N-Force Screws Augmented With N-Force Blue in Intracapsular Proximal Femur Fracture Treatment
Phase: NA
Conditions: Intracapsular Proximal Femur Fracture, Garden Grade I Subcapital Fracture of Femoral Neck, Garden Grade II Subcapital Fracture of Femoral Neck
Sponsor: Zimmer Biomet

N-Force Screws Augmented With N-Force
Blue in Intracapsular Proximal Femur
Fracture Treatment
Post Market Clinical 
Follow-Up Study 
(PMCF) 
Protocol # CMU2017-60T 
Region: United States 
[20JAN2020] – Version 3.0 
Previous Versions: v2 [18JUN2018]; v1 [9MAY2018] 
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 #: NCT03807349

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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 
1. 
Inclusion Criteria .......................................................................................................................... 10 
1. 
Exclusion Criteria ......................................................................................................................... 11 
VII. 
Study Device Information ............................................................................................................ 11 
VIII. Study Procedures .......................................................................................................................... 12 
A. Offer Study Participation .............................................................................................................. 12 
B. 
Informed Consent Process ............................................................................................................ 13 
C. 
Informed Consent / Enrollment Log ............................................................................................. 13 
D. Subject Enrollment ....................................................................................................................... 14 
E. 
Monitor Log ................................................................................................................................. 14 
F. 
Delegation of Authority (Site Signature Log) .............................................................................. 14 
G. Baseline/Pre-operative Assessment .............................................................................................. 14 
H. Surgical Technique ....................................................................................................................... 15 
I. 
Surgical, Immediate Post-surgical Procedures and Discharge (Data Collection) ......................... 15 
J. 
Post-surgical management ............................................................................................................ 15 
K. Post-operative Follow-up Procedures (Data Collection) .............................................................. 15 
L. 
Minimization of Subjects Lost to Follow-up ................................................................................ 16 
M. 
Radiographic Definitions and Methods .................................................................................... 16 
N. Recommended Revision Procedure .............................................................................................. 20 
IX. 
Reporting ...................................................................................................................................... 20 
A. Prior to Initiation of the Study ...................................................................................................... 20 
B. 
Clinical Data Collection/Submission............................................................................................ 21 
C. 
Reporting Requirements ............................................................................................................... 22 
D. Management of Incurrent Events ................................................................................................. 22 
E. 
Medical Events/Adverse Events Definitions and Classifications ................................................. 25 
F. 
Monitoring of the Study ............................................................................................................... 28 
X. Risk Analysis .................................................................................................................................... 29 

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XI. 
Statistical Considerations ............................................................................................................. 29 
A. General Statistical Methods.......................................................................................................... 29 
B. 
Sample Size .................................................................................................................................. 29 
XII. 
Quality Control & Quality Assurance .......................................................................................... 30 
XIII. Suspension or Premature Termination of the Clinical Investigation1 .......................................... 30 
XIV. Amendments to the Clinical Investigation Plan ........................................................................... 31 
XV. 
Publication Policy ........................................................................................................................ 31 
XVI. Document History ........................................................................................................................ 31 
References ................................................................................................................................................ 32 
II. 
Appendices: ...................................................................................................................................... 33 
 
 
 

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I. 
Study Synopsis 
 
Study Title 
N-Force Screws augmented with N-Force Blue in 
Intracapsular Proximal Femur Fracture Treatment 
Abbreviated Study Title 
N-Force Study 
Sponsor 
Zimmer Biomet, Warsaw, Indiana 
Protocol Number 
CMU2017-60T 
Anticipated Start Date 
Q4 2018 
Study Objectives 
The objective of this prospective study is to confirm safety 
and performance of N-Force Screws augmented with N-
Force Blue applied in intracapsular proximal femur fracture 
treatment. 
 
Further results will be compared to non-augmented standard 
cannulated screws (historic control). 
 
Primary Endpoint: 
 Re-operation within 12 months after initial surgery to 
promote fracture healing, relieve pain, treat infection, 
or improve function[4]. 
 
Secondary Endpoints: 
 Radiographic and clinical fracture healing of the 
proximal femur using standard scoring methods and 
patient satisfaction. 
 Cost effectiveness 
Target Population 
Patients with primary Garden I and II intracapsular proximal 
femur fractures requiring surgical intervention and eligible 
for fixation by three cannulated screws augmented with N-
Force Blue. 
Study Design 
Multicenter, prospective, non-controlled clinical study  
Study Type 
Post-market clinical follow-up study (PMCF) 
Sample Size 
190 Subjects (151 + 20% anticipated lost to follow-up) 
Length of Study 
3 years (1 year enrollment, 1 year follow-up and 1 year study 
close-out) 
Follow-up Intervals 
6 weeks, 3 months, 6 months and 12 months after surgery 
Inclusion/Exclusion Criteria 
Inclusion Criteria: 
 Patient has primary Garden I or II intracapsular 
proximal femur fracture requiring surgical 
intervention and is eligible for fixation by three 
cannulated screws augmented with N-Force Blue. 

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 Patient receives operative treatment within 7 days of 
injury. 
 Patient was ambulatory before injury. 
 Patient is 50 years of age or older.  
 
Exclusion Criteria: 
 Patient has Garden III or IV intracapsular proximal 
femur fracture. 
 Patient has major cognitive impairment (including 
dementia).  
 Patient is on dialysis. 
 Patient is not expected to survive follow-up schedule. 
 Patient is expected to have problems maintaining 
follow-up compliance, i.e. patients with no fixed 
address, patients not mentally competent to give 
informed consent, etc. (Investigator’s discretion). 
 Patient is a prisoner. 
 Patient is known to be pregnant and/or breastfeeding. 
 Patient is a known alcohol or drug abuser.  
 Patient had previous/has active acute or chronic 
infections, especially at the site of operation. 
 Patient has non-viable bone, or has areas where 
surrounding bone is not viable or capable of 
supporting and anchoring the implant.  
 Patient has traumatic injuries with open wounds or 
close to the proximal femur fracture, which are likely 
to become infected.  
 Patient is expected to be non-compliant with 
recommended post-operative weight-bearing 
instructions. 
 Physical conditions, in the opinion of the investigator, 
that would prohibit adequate implant support or 
impede healing. 
Study Device 
N-Force Fixation System 7.3 mm (Non-
fenestrated/fenestrated) applied with washers; N-Force Blue 
(Bone Substitute Material) 
Outcome Measures 
 RUSH Score 
 FIX-IT 
 Avascular necrosis (Steinberg classification) rate at 
12 months follow-up 
 Harris Hip Score 
 Timed “Up-And-Go” Test 
 EQ-5D-5L 
 Adverse Events 

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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 compliant with ISO 14155 Standard for Clinical Investigation of Medical Devices For 
Human Subjects – Good Clinical Practice [1] , is in accordance with US Code of Federal Regulations 21 
CFR Parts 11, 50 and 56 2, and The Declaration of Helsinki (DoH) – Ethical principles for medical 
research involving human subjects.   
 
 

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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 
Pre-op 
Operative & 
Discharge 
6 weeks 
Post-op  
(±- 14 days) 
3 months 
Post-op  
(± 30 days) 
6 months 
Post-op 
(± 60 days) 
12 months 
Post-op 
(± 90 days) 
Revision 
Informed Consent 
X 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
 
 
 
Demographic Evaluation 
X 
 
 
 
 
 
 
Operative & Surgical Device 
Information 
 
X 
 
 
 
 
 
Postoperative Discharge 
Assessment 
 
X 
 
 
 
 
 
Timed “Up and Go” Test 
 
 
X 
X 
X 
X 
 
X-rays (A/P and Lateral – 
Operated Side) 
X 
X 
X 
X 
X 
X 
X 
EQ-5D-5L 
 
 
 
 
 
 
 
Postoperative Follow-Up 
 
 
X 
X 
X 
X 
 
FIX-IT Score 
 
 
X 
X 
X 
X 
 
Harris Hip Score 
 
 
X 
X 
X 
X 
 
Study Completion 
 
* 
* 
* 
* 
* 
X 
**Adverse Event 
(Complication) 
* 
* 
* 
* 
* 
* 
X 
Protocol Deviation 
* 
* 
* 
* 
* 
* 
* 
Physician Radiographic 
Assessment (including RUSH) 
 
 
* 
* 
* 
* 
* 
 Steinberg Classification 
 
 
 
 
 
* 
 
Explanted Device 
 
* 
* 
* 
* 
* 
* 
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 forwarded to the sponsor within 
7 days of occurrence.  Supporting documents must be 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 
Intracapsular Proximal Femur Fractures are a common injury especially in the elderly 
population. Optimal treatment remains controversial. Frequently applied operative 
treatments include three cannulated screws, sliding hip screw, hemi- and total arthroplasty. 
AAOS Guidelines for femoral neck fractures in the elderly recommend operative fixation 
for stable non-displaced fractures and arthroplasty for unstable displaced fractures. In a 
recent landmark randomized trial including more than one thousand patients comparing 
sliding hip to cannulated screws, every fifth patient had to be repeated to promote fractures 

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healing [4]. Reoperation rates of 20% for sliding hip screw and 22% for cannulated screw 
were found; however, the difference was not statistically significant. 
 
Zimmer Biomet offers a Hip Screw technology that is capable of delivering a Bone 
Substitute Material (BSM) to the fracture-implant interface for fixation of fractures of the 
femoral neck [5][6]. This device allows hard setting BSM to the precise location, providing a 
multi-dimensional fixation that is critical to reduce the chance of joint collapse and 
articular fragment displacement and ultimately could reduce the high reoperation rates 
reported for this kind of injury.  
 
This study will assess the reoperation rates, including revision, and document the clinical 
and radiographic outcomes of hip fracture patients, utilizing the N-Force Fixation System. 
Results will be compared to “standard” non-augmented cannulated screw (historic control). 
IV. 
Study Objectives 
The objective of this prospective study is to assess safety and performance of N-Force 
Screws augmented with N-Force Blue applied in intracapsular proximal femur fracture 
treatment. Further results will be compared to non-augmented standard cannulated screws 
(historic control). 
 
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 fracture healing (union) rate at 6 weeks, 
3 months, 6 months, and 12 months postoperatively.   
The primary endpoint of this study is defined as re-operation within 12 months after initial 
surgery.  Reoperation is defined as a second surgery to correct the previous procedure or the 
complications of a previous surgery.  For this study, reoperation will include second 
surgeries to promote fracture healing, relieve pain, treat infection, or improve function 
including:  
 Removal of the implant prior to fracture healing 
 Internal fixation with another implant during revision surgery 
 Revision to total hip arthroplasty 
 Incision and drainage or other soft tissue procedure due to deep infection at the 
bone implant interface. 
Secondary endpoints of this study include: 

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 Clinical (FIX-IT) and radiologic (RUSH) [8][9] fracture healing at 6 weeks, 3, 6 and 12 
months post-surgery. 
 Length of femoral neck 1.a.[7] 
 Proportion of patients with avascular necrosis at one year FUP (Steinberg classification) 
 Functional Index for Trauma (FIX-IT) [10] 
 Harris Hip Score [11] 
 Timed “Up-And-Go” Test [12] 
 EQ-5D-5L 
 Adverse events (complications)  
Additionally, a cost effective analysis comparing N-Force to standard non-augmented 
cannulated screws will be performed. 
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. 
V. 
Study Design 
This is a prospective, multicenter, non-controlled clinical study designed to facilitate the 
collection and evaluation of fracture healing, pain, function, quality of life, radiographic 
assessment, and adverse event data.  A maximum of 16 sites will contribute to this study.  
Enrollment per site will be approximately 12 implanted devices with a site maximum of 47 
(25% of total study population).  Each Investigator will be skilled in proximal femur 
fracture treatment and experienced implanting the devices included in this study, as 
determined by the Sponsor. 
 
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 proximal femur fracture 
treatment using the commercially available (FDA cleared) N-Force Screws augmented with 
N-Force Blue.  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 

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with the subject. Patients who have previously received N-Force Screws augmented with 
N-Force Blue 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 pre-
operative and operative data 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 participation postoperatively. The consented 
patients will be followed prospectively at designated follow-up visits if all appropriate 
Ethics Committee approvals and patient consent is obtained. The post-operative clinical 
and radiographic evaluations will be conducted at 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 the incidence of loss of reduction, implant migration and 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 require intracapsular proximal femur fracture repair and satisfy the 
inclusion/exclusion criteria outlined in this section of the protocol.   In total, one-hundred-
and-ninety (190) patients will be enrolled. 
 
In order to avoid potential selection bias, each Investigator will offer study participation to 
each consecutive eligible patient presenting as a candidate for intracapsular femur fracture 
repair using the commercially available (FDA cleared) N-Force Screws augmented with N-
Force Blue.  Eligible candidates who express interest in study participation will be offered 
Informed Consent.  The Inclusion/Exclusion Criteria case report form should not be 
completed until the study-specific consent form has been completed.  
 
1. Inclusion Criteria 
 Patient has primary Garden I or II intracapsular proximal femur fracture requiring 
surgical intervention and is eligible for fixation by three cannulated screws 
augmented with N-Force Blue. 
 Patient receives operative treatment within 7 days of injury. 
 Patient was ambulatory before injury. 

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 Patient is 50 years of age or older.  
 
Note:  Patients who have previously received N-Force Screws augmented with N-
Force Blue may be enrolled in the study if informed consent occurs prior to the end 
of the 6 weeks follow-up visit window. 
1. Exclusion Criteria 
 Patient has Garden III or IV intracapsular proximal femur fracture. 
 Patient has major cognitive impairment (including dementia).  
 Patient is on dialysis. 
 Patient is not expected to survive follow-up schedule. 
 Patient is expected to have problems maintaining follow-up compliance, i.e. 
patients with no fixed address, patients not mentally competent to give informed 
consent, etc. (Investigator’s discretion). 
 Patient is a prisoner. 
 Patient is known to be pregnant and/or breastfeeding. 
 Patient is a known alcohol or drug abuser.  
 Patient had previous/has active acute or chronic infections, especially at the site 
of operation. 
 Patient has non-viable bone, or has areas where surrounding bone is not viable or 
capable of supporting and anchoring the implant.  
 Patient has traumatic injuries with open wounds or close to the proximal femur 
fracture, which are likely to become infected.  
 Patient is expected to be non-compliant with recommended post-operative 
weight-bearing instructions. 
 Physical conditions, in the opinion of the investigator, that would prohibit 
adequate implant support or impede healing.  
*Inclusion/Exclusion criteria address the N-Force Screw, N-Force Delivery System, 
and N-Force Blue 
VII. Study Device Information 
The N-Force Fixation System is designed to provide fracture fixation and stabilization of 
femoral neck fractures by the use of the N-Force 7.3mm Fenestrated and Non-Fenestrated 
Screws (Figure 1) (N-Force 4.0mm screws will not be used in this study). N-Force 7.3mm 
is intended for use in the femoral neck fractures of the proximal femur. Washers are 
available for use with the 7.3mm Screw design. 
 

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Figure 1: left 7.3 mm Non-Fenestrated Screw, right 7.3 mm Fenestrated Screw 
 
The N-Force Fixation System Screws and Washers are fabricated from Titanium alloy (Ti-
6AL-4V) and are biocompatible for human implantation.  
 
The N-Force Fixation System is designed to be used with the N-Force Blue Mixing & 
Delivery System (Figure 2). These components are single use instruments designed to be 
used for the mixing of bone substitute materials.  
 
 
Figure 2: 
 
The N-Force Blue Porous Bone Substitute material is a synthetic, biocompatible bone graft 
substitute material that forms a poorly crystalline hydroxyapatite at body temperature. It is 
provided in a single patient, single use kits in various volumes appropriate to the surgical 
site.  
VIII. Study Procedures 
 
A. Offer Study Participation 
Study participation will be offered to each consecutive eligible patient presenting 
as a potential candidate for intracapsular proximal femur fracture repair using the 
commercially available (FDA cleared) N-Force Screws with N-Force Blue.  
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.   
 

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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.  
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 

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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.  After a subject receives the study device during surgery, the date of 
surgery will be added to the log.  The subject will now be considered an active 
study subject.  In the event that a subject does not receive the study device at the 
time of surgery, a Study Completion case report form must be submitted and this 
will be documented as a screen failure on the Informed Consent/Enrollment Log. 
 
D. Subject Enrollment 
Once the Informed Consent has been signed and dated by the subject or delegated 
signatory, 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.  In 
the event that the subject does not receive the study device at the time of surgery, 
the subject will be considered a screen failure and documented on the Informed 
Consent/Enrollment Log (see above). 
 
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. 
 
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 Assessment 
Baseline/pre-operative data will be collected on the following case report forms 
at the time of enrollment: 
1. Informed Consent 

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2. Inclusion/Exclusion Criteria 
3. Demographic Evaluation 
4. Adverse Event Report(s) (as applicable) 
5. Protocol Deviation(s) (as applicable) 
 
 
H. Surgical Technique 
Standard operative procedures will be followed and all surgical procedures will 
be performed under aseptic conditions.  Investigators will implant all 
commercially available N-Force Screws with N-Force Blue and any other 
compatible products in compliance with corresponding labeling requirements 
and in accordance with appropriate surgical technique(s). 
 
I. Surgical, Immediate Post-surgical Procedures and Discharge (Data 
Collection) 
Surgical and immediate post-surgical data will be collected on the following 
case report forms: 
1. Operative and Surgical Device Information 
2. X-rays (AP and Lateral) 
3. Postoperative Discharge Assessment 
4. Adverse Event Report(s) (as applicable) 
5. Protocol Deviation(s) (as applicable) 
6. Explanted Device Form (as applicable) 
7. Study Completion (as applicable) 
J. Post-surgical management 
Post-surgical management for study subjects will follow the investigator’s 
standard of care for patients undergoing intracapsular proximal femur fracture. 
Post-surgical rehabilitative therapy will be as prescribed by the investigator. 
 
K. Post-operative Follow-up Procedures (Data Collection) 
Post-operative clinical evaluations/assessments will be conducted at 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 each interval: 
1. Postoperative Follow-up 
2. X-rays (AP and Lateral) 
3. Physician Radiograph Assessment including RUSH  

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4. Steinberg Classification (12 months Follow-Up only) 
5. EQ-5D-5L 
6. FIX-IT 
7. Timed “Up and Go” Test 
8. Harris Hip Score 
9. Adverse Event Reports(s) (as applicable) 
10. Protocol Deviation(s) (as applicable) 
11. Explanted Device Form (as applicable) 
12. Study Completion (as applicable) 
 
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), or expires.  See Management of 
Incurrent Events (Section IX, Subsection D of this protocol) for additional 
details.  Reason(s) for study completion must be documented on the Study 
Completion case report form. 
 
L. 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. 
 
M. 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 Assessment of Post-op Radiographs 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 Physicians Assessment of 
Post-op Radiograph case report form, or for any other findings identified as an 
adverse event. 
 
 
 
 

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o Method to derive the length of the femoral neck: 
1. Draw a line along the femoral shaft axis. 
2. Draw a line along the femoral neck axis. 
3. Measure the distance CD (blue line) in millimeter. 
4. Measure the distance AB (red line) of the inferior screw in millimeter. 
To adjust for x-ray magnification the actual length of the femoral neck will be 
calculated using the following formula: 
𝐿𝑒𝑛𝑔𝑡ℎ 𝑜𝑓 𝑡ℎ𝑒 𝑓𝑒𝑚𝑜𝑟𝑎𝑙 𝑛𝑒𝑐𝑘 [𝑚𝑚] = 𝐶𝐷𝑚𝑒𝑎𝑠𝑢𝑟𝑒𝑑×
𝐴𝐵𝑡𝑟𝑢𝑒 
𝐴𝐵𝑚𝑒𝑎𝑠𝑢𝑟𝑒𝑑
 
𝐴𝐵𝑡𝑟𝑢𝑒= 𝐾𝑛𝑜𝑤𝑛 𝑠𝑐𝑟𝑒𝑤 𝑙𝑒𝑛𝑔𝑡ℎ [mm]. 
 
 
 
 
 

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o Non-union definition: A total RUSH score below 18 at six month post-surgery 
is considered a non-union [9]. 
 RUSH scoring examples: 
 

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1. Required radiographic views 
Standing anteroposterior (AP) (a supine AP view will be accepted if the 
patient is unable to stand), and standard lateral radiographs of the operative 
femur are required to be captured at the pre-op, operative/post-op, 6 weeks, 
3 months, 6 months, and 12 months post-surgery. 
 
Radiographs should have similar exposure and must show the entire study 
device and surrounding bone.  For consistency, every effort should be made 
to capture all radiographic views for a given subject using the same 
institution throughout the study.  However, radiographs captured at a 
different institution may be used for the study, provided they meet required 
study specifications and are captured within the required interval window.  
The investigative site will retain copies (hard copy/CD/digital) of all 
radiographs referenced for the study. 
 
2. Submission to Sponsor 
At the Sponsor’s discretion, study radiographs may be requested from the 
sites for independent radiographic review and assessment of appropriate 
parameters. 
 

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N. Recommended Revision Procedure 
See Management of Incurrent Events (Section IX, Subsection D of this protocol) 
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 
 
 
3. Informed Consent 
A Sponsor-approved Informed Consent template (Appendix A Sample) 
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 

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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 intracapsular 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 
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 

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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(2).  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 
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 

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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. 
 
Prior to revision surgery, the Investigator or qualified Designee must 
document any significant radiographic findings related to the need for 
revision on the Physician Assessment of Postop Radiographs case report 
form.  An Adverse Event case report form must be completed for those 
findings indicated by an asterisk on the Physicians Assessment of Postop 
Radiograph case report form. 
 
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.  For the study completion status, select “Study Device 
Removed”.  This procedure also applies to partial revisions e.g. removal of 
one of the three screws. 
 
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 

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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. 
 
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 one 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), 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 

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laws/regulations. 
 
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. 
 
The following definitions are from ISO 14155:2011. 
 
1. Classification of the Event 
Adverse Event (AE): 
An adverse event 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.  
 
Note 1: This definition includes events related to the investigational 
device or the comparator.  
 
Note 2: This definition includes events related to the procedures 
involved.  
 
Note 3: For users or other persons, this definition is restricted to events 
related to investigational medical devices.   
 
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 

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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): 
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. 
 
 

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Device Deficiency: 
A Device Deficiency is defined as an inadequacy of medical device 
with respect to its identity, quality, durability, reliability, safety or 
performance.  
 
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.  
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. 
 

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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 reoperation and removal of a study 
device. 
 
Reoperation of Affected Hip: 
The adverse event resulted in reoperation of the fracture, but the 
reoperation did not include removal of a study device. 
 
Death: 
The outcome indicates the subject died as a direct result of the 
reported adverse event. 
 
F. Monitoring of the Study 
Prior to initiating the clinical study, the Sponsor may conduct a site evaluation 
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 

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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 Site Monitoring Visit Log (Appendix C). 
X. 
Risk Analysis 
This post-market clinical study is classified as minimal risk  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 labeling, the risks associated with the use of N-
Force Screws augmented with N-Force Blue are similar to those of standard intracapsular 
femur fracture treatment systems used for the same clinical indication or purpose.  These 
risks are categorized below as either general surgical risks or risks associated with the 
intracapsular femur fracture procedure/study device. Unanticipated adverse events can also 
occur. 
 
For general surgical risks, please refer to the FDA cleared instructions for use for this 
product.  
XI. 
Statistical Considerations 
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. 
B. Sample Size 
Using an observed historical control performance reoperation rate of ~15% [4][7],  

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for intracapsular femur fractures, 151 evaluable subjects will be required at 12 
months follow-up to show necessary statistical improvement from the historical 
revision rate. With an expected lost to follow-up rate of 20%, 190 subjects will 
be required for this clinical study. The assumed reoperation rate for the N-Force 
Screws augmented with N-Force Blue is 7.5%. 
XII. Quality Control & Quality Assurance 
The study is conducted in accordance with the Declaration of Helsinki and the ISO 
14155:2011.  
The Investigator will be required to permit representative(s) of the Sponsor’s monitoring 
team to inspect all Case Report Forms and corresponding sections of the study patients 
office records and/or hospital original medical records.  These audits will be done for 
quality assurance purposes, i.e. verifying adherence to the Clinical Investigation Plan and 
the completeness and accuracy of the data being entered on the Case Report Forms. 
The Clinical Investigation Plan will be provided to all participating study centers.  The 
Investigators will be fully trained in the proper reporting and submission of trial data prior 
to patient enrolment.  Completed Case Report Forms will be reviewed before entering the 
data into a central database by the Sponsor. 
The Clinical Study Manager is responsible for generating data queries for missing or 
unclear data if needed. It is the responsibility of the Clinical Study Manager to ensure data 
quality. 
There are regular meetings between the Investigators and Zimmer Biomet Clinical Affairs 
staff.  Written correspondence to all sites is used to inform the Investigators of routine 
study details and to update them on study status. 
 
XIII. Suspension or Premature Termination of the Clinical 
Investigation1 
Sponsor may suspend or prematurely terminate clinical investigation site(s) or entire 
clinical investigation for significant and documented reasons. If suspension or premature 
termination occurs at an individual investigation site, sponsor shall inform the responsible 
regulatory authority(s) as appropriate and ensure that ethic committee(s) are notified. If the 
suspension or premature termination was in the interest of safety, the sponsor shall inform 
all other principal investigators. If suspension or premature termination occurs, 
 The sponsor shall remain responsible for providing resources to fulfull the 
obligations from the clinical investigation plan and existing agreements for 
following up the subjects enrolled in the clinical investigation, and 

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 The principal investigator or authorized designee shall promptly inform the 
enrolled subjects at his/her investigation site, if appropriate.  
XIV. Amendments to the Clinical Investigation Plan 
All amendments shall be agreed upon with the Sponsor and the Investigator and be 
recorded with a justification for the amendment. Approval of the Institutional Review 
Board that reviewed the original protocol must be obtained if required according to the 
corresponding regulations. In the case of an amendment to the protocol, the revision history 
shall be documented.  
XV. Publication Policy 
Both the Clinical Investigator and the Sponsor have the right to publish or allow the results 
of the clinical trial to be published.  The Clinical Investigator recognizes that the Sponsor 
has a special interest in the results of the clinical study and will submit manuscripts to the 
Sponsor prior to publication.  If the Sponsor desires changes to be made, these are 
communicated to the Clinical Investigator within 30 days of submission.  Pooled data may 
be used for training and meetings 
XVI.  Document History 
Revision Number 
Date 
Description of 
Change 
Person in Charge 
of Change 
2.0 
18JUN2018 
Inclusion/Exclusion 
Criteria Updated 
Ryan Boylan 
3.0 
20JAN2020 
Inclusion Criteria 
Updated; AE 
Definitions Updated; 
Section 12, 13, 14, 15, 
and 16 added. 
Ryan Boylan 
 
 
 
 
 
 
 

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References 
 
[1] 
ISO 14155:2011(E). International Standard for Clinical investigation of medical devices for human subjects – 
Good clinical practice 
[2] 
Code of Federal Regulations 
 
Code of Federal Regulations, Title 21, Part 11: Electronic Records; Electronic Signatures 
 
Code of Federal Regulations, Title 21, Part 50: Protection of Human Subjects 
 
Code of Federal Regulations, Title 21, Part 56: Institutional Review Boards 
 
[3] 
https://www.aaos.org/research/guidelines/hipfxguideline.pdf 
[4] 
Bhandari M et al. Fracture fixation in the operative management of hip fractures (FAITH): an international, 
multicentre, randomised controlled trial. Lancet. 2017; 389(10078):1519-1527. DOI:10.1016/S0140-
6736(17)30066-1. 
[5] 
Russell TA, The Problem of Fracture Fixation Augmentation and Description of a Novel Technique and 
Implant for Femoral Neck Stabilization, Techniques in Orthopaedics Vol. 30 Nr. 1 2015  
[6] 
Russell TA, Leighton RK; Alpha-BSM Tibial Plateau Fracture Study Group. Comparison of autogenous bone 
graft and endothermic calcium phosphate cement for defect augmentation in tibial plateau fractures. A 
multicenter, prospective, randomized study. J Bone Joint Surg Am. 2008 Oct;90(10):2057-61. 
[7] 
Michelotti J, Clark J. Femoral neck length and hip fracture risk. J Bone MinerRes. 1999 Oct;14(10):1714-20. 
[8] 
Bhandari M, Chiavaras M, Ayeni O, Chakraverrty R, Parasu N, Choudur H, Bains S, Sprague S, Petrisor B; 
Assessment Group for Radiographic Evaluation and Evidence (AGREE) Study Group (AGREE Investigators 
Writing Committee). Assessment of radiographic fracture healing in patients with operatively treated femoral 
neck fractures. J Orthop Trauma. 2013 Sep;27(9):e213-9. 
[9] 
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. 
[10] Bhandari M, Wasserman SM, Yurgin N, Petrisor B, Sprague S, Dent RE. Development and preliminary 
validation of a Function IndeX for Trauma (FIX-IT). Can J Surg. 2013 Oct;56(5):E114-20.  
[11] Harris WH, Traumatic Arthritis of the Hip after Dislocation and Acetabular Fractures: Treatment by Mold 
Arthroplasty, JBJS, Vol. 55A, No. 4, June 1969 
[12] Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly 
persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. 
[13] Lee YS, Chen SH, Tsuang YH, Huang HL, Lo TY, Huang CR. Internal Fixation of Undisplaced Femoral 
Neck Fractures in the Elderyly: A Retrospective Comparison of Fixation Methods. J Trauma. 2008; 64:155-
162. DOI: 10.1097/TA.0b013e31802c821c.  
 
 
 
 
 
 
 
 
 
 

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II. 
Appendices: 
 
Appendix A Sample Informed Consent  
 
Appendix B Case Report Forms 
 
Appendix C Study Logs