approval of the protocol 
including version number and date, subject information sheet and informed consent 
including version and date and other adjunctive subject material including health 
questionnaires; 
• 
A current list of EC members, including name, title, occupation and any institutional 
affiliation of each member. If the EC members list is not available, a statement 
mentioning that the EC is working in accordance to ICH-GCP should be provided; 
• 
A signed study contract must be in place; 
 
11.3.1. Source Documents 
Regulations require that investigators maintain information in the study subject’s medical 
records (= source documents) which corroborate data collected on the CRF. In order to 
comply with these regulatory requirements, the following information will be maintained 
and made available as required by monitors and/or regulatory inspectors: 
• 
Medical history/physical condition of the study subject before involvement in the study 
sufficient to verify protocol entry criteria; 
• 
Medical record documenting the informed consent process; 
• 
Description of device implantation procedure; 
• 
All examination results and follow-up; 
• 
Dated and signed printouts or reports of examinations (e.g., radiographs); 
• 
Description of adverse events and follow-up of the adverse events (event description, 
severity, onset date, duration, relation to study device, study procedure, outcome and 
treatment for adverse event and concomitant medication at the time of the adverse 
event); 
• 
Study subject’s condition upon completion of or withdrawal from the study. 
Subject’s source documents minimally contain but are not limited to the above list. 
 
11.3.2. Source Data Verification 
The sponsor expects that, during the monitoring visits, the study coordinator and/or 
investigator will be available, the original source documentation will be available, and a 
suitable environment will be provided for review of study-related documents. Any 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 44 of 74 
 
discrepancies will be noted, discussed with the investigator or designee and resolved. 
11.3.3. Case Report Forms (CRFs) 
A Case Report Form will be completed by the investigator or its designee for each subject 
enrolled in the study. All required subject data must be recorded in the CRF. The CRF 
cannot be used as source documentation. The study monitor(s) will review completed 
CRFs at the site to verify source data accuracy. All CRF corrections are to be made by an 
investigator or other authorized study site personnel. The investigator/ sub-investigator 
must sign and date the specified section of the CRF to confirm that he/she has reviewed 
the data and that the data are complete and accurate. 
The investigator should complete CRFs as soon as possible after subject enrollment or 
follow-up visit. This will enable timely monitoring visits. 
Any study-related patient-reported outcomes will be completed by the study subject. 
 
11.3.4. Archiving and Data Retention 
All study records, reports and source documents that support the CRFs must be retained 
by the responsible investigator according to regulation requirements following notification 
by the sponsor or designee that all investigations have been completed, and will further 
be retained in accordance with local and international guidelines as identified in the clinical 
study agreement. 
This documentation must be accessible upon request by international regulatory 
authorities and the sponsor (or designee). The sponsor, or designee, must approve 
archiving or transfer of the documentation for relocation purposes of premises, in writing, 
prior to the actual file transfer. The investigator must notify the sponsor, in writing, of 
transfer location, duration, and the procedure for accessing study documentation. The 
investigator must contact the sponsor, or designee, before the destruction of any records 
and reports pertaining to the study to ensure they no longer need to be retained. 
If the investigator retires, relocates, or for other reasons withdraws from assuming primary 
responsibility for keeping the study records, custody per written notice must be submitted 
to the sponsor, or designee, indicating the name and address of the person accepting 
primary responsibility. 
11.3.5. Audit and Inspection 
In the event that audits are initiated by the sponsor (or its designee), or 
national/international regulatory authorities, the investigator allows access to the original 
medical records and provides all requested information. In the event that audits are 
initiated by a regulatory authority, the investigator will immediately notify the sponsor. 
 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 45 of 74 
 
12. ETHICS AND REGULATORY REQUIREMENTS 
12.1. Ethics Committees 
The protocol, informed consent form and other applicable study-related documents must 
be submitted to the appropriate EC and written approval must be obtained and submitted 
to the sponsor, or designee, prior to enrolling any subjects. 
The investigator will promptly report to the EC any change in the designation of Principal 
investigator role and all unanticipated problems involving risks to human subjects and will 
not make any changes in the research plan without EC approval, except when necessary 
to eliminate immediate hazards to human subjects. Those amendments involving 
significant risk or change require EC approval and written documentation of this approval 
must be submitted to the sponsor or designee. 
12.2. Informed consent 
Each subject (or a legally authorized representative) must sign and date the EC approved 
Informed Consent (and other locally required documents) after the nature of the study has 
been fully explained, and prior to performance of any study-related activity or procedure, 
that is not standard of care. 
The voluntary process of obtaining written informed consent confirms the subject’s 
willingness to participate in the study.  All aspects of the study must be explained to the 
subject prior to signing the informed consent.  The Investigator and/or designee must 
clearly document the process of obtaining informed consent in the subject clinical record.  
It is the Investigator’s responsibility to ensure that the informed consent process is 
performed in accordance with ICH-GCP, ISO 14155, EC requirements and country 
specific regulations. 
12.3. Subject Confidentiality 
Subject confidentiality will be maintained throughout the clinical study in a way that 
ensures the information can always be tracked back to the source data. For this purpose, 
a unique subject identification code (site number and subject number) will be used that 
allows identification of all data reported for each subject. 
Data relating to the study might be made available to third parties (for example in case of 
an audit performed by regulatory authorities) provided the data are treated confidentially 
and that the subject’s privacy is guaranteed. 
12.4. Protocol Amendments 
As appropriate, the sponsor or designee will submit changes in the protocol to the 
investigators, the appropriate regulatory authorities and ethics committees. Ethics 
Committee approval and Regulatory Authority approval are required for all substantial 
amendments prior to implementation of any changes to study procedures. 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 46 of 74 
 
An amendment is regarded substantial when they are likely to have a significant impact 
on: 
• 
The safety or physical or mental integrity of the subjects; 
• 
Scientific value of the trial; 
• 
Conduct or management of the trial; 
• 
Quality or safety of an investigational medical product used in the trial. 
12.5. Protocol Deviations 
A protocol deviation is defined as a divergence from a specific element of a protocol (e.g., 
missed test or procedure, visit out of window, non-adherence to inclusion/exclusion 
criteria). 
Investigators are required to obtain prior approval from the medical monitor before 
initiating deviations from protocol, except where necessary to protect the life or physical 
well-being of a subject in an emergency. Such approval will be documented in writing and 
maintained in study files. Prior approval is generally not expected in situations where 
unforeseen circumstances are beyond the investigator’s control, (e.g., subject did not 
attend scheduled follow-up visit, blood sample lost by laboratory, etc.); however, the event 
is still considered a deviation. 
Deviations shall be reported to the sponsor regardless of whether medically justifiable, 
preapproved by the medical monitor, or taken to protect the subject in an emergency. 
Subject specific deviations will be reported in the CRFs. Investigators will also adhere to 
procedures for reporting study deviations to their EC in accordance with their specific EC 
reporting policies and procedures. 
Regulations (ISO 14155, ICH-GCP) require that investigators maintain accurate, complete 
and current records, including documents showing the dates and reasons for each 
deviation from the protocol. 
 
13. DEVICES 
13.1. Investigational Device Accountability 
All received investigational devices will be inventoried and accounted for throughout the 
study on an ongoing basis: the investigator and/or trained designee will maintain adequate 
records of the receipt, use, disposition and return of the investigational devices. These 
investigational devices must be kept in a secure location with restricted access and stored 
according to the conditions outlined in the IFU. In all circumstances, the investigational 
device is intended for use by the investigator or sub-investigator for subjects consented 
for participation in this clinical study only. 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 47 of 74 
 
An accountability log will be used by each site to acknowledge receipt of all investigational 
devices and to record the disposition of all investigational devices on an ongoing basis 
throughout the course of the study. Detailed written instructions regarding this device 
accountability process will be provided by sponsor and explained thoroughly during the 
site initiation visit. The responsible monitor will review the investigational device 
accountability at each monitoring visit. 
In addition, the following paper study documents must be maintained as well: 
• 
Packing slips provided with each investigational device shipment (signed and dated); 
• 
Accountability records of each subject that received an investigational device (this 
may include source documents and/or package labels of investigational/commercial 
products used); 
• 
All forms documenting the investigational devices return process; 
• 
All shipment-related forms. 
13.2. Return of Study Devices 
All unopened and unused (e.g., expired), opened and unused, damaged, mislabeled or 
malfunctioning investigational devices must be returned to the sponsor. The appropriate 
form(s) must be completed and the device must be returned by courier to an address 
specified by the sponsor. Furthermore, the reason for each returned investigational device 
has to be reflected in the accountability system as well. 
Detailed instructions for return will be provided separately by sponsor and explained 
thoroughly during the site initiation visit. 
13.3. Device Complaint 
Device Complaints consist of the following: 
• 
The study device is damaged; 
• 
The study device is mislabeled; 
• 
The study device is malfunctioning. 
 
A Device Malfunction is the failure of a device to meet its performance specifications or 
otherwise perform as intended. Performance specifications include all claims made in the 
labeling for the device. The intended performance of a device refers to the intended use 
for which the device is labeled or marketed.  
It is important that all malfunctioning investigational devices are returned to the sponsor 
per instructions provided in the Study Manual and the return process will be explained 
thoroughly during the site initiation visit. In case of any device complaints, the site must 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 48 of 74 
 
notify the sponsor as soon as possible. In case of a device malfunction, the investigator 
will report the relevant information regarding the device malfunction in the appropriate 
CRF in addition to notifying the sponsor.  
 
Should a device malfunction occur within the control group, the site must notify the study 
monitor as soon as possible. The monitor will then coordinate appropriate 
communications and product return to JJMC QC per sponsor timelines. 
 
APPENDIX A:  DEFINITIONS 
 
ADVERSE EVENT 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, 
or untoward clinical signs (including abnormal laboratory findings) in subjects, users or 
other persons, whether or not related to the investigational medical device.  
 
DEVICE RELATED ADVERSE EVENT 
A device related adverse event is defined as any adverse event, for which a causal 
relationship between the device and the event is at least a reasonable possibility, i.e., the 
relationship cannot be excluded. 
Device Malfunction: The failure of a device to meet its performance specifications or 
otherwise perform as intended. Performance specifications include all claims made in the 
labeling for the device. The intended performance of a device refers to the intended use 
for which the device is labeled or marketed.  
Device Misuse: A misused device (one that is used by the Investigator in a manner that 
is contradictory to the Instructions for Use) will not be considered a malfunction. 
 
OUTCOMES IN CASE REPORT FORMS 
 
Harris Hip Score: The Harris Hip Score was developed for the assessment of the 
results of hip surgery, and is intended to evaluate various hip disabilities and methods of 
treatment in an adult population. The original version was published in 1969 [27]. The 
domains covered are pain, function, absence of deformity, and range of motion. The 
pain domain measures pain severity and its effect on activities and need for pain 
medication. The HHS is a clinician-based outcome measure administered by a qualified 
health care professional, such as a physician or a physical therapist. Possible scores 
range from 0 to 100, with higher scores reflecting better clinical outcome.  
 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 49 of 74 
 
SF-12: The Short Form-12 was designed to measure general health status from the 
patient's point of view. The SF-12 includes 8 concepts commonly represented in health 
surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, 
social functioning, role functioning emotional, and mental health. It contains 12 items from 
the SF-36 and provides an efficient way to measure the same health concepts relevant 
across age, disease, and treatment groups. Most patients can complete the SF-12 in less 
than 3 minutes without assistance.  
EuroQoL (Quality of Life)-5 Dimensions (EQ5D): The EQ5D is a patient reported 
outcome. It provides a simple descriptive profile and single index value for health status. 
This health-related, quality of life survey consists of five dimensions (mobility, self-care, 
usual activities, pain/discomfort, anxiety/depression) each of which can take one of five 
responses. The responses record five levels of severity (no problems/slight 
problems/moderate problems/severe problems/extreme problems) within a particular EQ-
5D dimension. 
PROTOCOL DEVIATION 
A protocol deviation is defined as an incident where the Investigator or site personnel did 
not conduct the study according to the investigational plan, protocol or the Investigator 
agreement. 
Major deviation:  Any deviation from patient inclusion and exclusion criteria or patient 
informed consent procedures. 
Minor deviation:  Deviation from a protocol requirement such as incomplete/inadequate 
patient testing procedures, follow-ups performed outside specified time windows, etc. 
 
 
SERIOUS ADVERSE EVENT 
A Serious Adverse Event (SAE) is any untoward event that: 
a) led to death, 
b) led to serious deterioration in the health of the subject, that either resulted in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function, 
c) led to foetal distress, foetal death or a congenital abnormality or birth defect 
NOTE Planned hospitalization for a pre-existing condition, or a procedure required by the 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 50 of 74 
 
CIP, without serious deterioration in health, is not considered a serious adverse event. 
 
 
UNANTICIPATED ADVERSE DEVICE EFFECT (UADE) 
An Unanticipated Adverse Device Effect (UADE) is defined as any serious adverse effect 
on health or safety or any life-threatening problem or death caused by, or associated 
with, a device, if that effect, problem, or death was not previously identified in nature, 
severity, or degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects. 
 
 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 51 of 74 
 
APPENDIX B:  REFERENCED PUBLISHED LITERATURE AND JOINT 
REGISTRIES 
 
1. Bonnaire, F., et al., [Osteoporotic fractures of the proximal femur. What's new?]. 
Chirurg, 2012. 83(10): p. 882-91. 
2. Ruedi, T., R. Buckley, and C. Moran, AO principles of fracture management. 
2007, AO Publishing: Davos. 
3. Kraus, M., et al., [Clinical evaluation of PFNA(R) and relationship between the 
tip-apex distance and mechanical failure]. Unfallchirurg, 2011. 114(6): p. 470-
8. 
4. Schipper, I.B., R.K. Marti, and C. van der Werken, Unstable trochanteric 
femoral fractures: extramedullary or intramedullary fixation. Review of 
literature. Injury, 2004. 35(2): p. 142-51. 
5. Shah, S., P. Desai, and V. Mounasamy, Retrograde nailing of femoral fractures: 
a retrospective study. Eur J Orthop Surg Traumatol, 2015. 25(6): p. 1093-7. 
6. Norris, R., D. Bhattacharjee, and M.J. Parker, Occurrence of secondary 
fracture around intramedullary nails used for trochanteric hip fractures: a 
systematic review of 13,568 patients. Injury, 2012. 43(6): p. 706-11. 
7. Simmermacher, R.K., et al., The new proximal femoral nail antirotation (PFNA) 
in daily practice: results of a multicentre clinical study. Injury, 2008. 39(8): p. 
932-9. 
8. Shih, K.S., C.C. Hsu, and T.P. Hsu, A biomechanical investigation of the effects 
of static fixation and dynamization after interlocking femoral nailing: a finite 
element study. J Trauma Acute Care Surg, 2012. 72(2): p. E46-53. 
9. Basumallick, M.N. and A. Bandopadhyay, Effect of dynamization in open 
interlocking nailing of femoral fractures. A prospective randomized 
comparative study of 50 cases with a 2-year follow-up. Acta Orthop Belg, 2002. 
68(1): p. 42-8. 
10. Windolf, M., et al., Quantification of cancellous bone-compaction due to DHS 
Blade insertion and influence upon cut-out resistance. Clin Biomech (Bristol, 
Avon), 2009. 24(1): p. 53-8. 
11. Sommers, M.B., et al., A laboratory model to evaluate cutout resistance of 
implants for pertrochanteric fracture fixation. J Orthop Trauma, 2004. 18(6): p. 
361-8. 
12. Windolf, M., et al., Is a helical shaped implant a superior alternative to the 
Dynamic Hip Screw for unstable femoral neck fractures? A biomechanical 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 52 of 74 
 
investigation. Clin Biomech (Bristol, Avon), 2009. 24(1): p. 59-64. 
13. Yang, Y.H., et al., Proximal femoral nail antirotation and third-generation 
Gamma nail: which is a better device for the treatment of intertrochanteric 
fractures? Singapore Med J, 2013. 54(8): p. 446-50. 
14. Queally, J.M., et al., Intramedullary nails for extracapsular hip fractures in 
adults. Cochrane Database Syst Rev, 2014. 9: p. CD004961. 
15. Nork, S., Femoral shaft fracture, in Rockwood and Green's Fractures in Adults, 
S. Court-Brown, et al., Editors. 2014, Wolters Klewer: Philadelphia. p. 2149-
2228. 
16. Zhang, S., et al., InterTan nail versus Proximal Femoral Nail Antirotation-Asia 
in the treatment of unstable trochanteric fractures. Orthopedics, 2013. 36(3): 
p. e288-94. 
17. Macheras, G.A., et al., Does PFNA II avoid lateral cortex impingement for 
unstable peritrochanteric fractures? Clin Orthop Relat Res, 2012. 470(11): p. 
3067-76. 
18. Chang, S.M., et al., Fracture reduction with positive medial cortical support: a 
key element in stability reconstruction for the unstable pertrochanteric hip 
fractures. Arch Orthop Trauma Surg, 2015. 135(6): p. 811-8. 
19. Chen, S.H., et al., Finite element comparison of retrograde intramedullary 
nailing and locking plate fixation with/without an intramedullary allograft for 
distal femur fracture following total knee arthroplasty. Knee, 2014. 21 (1)(1): p. 
224-231. 
20. Han, C.D., et al., Relationship between distal screws and femoral arteries in 
closed hip nailing on computed tomography angiography. Arch Orthop Trauma 
Surg, 2013. 133(3): p. 361-6. 
21. Li, J., L. Cheng, and J. Jing, The Asia proximal femoral nail antirotation versus 
the standard proximal femoral antirotation nail for unstable intertrochanteric 
fractures in elderly Chinese patients. Orthop Traumatol Surg Res, 2015. 101(2): 
p. 143-6. 
22. Li, M., et al., Clinical evaluation of the Asian proximal femur intramedullary nail 
antirotation system (PFNA-II) for treatment of intertrochanteric fractures. J 
Orthop Surg Res, 2014. 9: p. 112. 
23. Sawaguchi, T., et al., Do design adaptations of a trochanteric nail make sense 
for Asian patients? Results of a multicenter study of the PFNA-II in Japan. 
Injury, 2014. 45(10): p. 1624-31. 
24. Lee, S.Y., et al., Complete traumatic backout of the blade of proximal femoral 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 53 of 74 
 
nail antirotation: a case report. Orthop Traumatol Surg Res, 2014. 100(4): p. 
441-3. 
25. Russell, T., Intertrochanteric fractures of the hip, in Rockwood and Green's 
Fractures in Adults, S. Court-Brown, et al., Editors. 2014, Wolters Klewer: 
Philadelphia. p. 2104-2107. 
26. Handoll, H.H. and M.J. Parker, Conservative versus operative treatment for hip 
fractures in adults. Cochrane Database Syst Rev, 2008(3): p. CD000337. 
27. Harris, W.H., Traumatic arthritis of the hip after dislocation and acetabular 
fractures: treatment by mold arthroplasty. An end-result study using a new 
method of result evaluation. J Bone Joint Surg Am, 1969. 51(4): p. 737-55. 
 
 
 
APPENDIX C:  DEVICE PART CODES AND SPECIFICATIONS – TFNA 
 
Table C.1. TFNA Implants 
1 
04.037.912S 
TFNA Femoral Nail Ø 9mm, 125°, L 170mm  
2 
04.037.913S 
TFNA Femoral NailØ 9mm, 125°, L 200mm  
3 
04.037.914S 
TFNA Femoral Nail Ø 9mm, right, 125°, L 235mm  
4 
04.037.915S 
TFNA Femoral Nail Ø 9mm, left, 125°, L 235mm  
5 
04.037.916S 
TFNA Femoral Nail Ø 9mm, right, 125°, L 260mm  
6 
04.037.917S 
TFNA Femoral Nail Ø 9mm, left, 125°, L 260mm  
7 
04.037.918S 
TFNA Femoral Nail Ø 9mm, right, 125°, L 280mm  
8 
04.037.919S 
TFNA Femoral Nail Ø 9mm, left, 125°, L 280mm  
9 
04.037.920S 
TFNA Femoral Nail Ø 9mm, right, 125°, L 300mm  
10 
04.037.921S 
TFNA Femoral Nail Ø 9mm, left, 125°, L 300mm  
11 
04.037.922S 
TFNA Femoral Nail Ø 9mm, right, 125°, L 320mm  
12 
04.037.923S 
TFNA Femoral Nail Ø 9mm, left, 125°, L 320mm  
13 
04.037.924S 
TFNA Femoral Nail Ø 9mm, right, 125°, L 340mm  
14 
04.037.925S 
TFNA Femoral Nail Ø 9mm, left, 125°, L 340mm  
15 
04.037.926S 
TFNA Femoral Nail Ø 9mm, right, 125°, L 360mm  
16 
04.037.927S 
TFNA Femoral Nail Ø 9mm, left, 125°, L 360mm  
17 
04.037.928S 
TFNA Femoral Nail Ø 9mm, right, 125°, L 380mm  
18 
04.037.929S 
TFNA Femoral Nail Ø 9mm, left, 125°, L 380mm  
19 
04.037.930S 
TFNA Femoral Nail Ø 9mm, right, 125°, L 400mm  
20 
04.037.931S 
TFNA Femoral Nail Ø 9mm, left, 125°, L 400mm  
21 
04.037.932S 
TFNA Femoral Nail Ø 9mm, right, 125°, L 420mm  
22 
04.037.933S 
TFNA Femoral Nail Ø 9mm, left, 125°, L 420mm  

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 54 of 74 
 
23 
04.037.934S 
TFNA Femoral Nail Ø 9mm, right, 125°, L 440mm  
24 
04.037.935S 
TFNA Femoral Nail Ø 9mm, left, 125°, L 440mm  
25 
04.037.936S 
TFNA Femoral Nail Ø 9mm, right, 125°, L 460mm  
26 
04.037.937S 
TFNA Femoral Nail Ø 9mm, left, 125°, L 460mm  
27 
04.037.938S 
TFNA Femoral Nail Ø 9mm, right, 125°, L 480mm  
28 
04.037.939S 
TFNA Femoral Nail Ø 9mm, left, 125°, L 480mm  
29 
04.037.942S 
TFNA Femoral Nail Ø 9mm, 130°, L 170mm  
30 
04.037.943S 
TFNA Femoral Nail Ø 9mm, 130°, L 200mm  
31 
04.037.944S 
TFNA Femoral Nail Ø 9mm, right, 130°, L 235mm  
32 
04.037.945S 
TFNA Femoral Nail Ø 9mm, left, 130°, L 235mm  
33 
04.037.946S 
TFNA Femoral Nail Ø 9mm, right, 130°, L 260mm  
34 
04.037.947S 
TFNA Femoral Nail Ø 9mm, left, 130°, L 260mm  
35 
04.037.948S 
TFNA Femoral Nail Ø 9mm, right, 130°, L 280mm  
36 
04.037.949S 
TFNA Femoral Nail Ø 9mm, left, 130°, L 280mm  
37 
04.037.950S 
TFNA Femoral Nail Ø 9mm, right, 130°, L 300mm  
38 
04.037.951S 
TFNA Femoral Nail Ø 9mm, left, 130°, L 300mm  
39 
04.037.952S 
TFNA Femoral Nail Ø 9mm, right, 130°, L 320mm  
40 
04.037.953S 
TFNA Femoral Nail Ø 9mm, left, 130°, L 320mm  
41 
04.037.954S 
TFNA Femoral Nail Ø 9mm, right, 130°, L 340mm  
42 
04.037.955S 
TFNA Femoral Nail Ø 9mm, left, 130°, L 340mm 
43 
04.037.956S 
TFNA Femoral Nail Ø 9mm, right, 130°, L 360mm  
44 
04.037.957S 
TFNA Femoral Nail Ø 9mm, left, 130°, L 360mm  
45 
04.037.958S 
TFNA Femoral Nail Ø 9mm, right, 130°, L 380mm  
46 
04.037.959S 
TFNA Femoral Nail Ø 9mm, left, 130°, L 380mm  
47 
04.037.960S 
TFNA Femoral Nail Ø 9mm, right, 130°, L 400mm  
48 
04.037.961S 
TFNA Femoral Nail Ø 9mm, left, 130°, L 400mm  
49 
04.037.962S 
TFNA Femoral Nail Ø 9mm, right, 130°, L 420mm  
50 
04.037.963S 
TFNA Femoral Nail Ø 9mm, left, 130°, L 420mm  
51 
04.037.964S 
TFNA Femoral Nail Ø 9mm, right, 130°, L 440mm  
52 
04.037.965S 
TFNA Femoral Nail Ø 9mm, left, 130°, L 440mm  
53 
04.037.966S 
TFNA Femoral Nail Ø 9mm, right, 130°, L 460mm  
54 
04.037.967S 
TFNA Femoral Nail Ø 9mm, left, 130°, L 460mm  
55 
04.037.968S 
TFNA Femoral Nail Ø 9mm, right, 130°, L 480mm  
56 
04.037.969S 
TFNA Femoral Nail Ø 9mm, left, 130°, L 480mm  
57 
04.037.972S 
TFNA Femoral Nail Ø 9mm, 135°, L 170mm  
58 
04.037.973S 
TFNA Femoral Nail Ø 9mm, 135°, L 200mm  
59 
04.037.974S 
TFNA Femoral Nail Ø 9mm, right, 135°, L 235mm  
60 
04.037.975S 
TFNA Femoral Nail Ø 9mm, left, 135°, L 235mm  
61 
04.037.012S 
TFNA Femoral Nail Ø 10mm, 125°, L 170mm  

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 55 of 74 
 
62 
04.037.013S 
TFNA Femoral Nail Ø 10mm, 125°, L 200mm  
63 
04.037.014S 
TFNA Femoral Nail Ø 10mm, right, 125°, L 235mm  
64 
04.037.015S 
TFNA Femoral Nail Ø 10mm, left, 125°, L 235mm  
65 
04.037.016S 
TFNA Femoral Nail Ø 10mm, right, 125°, L 260mm  
66 
04.037.017S 
TFNA Femoral Nail Ø 10mm, left, 125°, L 260mm  
67 
04.037.018S 
TFNA Femoral Nail Ø 10mm, right, 125°, L 280mm  
68 
04.037.019S 
TFNA Femoral Nail Ø 10mm, left, 125°, L 280mm  
69 
04.037.020S 
TFNA Femoral Nail Ø 10mm, right, 125°, L 300mm  
70 
04.037.021S 
TFNA Femoral Nail Ø 10mm, left, 125°, L 300mm  
71 
04.037.022S 
TFNA Femoral Nail Ø 10mm, right, 125°,  L 320mm 
72 
04.037.023S 
TFNA Femoral Nail Ø 10mm, left, 125°, L 320mm  
73 
04.037.024S 
TFNA Femoral Nail Ø 10mm, right, 125°, L 340mm  
74 
04.037.025S 
TFNA Femoral Nail Ø 10mm, left, 125°, L 340mm  
75 
04.037.026S 
TFNA Femoral Nail Ø 10mm, right, 125°, L 360mm 
76 
04.037.027S 
TFNA Femoral Nail Ø 10mm, left, 125°, L 360mm  
77 
04.037.028S 
TFNA Femoral Nail Ø 10mm, right, 125°, L 380mm  
78 
04.037.029S 
TFNA Femoral Nail Ø 10mm, left, 125°, L 380mm  
79 
04.037.030S 
TFNA Femoral Nail Ø 10mm, right, 125°, L 400mm  
80 
04.037.031S 
TFNA Femoral Nail Ø 10mm, left, 125°, L 400mm  
81 
04.037.032S 
TFNA Femoral Nail Ø 10mm, right, 125°, L 420mm  
82 
04.037.033S 
TFNA Femoral Nail Ø 10mm, left, 125°, L 420mm  
83 
04.037.034S 
TFNA Femoral Nail Ø 10mm, right, 125°, L 440mm  
84 
04.037.035S 
TFNA Femoral Nail Ø 10mm, left, 125°, L 440mm  
85 
04.037.036S 
TFNA Femoral Nail Ø 10mm, right, 125°, L 460mm  
86 
04.037.037S 
TFNA Femoral Nail Ø 10mm, left, 125°, L 460mm  
87 
04.037.038S 
TFNA Femoral Nail Ø 10mm, right, 125°, L 480mm  
88 
04.037.039S 
TFNA Femoral Nail Ø 10mm, left, 125°, L 480mm  
89 
04.037.042S 
TFNA Femoral Nail Ø 10mm, 130°, L 170mm  
90 
04.037.043S 
TFNA Femoral Nail Ø 10mm, 130°, L 200mm  
91 
04.037.044S 
TFNA Femoral Nail Ø 10mm, right, 130°, L 235mm  
92 
04.037.045S 
TFNA Femoral Nail Ø 10mm, left, 130°, L 235mm  
93 
04.037.046S 
TFNA Femoral Nail Ø 10mm, right, 130°, L 260mm  
94 
04.037.047S 
TFNA Femoral Nail Ø 10mm, left, 130°, L 260mm  
95 
04.037.048S 
TFNA Femoral Nail Ø 10mm, right, 130°, L 280mm  
96 
04.037.049S 
TFNA Femoral Nail Ø 10mm, left, 130°, L 280mm  
97 
04.037.050S 
TFNA Femoral Nail Ø 10mm, right, 130°, L 300mm  
98 
04.037.051S 
TFNA Femoral Nail Ø 10mm, left, 130°, L 300mm  
99 
04.037.052S 
TFNA Femoral Nail Ø 10mm, right, 130°, L 320mm  
100 
04.037.053S 
TFNA Femoral Nail Ø 10mm, left, 130°, L 320mm  

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 56 of 74 
 
101 
04.037.054S 
TFNA Femoral Nail Ø 10mm, right, 130°, L 340mm  
102 
04.037.055S 
TFNA Femoral Nail Ø 10mm, left, 130°, L 340mm  
103 
04.037.056S 
TFNA Femoral Nail Ø 10mm, right, 130°, L 360mm  
104 
04.037.057S 
TFNA Femoral Nail Ø 10mm, left, 130°, L 360mm  
105 
04.037.058S 
TFNA Femoral Nail Ø 10mm, right, 130°, L 380mm  
106 
04.037.059S 
TFNA Femoral Nail Ø 10mm, left, 130°, L 380mm  
107 
04.037.060S 
TFNA Femoral Nail Ø 10mm, right, 130°, L 400mm  
108 
04.037.061S 
TFNA Femoral Nail Ø 10mm, left, 130°, L 400mm  
109 
04.037.062S 
TFNA Femoral Nail Ø 10mm, right, 130°, L 420mm  
110 
04.037.063S 
TFNA Femoral Nail Ø 10mm, left, 130°, L 420mm  
111 
04.037.064S 
TFNA Femoral Nail Ø 10mm, right, 130°, L 440mm  
112 
04.037.065S 
TFNA Femoral Nail Ø 10mm, left, 130°, L 440mm  
113 
04.037.066S 
TFNA Femoral Nail Ø 10mm, right, 130°, L 460mm  
114 
04.037.067S 
TFNA Femoral Nail Ø 10mm, left, 130°, L 460mm  
115 
04.037.068S 
TFNA Femoral Nail Ø 10mm, right, 130°, L 480mm  
116 
04.037.069S 
TFNA Femoral Nail Ø 10mm, left, 130°, L 480mm  
117 
04.037.072S 
TFNA Femoral Nail Ø 10mm, 135°, L 170mm  
118 
04.037.073S 
TFNA Femoral Nail Ø 10mm, 135°, L 200mm  
119 
04.037.074S 
TFNA Femoral Nail Ø 10mm, right, 135°, L 235mm  
120 
04.037.075S 
TFNA Femoral Nail Ø 10mm, left, 135°, L 235mm  
121 
04.037.112S 
TFNA Femoral Nail Ø 11mm, 125°, L 170mm  
122 
04.037.113S 
TFNA Femoral Nail Ø 11mm, 125°, L 200mm  
123 
04.037.114S 
TFNA Femoral Nail Ø 11mm, right, 125°, L 235mm  
124 
04.037.115S 
TFNA Femoral Nail Ø 11mm, left, 125°, L 235mm  
125 
04.037.120S 
TFNA Femoral Nail Ø 11mm, right, 125°, L 300mm  
126 
04.037.121S 
TFNA Femoral Nail Ø 11mm, left, 125°, L 300mm  
127 
04.037.122S 
TFNA Femoral Nail Ø 11mm, right, 125°, L 320mm  
128 
04.037.123S 
TFNA Femoral Nail Ø 11mm, left, 125°, L 320mm  
129 
04.037.124S 
TFNA Femoral Nail Ø 11mm, right, 125°, L 340mm  
130 
04.037.125S 
TFNA Femoral Nail Ø 11mm, left, 125°, L 340mm  
131 
04.037.126S 
TFNA Femoral Nail Ø 11mm, right, 125°, L 360mm  
132 
04.037.127S 
TFNA Femoral Nail Ø 11mm, left, 125°, L 360mm  
133 
04.037.128S 
TFNA Femoral Nail Ø 11mm, right, 125°, L 380mm  
134 
04.037.129S 
TFNA Femoral Nail Ø 11mm, left, 125°, L 380mm  
135 
04.037.130S 
TFNA Femoral Nail Ø 11mm, right, 125°, L 400mm  
136 
04.037.131S 
TFNA Femoral Nail Ø 11mm, left, 125°, L 400mm  
137 
04.037.132S 
TFNA Femoral Nail Ø 11mm, right, 125°, L 420mm  
138 
04.037.133S 
TFNA Femoral Nail Ø 11mm, left, 125°, L 420mm  
139 
04.037.134S 
TFNA Femoral Nail Ø 11mm, right, 125°, L 440mm  

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 57 of 74 
 
140 
04.037.135S 
TFNA Femoral Nail Ø 11mm, left, 125°, L 440mm  
141 
04.037.136S 
TFNA Femoral Nail Ø 11mm, right, 125°, L 460mm  
142 
04.037.137S 
TFNA Femoral Nail Ø 11mm, left, 125°, L 460mm  
143 
04.037.138S 
TFNA Femoral Nail Ø 11mm, right, 125°, L 480mm  
144 
04.037.139S 
TFNA Femoral Nail Ø 11mm, left, 125°, L 480mm  
145 
04.037.142S 
TFNA Femoral Nail Ø 11mm, 130°, L 170mm  
146 
04.037.143S 
TFNA Femoral Nail Ø 11mm, 130°, L 200mm  
147 
04.037.144S 
TFNA Femoral Nail Ø 11mm, right, 130°, L 235mm  
148 
04.037.145S 
TFNA Femoral Nail Ø 11mm, left, 130°, L 235mm  
149 
04.037.150S 
TFNA Femoral Nail Ø 11mm, right, 130°, L 300mm  
150 
04.037.151S 
TFNA Femoral Nail Ø 11mm, left, 130°, L 300mm  
151 
04.037.152S 
TFNA Femoral Nail Ø 11mm, right, 130°, L 320mm  
152 
04.037.153S 
TFNA Femoral Nail Ø 11mm, left, 130°, L 320mm  
153 
04.037.154S 
TFNA Femoral Nail Ø 11mm, right, 130°, L 340mm  
154 
04.037.155S 
TFNA Femoral Nail Ø 11mm, left, 130°, L 340mm  
155 
04.037.156S 
TFNA Femoral Nail Ø 11mm, right, 130°, L 360mm  
156 
04.037.157S 
TFNA Femoral Nail Ø 11mm, left, 130°, L 360mm  
157 
04.037.158S 
TFNA Femoral Nail Ø 11mm, right, 130°, L 380mm  
158 
04.037.159S 
TFNA Femoral Nail Ø 11mm, left, 130°, L 380mm  
159 
04.037.160S 
TFNA Femoral Nail Ø 11mm, right, 130°, L 400mm  
160 
04.037.161S 
TFNA Femoral Nail Ø 11mm, left, 130°, L 400mm  
161 
04.037.162S 
TFNA Femoral Nail Ø 11mm, right, 130°, L 420mm  
162 
04.037.163S 
TFNA Femoral Nail Ø 11mm, left, 130°, L 420mm  
163 
04.037.164S 
TFNA Femoral Nail Ø 11mm, right, 130°, L 440mm  
164 
04.037.165S 
TFNA Femoral Nail Ø 11mm, left, 130°, L 440mm  
165 
04.037.166S 
TFNA Femoral Nail Ø 11mm, right, 130°, L 460mm  
166 
04.037.167S 
TFNA Femoral Nail Ø 11mm, left, 130°, L 460mm  
167 
04.037.168S 
TFNA Femoral Nail Ø 11mm, right, 130°, L 480mm  
168 
04.037.169S 
TFNA Femoral Nail Ø 11mm, left, 130°, L 480mm  
169 
04.037.172S 
TFNA Femoral Nail Ø 11mm, 135°, L 170mm  
170 
04.037.173S 
TFNA Femoral Nail Ø 11mm, 135°, L 200mm  
171 
04.037.174S 
TFNA Femoral Nail Ø 11mm, right, 135°, L 235mm  
172 
04.037.175S 
TFNA Femoral Nail Ø 11mm, left, 135°, L 235mm  
173 
04.037.180S 
TFNA Femoral Nail Ø 11mm, right, 135°, L 300mm  
174 
04.037.181S 
TFNA Femoral Nail Ø 11mm, left, 135°, L 300mm  
175 
04.037.182S 
TFNA Femoral Nail Ø 11mm, right, 135°, L 320mm  
176 
04.037.183S 
TFNA Femoral Nail Ø 11mm, left, 135°, L 320mm  
177 
04.037.184S 
TFNA Femoral Nail Ø 11mm, right, 135°, L 340mm  
178 
04.037.185S 
TFNA Femoral Nail Ø 11mm, left, 135°, L 340mm  

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 58 of 74 
 
179 
04.037.186S 
TFNA Femoral Nail Ø 11mm, right, 135°, L 360mm  
180 
04.037.187S 
TFNA Femoral Nail Ø 11mm, left, 135°, L 360mm  
181 
04.037.188S 
TFNA Femoral Nail Ø 11mm, right, 135°, L 380mm  
182 
04.037.189S 
TFNA Femoral Nail Ø 11mm, left, 135°, L 380mm  
183 
04.037.190S 
TFNA Femoral Nail Ø 11mm, right, 135°, L 400mm  
184 
04.037.191S 
TFNA Femoral Nail Ø 11mm, left, 135°, L 400mm  
185 
04.037.192S 
TFNA Femoral Nail Ø 11mm, right, 135°, L 420mm  
186 
04.037.193S 
TFNA Femoral Nail Ø 11mm, left, 135°, L 420mm  
187 
04.037.194S 
TFNA Femoral Nail Ø 11mm, right, 135°, L 440mm  
188 
04.037.195S 
TFNA Femoral Nail Ø 11mm, left, 135°, L 440mm  
189 
04.037.196S 
TFNA Femoral Nail Ø 11mm, right, 135°, L 460mm  
190 
04.037.197S 
TFNA Femoral Nail Ø 11mm, left, 135°, L 460mm  
191 
04.037.198S 
TFNA Femoral Nail Ø 11mm, right, 135°, L 480mm  
192 
04.037.199S 
TFNA Femoral Nail Ø 11mm, left, 135°, L 480mm  
193 
04.037.212S 
TFNA Femoral Nail Ø 12mm, 125°, L 170mm  
194 
04.037.213S 
TFNA Femoral Nail Ø 12mm, 125°, L 200mm  
195 
04.037.214S 
TFNA Femoral Nail Ø 12mm, right, 125°, L 235mm  
196 
04.037.215S 
TFNA Femoral Nail Ø 12mm, left, 125°, L 235mm  
197 
04.037.220S 
TFNA Femoral Nail Ø 12mm, right, 125°, L 300mm  
198 
04.037.221S 
TFNA Femoral Nail Ø 12mm, left, 125°, L 300mm  
199 
04.037.222S 
TFNA Femoral Nail Ø 12mm, right, 125°, L 320mm  
200 
04.037.223S 
TFNA Femoral Nail Ø 12mm, left, 125°, L 320mm  
201 
04.037.224S 
TFNA Femoral Nail Ø 12mm, right, 125°, L 340mm  
202 
04.037.225S 
TFNA Femoral Nail Ø 12mm, left, 125°, L 340mm  
203 
04.037.226S 
TFNA Femoral Nail Ø 12mm, right, 125°, L 360mm  
204 
04.037.227S 
TFNA Femoral Nail Ø 12mm, left, 125°, L 360mm  
205 
04.037.228S 
TFNA Femoral Nail Ø 12mm, right, 125°, L 380mm  
206 
04.037.229S 
TFNA Femoral Nail Ø 12mm, left, 125°, L 380mm  
207 
04.037.230S 
TFNA Femoral Nail Ø 12mm, right, 125°, L 400mm  
208 
04.037.231S 
TFNA Femoral Nail Ø 12mm, left, 125°, L 400mm  
209 
04.037.232S 
TFNA Femoral Nail Ø 12mm, right, 125°, L 420mm  
210 
04.037.233S 
TFNA Femoral Nail Ø 12mm, left, 125°, L 420mm  
211 
04.037.234S 
TFNA Femoral Nail Ø 12mm, right, 125°, L 440mm  
212 
04.037.235S 
TFNA Femoral Nail Ø 12mm, left, 125°, L 440mm  
213 
04.037.236S 
TFNA Femoral Nail Ø 12mm, right, 125°, L 460mm  
214 
04.037.237S 
TFNA Femoral Nail Ø 12mm, left, 125°, L 460mm  
215 
04.037.238S 
TFNA Femoral Nail Ø 12mm, right, 125°, L 480mm  
216 
04.037.239S 
TFNA Femoral Nail Ø 12mm, left, 125°, L 480mm  
217 
04.037.242S 
TFNA Femoral Nail Ø 12mm, 130°, L 170mm  

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 59 of 74 
 
218 
04.037.243S 
TFNA Femoral Nail Ø 12mm, 130°, L 200mm  
219 
04.037.244S 
TFNA Femoral Nail Ø 12mm, right, 130°, L 235mm  
220 
04.037.245S 
TFNA Femoral Nail Ø 12mm, left, 130°, L 235mm  
221 
04.037.250S 
TFNA Femoral Nail Ø 12mm, right, 130°, L 300mm  
222 
04.037.251S 
TFNA Femoral Nail Ø 12mm, left, 130°, L 300mm  
223 
04.037.252S 
TFNA Femoral Nail Ø 12mm, right, 130°, L 320mm  
224 
04.037.253S 
TFNA Femoral Nail Ø 12mm, left, 130°, L 320mm  
225 
04.037.254S 
TFNA Femoral Nail Ø 12mm, right, 130°, L 340mm  
226 
04.037.255S 
TFNA Femoral Nail Ø 12mm, left, 130°, L 340mm  
227 
04.037.256S 
TFNA Femoral Nail Ø 12mm, right, 130°, L 360mm  
228 
04.037.257S 
TFNA Femoral Nail Ø 12mm, left, 130°, L 360mm  
229 
04.037.258S 
TFNA Femoral Nail Ø 12mm, right, 130°, L 380mm  
230 
04.037.259S 
TFNA Femoral Nail Ø 12mm, left, 130°, L 380mm  
231 
04.037.260S 
TFNA Femoral Nail Ø 12mm, right, 130°, L 400mm  
232 
04.037.261S 
TFNA Femoral Nail Ø 12mm, left, 130°, L 400mm  
233 
04.037.262S 
TFNA Femoral Nail Ø 12mm, right, 130°, L 420mm  
234 
04.037.263S 
TFNA Femoral Nail Ø 12mm, left, 130°, L 420mm  
235 
04.037.264S 
TFNA Femoral Nail Ø 12mm, right, 130°, L 440mm  
236 
04.037.265S 
TFNA Femoral Nail Ø 12mm, left, 130°, L 440mm  
237 
04.037.266S 
TFNA Femoral Nail Ø 12mm, right, 130°, L 460mm  
238 
04.037.267S 
TFNA Femoral Nail Ø 12mm, left, 130°, L 460mm  
239 
04.037.268S 
TFNA Femoral Nail Ø 12mm, right, 130°, L 480mm  
240 
04.037.269S 
TFNA Femoral Nail Ø 12mm, left, 130°, L 480mm  
241 
04.037.272S 
TFNA Femoral Nail Ø 12mm, 135°, L 170mm  
242 
04.037.273S 
TFNA Femoral Nail Ø 12mm, 135°, L 200mm  
243 
04.037.274S 
TFNA Femoral Nail Ø 12mm, right, 135°, L 235mm  
244 
04.037.275S 
TFNA Femoral Nail Ø 12mm, left, 135°, L 235mm  
245 
04.037.450S 
TFNA Femoral Nail Ø 14mm, right, 130°, L 300mm 
246 
04.037.451S 
TFNA Femoral Nail Ø 14mm, left, 130°, L 300mm  
247 
04.037.452S 
TFNA Femoral Nail Ø 14mm, right, 130°, L 320mm  
248 
04.037.453S 
TFNA Femoral Nail Ø 14mm, left, 130°, L 320mm  
249 
04.037.454S 
TFNA Femoral Nail Ø 14mm, right, 130°, L 340mm 
250 
04.037.455S 
TFNA Femoral Nail Ø 14mm, left, 130°, L 340mm  
251 
04.037.456S 
TFNA Femoral Nail Ø 14mm, right, 130°, L 360mm  
252 
04.037.457S 
TFNA Femoral Nail Ø 14mm, left, 130°, L 360mm  
253 
04.037.458S 
TFNA Femoral Nail Ø 14mm, right, 130°, L 380mm 
254 
04.037.459S 
TFNA Femoral Nail Ø 14mm, left, 130°, L 380mm  
255 
04.037.460S 
TFNA Femoral Nail Ø 14mm, right, 130°, L 400mm  
256 
04.037.461S 
TFNA Femoral Nail Ø 14mm, left, 130°, L 400mm  

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 60 of 74 
 
257 
04.037.462S 
TFNA Femoral Nail Ø 14mm, right, 130°, L 420mm 
258 
04.037.463S 
TFNA Femoral Nail Ø 14mm, left, 130°, L 420mm  
259 
04.037.464S 
TFNA Femoral Nail Ø 14mm, right, 130°, L 440mm  
260 
04.037.465S 
TFNA Femoral Nail Ø 14mm, left, 130°, L 440mm  
261 
04.037.466S 
TFNA Femoral Nail Ø 14mm, right, 130°, L 460mm 
262 
04.037.467S 
TFNA Femoral Nail Ø 14mm, left, 130°, L 460mm  
263 
04.037.468S 
TFNA Femoral Nail Ø 14mm, right, 130°, L 480mm  
264 
04.037.469S 
TFNA Femoral Nail Ø 14mm, left, 130°, L 480mm  
265 
04.038.170S 
TFNA Screw, perforated, L 70mm 
266 
04.038.175S 
TFNA Screw, perforated, L 75mm 
267 
04.038.180S 
TFNA Screw, perforated, L 80mm 
268 
04.038.185S 
TFNA Screw, perforated, L 85mm 
269 
04.038.190S 
TFNA Screw, perforated, L 90mm 
270 
04.038.195S 
TFNA Screw, perforated, L 95mm 
271 
04.038.200S 
TFNA Screw, perforated, L 100mm 
272 
04.038.205S 
TFNA Screw, perforated, L 105mm 
273 
04.038.210S 
TFNA Screw, perforated, L 110mm 
274 
04.038.215S 
TFNA Screw, perforated, L 115mm 
275 
04.038.220S 
TFNA Screw, perforated, L 120mm 
276 
04.038.225S 
TFNA Screw, perforated, L 125mm 
277 
04.038.230S 
TFNA Screw, perforated, L 130mm 
278 
04.038.370S 
TFNA Helical Blade, perforated, L 70mm 
279 
04.038.375S 
TFNA Helical Blade, perforated, L 75mm 
280 
04.038.380S 
TFNA Helical Blade, perforated, L 80mm 
281 
04.038.385S 
TFNA Helical Blade, perforated, L 85mm 
282 
04.038.390S 
TFNA Helical Blade, perforated, L 90mm 
283 
04.038.395S 
TFNA Helical Blade, perforated, L 95mm 
284 
04.038.400S 
TFNA Helical Blade, perforated, L 100mm 
285 
04.038.405S 
TFNA Helical Blade, perforated, L 105mm 
286 
04.038.410S 
TFNA Helical Blade, perforated, L 110mm 
287 
04.038.415S 
TFNA Helical Blade, perforated, L 115mm 
288 
04.038.420S 
TFNA Helical Blade, perforated, L 120mm 
289 
04.038.425S 
TFNA Helical Blade, perforated, L 125mm 
290 
04.038.430S 
TFNA Helical Blade, perforated, L 130mm 
291 
04.038.000S 
TFNA End Cap, extension 0mm 
292 
04.038.005S 
TFNA End Cap, extension 5mm 
293 
04.038.010S 
TFNA End Cap, extension 10mm 
294 
04.038.015S 
TFNA End Cap, extension 15mm 
295 
459.260 
Locking Bolt Ø 4.9mm, self-tapp., L 26mm 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 61 of 74 
 
296 
459.280 
Locking Bolt Ø 4.9mm, self-tapp., L 28mm 
297 
459.300 
Locking Bolt Ø 4.9mm, self-tapp., L 30mm 
298 
459.320 
Locking Bolt Ø 4.9mm, self-tapp., L 32mm 
299 
459.340 
Locking Bolt Ø 4.9mm, self-tapp., L 34mm 
300 
459.360 
Locking Bolt Ø 4.9mm, self-tapp., L 36mm 
301 
459.380 
Locking Bolt Ø 4.9mm, self-tapp., L 38mm 
302 
459.400 
Locking Bolt Ø 4.9mm, self-tapp., L 40mm 
303 
459.420 
Locking Bolt Ø 4.9mm, self-tapp., L 42mm 
304 
459.440 
Locking Bolt Ø 4.9mm, self-tapp., L 44mm 
305 
459.460 
Locking Bolt Ø 4.9mm, self-tapp., L 46mm 
306 
459.480 
Locking Bolt Ø 4.9mm, self-tapp., L 48mm 
307 
459.500 
Locking Bolt Ø 4.9mm, self-tapp., L 50mm 
308 
459.520 
Locking Bolt Ø 4.9mm, self-tapp., L 52mm 
309 
459.540 
Locking Bolt Ø 4.9mm, self-tapp., L 54mm 
310 
459.560 
Locking Bolt Ø 4.9mm, self-tapp., L 56mm 
311 
459.580 
Locking Bolt Ø 4.9mm, self-tapp., L 58mm 
312 
459.600 
Locking Bolt Ø 4.9mm, self-tapp., L 60mm 
313 
459.640 
Locking Bolt Ø 4.9mm, self-tapp., L 64mm 
314 
459.680 
Locking Bolt Ø 4.9mm, self-tapp., L 68mm 
315 
459.720 
Locking Bolt Ø 4.9mm, self-tapp., L 72mm 
316 
459.760 
Locking Bolt Ø 4.9mm, self-tapp., L 76mm 
317 
459.800 
Locking Bolt Ø 4.9mm, self-tapp., L 80mm 
318 
459.850 
Locking Bolt Ø 4.9mm, self-tapp., L 85mm 
319 
459.900 
Locking Bolt Ø 4.9mm, self-tapp., L 90mm 
320 
459.950 
Locking Bolt Ø 4.9mm, self-tapp., L 95mm 
321 
459.960 
Locking Bolt Ø 4.9mm, self-tapp., L 100mm 
322 
04.005.516S 
Locking Screw Ø 5.0mm, L 26mm, f/Medullary Nails 
323 
04.005.518S 
Locking Screw Ø 5.0mm, L 28mm, f/Medullary Nails 
324 
04.005.520S 
Locking Screw Ø 5.0mm, L 30mm, f/Medullary Nails 
325 
04.005.522S 
Locking Screw Ø 5.0mm, L 32mm, f/Medullary Nails 
326 
04.005.524S 
Locking Screw Ø 5.0mm, L 34mm, f/Medullary Nails 
327 
04.005.526S 
Locking Screw Ø 5.0mm, L 36mm, f/Medullary Nails 
328 
04.005.528S 
Locking Screw Ø 5.0mm, L 38mm, f/Medullary Nails 
329 
04.005.530S 
Locking Screw Ø 5.0mm, L 40mm, f/Medullary Nails 
330 
04.005.532S 
Locking Screw Ø 5.0mm, L 42mm, f/Medullary Nails 
331 
04.005.534S 
Locking Screw Ø 5.0mm, L 44mm, f/Medullary Nails 
332 
04.005.536S 
Locking Screw Ø 5.0mm, L 46mm, f/Medullary Nails 
333 
04.005.538S 
Locking Screw Ø 5.0mm, L 48mm, f/Medullary Nails 
334 
04.005.540S 
Locking Screw Ø 5.0mm, L 50mm, f/Medullary Nails 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 62 of 74 
 
335 
04.005.542S 
Locking Screw Ø 5.0mm, L 52mm, f/Medullary Nails 
336 
04.005.544S 
Locking Screw Ø 5.0mm, L 54mm, f/Medullary Nails 
337 
04.005.546S 
Locking Screw Ø 5.0mm, L 56mm, f/Medullary Nails 
338 
04.005.548S 
Locking Screw Ø 5.0mm, L 58mm, f/Medullary Nails 
339 
04.005.550S 
Locking Screw Ø 5.0mm, L 60mm, f/Medullary Nails 
340 
04.005.552S 
Locking Screw Ø 5.0mm, L 62mm, f/Medullary Nails 
341 
04.005.554S 
Locking Screw Ø 5.0mm, L 64mm, f/Medullary Nails 
342 
04.005.558S 
Locking Screw Ø 5.0mm, L 68mm, f/Medullary Nails 
343 
04.005.560S 
Locking Screw Ø 5.0mm, L 70mm, f/Medullary Nails 
344 
04.005.562S 
Locking Screw Ø 5.0mm, L 72mm, f/Medullary Nails 
345 
04.005.564S 
Locking Screw Ø 5.0mm, L 74mm, f/Medullary Nails 
346 
04.005.566S 
Locking Screw Ø 5.0mm, L 76mm, f/Medullary Nails 
347 
04.005.568S 
Locking Screw Ø 5.0mm, L 78mm, f/Medullary Nails 
348 
04.005.570S 
Locking Screw Ø 5.0mm, L 80mm, f/Medullary Nails 
349 
04.005.575S 
Locking Screw Ø 5.0mm, L 85mm, f/Medullary Nails 
350 
04.005.580S 
Locking Screw Ø 5.0mm, L 90mm, f/Medullary Nails 
351 
04.005.585S 
Locking Screw Ø 5.0mm, L 95mm, f/Medullary Nails 
352 
04.005.590S 
Locking Screw Ø 5.0mm, L 100mm, f/Medullary Nails 
353 
04.005.516 
Locking Screw Stardrive® Ø 5.0mm, L 26mm 
354 
04.005.518 
Locking Screw Stardrive® Ø 5.0mm, L 28mm 
355 
04.005.520 
Locking Screw Stardrive® Ø 5.0mm, L 30mm 
356 
04.005.522 
Locking Screw Stardrive® Ø 5.0mm, L 32mm 
357 
04.005.524 
Locking Screw Stardrive® Ø 5.0mm, L 34mm 
358 
04.005.526 
Locking Screw Stardrive® Ø 5.0mm, L 36mm 
359 
04.005.528 
Locking Screw Stardrive® Ø 5.0mm, L 38mm 
360 
04.005.530 
Locking Screw Stardrive® Ø 5.0mm, L 40mm 
361 
04.005.532 
Locking Screw Stardrive® Ø 5.0mm, L 42mm 
362 
04.005.534 
Locking Screw Stardrive® Ø 5.0mm, L 44mm 
363 
04.005.536 
Locking Screw Stardrive® Ø 5.0mm, L 46mm 
364 
04.005.538 
Locking Screw Stardrive® Ø 5.0mm, L 48mm 
365 
04.005.540 
Locking Screw Stardrive® Ø 5.0mm, L 50mm 
366 
04.005.542 
Locking Screw Stardrive® Ø 5.0mm, L 52mm 
367 
04.005.544 
Locking Screw Stardrive® Ø 5.0mm, L 54mm 
368 
04.005.546 
Locking Screw Stardrive® Ø 5.0mm, L 56mm 
369 
04.005.548 
Locking Screw Stardrive® Ø 5.0mm, L 58mm 
370 
04.005.550 
Locking Screw Stardrive® Ø 5.0mm, L 60mm 
371 
04.005.552 
Locking Screw Stardrive® Ø 5.0mm, L 62mm 
372 
04.005.554 
Locking Screw Stardrive® Ø 5.0mm, L 64mm 
373 
04.005.556 
Locking Screw Stardrive® Ø 5.0mm, L 66mm 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 63 of 74 
 
374 
04.005.558 
Locking Screw Stardrive® Ø 5.0mm, L 68mm 
375 
04.005.560 
Locking Screw Stardrive® Ø 5.0mm, L 70mm 
376 
04.005.562 
Locking Screw Stardrive® Ø 5.0mm, L 72mm 
377 
04.005.564 
Locking Screw Stardrive® Ø 5.0mm, L 74mm 
378 
04.005.566 
Locking Screw Stardrive® Ø 5.0mm, L 76mm 
379 
04.005.568 
Locking Screw Stardrive® Ø 5.0mm, L 78mm 
380 
04.005.570 
Locking Screw Stardrive® Ø 5.0mm, L 80mm 
381 
04.005.575 
Locking Screw Stardrive® Ø 5.0mm, L 85mm 
382 
04.005.580 
Locking Screw Stardrive® Ø 5.0mm, L 90mm 
383 
04.005.585 
Locking Screw Stardrive® Ø 5.0mm, L 95mm 
384 
04.005.590 
Locking Screw Stardrive® Ø 5.0mm, L 100mm 
385 
459.260S 
Locking Bolt Ø 4.9mm, self-tapp., L 26mm 
386 
459.280S 
Locking Bolt Ø 4.9mm, self-tapp., L 28mm 
387 
459.300S 
Locking Bolt Ø 4.9mm, self-tapp., L 30mm 
388 
459.320S 
Locking Bolt Ø 4.9mm, self-tapp., L 32mm 
389 
459.340S 
Locking Bolt Ø 4.9mm, self-tapp., L 34mm 
390 
459.360S 
Locking Bolt Ø 4.9mm, self-tapp., L 36mm 
391 
459.380S 
Locking Bolt Ø 4.9mm, self-tapp., L 38mm 
392 
459.400S 
Locking Bolt Ø 4.9mm, self-tapp., L 40mm 
393 
459.420S 
Locking Bolt Ø 4.9mm, self-tapp., L 42mm 
394 
459.440S 
Locking Bolt Ø 4.9mm, self-tapp., L 44mm 
395 
459.460S 
Locking Bolt Ø 4.9mm, self-tapp., L 46mm 
396 
459.480S 
Locking Bolt Ø 4.9mm, self-tapp., L 48mm 
397 
459.500S 
Locking Bolt Ø 4.9mm, self-tapp., L 50mm 
398 
459.520S 
Locking Bolt Ø 4.9mm, self-tapp., L 52mm 
399 
459.540S 
Locking Bolt Ø 4.9mm, self-tapp., L 54mm 
400 
459.560S 
Locking Bolt Ø 4.9mm, self-tapp., L 56mm 
401 
459.580S 
Locking Bolt Ø 4.9mm, self-tapp., L 58mm 
402 
459.600S 
Locking Bolt Ø 4.9mm, self-tapp., L 60mm 
403 
459.640S 
Locking Bolt Ø 4.9mm, self-tapp., L 64mm 
404 
459.680S 
Locking Bolt Ø 4.9mm, self-tapp., L 68mm 
405 
459.720S 
Locking Bolt Ø 4.9mm, self-tapp., L 72mm 
406 
459.760S 
Locking Bolt Ø 4.9mm, self-tapp., L 76mm 
407 
459.800S 
Locking Bolt Ø 4.9mm, self-tapp., L 80mm 
408 
459.850S 
Locking Bolt Ø 4.9mm, self-tapp., L 85mm 
409 
459.900S 
Locking Bolt Ø 4.9mm, self-tapp., L 90mm 
410 
459.950S 
Locking Bolt Ø 4.9mm, self-tapp., L 95mm 
411 
459.960S 
Locking Bolt Ø 4.9mm, self-tapp., L 100mm 
 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 64 of 74 
 
 
 
 
APPENDIX D: DEVICE PART CODES AND SPECIFICATIONS – PFNA-II 
  
Table D.1 Implants 
Part 
number 
Description 
473.800S 
PFNA-II Ø 9.0mm, 125°, L 240mm  
473.801S 
PFNA-II Ø 10.0mm, 125°, L 240mm  
473.802S 
PFNA-II Ø 11.0mm, 125°, L 240mm  
473.803S 
PFNA-II Ø 12.0mm, 125°, L 240mm  
473.804S 
PFNA-II Ø 9.0mm, 130°, L 240mm  
473.805S 
PFNA-II Ø 10.0mm, 130°, L 240mm  
473.806S 
PFNA-II Ø 11.0mm, 130°, L 240mm  
473.807S 
PFNA-II Ø 12.0mm, 130°, L 240mm  
472.110S 
PFNA-II Ø 9.0mm, small, 125°, L 200mm  
472.111S 
PFNA-II Ø 10.0mm, small, 125°, L 200mm  
472.112S 
PFNA-II Ø 11.0mm, small, 125°, L 200mm  
472.113S 
PFNA-II Ø 12.0mm, small, 125°, L 200mm  
472.114S 
PFNA-II Ø 9.0mm, small, 130°, L 200mm  
472.115S 
PFNA-II Ø 10.0mm, small, 130°, L 200mm  
472.116S 
PFNA-II Ø 11.0mm, small, 130°, L 200mm  
472.117S 
PFNA-II Ø 12.0mm, small, 130°, L 200mm  
472.100S 
PFNA-II Ø 9.0mm, extra-small, 125°, L 170mm  
472.101S 
PFNA-II Ø 10.0mm, extra-small, 125°, L 170mm  
472.102S 
PFNA-II Ø 11.0mm, extra-small, 125°, L 170mm  
472.103S 
PFNA-II Ø 12.0mm, extra-small, 125°, L 170mm  
472.104S 
PFNA-II Ø 9.0mm, extra-small, 130°, L  170mm 
472.105S 
PFNA-II Ø 10.0mm, extra-small, 130°, L 170mm  
472.106S 
PFNA-II Ø 11.0mm, extra-small, 130°, L 170mm  
472.107S 
PFNA-II Ø 12.0mm, extra-small, 130°, L 170mm  
473.023S 
PFNA-II Ø 10.0mm left, 125°, L 300mm  
473.025S 
PFNA-II Ø 10.0mm left, 125°, L 340mm  
473.027S 
PFNA-II Ø 10.0mm left, 125°, L 380mm  
473.029S 
PFNA-II Ø 10.0mm left, 125°, L 420mm  
473.031S 
PFNA-II Ø 9.0mm left, 125°, L 300mm  
473.033S 
PFNA-II Ø 9.0mm left, 125°, L 340mm  
473.050S 
PFNA-II Ø 10.0mm, long left, 125°, L 260mm  

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 65 of 74 
 
473.052S 
PFNA-II Ø 10.0mm, long left, 125°, L 280mm  
473.054S 
PFNA-II Ø 10.0mm, long left, 125°, L 320mm  
473.070S 
PFNA-II Ø 9.0mm, long left, 125°, L 260mm  
473.072S 
PFNA-II Ø 9.0mm, long left, 125°, L 280mm  
473.074S 
PFNA-II Ø 9.0mm, long left, 125°, L 320mm 
473.024S 
PFNA-II Ø 10.0mm left, 130°, L 300mm  
473.026S 
PFNA-II Ø 10.0mm left, 130°, L 340mm  
473.028S 
PFNA-II Ø 10.0mm left, 130°, L 380mm  
473.030S 
PFNA-II Ø 10.0mm left, 130°, L 420mm  
473.032S 
PFNA-II Ø 9.0mm left, 130°, L 300mm  
473.034S 
PFNA-II Ø 9.0mm left, 130°, L 340mm  
473.051S 
PFNA-II Ø 10.0mm, long left, 130°, L 260mm  
473.053S 
PFNA-II Ø 10.0mm, long left, 130°, L 280mm  
473.055S 
PFNA-II Ø 10.0mm, long left, 130°, L 320mm  
473.071S 
PFNA-II Ø 9.0mm, long left, 130°, L 260mm  
473.073S 
PFNA-II Ø 9.0mm, long left, 130°, L 280mm  
473.075S 
PFNA-II Ø 9.0mm, long left, 130°, L 320mm  
473.015S 
PFNA-II Ø 10.0mm right, 125°, L 300mm  
473.017S 
PFNA-II Ø 10.0mm right, 125°, L 340mm  
473.019S 
PFNA-II Ø 10.0mm right, 125°, L 380mm  
473.021S 
PFNA-II Ø 10.0mm right, 125°, L 420mm  
473.035S 
PFNA-II Ø 9.0mm right, 125°, L 300mm  
473.037S 
PFNA-II Ø 9.0mm right, 125°, L 340mm  
473.040S 
PFNA-II Ø 10.0mm, long right, 125°, L 260mm  
473.042S 
PFNA-II Ø 10.0mm, long right, 125°, L 280mm  
473.044S 
PFNA-II Ø 10.0mm, long right, 125°, L 320mm  
473.060S 
PFNA-II Ø 9.0mm, long right, 125°, L 260mm  
473.062S 
PFNA-II Ø 9.0mm, long right, 125°, L 280mm  
473.064S 
PFNA-II Ø 9.0mm, long right, 125°, L 320mm  
473.016S 
PFNA-II Ø 10.0mm right, 130°, L 300mm  
473.018S 
PFNA-II Ø 10.0mm right, 130°, L 340mm  
473.020S 
PFNA-II Ø 10.0mm right, 130°, L 380mm  
473.022S 
PFNA-II Ø 10.0mm right, 130°, L 420mm  
473.036S 
PFNA-II Ø 9.0mm right, 130°, L 300mm  
473.038S 
PFNA-II Ø 9.0mm right, 130°, L 340mm  
473.041S 
PFNA-II Ø 10.0mm, long right, 130°, L 260mm  
473.043S 
PFNA-II Ø 10.0mm, long right, 130°, L 280mm  
473.045S 
PFNA-II Ø 10.0mm, long right, 130°, L 320mm  
473.061S 
PFNA-II Ø 9.0mm, long right, 130°, L 260mm  

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 66 of 74 
 
473.063S 
PFNA-II Ø 9.0mm, long right, 130°, L 280mm  
473.065S 
PFNA-II Ø 9.0mm, long right, 130°, L 320mm  
456.759S 
PFNA-II Blade, length 75 mm, Titanium Alloy (TAN), sterile 
456.760S 
PFNA-II Blade, length 80 mm, Titanium Alloy (TAN), sterile 
456.761S 
PFNA-II Blade, length 85 mm, Titanium Alloy (TAN), sterile 
456.762S 
PFNA-II Blade, length 90 mm, Titanium Alloy (TAN), sterile 
456.763S 
PFNA-II Blade, length 95 mm, Titanium Alloy (TAN), sterile 
456.764S 
PFNA-II Blade, length 100 mm, Titanium Alloy (TAN), sterile 
456.765S 
PFNA-II Blade, length 105 mm, Titanium Alloy (TAN), sterile 
456.766S 
PFNA-II Blade, length 110 mm, Titanium Alloy (TAN), sterile 
456.767S 
PFNA-II Blade, length 115 mm, Titanium Alloy (TAN), sterile 
456.768S 
PFNA-II Blade, length 120 mm, Titanium Alloy (TAN), sterile 
04.027.050S PFNA-II Blade, length 75 mm, Titanium Alloy (TAN), sterile 
04.027.051S PFNA-II Blade, length 80 mm, Titanium Alloy (TAN), sterile 
04.027.052S PFNA-II Blade, length 85 mm, Titanium Alloy (TAN), sterile 
04.027.053S PFNA-II Blade, length 90 mm, Titanium Alloy (TAN), sterile 
04.027.054S PFNA-II Blade, length 95 mm, Titanium Alloy (TAN), sterile 
04.027.055S PFNA-II Blade, length 100 mm, Titanium Alloy (TAN), sterile 
04.027.056S PFNA-II Blade, length 105 mm, Titanium Alloy (TAN), sterile 
04.027.057S PFNA-II Blade, length 110 mm, Titanium Alloy (TAN), sterile 
04.027.058S PFNA-II Blade, length 115 mm, Titanium Alloy (TAN), sterile 
04.027.059S PFNA-II Blade, length 120 mm, Titanium Alloy (TAN), sterile 
473.170S 
PFNA-II End Cap, extension 0 mm, Titanium Alloy (TAN), sterile 
473.171S 
PFNA-II End Cap, extension 5 mm, Titanium Alloy (TAN), sterile 
473.172S 
PFNA-II End Cap, extension 10 mm, Titanium Alloy (TAN), sterile 
473.173S 
PFNA-II End Cap, extension 15 mm, Titanium Alloy (TAN), sterile 
04.027.005S PFNA-II End Cap, extension 0 mm, Titanium Alloy (TAN), sterile 
04.027.006S PFNA-II End Cap, extension 5 mm, Titanium Alloy (TAN), sterile 
04.027.007S PFNA-II End Cap, extension 10 mm, Titanium Alloy (TAN), sterile 
04.027.008S PFNA-II End Cap, extension 15 mm, Titanium Alloy (TAN), sterile 
459.260  
Locking Bolt Ø 4.9 mm, self-tapping, length 26 mm, Titanium Alloy (TAN), green 
459.280  
Locking Bolt Ø 4.9 mm, self-tapping, length 28 mm, Titanium Alloy (TAN), green 
459.300  
Locking Bolt Ø 4.9 mm, self-tapping, length 30 mm, Titanium Alloy (TAN), green 
459.320  
Locking Bolt Ø 4.9 mm, self-tapping, length 32 mm, Titanium Alloy (TAN), green 
459.340  
Locking Bolt Ø 4.9 mm, self-tapping, length 34 mm, Titanium Alloy (TAN), green 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 67 of 74 
 
459.360  
Locking Bolt Ø 4.9 mm, self-tapping, length 36 mm, Titanium Alloy (TAN), green 
459.380  
Locking Bolt Ø 4.9 mm, self-tapping, length 38 mm, Titanium Alloy (TAN), green 
459.400  
Locking Bolt Ø 4.9 mm, self-tapping, length 40 mm, Titanium Alloy (TAN), green 
459.420  
Locking Bolt Ø 4.9 mm, self-tapping, length 42 mm, Titanium Alloy (TAN), green 
459.440  
Locking Bolt Ø 4.9 mm, self-tapping, length 44 mm, Titanium Alloy (TAN), green 
459.460  
Locking Bolt Ø 4.9 mm, self-tapping, length 46 mm, Titanium Alloy (TAN), green 
459.480  
Locking Bolt Ø 4.9 mm, self-tapping, length 48 mm, Titanium Alloy (TAN), green 
459.500  
Locking Bolt Ø 4.9 mm, self-tapping, length 50 mm, Titanium Alloy (TAN), green 
459.520  
Locking Bolt Ø 4.9 mm, self-tapping, length 52 mm, Titanium Alloy (TAN), green 
459.540  
Locking Bolt Ø 4.9 mm, self-tapping, length 54 mm, Titanium Alloy (TAN), green 
459.560  
Locking Bolt Ø 4.9 mm, self-tapping, length 56 mm, Titanium Alloy (TAN), green 
459.580  
Locking Bolt Ø 4.9 mm, self-tapping, length 58 mm, Titanium Alloy (TAN), green 
459.600  
Locking Bolt Ø 4.9 mm, self-tapping, length 60 mm, Titanium Alloy (TAN), green 
459.640  
Locking Bolt Ø 4.9 mm, self-tapping, length 64 mm, Titanium Alloy (TAN), green 
459.680  
Locking Bolt Ø 4.9 mm, self-tapping, length 68 mm, Titanium Alloy (TAN), green 
459.720  
Locking Bolt Ø 4.9 mm, self-tapping, length 72 mm, Titanium Alloy (TAN), green 
459.760  
Locking Bolt Ø 4.9 mm, self-tapping, length 76 mm, Titanium Alloy (TAN), green 
459.800  
Locking Bolt Ø 4.9 mm, self-tapping, length 80 mm, Titanium Alloy (TAN), green 
459.850  
Locking Bolt Ø 4.9 mm, self-tapping, length 85 mm, Titanium Alloy (TAN), green 
459.900  
Locking Bolt Ø 4.9 mm, self-tapping, length 90 mm, Titanium Alloy (TAN), green 
459.950  
Locking Bolt Ø 4.9 mm, self-tapping, length 95 mm, Titanium Alloy (TAN), green 
459.960  
Locking Bolt Ø 4.9 mm, self-tapping, length 100 mm, Titanium Alloy (TAN), green 
459.260S 
Locking Bolt Ø 4.9 mm, self-tapping, length 26 mm, Titanium Alloy (TAN), green, 
sterile 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 68 of 74 
 
459.280S 
Locking Bolt Ø 4.9 mm, self-tapping, length 28 mm, Titanium Alloy (TAN), green, 
sterile 
459.300S 
Locking Bolt Ø 4.9 mm, self-tapping, length 30 mm, Titanium Alloy (TAN), green, 
sterile 
459.320S 
Locking Bolt Ø 4.9 mm, self-tapping, length 32 mm, Titanium Alloy (TAN), green, 
sterile 
459.340S 
Locking Bolt Ø 4.9 mm, self-tapping, length 34 mm, Titanium Alloy (TAN), green, 
sterile 
459.360S 
Locking Bolt Ø 4.9 mm, self-tapping, length 36 mm, Titanium Alloy (TAN), green, 
sterile 
459.380S 
Locking Bolt Ø 4.9 mm, self-tapping, length 38 mm, Titanium Alloy (TAN), green, 
sterile 
459.400S 
Locking Bolt Ø 4.9 mm, self-tapping, length 40 mm, Titanium Alloy (TAN), green, 
sterile 
459.420S 
Locking Bolt Ø 4.9 mm, self-tapping, length 42 mm, Titanium Alloy (TAN), green, 
sterile 
459.440S 
Locking Bolt Ø 4.9 mm, self-tapping, length 44 mm, Titanium Alloy (TAN), green, 
sterile 
459.460S 
Locking Bolt Ø 4.9 mm, self-tapping, length 46 mm, Titanium Alloy (TAN), green, 
sterile 
459.480S 
Locking Bolt Ø 4.9 mm, self-tapping, length 48 mm, Titanium Alloy (TAN), green, 
sterile 
459.500S 
Locking Bolt Ø 4.9 mm, self-tapping, length 50 mm, Titanium Alloy (TAN), green, 
sterile 
459.520S 
Locking Bolt Ø 4.9 mm, self-tapping, length 52 mm, Titanium Alloy (TAN), green, 
sterile 
459.540S 
Locking Bolt Ø 4.9 mm, self-tapping, length 54 mm, Titanium Alloy (TAN), green, 
sterile 
459.560S 
Locking Bolt Ø 4.9 mm, self-tapping, length 56 mm, Titanium Alloy (TAN), green, 
sterile 
459.580S 
Locking Bolt Ø 4.9 mm, self-tapping, length 58 mm, Titanium Alloy (TAN), green, 
sterile 
459.600S 
Locking Bolt Ø 4.9 mm, self-tapping, length 60 mm, Titanium Alloy (TAN), green, 
sterile 
459.640S 
Locking Bolt Ø 4.9 mm, self-tapping, length 64 mm, Titanium Alloy (TAN), green, 
sterile 
459.680S 
Locking Bolt Ø 4.9 mm, self-tapping, length 68 mm, Titanium Alloy (TAN), green, 
sterile 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 69 of 74 
 
459.720S 
Locking Bolt Ø 4.9 mm, self-tapping, length 72 mm, Titanium Alloy (TAN), green, 
sterile 
459.760S 
Locking Bolt Ø 4.9 mm, self-tapping, length 76 mm, Titanium Alloy (TAN), green, 
sterile 
459.800S 
Locking Bolt Ø 4.9 mm, self-tapping, length 80 mm, Titanium Alloy (TAN), green, 
sterile 
459.850S 
Locking Bolt Ø 4.9 mm, self-tapping, length 85 mm, Titanium Alloy (TAN), green, 
sterile 
459.900S 
Locking Bolt Ø 4.9 mm, self-tapping, length 90 mm, Titanium Alloy (TAN), green, 
sterile 
459.950S 
Locking Bolt Ø 4.9 mm, self-tapping, length 95 mm, Titanium Alloy (TAN), green, 
sterile 
459.960S 
Locking Bolt Ø 4.9 mm, self-tapping, length 100 mm, Titanium Alloy (TAN), 
green, sterile 
458.926  
Locking Screw Ø 5.0 mm, self-tapping, length 26 mm, Titanium Alloy (TAN) 
458.928  
Locking Screw Ø 5.0 mm, self-tapping, length 28 mm, Titanium Alloy (TAN) 
458.930  
Locking Screw Ø 5.0 mm, self-tapping, length 30 mm, Titanium Alloy (TAN) 
458.932  
Locking Screw Ø 5.0 mm, self-tapping, length 32 mm, Titanium Alloy (TAN) 
458.934  
Locking Screw Ø 5.0 mm, self-tapping, length 34 mm, Titanium Alloy (TAN) 
458.936  
Locking Screw Ø 5.0 mm, self-tapping, length 36 mm, Titanium Alloy (TAN) 
458.938  
Locking Screw Ø 5.0 mm, self-tapping, length 38 mm, Titanium Alloy (TAN) 
458.940  
Locking Screw Ø 5.0 mm, self-tapping, length 40 mm, Titanium Alloy (TAN) 
458.942  
Locking Screw Ø 5.0 mm, self-tapping, length 42 mm, Titanium Alloy (TAN) 
458.944  
Locking Screw Ø 5.0 mm, self-tapping, length 44 mm, Titanium Alloy (TAN) 
458.946  
Locking Screw Ø 5.0 mm, self-tapping, length 46 mm, Titanium Alloy (TAN) 
458.948  
Locking Screw Ø 5.0 mm, self-tapping, length 48 mm, Titanium Alloy (TAN) 
458.950  
Locking Screw Ø 5.0 mm, self-tapping, length 50 mm, Titanium Alloy (TAN) 
458.952  
Locking Screw Ø 5.0 mm, self-tapping, length 52 mm, Titanium Alloy (TAN) 
458.954  
Locking Screw Ø 5.0 mm, self-tapping, length 54 mm, Titanium Alloy (TAN) 
458.956  
Locking Screw Ø 5.0 mm, self-tapping, length 56 mm, Titanium Alloy (TAN) 
458.958  
Locking Screw Ø 5.0 mm, self-tapping, length 58 mm, Titanium Alloy (TAN) 
458.960  
Locking Screw Ø 5.0 mm, self-tapping, length 60 mm, Titanium Alloy (TAN) 
458.964  
Locking Screw Ø 5.0 mm, self-tapping, length 64 mm, Titanium Alloy (TAN) 
458.968  
Locking Screw Ø 5.0 mm, self-tapping, length 68 mm, Titanium Alloy (TAN) 
458.972  
Locking Screw Ø 5.0 mm, self-tapping, length 72 mm, Titanium Alloy (TAN) 
458.976  
Locking Screw Ø 5.0 mm, self-tapping, length 76 mm, Titanium Alloy (TAN) 
458.980  
Locking Screw Ø 5.0 mm, self-tapping, length 80 mm, Titanium Alloy (TAN) 
458.985  
Locking Screw Ø 5.0 mm, self-tapping, length 85 mm, Titanium Alloy (TAN) 
458.990  
Locking Screw Ø 5.0 mm, self-tapping, length 90 mm, Titanium Alloy (TAN) 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 70 of 74 
 
458.995  
Locking Screw Ø 5.0 mm, self-tapping, length 95 mm, Titanium Alloy (TAN) 
458.999  
Locking Screw Ø 5.0 mm, self-tapping, length 100 mm, Titanium Alloy (TAN) 
04.005.516 
Locking Screw Stardrive® Ø 5.0 mm, length 26 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.518 
Locking Screw Stardrive® Ø 5.0 mm, length 28 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.520 
Locking Screw Stardrive® Ø 5.0 mm, length 30 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.522 
Locking Screw Stardrive® Ø 5.0 mm, length 32 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.524 
Locking Screw Stardrive® Ø 5.0 mm, length 34 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.526 
Locking Screw Stardrive® Ø 5.0 mm, length 36 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.528 
Locking Screw Stardrive® Ø 5.0 mm, length 38 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.530 
Locking Screw Stardrive® Ø 5.0 mm, length 40 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.532 
Locking Screw Stardrive® Ø 5.0 mm, length 42 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.534 
Locking Screw Stardrive® Ø 5.0 mm, length 44 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.536 
Locking Screw Stardrive® Ø 5.0 mm, length 46 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.538 
Locking Screw Stardrive® Ø 5.0 mm, length 48 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.540 
Locking Screw Stardrive® Ø 5.0 mm, length 50 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.542 
Locking Screw Stardrive® Ø 5.0 mm, length 52 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.544 
Locking Screw Stardrive® Ø 5.0 mm, length 54 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.546 
Locking Screw Stardrive® Ø 5.0 mm, length 56 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.548 
Locking Screw Stardrive® Ø 5.0 mm, length 58 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.550 
Locking Screw Stardrive® Ø 5.0 mm, length 60 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 71 of 74 
 
04.005.552 
Locking Screw Stardrive® Ø 5.0 mm, length 62 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.554 
Locking Screw Stardrive® Ø 5.0 mm, length 64 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.556 
Locking Screw Stardrive® Ø 5.0 mm, length 66 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.558 
Locking Screw Stardrive® Ø 5.0 mm, length 68 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.560 
Locking Screw Stardrive® Ø 5.0 mm, length 70 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.562 
Locking Screw Stardrive® Ø 5.0 mm, length 72 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.564 
Locking Screw Stardrive® Ø 5.0 mm, length 74 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.566 
Locking Screw Stardrive® Ø 5.0 mm, length 76 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.568 
Locking Screw Stardrive® Ø 5.0 mm, length 78 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.570 
Locking Screw Stardrive® Ø 5.0 mm, length 80 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.575 
Locking Screw Stardrive® Ø 5.0 mm, length 85 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.580 
Locking Screw Stardrive® Ø 5.0 mm, length 90 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.585 
Locking Screw Stardrive® Ø 5.0 mm, length 95 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.590 
Locking Screw Stardrive® Ø 5.0 mm, length 100 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green 
04.005.516S Locking Screw Stardrive® Ø 5.0 mm, length 26 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.518S Locking Screw Stardrive® Ø 5.0 mm, length 28 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.520S Locking Screw Stardrive® Ø 5.0 mm, length 30 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.522S Locking Screw Stardrive® Ø 5.0 mm, length 32 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.524S Locking Screw Stardrive® Ø 5.0 mm, length 34 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 72 of 74 
 
04.005.526S Locking Screw Stardrive® Ø 5.0 mm, length 36 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.528S Locking Screw Stardrive® Ø 5.0 mm, length 38 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.530S Locking Screw Stardrive® Ø 5.0 mm, length 40 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.532S Locking Screw Stardrive® Ø 5.0 mm, length 42 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.534S Locking Screw Stardrive® Ø 5.0 mm, length 44 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.536S Locking Screw Stardrive® Ø 5.0 mm, length 46 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.538S Locking Screw Stardrive® Ø 5.0 mm, length 48 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.540S Locking Screw Stardrive® Ø 5.0 mm, length 50 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.542S Locking Screw Stardrive® Ø 5.0 mm, length 52 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.544S Locking Screw Stardrive® Ø 5.0 mm, length 54 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.546S Locking Screw Stardrive® Ø 5.0 mm, length 56 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.548S Locking Screw Stardrive® Ø 5.0 mm, length 58 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.550S Locking Screw Stardrive® Ø 5.0 mm, length 60 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.552S Locking Screw Stardrive® Ø 5.0 mm, length 62 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.554S Locking Screw Stardrive® Ø 5.0 mm, length 64 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.556S Locking Screw Stardrive® Ø 5.0 mm, length 66 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.558S Locking Screw Stardrive® Ø 5.0 mm, length 68 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.560S Locking Screw Stardrive® Ø 5.0 mm, length 70 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.562S Locking Screw Stardrive® Ø 5.0 mm, length 72 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 73 of 74 
 
04.005.564S Locking Screw Stardrive® Ø 5.0 mm, length 74 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.566S Locking Screw Stardrive® Ø 5.0 mm, length 76 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.568S Locking Screw Stardrive® Ø 5.0 mm, length 78 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.570S Locking Screw Stardrive® Ø 5.0 mm, length 80 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.575S Locking Screw Stardrive® Ø 5.0 mm, length 85 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.580S Locking Screw Stardrive® Ø 5.0 mm, length 90 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.585S Locking Screw Stardrive® Ø 5.0 mm, length 95 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
04.005.590S Locking Screw Stardrive® Ø 5.0 mm, length 100 mm, for Medullary Nails, 
Titanium Alloy (TAN), light green, sterile 
 
 
 
 
APPENDIX E: ABBREVIATIONS 
 
Abbreviation Terms 
GCP 
Good Clinical Practice 
CRF 
Case Report Form 
SF-12 
Short Form - 12 
IRB 
Institutional Review Board 
EC 
Ethics Committee 
ERB 
Ethics Review Board 
BMI 
Body Mass Index 
IFU 
Instructions for Use 
AE 
Adverse Event 
SAE 
Serious Adverse Event 
UADE 
Unanticipated Device Effect 
ICH-GCP 
International Conference on Harmonization – Good Clinical 
Practices 
CV 
Curriculum Vitae 
HHS 
Harris Hip Score 
EQ5D 
EuroQoL (Quality of Life)-5 Dimensions 

Johnson & Johnson Medical Shanghai, The CHINA TFNA Study 
Protocol No. :  DPS-201502 
Version Date:  8 Jan 2019 
 
Confidential 
 
Page 74 of 74