Intracapsular and Intertrochanteric Fracture Fixation With the THP Hip Fracture Plating System
Phase: NA
Conditions: Femur Fracture, Femur Fracture Intertrochanteric, Garden Grade I Subcapital Fracture of Femoral Neck, Garden Grade II Subcapital Fracture of Femoral Neck, Garden Grade III Subcapital Fracture of Femoral Neck, Garden Grade IV Subcapital Fracture of Femoral Neck
Sponsor: Zimmer Biomet

Intracapsular and Intertrochanteric 
Fracture Fixation with the THP™ Hip 
Fracture Plating System 
Clinical Outcome Study 
Protocol Number: CSU2017-22T 
Protocol Version: Version 2.0 
Region: 
United States 
18 June 2018 (FINAL) 
Zimmer Biomet 
Clinical Affairs Department 
1800 West Center Street 
Warsaw, IN 46580 
800-613-6131
CONFIDENTIAL - This document contains confidential information belonging to Zimmer Biomet except as 
otherwise agreed to in writing, by accepting or reviewing this document, you agree to hold this information in 
confidence and not distribute or disclose it to others (except where required by  applicable law) or use it for 
unauthorized purposes.  In the event of any actual or suspected breach of this obligation, Zimmer Inc. must be 
promptly notified.  Duplication and distribution of this document in any form or shape requires prior approval from 
Zimmer Inc. 
Clinicaltrials.gov NCT #: NCT03870477

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Table of Contents 
I. 
Study Synopsis ................................................................................................................................... 4 
II. 
Data Collection Overview .................................................................................................................. 7 
III. 
Introduction and Purpose ................................................................................................................ 7 
IV. 
Study Objectives............................................................................................................................. 8 
V. Study Design ...................................................................................................................................... 9 
VI. 
Study Population .......................................................................................................................... 10 
A. Inclusion Criteria .......................................................................................................................... 10 
B. 
Exclusion Criteria ......................................................................................................................... 11 
VII. 
Study Device Information ............................................................................................................ 11 
VIII. Study Procedures .......................................................................................................................... 13 
A. Offer Study Participation .............................................................................................................. 13 
B. 
Informed Consent Process ............................................................................................................ 13 
C. 
Informed Consent / Enrollment Log ............................................................................................. 14 
D. Subject Enrollment ....................................................................................................................... 14 
E. 
Monitor Log ................................................................................................................................. 14 
F. 
Delegation of Authority (Site Signature Log) .............................................................................. 15 
G. Baseline/Pre-operative/Operative/Discharge Assessment ............................................................ 15 
H. Post-Surgical Management........................................................................................................... 15 
I. 
Post-operative Follow-up Procedures (Data Collection) .............................................................. 15 
J. 
Minimization of Subjects Lost to Follow-up ................................................................................ 16 
K. Radiographic Definitions and Methods ........................................................................................ 16 
IX. 
Reporting ...................................................................................................................................... 18 
A. Prior to Initiation of the Study ...................................................................................................... 18 
B. 
Clinical Data Collection/Submission............................................................................................ 19 
C. 
Reporting Requirements ............................................................................................................... 20 
D. Management of Incurrent Events ................................................................................................. 20 
E. 
Medical Events/Adverse Events Definitions and Classifications ................................................. 23 
F. 
Monitoring of the Study ............................................................................................................... 26 
X. Risk Analysis .................................................................................................................................... 26 
XI. 
Statistical Considerations ............................................................................................................. 27 
A. General Statistical Methods.......................................................................................................... 27 
B. 
Sample Size .................................................................................................................................. 27 

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XII. 
References .................................................................................................................................... 28 
XIII. Appendices: .................................................................................................................................. 28 
 
 
 

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I. 
Study Synopsis 
 
Study Title 
Intracapsular and Intertrochanteric Fracture Fixation with 
the THP Hip Fracture Plating System Clinical Outcome 
Study 
Abbreviated Study Title 
THP Clinical Outcome Study 
Sponsor 
Zimmer Biomet, Warsaw, Indiana 
Protocol Number 
CSU2017-22T 
Anticipated Start Date 
Q3 2018 
Study Objectives 
The objective of this observational prospective study is to 
systematically document the clinical outcome of THP Hip 
Fracture Plating System when used to treat intracapsular and 
intertrochanteric fractures.   
 
Primary Endpoint: 
 Revision rate due to device related complication(s) or 
non-union of the femur. 
 
Secondary Endpoints: 
 Radiographic and clinical fracture healing of the 
proximal femur using standard scoring methods. 
Target Population 
190 subjects who have undergone one of the following with 
the THP Hip Fracture Plating System: 
 Intracapsular  fracture repair (101 subjects) 
 Intertrochanteric fracture repair (89 subjects) 
Study Design 
Multicenter, prospective, observational study 
Study Type 
Post-Market Clinical Follow-up Study (PMCF) 
Sample Size 
190 
Length of Study 
3 years (2 years of enrollment and 1 year of follow-up) 
Follow-up Intervals 
1 to 6 weeks, 3 months, 6 months, and 12 months after 
surgery 
Inclusion/Exclusion Criteria 
Inclusion Criteria 
 Patient must be 18 years of age or older. 
 Patient must be eligible for an open reduction and 
internal fixation of the proximal femur.  
 Patient must have an intracapsular or 
intertrochanteric fracture. 
 Patient must have need for alignment, stabilization, 
and reduction of bone fractures. 
 Patient must have ability and willingness to follow 

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postoperative care instructions until healing is 
complete.  
 Patient must be in good nutritional state.  
 Patient must be able and willing to sign the IRB/EC 
approved informed consent. 
 
Exclusion Criteria 
 Patient is a prisoner. 
 Patient is a current alcohol or drug abuser. 
 Patient is known to be pregnant or breastfeeding.  
 Patient has a psychiatric illness or cognitive deficit 
that will not allow proper informed consent. 
 Infection. 
 Patient conditions including bloody supply 
limitations, obesity or insufficient quantity or quality 
of bone. 
 Patient with mental or neurologic conditions who are 
unwilling or incapable of following postoperative 
care instructions. 
 Patient has foreign body sensitivity. Where material 
sensitivity is suspected or unknown, testing is to be 
completed prior to implantation of the device. 
 Patient is expected to be non-compliant with 
recommended post-operative weight-bearing 
instructions. 
 
Study Device 
THP™ Hip Fracture Plating System 
Outcome Measures 
 VAS Pain Scale  
 EQ-5D-5L 
 RUSH Score 
 FIX-IT 
 Implant Survivorship 
 Adverse Events 
 Operative Time 
 Readmissions 
 Reoperations 
 
Documentation 
Electronic Case Report Forms 
Statistical Reporting 
Data collected will be summarized and reported to each 
participating investigator.  Statistical analysis will be 
conducted by Zimmer Biomet or its designee. 
 
 
This protocol is written based on guidelines from ISO 14155 Standard for Clinical Investigation of 

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Medical Devices For Human Subjects – Good Clinical Practice (i) and is in accordance with US Code 
of Federal Regulations 21 CFR Parts 11, 50 and 56 (ii) 
 
 

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II. 
Data Collection Overview 
 
The following table indicates the necessary case report forms to be completed at the 
given time point: 
 
Form Name 
Enrollment 
Operative 
Discharge 
Assessment 
 1 to 6 
Weeks 
Post-op 
(+14 days) 
3 Months 
Post-op (± 30 
days) 
6 Months 
Post-op (± 60 
days) 
1 Year Post-
op (± 90 
days) 
Revision 
Enrollment Form 
X 
 
 
 
 
 
 
 
Demographic Evaluation 
X 
 
 
 
 
 
 
 
Operative Record 
 
X 
 
 
 
 
 
 
Postoperative Discharge 
Assessment 
 
 
X 
 
 
 
 
 
VAS Pain 
 
 
 
 
 
 
 
 
EQ-5D-5L 
 
 
 
 
 
 
 
 
FIX-IT 
 
 
 
X 
X 
X 
X 
 
X-rays 
X 
X 
X 
X 
X 
X 
X 
X 
Postoperative Follow-up 
Evaluation 
 
 
 
X 
X 
X 
X 
 
Study Completion 
 
* 
* 
* 
* 
* 
* 
X 
**Adverse Event (Complication) 
* 
* 
* 
* 
* 
* 
* 
X 
Protocol Deviation 
* 
* 
* 
* 
* 
* 
* 
* 
Physician Radiographic 
Assessment (Including RUSH) 
 
 
 
* 
* 
* 
* 
* 
Explant Device 
 
 
X 
X 
X 
X 
X 
X 
 
X  Completed by Investigator or Designee (required) 
   Completed by Patient  
   Completed by Investigator or Designee (as applicable) 
  Independent radiographic review may be performed by Sponsor’s designee if requested by the Sponsor. 
 
** If device related Adverse Event occurs, a Product Experience Report (PER) must be completed and sent to the sponsor as well and include the 
Operative Report (index and revision) and Radiographs (immediate post-op, all follow-up visits, and pre-revision). 
 
 
III. 
Introduction and Purpose 
 
 
 
Zimmer Biomet has developed a telescoping lag Screw and Hip Fracture Plate for fixation 
of fractures of the proximal femur, intracapsular and intertrochanteric femoral fractures. 
The device will compete with traditional devices, including cannulated screws used for 

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neck fractures and compression hip screws use for intertrochanteric fractures.  Hemi-hip 
arthroplasty is also an alternative for some patients. 
 
Although various techniques have been developed for internal fixation with open or closed 
reduction of femoral neck fractures, numerous complications such as non-union and femoral 
head avascular necrosis may require additional interventions.[3]  This study will document 
the clinical and radiographic outcomes of hip fracture patients, utilizing a hip fracture plate 
construct manufactured by Zimmer Biomet. 
IV. 
Study Objectives 
The objective of this observational prospective study is to systematically document the 
clinical outcome of the THP Hip Fracture Plating System when used infractures of the 
proximal femur, intracapsular and intertrochanteric fractures, as compared to historical 
literature data for the same indications when using cannulated or hip screws [1][2].  These 
objectives will be assessed using standard scoring systems, radiographic evidence, and 
adverse event records.  
Safety:  Will be assessed by monitoring the frequency and incidence of adverse events (AE), 
serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects 
(SADE), and unanticipated serious adverse device effects (USADE) and device deficiencies. 
Performance:  Will be determined by analyzing the implant survival, overall pain and 
functional performances on standard scales, subject quality of life, and radiographic 
parameters of subjects who received the subject device(s). Operative time and readmissions 
will also be analyzed.  Implant survival will be based on removal or intended removal and 
determined using the Kaplan-Meier method. 
 Overall pain and functional performance will be based on Visual Analog 
Scale (VAS) Pain, Rush Score, EuroQul 5D-5L (ED-5D-5L), and Functional 
Index for Trauma (FIX-IT). 
 Survivorship will be based on the rate of revision in the study device due to 
fixation failure or non-union of the femur. 
 Radiographic parameters to be analyzed may include, but are not limited to, 
implant fracture, significant implant migration or subsidence, and implant 
loosening. Other significant findings may also be observed and reported 
during the course of this study. 
It is planned that once sufficient data has been collected allowing meaningful statistical 
analysis; contributing investigators can use the data for peer reviewed publications, podium 
presentations and as a basis for surgeon discussions and learning. 

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Study Endpoints: The primary endpoint of this study is defined as the rate of revision after 
12 months due to device related complication or non-union of the femur. The secondary 
endpoints of this study are defined as radiographic and clinical fracture healing of the 
proximal femur using standard scoring methods. 
V. 
Study Design 
This is a prospective, multicenter, non-controlled clinical study designed to facilitate the 
collection and evaluation of pain, function, quality of life, radiographic assessment, and 
adverse event data.  A maximum of 10 sites will contribute to this study to enroll a study 
maximum of 190 subjects.  Enrollment per site will not exceed 57 subjects (30% of the 
total sample).  Each Investigator will be skilled in femur fracture treatment and experienced 
implanting the devices included in this study, as determined by the Sponsor. 
 
Due to the different historical revision rates for intertrochanteric fractures (~7%)[1] and 
neck fractures (~20%)[2], study enrollment will be split between the two groups to maintain 
the integrity of the sample size with an expectant lost to follow-up rate of 15%. 
Intertrochanteric fractures will be limited to a maximum of 89 enrolled subjects and 
intracapsular fractures will be limited to a maximum of 101 enrolled subjects. This will 
provide enough evaluable data for both indications to show the necessary statistical 
improvement from the historical revision rates[1][2]. 
 
Each Principal Investigator will be responsible for obtaining Institutional Review Board 
(IRB) or Ethics Committee (EC) approval as required prior to conducting the study.  In 
order to avoid potential selection bias, each Investigator will offer study participation to 
each consecutive eligible patient presenting as a candidate for hip fracture repair using the 
commercially available (FDA cleared) THP Hip Fracture Plating System.  Eligible 
candidates who express interest in study participation will be offered Informed Consent.  
All potential study subjects will be required to participate in the Informed Consent process 
and will not be considered enrolled in the study until the candidate has signed and dated the 
IRB/EC approved patient Informed Consent.  Study data cannot be collected until the 
candidate has completed the Informed Consent process and signed and dated the IRB or EC 
approved Informed Consent.  
 
Once Informed Consent has been obtained, preoperative, operative, and discharge 
documentation will be collected either via retrospective chart review or direct interview 
with the subject. Patients who have previously received THP Hip Fracture Plating System 
may be enrolled in the study if Informed Consent occurs prior to the end of the 6 weeks 
follow-up visit window.  This will include retrospective chart review for patients who meet 
the inclusion criteria (and do not meet any of the exclusion criteria) and have available 
surgical data. Patients that meet these requirements will be asked to consent to study 

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participation postoperatively. The consented patients will be followed prospectively at 
designated follow-up visits if all appropriate IRB/EC approvals and patient consent is 
obtained. The post-operative clinical and radiographic evaluations will be conducted at 1 to 
6 weeks, 3 months, 6 months, and 12 months post-surgery. 
 
Review of radiographs will be completed by the investigators at each clinical follow-up 
interval to determine radiographic evidence of fracture healing.  In addition, the 
Investigator will review radiographs at each clinical follow-up interval to ensure 
radiographic evidence of adverse events is documented and reported to the IRB or EC and 
the Sponsor as required.  At the Sponsor’s discretion, the Sponsor may request copies of 
these radiographs for independent radiologic review.  The Sponsor may request one central 
reviewer for all radiographs independent of the surgeon and institution. 
VI. 
Study Population 
The study population for primary statistical analysis will be comprised of males and 
females who satisfy the inclusion/exclusion criteria outlined in this section of the protocol.   
In order to avoid potential selection bias, each Investigator will offer study participation to 
each consecutive eligible patient presenting as a candidate.  Eligible candidates who 
express interest in study participation will be offered Informed Consent.  
Inclusion/Exclusion Criteria should not be evaluated until the study-specific consent form 
has been completed.  
 
A. Inclusion Criteria 
a. Patient must be 18 years of age or older. 
b. Patient must be eligible for an open reduction and internal fixation of the 
proximal femur.  
c. Patient must have an intracapsular or intertrochanteric fracture. 
d. Patient must have need for alignment, stabilization, and reduction of bone 
fractures. 
e. Patient must have ability and willingness to follow postoperative care 
instructions until healing is complete.  
f. Patient must be in good nutritional state.  
g. Patient must be able and willing to sign the IRB/EC approved informed consent. 
 
Note:  Patients who have previously received THP Hip Fracture Plating System 
may be enrolled in the study if informed consent occurs prior to the end of the 6 
weeks follow-up visit window. 

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B. Exclusion Criteria 
a. Patient is a prisoner. 
b. Patient is a current alcohol or drug abuser. 
c. Patient is known to be pregnant or breastfeeding.  
d. Patient has a psychiatric illness or cognitive deficit that will not allow proper 
informed consent. 
e. Infection. 
f. Patient conditions including bloody supply limitations, obesity or insufficient 
quantity or quality of bone. 
g. Patient with mental or neurologic conditions who are unwilling or incapable of 
following postoperative care instructions. 
h. Patient has foreign body sensitivity. Where material sensitivity is suspected or 
unknown, testing is to be completed prior to implantation of the device. 
i. Patient is expected to be non-compliant with recommended post-operative 
weight-bearing instructions. 
VII. Study Device Information 
The THP Hip Fracture Plating System are left or right side specific plates designed to 
provide fracture fixation and stabilization of intracapsular fractures and intertrochanteric 
fractures by the use of telescoping lag screws.  The plates are secured to the lateral aspect 
of the femoral shaft with either locking or non-locking cortical screws.  They are intended 
for use in intracapsular fractures and intertrochanteric fractures of the proximal femur. 
Figure 1 depicts the Hip Fracture Plates and the associated telescoping lag screws.   
 
         
 
 
 
 
 
 
 
FIGURE 1: THP Hip Fracture Plate 

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The fracture plates are contoured plates made of Ti-6Al-4V titanium alloy conforming to 
ASTM F-136 with aTiMax™ Type II anodized surface finish.  There are three (3) proximal 
threaded screw holes oriented 130 degrees from the plate surface to replicate a 130-degree 
femoral neck angle.  The screw holes are threaded to allow the telescoping lag screws to 
lock into the plate.  There are either two (2) or four (4) holes along the plate body designed 
for use with cortical bone screws.  The screw holes in the plates are threaded, utilizing 
SphereLock™ Technology, to allow for the use of locking or non-locking cortical screws at 
the surgeons discretion.   
The telescoping lag screws are 7.5mm in diameter with lengths ranging from 70mm to 
130mm in 5mm increments.  The head of the lag screw barrel is threaded to allow it to lock 
into the threads of the fracture plate.  The telescoping screw portion is free to translate as 
much as 20mm within the barrel.  The telescoping lag screws are made entirely of Ti-6Al-
4V titanium alloy conforming to ASTM F-136 with a TiMax Type II anodized surface 
finish.  
Optional limited collapse sleeves are available in 5mm, 10mm, 15mm and 20mm lengths to 
limit the amount of translation of the screws within the barrel.  They are designed to slide 
into the barrel of the screw and lock into place.  The use of a 5mm insert will limit the 
translation to 15mm whereas the use of a 15mm insert will limit the translation to 
5mm.  The use of the 20mm insert will make the screw virtually a non-translational (solid 
body) screw.  The limited collapse sleeves are made of Ti-6Al-4V titanium alloy 
conforming to ASTM F-136 with a Type III color anodized surface finish.  Figure 2 
represents a 10mm limited collapse sleeve. 
 
FIGURE 2: Limited Collapse (Sleeve 10mm)  
The THP Hip Fracture Plating System plates are secured to the lateral aspect of the proximal 
femur by the use of 5.0mm diameter cortical screws.  The cortical screws come in either a 
locking design or a non-locking design.  The screw heads utilize a hexalobular drive design and 
the locking design screws have external threads incorporated into the screw head so that the 
screw can be locked into the threaded holes on the plate body.  The head of the non-locking 
screws do not include the external threads.  The cortical screws are made of Ti-6Al-4V ELI and 

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conforming to ASTM F136 with Type II color anodized surface finish.  The cortical screws are 
available in lengths of 14mm to 60mm in 2mm increments, and from 60mm to 95mm in 5mm 
increments.  
 
VIII. Study Procedures 
 
A. Offer Study Participation 
Study participation will be offered to each consecutive eligible patient presenting 
as a potential candidate for the study.  Eligible candidates who express interest in 
study participation will be offered Informed Consent.  Prior to patient 
involvement in the study, the patient must participate in the Informed Consent 
process and sign and date the IRB or EC approved Informed Consent.   
 
B. Informed Consent Process 
For candidates that express interest, the Investigator or Designee will describe 
relevant study information, including the purpose, procedures, possible risks, and 
potential benefits associated with study participation.  The Investigator or 
Designee will also review, along with the candidates, the Informed Consent 
approved by both the governing IRB or EC and the study Sponsor.  Candidates 
shall have sufficient time to read and understand the IRB or EC approved 
Informed Consent and discuss whether they wish to participate in the study.  
Candidates will be asked to acknowledge whether all of their questions and 
concerns have been addressed to their satisfaction.  Any questions that candidates 
may have will be addressed appropriately by the Investigator or Designee.  
Candidates will be further instructed that they are free to obtain additional 
information from the Investigator or Designee at any time, that they are free to 
decline participation, and that they are free to withdraw their consent and 
discontinue their participation at any time without prejudice. 
 
After completing the Informed Consent process, candidates who agree to enter 
the study must sign and date the IRB or EC approved Informed Consent.  The 
Informed Consent must be signed and dated prior to the date of the study surgery 
for prospective subjects. Subjects enrolled retrospectively may sign and date the 
Informed Consent after surgery. 
 
A copy of the signed Informed Consent must be provided to the study subject.  

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The original signed Informed Consent is to be filed in the subject’s medical 
record, study subject binder, or regulatory binder. 
 
Study data will not be collected until the Informed Consent has been signed and 
dated.  If the candidate does not wish to participate (does not sign and date the 
Informed Consent), data for that candidate will not be collected for this study. 
 
C. Informed Consent / Enrollment Log 
An Informed Consent / Enrollment Log (Appendix C) will be maintained at the 
site throughout the course of the study.  The purpose of the log is to provide 
documentation that all enrolled study subjects underwent the Informed Consent 
process, signed and dated the IRB or EC approved Informed Consent, and were 
provided with a copy of the fully executed consent with all required signatures.  
All candidates who sign and date the approved Informed Consent for the study 
must be entered in the log.  If a subject signs and dates additional Informed 
Consent(s) after enrollment (e.g., due to a protocol amendment, protocol 
revisions, etc.), subsequent signings will also be recorded in the log.  The 
Informed Consent/Enrollment Log will be filed in the site Regulatory Binder for 
the study.   
 
D. Subject Enrollment 
Once the Informed Consent has been signed and dated by the subject, the subject 
will be considered enrolled in the study.  A unique case identification number 
(Case ID) will be assigned to each participating subject/femur (bilateral subjects 
will be assigned a unique case ID number for each femur).  This unique case ID 
number will be used throughout the study for identification.  Case ID numbers 
will be assigned consecutively in ascending order per site, with the starting 
number for a given site defined by the Sponsor.   
 
E. Monitor Log 
The Site Monitoring Visit Log (Appendix C) will be maintained throughout the 
course of the study.  The log will contain the visit date, monitor name/signature 
and the purpose of the visit (i.e. site initiation, onsite interim monitoring (as 
applicable), site close-out, etc.).  The site monitoring visit log will be filed in the 
site Regulatory Binder for the study. 
 

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F. Delegation of Authority (Site Signature Log) 
A Delegation of Authority/Site Signature Log (Appendix C) will be maintained 
throughout the study and will contain the names, initials, signatures and study 
responsibilities of all site personnel/designees involved in study procedures and 
data collection.  This log will be filed in the site Regulatory Binder for the study. 
G. Baseline/Pre-operative/Operative/Discharge Assessment 
Data collection required for baseline, operative, and discharge will be collected 
preoperatively if the subject signs their informed consent prior to surgery. If the 
subject meets all inclusion and none of the exclusion criteria and signs an 
informed consent prior to the end of the 6 weeks follow-up visit window, 
retrospective chart review will be conducted for preoperative data. At a minimum, 
this will include physical exam data, demographic data, and operative data. 
However, it may include additional information related to pain, function, and 
radiographic evaluation if available. The following case report forms will be 
collected baseline, operatively, and at discharge:  
1. Enrollment Form 
2. Demographic Evaluation 
3. Operative Record 
4. Postoperative Discharge Assessment 
5. X-Rays (any available views) 
6. Adverse Event(s) 
7. Protocol Deviation(s) 
8. Study Completion 
9. Explanted Device 
 
H. Post-Surgical Management 
Post-surgical management for study subjects will follow the investigator’s 
standard of care for patients undergoing femoral neck or intertrochanteric 
fracture repair.  Post-surgical rehabilitative therapy will be as prescribed by the 
investigator.  The FDA cleared instructions for use and surgical technique must 
be followed for this product.  Please refer to the latest versions of these 
documents on the zimmerbiomet.com website or contact your local clinical 
study manager or Zimmer Biomet sales associate for additional details. 
I. Post-operative Follow-up Procedures (Data Collection) 
Post-operative clinical evaluations/assessments will be conducted at 1 to 6 
weeks (+ 14 days), 3 months (± 30 days), 6 months (± 60 days), and 12 months 
(± 90 days) post-surgery.  The following case report forms will be collected at 

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each interval: 
1. Postoperative Follow-up 
2. VAS Pain 
3. EQ-5D-5L 
4. RUSH 
5. FIX-IT 
6. X-rays (A/P and lateral views of the hip or pelvis) 
7. Physician Radiographic Assessment 
8. Adverse Event(s) 
9. Protocol Deviation(s) 
10. Study Completion 
11. Explanted Device 
 
Subjects will be followed post-operatively for 12 months.  Unless the study is 
otherwise closed, data will continue to be collected until the subject completes 
the study per the protocol, voluntarily withdraws from the study, is withdrawn 
from the study by the investigator, is lost to follow-up, undergoes revision to 
remove a study device, (due to complication) including partial removal i.e. 
screw, or expires.  See Management of Incurrent Events for additional details.  
Reason(s) for study completion must be documented on the Study Completion 
case report form. 
 
J. Minimization of Subjects Lost to Follow-up 
Subject follow-up is extremely important for the conduct of a clinical study, and 
the expectation is to maintain the highest possible rate of follow-up compliance 
throughout this study.  During the informed consent process and at each follow-
up interval, subjects should be counseled on the importance of completing 
future study follow-up intervals. 
 
K. Radiographic Definitions and Methods 
All postoperative radiographic evaluations performed according to the protocol 
will be reviewed by the Investigator at the time of the evaluation and 
documented using the Physician Radiographic Assessment case report form.  
This includes documentation of any significant radiographic findings.  In 
addition, an Adverse Event case report form must be completed for those 
findings indicated by an asterisk on the Physician Radiographic Assessment 
case report form, or for any other findings identified as an adverse event. 
 

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o Non-union definition: A total RUSH score below 18 at six month post-surgery is 
considered a non-union[4]. 
 RUSH scoring examples: 
 
 

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Acceptable views include A/P and lateral views of the hip and/or pelvis and 
must include view of the implanted devices and the treated fracture and/or 
healing or healed fracture. 
 
At the Sponsor’s discretion, study radiographs may be requested from the sites 
for independent radiographic review and assessment of appropriate parameters. 
IX. 
Reporting 
The management of all study data received by the Sponsor will be the responsibility 
of the Sponsor or its Designee.  The use or disclosure of all protected health 
information will comply with the Health Insurance Portability and Accountability 
Act (HIPAA).  All information will be treated with strict adherence to professional 
standards of confidentiality and will be filed by the Sponsor under adequate security 
and restricted accessibility by clinical personnel.  All electronic systems used to 
create, modify, maintain, or transmit study records will be validated according to 21 
CFR Part 11(ii).  Reports and communications relating to study subjects will 
typically identify each subject only by the subject’s initials, assigned study subject 
Case ID number, date of surgery, operative side, and date of birth.   
 
A. Prior to Initiation of the Study 
1. Clinical Trial Agreement (CTA) 
A fully executed (signed by all required parties) CTA must be on file with 
the Sponsor prior to any investigator participating in this study. 
 
2. Institutional Review Board/Ethics Committee Protocol Approval 
This study protocol must be submitted to and approved by the 
Investigator’s Institutional Review Board (IRB) or Ethics Committee (EC).  
A copy of the IRB or EC approval letter must be submitted to the Sponsor.   
The letter should identify the following: 
 Protocol name and/or number 
 Date of IRB or EC meeting (if available) 
 Date of approval 
 Date of expiration 
 Signature of IRB or EC 
 

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3. Informed Consent 
A Sponsor-approved Informed Consent template will be provided along 
with the study protocol for IRB or EC submission and approval. If the IRB 
or EC requires revisions to the provided Informed Consent, the requested 
revisions must be submitted by the Investigator to the Sponsor for review 
and approval.  Once the Sponsor has reviewed and approved the revision, 
the Informed Consent will be re-submitted to the IRB or EC for final 
review and approval.  A copy of the final IRB or EC approved Informed 
Consent form (ICF) must be submitted to the Sponsor. 
 
4. ClinicalTrials.gov Registration 
The Sponsor will be responsible for registering this study on 
www.ClinicalTrials.gov if required by local and national regulations. 
 
B. Clinical Data Collection/Submission 
1. Summary of Case Report Form Data Collection 
a. Study data will be collected on source documents which may 
include study-specific worksheets provided by the Sponsor.  For 
subjects having bilateral proximal femur facture treatment, separate 
case report forms must be completed for each operative side. 
 
b. The following source document/CRF completion guidelines should 
be followed: 
i. Complete carefully and accurately. 
ii. Complete header information consistently across all case 
report forms for each individual study subject (when study-
specific CRFs are used). 
iii. Be sure that data on the source documents match that which 
is entered through the electronic data capture (EDC) system 
iv. Use the study subject’s unique Case ID number assigned as 
instructed. Do not provide information that is not requested 
on the CRFs. 
v. Ensure that all fields are completed.  For fields completed 
by the subject, efforts should be made to obtain any missing 
responses prior to the subject completing their visit. 
 
2. Data Submission 
a. Completed CRFs will be submitted directly to the Sponsor by 
electronic data capture and submission via a method approved by 

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the Sponsor.  Every effort must be made to ensure data submission 
to the Sponsor is made within 30 days of the visit completion. 
 
3. Quality Assurance of Data 
a. The Investigator should ensure the accuracy, completeness, 
legibility, and timeliness of the data reported to the Sponsor in the 
CRFs and in all required reports.  Data reported on the CRF, which 
are derived from source documents, should be consistent with the 
source documents or the discrepancies should be explained.  All 
electronic systems used to create, modify, maintain, or transmit 
electronic study records will be validated according to 21 CFR Part 
11(ii).  The Sponsor will maintain quality control systems, in 
accordance with the Sponsor’s policies and procedures. 
 
C. Reporting Requirements 
1. Investigator Reporting Responsibilities 
The Investigator should ensure the accuracy, completeness, legibility, and 
timeliness of data reported to the Sponsor in accordance with this protocol.  
The Investigator or Designee will provide periodic reports to their IRB or 
EC as required to maintain IRB or EC approval throughout the study, and 
will provide any required final reporting to the IRB or EC upon study 
completion/termination.  A copy of all IRB or EC re-approval letters must 
be submitted to the Sponsor.  If the IRB or EC terminates or suspends its 
approval of the study, the Investigator or Designee will suspend study-
related activities and will promptly notify the Sponsor.  The Investigator 
should also promptly provide written reports to the Sponsor and the IRB or 
EC regarding any changes significantly affecting the conduct of the study, 
and/or increasing risk to the subjects. 
 
2. Retention of Records 
Study records must be retained by the Investigator or Designee for a 
minimum of 2 years from the Investigator’s study termination date, or per 
applicable regulatory and/or IRB or EC requirements (whichever time 
period is greater).  Measures shall be taken to prevent accidental or 
premature destruction. 
 
D. Management of Incurrent Events 
1. Failure to Obtain Informed Consent 
Study data will not be collected until the Informed Consent has been 

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signed and dated by the candidate.  If a candidate does not wish to 
participate (does not sign and date the Informed Consent), data for that 
candidate will not be collected for this study. 
 
2. Adverse Events 
An adverse event is any unfavorable or unintended sign, symptom, or 
disease that impacts the subject.  Adverse event is synonymous with 
complication or medical event. 
 
See Section IX, Subsection E of this protocol for additional information 
regarding adverse event classifications.  Femur related, serious, and 
unanticipated events are required to be reported on the Adverse Event 
Report case report form.  The completed Adverse Event Report case 
report form must be submitted to the Sponsor in a timely manner.  The 
Investigator or Designee will also promptly provide the Sponsor with any 
additional requested information required for the Sponsor to comply with 
regulatory requirements.  If applicable per their reporting requirements, the 
Investigator or Designee will also report applicable adverse event(s) to 
their IRB or EC. 
 
3. Revision 
In the event that removal of one or more of the study related components is 
necessary (due to complication), the Investigator will determine the best 
treatment and/or revision method for the subject.  Once the revision 
surgery has been completed, the Investigator or qualified Designee must 
complete an Adverse Event Report case report form as well as a Study 
Completion case report form terminating the subject from the study.  
 
4. Investigator Withdrawal 
The Investigator can choose to withdraw a subject from the study if the 
subject no longer meets study inclusion/exclusion criteria.  The reason for 
the Investigator’s withdrawal of the subject must be documented on the 
Study Completion case report form. 
 
5. Subject Withdrawal 
Study subjects may choose to withdraw from the study at any time, for any 
reason.  If possible, a final evaluation will be completed for any subject 
who no longer wishes to participate in the study.  The reason for the 
subject withdrawal must be documented on the Study Completion case 
report form. 

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6. Lost to Follow-up 
A study subject will be considered lost to follow-up after they have missed 
a visit and a reasonable number of attempts to locate and evaluate them 
have failed.  All attempts to contact the subject are to be documented in the 
subject’s medical record and on the Study Completion case report form. 
In particular, the reason for the Study Completion must be documented. 
Missed visit(s) also must be documented using the Protocol Deviation 
case report form, unless the visit is retrospective.  
 
7. Protocol Deviations 
Investigators should not deviate from the study protocol.  If a protocol 
deviation does occur, the deviation must be documented on the Protocol 
Deviation case report form and submitted to the Sponsor.  If applicable per 
their reporting requirements, the Investigator or Designee will also report 
applicable protocol deviations to their IRB or EC. 
 
8. Study Termination 
Study subject participation is expected to end upon completion of the 
subject’s 1 year follow-up visit unless the subject voluntarily withdraws 
from the study, is withdrawn from the study by the Investigator, is lost to 
follow-up, undergoes revision to remove a study device, (due to 
complication) including partial removal i.e. screw, or expires. Reason(s) 
for study completion must be documented on the Study Completion case 
report form. 
 
If the Sponsor decides to terminate the study early, the Sponsor will inform 
the Investigators of the reason for early study termination.  It is the 
responsibility of the Investigators to inform their IRB or EC as applicable 
according to local and national laws/regulations. 
 
9. Modification of the Protocol 
All amendments to this clinical protocol shall be agreed to by the Sponsor 
and be recorded with a justification for the amendment prior to 
implementation.  Approval of the applicable IRB or EC must be obtained 
prior to implementation, if required according to the local and/or national 
laws/regulations. 

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E. Medical Events/Adverse Events Definitions and Classifications 
An adverse event is any unfavorable or unintended sign, symptom, or disease that 
impacts the subject.  Adverse event is synonymous with complication or medical 
event.   
 
Adverse events are required to be reported on the Adverse Event Report 
case report form.  The completed Adverse Event Report case report form 
must be submitted to the Sponsor in a timely manner.  The Investigator or 
Designee will also promptly provide the Sponsor with any additional requested 
information required for the Sponsor to comply with regulatory requirements.  
If applicable per their reporting requirements, the Investigator or Designee will 
also report applicable adverse event(s) to their IRB or EC. 
 
1. Classification of the Event 
Adverse Event (AE): 
An adverse event is any unfavorable or unintended sign, symptom, or 
disease that impacts the subject.   
 
Serious Adverse Event (SAE)(i): 
A Serious Adverse Event is 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 impairment to 
a body structure or a body function 
c. led to fetal distress, fetal death or a congenital abnormality 
or birth defect. 
 
Note: Planned hospitalization for a pre-existing condition, or a 
procedure required by the protocol, without serious deterioration in 
health, is not considered a serious adverse event. 
 
Adverse Device Effect (ADE)(i): 

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An Adverse Device Effect is an adverse event related to the use of a 
medical device. 
 
Note 1: This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation, or any malfunction of the 
medical device. 
 
Note 2: This definition includes any event resulting from use error or 
from intentional misuse of the medical device. 
 
Serious Adverse Device Effect (SADE)(i): 
A Serious Adverse Device Effect is an adverse device effect that has 
resulted in any of the consequences characteristic of a serious adverse 
event. 
 
The Sponsor is responsible for determining the final classification of adverse 
events. 
 
If an Unanticipated Serious Adverse Device Effect (USADE) is identified by 
the Sponsor, it will be promptly reported to concerned Investigators and 
regulatory authorities as required by applicable regulatory requirements.  If 
applicable per their reporting requirements, the Investigator or Designee will 
report the USADE to their IRB or EC. 
 
2. Intensity of Symptoms 
Mild: 
The subject is aware of the sign or symptom, but finds it easily 
tolerated.  The event is of little concern to the subject and/or little 
clinical significance.  The event is not expected to have any effect on 
the subject’s overall health or well-being. 
 
Moderate: 
The subject has discomfort enough to cause interference with or 
change in usual activities.   The event is of some concern to the 
subject’s health or well-being and may require medical intervention 
and/or close follow-up. 
 
Severe: 
The event interferes considerable with the subject’s usual activities.  

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The event is of definite concern to the subject and/or poses 
substantial risk to the subject’s health or well- being.  The event is 
likely to require medical intervention and/or close follow-up and may 
be incapacitating or life threatening.  Hospitalization and treatment 
may be required. 
 
NOTE:  The term “severe” refers to the intensity of the event and 
can be used with any event, without regard to whether or not it meets 
the criteria for being classified as “serious” or “unanticipated”.  For 
example, a subject can have a severe headache, but it is not a serious 
event. 
 
3. Outcome Definitions 
The outcome is in relationship to the Adverse Event, not the treatment 
rendered for the event (if any). 
 
Resolved: 
The adverse event has been resolved and/or no further treatment is 
required to treat the reported condition or illness. 
 
Tolerated: 
The adverse event will most likely never be resolved.  The subject 
“tolerates” the illness or condition as a matter of life. 
 
Pending: 
Treatment or diagnostic studies were prescribed for the adverse 
event and the outcome of the adverse event is not yet known. 
 
Study Withdrawal: 
Due to the adverse event, the subject was withdrawn from the study. 
 
Device Removal: 
The adverse event resulted in the removal of a study device. 
 
Reoperation of Affected Joint: 
The adverse event resulted in reoperation of the study joint, but the 
reoperation did not include removal of a study device. 
 
Death: 
The outcome indicates the subject died as a direct result of the 

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reported adverse event. 
 
F. Monitoring of the Study 
Prior to initiating the clinical study, the Sponsor may conduct a site initiation 
visit to ensure the Investigator(s) and study staff understands the study 
protocol and requirements and have adequate time and resources to implement 
and conduct the study.  Prior to study initiation, the Investigator must have a 
fully executed CTA and IRB or EC approval of the study protocol and the 
study Informed Consent. 
 
During the course of the study, the Sponsor will conduct periodic central 
monitoring and maintain contact with the study staff to monitor compliance 
and evidence of adverse events, in accordance with the Sponsor’s policies and 
procedures.  The Sponsor will address any identified non-compliance with the 
executed CTA, study protocol, and applicable regulatory requirements. 
 
If onsite monitoring visit(s) are deemed appropriate by the Sponsor, the 
Investigator will permit representatives of the Sponsor’s monitoring team to 
have direct access to inspect all source data/documents, study 
documents/binders, study subject case report forms, corresponding sections of 
study subject medical/hospital records, and any other documents relevant to the 
study.  All Sponsor visits (including site initiation) will be documented using 
the Monitoring Visit Log. 
X. 
Risk Analysis 
This post-market clinical study is classified as minimal risk(ii) and there are no 
anticipated risks specific to study participation other than the potential loss of 
confidentiality.  There are no experimental procedures in this study, and 
participation in this study is not anticipated to affect the medical treatment of 
enrolled subjects.  
 
When used in accordance with product labelling, the risks associated with the 
use of the THP System are similar to those of standard femoral neck or 
intertrochanteric fracture treatment system used for the same clinical indication 
or purpose. Unanticipated adverse events can also occur.  
 
For general surgical risks, please refer to the FDA cleared instructions for use 
for this product.  

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XI. 
Statistical Considerations 
Performance of the commercially available THP System for treatment of 
femoral neck fractures or intertrochanteric fractures will be evaluated for 
fracture healing, pain, function, quality of life, and survivorship.  Data collected 
in this study will be summarized descriptively and descriptive summaries will 
be the basis of any study reports issued.  These summaries may be used for 
interim study reports and may also be used to support regulatory submissions, 
presentations, and/or publications.  Additional surgical technique and 
instrumentation data may be collected and evaluated. 
 
A. General Statistical Methods 
Statistical methodology will consist of summarizing collected data descriptively.  
Categorical data (e.g., gender or race) will be summarized using counts and 
percentages, and 95% Confidence Interval (CI), over the time periods of interest. 
Continuous data, such as age, will be summarized by using means, medians, 
standard deviation, minimum, maximum, and 95% CI over the time periods of 
interest.  Implant survival and return to function will be summarized using a 
Kaplan-Meier method and presented with rates (as percentages) and confidence 
intervals. 
 
B. Sample Size 
Due to the different historical revision rates for intertrochanteric fractures 
(~7%)[1] and intracapsular fractures (~20%)[2], study enrollment will be split 
between the two groups to maintain the integrity of the sample size with an 
expectant lost to follow-up rate of 15%. Intertrochanteric fractures will be 
limited to a maximum of 89 enrolled subjects and intracapsular fractures will be 
limited to a maximum of 101 enrolled subjects. This will provide enough 
evaluable data for both indications to show the necessary statistical improvement 
from the historical revision rates[1][2]. The assumed revision rate of the THP Hip 
Fracture Plating System is 15% for intracapsular fractures and 5% for 
intertrochanteric fractures with a non-inferiority margin of 8%. 

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XII. References 
[1] Matre K, Havelin LI, Gjertsen JE, Vinje T, Espehaug B, Fevang JM. Sliding 
hip screw versus IM nail in reverse oblique trochanteric and subtrochanteric 
fractures. A study of 2716 patients in the Norwegian Hip Fracture Register. 
Injury. 2013 Jun;44(6):735-42. 
[2] Fixation using Alternative Implants for the Treatment of Hip fractures 
(FAITH) Investigators. Fracture fixation in the operative management of hip 
fractures (FAITH): an international, multicentre, randomised controlled 
trial. Lancet. 2017 Apr 15; 389(10078):1519-1527. 
[3] Stiasny J, Dragan S, Kulej M,  et al. Comparison analysis of the operative 
treatment results of the femoral neck fractures using side-plate and 
compression screw and cannulated AO screws. Ortop Traumatol Rehabil. 
2008 Jul-Aug; 10(4): 350-61. 
[4] Frank T, Osterhoff G, Sprague S, Garibaldi A, Bhandari M, Slobogean GP; 
FAITH Investigators. The Radiographic Union Score for Hip (RUSH) 
Identifies Radiographic Nonunion of Femoral Neck Fractures. Clin Orthop 
Relat Res. 2016 Jun;474(6):1396-404. 
 
 
Guideline Reference: 
i. 
ISO 14155:2011(E). International Standard for Clinical investigation of medical 
devices for human subjects – Good clinical practice 
ii. 
Code of Federal Regulations 
1. Code of Federal Regulations, Title 21, Part 11: Electronic Records; 
Electronic Signatures 
2. Code of Federal Regulations, Title 21, Part 50: Protection of Human Subjects 
3. Code of Federal Regulations, Title 21, Part 56: Institutional Review Boards 
 
XIII. Appendices: 
 
Appendix A Sample Informed Consent  
 
Appendix B Case Report Forms 
 
Appendix C Study Logs