FastFrame™ External Fixation System Post-Market Clinical Follow-Up Study: Knee Spanning Kit and Damage Control Kit
Phase: NA
Conditions: Fracture, Fractures, Bone, Fractures, Closed, Fractures, Open
Sponsor: Zimmer Biomet

FastFrame External Fixation System PMCF 
CMU2017-95T 
Rev 1, 16 Sep 20 
 FINAL
CF12202 Rev 2, Eff. Date: 13 Jun 2019 
Ref: CP12000 Review and Approval of Clinical Research Involving Human Subjects 
Page 1 of 30 
FastFrame™ External Fixation System   
Post-Market Clinical Follow-Up Study 
Knee Spanning Kit and Damage Control Kit 
Post-Market Clinical Follow-Up Study 
CMU2017-95T 
Rev 1 
16 Sep 2020 
United States 
STUDY SPONSOR 
Zimmer Biomet 
Clinical Affairs Department 
1800 W. Center Street 
Warsaw, IN 46580 
United States 
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 Biomet.
NCT04730739
11-DEC-2024

 
 
FastFrame External Fixation System PMCF 
CMU2017-95T 
Rev 1, 16 Sep 20 
 FINAL                 
 
 
CF12202 Rev 2, Eff. Date: 13 Jun 2019 
Ref: CP12000 Review and Approval of Clinical Research Involving Human Subjects 
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Contents 
I. 
Contact Information ................................................................................................................... 3 
II. 
Abbreviations ............................................................................................................................. 4 
III. 
Study Synopsis .......................................................................................................................... 4 
IV. 
Data Collection Overview .......................................................................................................... 7 
V. 
Introduction and Purpose........................................................................................................... 7 
VI. 
Study Objectives ........................................................................................................................ 8 
VII. 
Study Design and Endpoints ..................................................................................................... 8 
VIII. 
Study Population ....................................................................................................................... 9 
IX. 
Study Device Information ......................................................................................................... 10 
X. 
Study Procedures .................................................................................................................... 11 
XI. 
Reporting ................................................................................................................................. 15 
XII. 
Safety Management – Medical Events/Adverse Events .......................................................... 20 
XIII. 
Monitoring ................................................................................................................................ 25 
XIV. Risk Analysis ........................................................................................................................... 26 
XV. 
Statistical Methods ................................................................................................................... 26 
XVI. Quality Control & Quality Assurance ....................................................................................... 26 
XVII. Suspension or Premature Termination of the Clinical Investigation ........................................ 28 
XVIII. Vulnerable Populations ............................................................................................................ 28 
XIX. Amendments to the Clinical Investigation Plan ........................................................................ 29 
XX. 
Publication Policy..................................................................................................................... 29 
XXI. Document History .................................................................................................................... 29 
XXII. References .............................................................................................................................. 29 
 
 
 
 

 
 
FastFrame External Fixation System PMCF 
CMU2017-95T 
Rev 1, 16 Sep 20 
 FINAL                 
 
 
CF12202 Rev 2, Eff. Date: 13 Jun 2019 
Ref: CP12000 Review and Approval of Clinical Research Involving Human Subjects 
Page 3 of 30 
I. 
Contact Information 
 
Title 
 
FastFrame™ External Fixation System Post-Market Clinical 
Follow-Up Study 
 
Protocol Number 
 
CMU2017-95T 
 
Study Sponsor Contact 
Information 
 
 
Zimmer Biomet 
1800 W. Center Street 
Warsaw, IN 46580 USA 
(800) 613-6131 
 
 
Monitoring Contact 
Information 
 
 
Madison Murphy, Zimmer Biomet (or Designee) 
1800 W. Center Street, MS4020 
Warsaw, IN 46580 USA 
(574) 373-2265 
 
 
 
 

 
 
FastFrame External Fixation System PMCF 
CMU2017-95T 
Rev 1, 16 Sep 20 
 FINAL                 
 
 
CF12202 Rev 2, Eff. Date: 13 Jun 2019 
Ref: CP12000 Review and Approval of Clinical Research Involving Human Subjects 
Page 4 of 30 
II. 
Abbreviations 
A/P 
Anterior/Posterior 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CI 
Confidence Interval 
CRF 
Case Report Form 
CTA 
Clinical Trial Agreement 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EEA 
European Economic Area  
EU MDD 
EU MDR 
FastFrame 
European Medical Device Directive MDD/93/42/EEC 
European Regulation (EU) 2017/745 
FastFrame External Fixation Kit 
FDA 
Food and Drug Administration 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
ICH  
International Conference on Harmonisation 
ID 
IRB 
Identification 
Institutional Review Board 
ISO 
International Standards Organization 
LAR 
OR 
PMCF 
Legally Authorized Representative 
Operating Room 
Post-Market Clinical Follow-Up 
SAE 
Serious Adverse Event 
 
III. 
Study Synopsis 
Title 
FastFrame™ External Fixation System Post-Market Clinical 
Follow-Up Study 
Protocol Number 
CMU2017-95T 
Sponsor 
Zimmer Biomet 
Legal Manufacturer 
Zimmer, Inc. 
Study Device(s) 
• FastFrame External Fixation System – Knee Spanning Kit 
• FastFrame External Fixation System – Damage Control Kit 
Study Objectives/Endpoints 
The objective of this observational, prospective study is to 
confirm safety and performance of the FastFrame External 
Fixation System and corresponding instrumentation. 
 
• Primary Endpoint 
Frequency and incidence of device-related adverse 
events and device deficiencies before the FastFrame 

 
 
FastFrame External Fixation System PMCF 
CMU2017-95T 
Rev 1, 16 Sep 20 
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CF12202 Rev 2, Eff. Date: 13 Jun 2019 
Ref: CP12000 Review and Approval of Clinical Research Involving Human Subjects 
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External Fixation System is exchanged by another device 
(i.e. plates, screws, etc.).  
 
• Secondary Endpoint 
Adverse events that occur between application of the 
FastFrame External Fixation System and exchange with 
another device that do not fall within the primary endpoint.  
Indications/Target population 
66 patients in the United States who have undergone fracture 
stabilization using the FastFrame External Fixation System - 
Knee Spanning Kit or Damage Control Kit 
Inclusion/Exclusion criteria 
Inclusion Criteria: 
• Patient must be 18 years of age or older 
• Patient must have been treated with either Knee Spanning 
or Damage Control FastFrame External Fixation System 
according to the indications stated in this protocol* 
      
Exclusion Criteria: 
• Patient has an active or suspected infection 
• Conditions that limit the patient’s ability and/or willingness to 
follow instructions during the healing process 
• Inadequate skin, bone, or neurovascular status 
• Patient is a prisoner 
• Patient is pregnant and/or breastfeeding 
• Patient is a known current alcohol and/or drug abuser in the 
opinion of the Investigator 
• Patient has a mental or neurologic condition that will not 
allow for proper informed consent and/or participation in 
follow-up program in the opinion of the Investigator 
 
*EEA Indications (a subset of the cleared US indications): 
The FastFrame External Fixation System – Knee Spanning Kit 
is indicated for use in treatment of long bone (distal femur, 
proximal tibia) fractures. Specifically, the system is intended 
for temporary stabilization of open or closed fractures about 
the knee, typically in the context of polytrauma or where open 
or alternative closed treatment is undesirable or otherwise 
contraindicated. 
 
The FastFrame External Fixation System – Damage Control 
Kit is indicated for use in treatment of mid-shaft long bone 
(femur, tibia) fractures. Specifically, the system is intended for 
temporary stabilization of open or closed fractures of the 
femur and tibia, typically in the context of polytrauma or where 
open or alternative closed treatment is undesirable or 
otherwise contraindicated. 

 
 
FastFrame External Fixation System PMCF 
CMU2017-95T 
Rev 1, 16 Sep 20 
 FINAL                 
 
 
CF12202 Rev 2, Eff. Date: 13 Jun 2019 
Ref: CP12000 Review and Approval of Clinical Research Involving Human Subjects 
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Study Design 
Prospective enrollment, prospective follow-up, single cohort 
study 
Clinical Phase 
Postmarket 
Sample Size  
Considering a 95% device success rate (5% device related 
complications) and a 10% non-inferiority margin, 60 subjects 
with a follow-up are required. With an estimated lost to follow-
up/subject withdrawal rate of 10%, 66 subjects will have to be 
enrolled. 
Length of Study 
3 years (2 years of enrollment plus follow-up until exchange 
with another device)  
 
A follow-up visit will be completed at the time of exchange 
from FastFrame System to another device. Typically, this 
exchange occurs 2 to 4 weeks after injury. 
Materials and Methods 
Device-related complications and device deficiencies will be 
reported at the baseline/operative and follow-up visits, if 
applicable. If required, photographs of the study device will be 
taken to document any loss of stability requiring unplanned 
adjustment of the study device.  
Data Collection 
eCRF 
Statistical Reporting 
Data collected will be summarized and reported to each 
participating Investigator. Statistical analysis will be conducted 
by Zimmer Biomet (or Designee). 
Scores/Performance 
Assessments 
Device-related complication and device deficiency rates will be 
recorded 
Standards 
The PMCF is compliant with the below: 
• ISO 14155:2020 - Clinical investigation of medical devices 
for human subjects - Good clinical practice. 
• The Declaration of Helsinki (DoH) - Ethical principles for 
medical research involving human subjects. 
• European Regulation (EU) 2017/745 
• MDCG 2020-10/1 
• Safety reporting in clinical investigations of medical devices 
under the Regulation (EU) 2017/745 
 
 
 

 
 
FastFrame External Fixation System PMCF 
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Rev 1, 16 Sep 20 
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IV. 
Data Collection Overview 
The following table indicates the necessary CRFs to be completed at each given 
time point throughout the study. The person responsible for completing each CRF 
is also listed. Please note the Site Delegation Log may list designees for the 
investigator who are also allowed to complete specific CRFs. 
CRF 
Baseline/Operative  
(Day 1) 
Follow-Up         
(Day 14-28) 
Informed Consent 
(ICF) 
Patient 
 
Inclusion/Exclusion 
Criteria 
Investigator 
 
Demographic 
Evaluation 
Investigator 
 
Operative Record 
Investigator 
 
Surgical Device 
Investigator 
 
Physician Imaging 
Assessment 
Investigator 
Investigator        
(as applicable) 
Physician Follow-
Up Assessment 
 
Investigator 
Study Completion 
 
Investigator 
Adverse Event 
Report* 
Investigator         
(as applicable) 
Investigator        
(as applicable) 
Protocol Deviation 
Investigator         
(as applicable) 
Investigator        
(as applicable) 
V. 
Introduction and Purpose 
The management of orthopaedic polytrauma patients has developed greatly since 
the 1970s, when patients were deemed incapable of undergoing surgery3. In 
recent years, the use of temporary stabilization of fractures has been used with 
the goal to decrease operative time3, blood loss3, and the “second hit” 
inflammatory response from definitive surgical fixation2. External fixators, a type of 
device intended for temporary stabilization, are typically made up of a combination 
of a frame, clamps, pins, and bars that properly stabilize and support the injured 
limb1. In order for this stabilization to occur, the fractured bones are adjusted to 
reduce the fracture and the bars are connected to maintain the reduction1. 
Unlike typical external fixators, the FastFrame External Fixation frames are pre-
assembled and are designed for simplicity in the operating room. Each kit 
includes clamp bodies, pins, and telescoping bars that allow for proper reduction 
and rigid external fixation. This study will document the clinical outcomes of 
* 
If a device-related Adverse Event occurs, supporting documents must be sent to the Sponsor 
and include the operative report and any relevant imaging 
 
Required for Patient to be considered enrolled in the study 

 
 
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Ref: CP12000 Review and Approval of Clinical Research Involving Human Subjects 
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trauma patients who require the use of the FastFrame External Fixation System - 
Knee Spanning and Damage Control kits legally manufactured by Zimmer, Inc.  
VI. 
Study Objectives 
The objective of this observational, prospective study is to confirm safety and 
performance of the FastFrame External Fixation System and corresponding 
instrumentation. The endpoints are defined to include the following: 
Primary Endpoints 
 
• Frequency and incidence of device-related adverse events and device 
deficiencies before the FastFrame External Fixation System is exchanged 
by another device (i.e. plates, screws, etc.). Refer to Section XII for 
additional details related to adverse event classification and device 
deficiencies.  
 
Examples of device-related adverse events and device deficiencies 
include: 
o Pin breakage and/or loosening requiring surgical intervention (i.e. 
pin removal or exchange) before planned exchange of the complete 
frame by another device 
o Frame component failure (i.e. loosening, breakage, etc.) leading to 
clinically unacceptable loss of stability requiring unplanned 
readjustment or replacement of the frame 
Secondary Endpoints 
 
• Adverse events that occur between application of the FastFrame External 
Fixation System and exchange with another device that do not fall within 
the primary endpoint. Refer to Section XII for additional details related to 
adverse event classification.  
VII. Study Design and Endpoints 
This is a PMCF study designed to collect and evaluate outcome measures and 
adverse event data. A maximum of three sites will contribute to this study. Each 
Investigator will be skilled in external fracture stabilization and experienced in 
implanting the devices included in this study, as determined by the Sponsor. 
 
Each Investigator will be responsible for obtaining IRB approval as required prior 

 
 
FastFrame External Fixation System PMCF 
CMU2017-95T 
Rev 1, 16 Sep 20 
 FINAL                 
 
 
CF12202 Rev 2, Eff. Date: 13 Jun 2019 
Ref: CP12000 Review and Approval of Clinical Research Involving Human Subjects 
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to conducting the study. In order to avoid potential selection bias, each 
Investigator will offer study participation to each consecutive eligible patient 
presenting need for temporary stabilization with the FastFrame External Fixation 
System - Knee Spanning or Damage Control Kits. 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 approved Informed Consent and the study device has 
been implanted.  
VIII. Study Population 
A maximum of three (3) sites in the United States will contribute to this study. No 
randomization will take place, as all subjects must receive the study device that 
best treats their clinical need.  
 
The study population for primary statistical analysis will be comprised of all 
enrolled subjects who satisfy the Inclusion/Exclusion Criteria outlined in 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 
Informed Consent has been completed.   
 
Inclusion Criteria 
• Patient must be 18 years of age or older 
• Patient must be treated with either the Knee Spanning or Damage Control 
FastFrame External Fixation System according to the indications stated in 
this protocol* 
 
 
 
*EEA Indications (a subset of the cleared US indications): 
The FastFrame External Fixation System – Knee Spanning Kit is indicated for 
use in treatment of long bone (distal femur, proximal tibia) fractures. 
Specifically, the system is intended for temporary stabilization of open or 
closed fractures about the knee, typically in the context of polytrauma or where 
open or alternative closed treatment is undesirable or otherwise 
contraindicated. 

 
 
FastFrame External Fixation System PMCF 
CMU2017-95T 
Rev 1, 16 Sep 20 
 FINAL                 
 
 
CF12202 Rev 2, Eff. Date: 13 Jun 2019 
Ref: CP12000 Review and Approval of Clinical Research Involving Human Subjects 
Page 10 of 30 
 
The FastFrame External Fixation System – Damage Control Kit is indicated for 
use in treatment of mid-shaft long bone (femur, tibia) fractures. Specifically, 
the system is intended for temporary stabilization of open or closed fractures 
of the femur and tibia, typically in the context of polytrauma or where open or 
alternative closed treatment is undesirable or otherwise contraindicated. 
 
Exclusion Criteria 
• Patient has an active or suspected infection 
• Patient has conditions that limit their ability and/or willingness to follow 
instructions during the healing process 
• Patient has inadequate skin, bone, or neurovascular status 
• Patient is a prisoner 
• Patient is pregnant and/or breastfeeding 
• Patient is a known current alcohol and/or drug abuser in the opinion of the 
Investigator 
• Patient has a mental or neurologic condition that will not allow for proper 
Informed Consent and/or participation in follow-up program in the opinion of 
the Investigator 
IX. 
Study Device Information 
The FastFrame External Fixation System Knee Spanning and Damage Control 
Kits are single-use external fixators that are sterile packed with all the required 
components (i.e., frame, pins, driver, tissue sleeve, and lockout tab). The device 
indications and contraindications for use can be found on the applicable package 
inserts. Surgical procedures involved in the use of FastFrame are located on the 
Zimmer Biomet website.   
 
The following components and materials, used in both FastFrame Kits, have 
direct human tissue contact during the surgical procedure: 
 
• 5mm Pin – 316L Stainless Steel 
• Tissue Trocar – ULTEM® (Black) 
• Tissue Sleeve Shaft – 304 Stainless Steel 
 

 
 
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These materials were tested for cytotoxicity, sensitization, intracutaneous 
reactivity, and acute systemic toxicity. The test results concluded that these 
materials are biocompatible and toxicologically safe for use as materials in 
orthopaedic surgery.  
X. 
Study Procedures 
All procedures are to be conducted in accordance with the current surgical 
techniques supplied to all Investigators in the clinical study and found on the 
Zimmer Biomet website.  
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.  
 
Informed Consent Process  
Informed Consent will be completed by patients who are able to consent 
themselves or if unable, have a proxy available. The patient will be given an 
adequate amount of time to read the consent and ask questions to the investigator 
and/or research staff. If the patient agrees to participate in the study, he/she will 
sign the consent form. If a patient is unable to consent for him/herself due to the 
need for immediate surgical intervention, a proxy signature may be used to consent 
on the patient's behalf. The following individuals may serve as a proxy on behalf of 
the patient during the Informed Consent process: legal guardian, proxy health care 
agent, or a close family member of the patient. The relationship of the proxy to the 
patient must be documented on the Informed Consent Log. If the patient 
becomes able to consent himself or herself at any point in time, a re-consent must 
occur with the patient’s signature. Due to the immediate surgical intervention 
regarding the study operation, Informed Consent can be obtained after surgery, but 
no later than the follow-up visit defined in this protocol. 
Informed Consent/Enrollment Log 
An Informed Consent/Enrollment Log 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 and/or proxies as defined in the Informed Consent 
Process section of this protocol underwent the Informed Consent process, signed 
and dated the IRB 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 

 
 
FastFrame External Fixation System PMCF 
CMU2017-95T 
Rev 1, 16 Sep 20 
 FINAL                 
 
 
CF12202 Rev 2, Eff. Date: 13 Jun 2019 
Ref: CP12000 Review and Approval of Clinical Research Involving Human Subjects 
Page 12 of 30 
log. If a subject signs and dates additional Informed Consent(s) after enrollment 
(i.e., due to a protocol amendment, protocol revisions, re-consent after surgery, 
etc.), subsequent signings will also be recorded in the log. If a proxy signature is 
used, the relationship of the proxy to the patient must be documented. The 
Informed Consent/Enrollment Log will be filed in the site Regulatory Binder for 
the study.  
 
Subject Enrollment 
Once the Informed Consent has been signed and dated by the subject (or proxy 
as defined in the Informed Consent Process section of this protocol) and a 
FastFrame System has been implanted, the subject will be considered enrolled in 
the study. A unique case identification number (Case ID) will be assigned to each 
participating subject (bilateral subjects will be assigned a unique case ID number 
for each temporary stabilization procedure). 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. 
 
Monitoring Log 
The Site Monitoring Visit Log 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 
closeout, etc.). The Site Monitoring Visit Log will be filed in the site Regulatory 
Binder for the study.  
 
Delegation of Authority/Site Signature Log 
A Delegation of Authority/Site Signature Log will be maintained throughout the 
study and will contain the names, initials, signatures, and study responsibilities of 
all site personnel and designees involved in the study procedures and data 
collection. The Investigator is responsible to sign and date the log after any 
updates to the log to acknowledge the change(s). The Delegation of 
Authority/Site Signature Log will be filed in the site Regulatory Binder for the 
study. 
 
Baseline Procedure 
Subjects will be enrolled prior to undergoing a procedure using the FastFrame 
External Fixation System, therefore allowing for the capture of baseline data to be 

 
 
FastFrame External Fixation System PMCF 
CMU2017-95T 
Rev 1, 16 Sep 20 
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CF12202 Rev 2, Eff. Date: 13 Jun 2019 
Ref: CP12000 Review and Approval of Clinical Research Involving Human Subjects 
Page 13 of 30 
collected on the following CRFs: 
 
• Inclusion/Exclusion Criteria 
• Demographic Evaluation 
• Protocol Deviation, if applicable 
 
Operative/Immediate Post-Operative Procedure 
All surgeries will take place following the standard, approved surgical 
technique. During the course of the surgery, a Surgical Device CRF must be 
completed documenting the part and lot numbers of the implants. The FDA 
cleared or other local government regulatory body approved instructions for 
use and surgical technique must be followed for this product. Please refer to 
the latest versions of these documents on the Zimmer Biomet website, contact 
your local Clinical Study Manager, or contact a Zimmer Biomet sales associate 
for additional details. The following operative data will be collected on the 
following CRFs: 
 
• Operative Record 
• Surgical Device 
• Protocol Deviation, if applicable 
• Adverse Event Report, if applicable 
• Physician Imaging Assessment  
• Photographs of study device in two (2) planes (A/P and lateral) 
  
Photographs will be stored in the Subject Binder as part of their casebook. 
Please write the Subject Case ID Number, Subject Initials, and Date (YYYY-
MM-DD) on the photographs. If an adverse event occurs, an Adverse Event 
Report CRF will also be completed. See Management of Incurrent Events for 
additional details. Reason(s) for study completion must be documented on 
the Study Completion CRF. 
 
 
Post-Operative Follow-Up Procedure 
Post-operative clinical assessment will be conducted at the device exchange 
follow-up visit after the procedure. The device exchange of a FastFrame 
External Fixation Kit typically occurs 2-4 weeks after surgery. The following 

 
 
FastFrame External Fixation System PMCF 
CMU2017-95T 
Rev 1, 16 Sep 20 
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CF12202 Rev 2, Eff. Date: 13 Jun 2019 
Ref: CP12000 Review and Approval of Clinical Research Involving Human Subjects 
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CRFs will be collected at the follow-up visit when the study device is removed 
from the subject: 
 
• Physician Follow-Up Assessment 
• Protocol Deviation, if applicable 
• Adverse Event Report, if applicable 
• Physician Imaging Assessment, if required  
• Photographs of study device in two (2) planes (A/P and lateral), if  
 
required  
• Study Completion  
 
Subjects will be followed post-operatively until the FastFrame External 
Fixation Kit is exchanged with another device or unless the primary endpoint 
is reached prior. 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 (does not 
include device removal as part of standard treatment), or expires.  
If the surgeon anticipates a loss of stability that will require unplanned device 
adjustment, photographs of the study device will be taken to document any 
loss of stability that occurs. It is up to the Investigator or Designee to take the 
appropriate amount and type of photographs to clearly show the stability 
issue(s) with the study device. Please write the Subject Case ID Number, 
Subject Initials, and Date (YYYY-MM-DD) on the photographs. Photographs 
(baseline and post-operative) will be sent to the Study Manager via e-mail 
within 14 days of the occurrence and stored in the Subject Binder as part of 
their casebook. If an adverse event occurs, an Adverse Event Report CRF 
will also be completed. See Management of Incurrent Events for additional 
details. Reason(s) for study completion must be documented on the Study 
Completion CRF. 
 
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, subjects should 
be counseled on the importance of completing the future study follow-up visit. 

 
 
FastFrame External Fixation System PMCF 
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CF12202 Rev 2, Eff. Date: 13 Jun 2019 
Ref: CP12000 Review and Approval of Clinical Research Involving Human Subjects 
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XI. 
Reporting 
The management of all study data received by the Sponsor will be the 
responsibility of the Sponsor (or Designee). The use or disclosure of all protected 
health information will comply with the 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. 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 or year of birth.  
Activities Required Prior to Initiation of the Study 
Clinical Trial Agreement (CTA) and Financial Arrangements 
A fully executed (signed by all required parties) CTA must be on file with the Sponsor 
prior to any Investigator participating in this study. This agreement must explain the 
financial arrangement with the investigative site.  
 
Institutional Review Board Protocol Approval 
This study protocol must be submitted to and approved by the Investigator’s 
Institutional Review Board (IRB). A copy of the IRB approval letter must be submitted 
to the Sponsor. The letter should identify the following: 
• Protocol name and/or number 
• Date of IRB meeting (if available) 
• Date of approval 
• Date of expiration 
• Signature of IRB  
 
ClinicalTrials.gov Registration 
The Sponsor will be responsible for registering this study on www.ClinicalTrials.gov if 
required by local and national regulations. 
 

 
 
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Clinical Data Collection/Submission 
Summary of Case Report Form Data Collection 
Study data will be collected on source documents, which may include study-specific 
worksheets provided by the Sponsor. For subjects undergoing temporary stabilization 
using multiple FastFrame External Fixation Kits, separate case report forms must be 
completed for each operative device.  
The following source document/CRF completion guidelines should be followed: 
• Complete carefully and accurately 
• Complete header information consistently across all case report forms for each 
individual study subject  
• Be sure that data on the source documents match that which is entered through 
the EDC system 
• Use the study subject’s unique Case ID number assigned as instructed 
• Do not provide information that is not requested on the CRFs 
• 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. 
 
Data Submission 
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. 
 
Quality Assurance of Data 
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. The Sponsor will maintain quality control systems, in 
accordance with the Sponsor’s policies and procedures. 
 

 
 
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Reporting Requirements 
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 as required to maintain IRB 
approval throughout the study, and will provide any required final reporting to the IRB 
upon study completion/termination. A copy of all IRB re-approval letters must be 
submitted to the Sponsor. If the IRB 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 regarding any changes significantly affecting the conduct of 
the study, and/or increasing risk to the subjects.  
 
Retention of Records 
For this study, study records must be retained by the Investigator or Designee for a 
minimum of 15 years from the Investigator’s study termination date, or per applicable 
regulatory and/or IRB requirements (whichever time period is greater). Measures 
shall be taken to prevent accidental or premature destruction.  
 
Study records are defined as the all information in original records, certified copies of 
original records of clinical findings, observations or other activities in a clinical study, 
including source data initially recorded in an electronic format, necessary for the 
reconstruction and evaluation of the clinical study. This may include but is not limited 
to: hospital records, clinic records, laboratory notes, device accountability records, 
photographs, radiographs, subject casebooks, regulatory records, signed informed 
consents, and all other study-related documents.    
 
 
 
Management of Incurrent Events 
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 ICF), data for that candidate will not be collected for this study. 
 

 
 
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Adverse Events 
See Safety Management – Medical Events/Adverse Events Section of this protocol 
for additional information regarding adverse event classifications.   
Reporting and Documentation of Adverse Events and Adverse Device Effects  
Adverse Events and Adverse Device Effects have to be documented on the Adverse 
Event Report form over the whole time of the investigation including information on 
the date of onset, treatment and resolution, as well as assessment of both the 
seriousness and the relationship to the study device. Further, the outcome of 
complications has to be documented and any changes in outcome are to be updated 
during the course of the study. In case of early termination of the study, further follow-
up of the patient shall proceed according to the hospital’s standard procedure. 
Reporting and Documentation of Serious Adverse Events, Serious Adverse Device 
Effects, and Device Deficiencies 
Serious Adverse Events and Serious Adverse Device Effects have to be 
reported to the Sponsor as soon as possible. The incidence has to be 
documented on the Adverse Event Report form over the whole time of the 
investigation including information on the date of onset, treatment and resolution, as 
well as assessment of both the seriousness and the relationship to the study device 
based on the evaluation of the Investigator. The outcome of such complications has 
to be documented and any changes in outcome have to be updated during the 
course of the study. In case of early termination of the study, further follow-up of the 
study subject shall proceed according to the hospital’s standard procedure. 
Device Deficiencies that did not lead to an adverse event but could have led to a 
medical occurrence if suitable actions had not been taken, if intervention had not 
been made or if circumstances had been less fortunate shall be reported to the 
Sponsor as soon as possible, as well. 
The Investigator is responsible for reporting all SAEs, SADEs and Device 
Deficiencies that could have led to a SADE to the Institutional Review Board if 
required by national regulations or by the IRB. 
 
Schedule 
 
In the event that early removal of one or more of the study related components is 
necessary, the Investigator will determine the best treatment and/or revision method 
for the subject. Once the revision surgery has been completed, the Investigator or 

 
 
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qualified Designee must complete an Adverse Event report CRF as well as a Study 
Completion CRF terminating the subject from the study. Relevant radiographs 
and/or photographs of the explanted component(s) will be sent to the Sponsor.  
 
All components removed outside of standard of care should be promptly returned to 
Zimmer Biomet for analysis. The Investigator or Designee must notify the Clinical 
Study Manager prior to the return of any device. Properly prepared components are 
to be sent to the following address: 
 
Zimmer Biomet 
Attention: Product Services Department 
1777 W. Center St. 
Warsaw, IN 46580 USA 
 
Investigator Withdrawal 
The Investigator can choose to withdraw a subject from the study if it is deemed to be 
in the subject’s best interest or the subject does not consent to continue in the study 
after being informed of changes in the research that might affect them. The reason 
for the Investigator’s withdrawal of the subject must be documented on the Study 
Completion CRF. 
 
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 whom no longer wishes 
to participate in the study. The reason for the subject withdrawal must be 
documented on the Study Completion CRF. 
 
Lost to Follow-up 
Subjects will be considered lost to follow-up after they have missed their follow-up 
visit and a reasonable number of attempts to locate and evaluate them have failed. 
All attempts of contact have to be documented on the Study Completion CRF and in 
particular, the reason should be documented. Patients lost to follow-up will not be 
replaced within the study. 
 
Protocol Deviations 
The Investigator should not deviate from the agreed upon protocol unless it is to 
eliminate hazard to the patient. However, any deviation from the protocol has to be 
documented on the Protocol Deviation CRF along with an explanation for the 

 
 
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deviation and reported to the Sponsor. Each significant deviation will be reported to 
the IRB, if applicable, within the appropriate deadlines stipulated by the appropriate 
regulatory authorities. Significant deviations are defined as those impacting or 
potentially impacting patient safety. 
Investigator disqualification criteria leading to exclusion from the clinical study include 
fraud, misconduct, and serial non-compliance. 
 
Study Termination 
Study subject participation is expected to end upon completion of the subject’s device 
exchange 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 an 
unplanned revision to remove a study device, or expires. Reason(s) for study 
completion must be documented on the Study Completion CRF.  
 
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 as applicable according to local and national 
laws/regulations.   
 
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 must be obtained prior to implementation, if required according to 
the local and/or national laws/regulations.  
XII. Safety Management – Medical Events/Adverse Events  
Adverse events are required to be reported on the Adverse Event Report CRF. 
The completed Adverse Event Report CRF 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. 
 
The following definitions are from ISO 14155:2020 and Regulation (EU) 2017/745: 
Safety reporting in clinical investigations of medical devices. 

 
 
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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 and whether anticipated or unanticipated. 
 
Note 1: This definition includes events related to the investigational medical 
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 or comparators.  
 
Serious Adverse Event (SAE): 
A Serious Adverse Event is any adverse event that: 
a. led to death. 
b. led to serious deterioration in the health of the subject, users or other 
persons as defined by one or more of the following: 
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function, 
including chronic diseases, or 
3. in-patient or prolonged hospitalization, or 
4. medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body 
function. 
c. led to fetal distress, fetal death or a congenital abnormality or birth defect 
including physical or mental impairment. 
 
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. 
 
 
 

 
 
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Adverse Device Effect (ADE): 
An Adverse Device Effect is an adverse event related to the use of an 
investigational medical device. 
 
Note 1: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or 
operation, or any malfunction of the 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): 
A Serious Adverse Device Effect is an adverse device effect that has resulted in 
any of the consequences characteristic of a serious adverse event. 
 
Unanticipated Adverse Device Effect (UADE) 
An unanticipated adverse device effect is a serious adverse device effect which 
nature, incidence, severity, or outcome has not been identified in the current risk 
assessment. 
 
Note 1: Anticipated serious adverse device effect is an effect, which by nature, 
incidence, severity or outcome has been identified in the risk assessment. 
 
Device Deficiency 
A Device Deficiency is defined as an inadequacy of a medical device with respect 
to its identity, quality, durability, reliability, usability, safety, or performance.  
 
Note 1: Device Deficiencies include malfunctions, use errors, and inadequacy in 
the information supplied by the manufacturer including labeling.  
 
Note 2: This definition includes device deficiencies related to the investigational 
medical device or the comparator. 
 
It is important to document in the study also all device deficiencies that could have 
led to a medical occurrence, but did not lead to an adverse event. 

 
 
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Causality Assessment (Relation to Device) 
The relationship between the use of the medical device (including the medical - 
surgical procedure) and the occurrence of each adverse event shall be assessed 
and categorized. 
 
During causality assessment activity, clinical judgement shall be used and the 
relevant documents, such as the Investigator’s Brochure, the Clinical Investigation 
Plan, or the Risk Analysis Report shall be consulted, as all the foreseeable 
serious adverse events and the potential risks are listed and assessed there. The 
presence of confounding factors, such as concomitant medication/treatment, the 
natural history of the underlying disease, other concurrent illness or risk factors 
shall also be considered. 
 
Each adverse event will be classified according to four different levels of causality: 
• Not Related 
• Possible 
• Probable 
• Causal Relationship (Definitely Related) 
 
The sponsor and the investigators will use the following definitions to assess the 
relationship of the adverse event to the investigational device, the comparator or 
the investigation procedure. 
 
Not Related:  
Relationship to the device, comparator or procedures can be excluded when: 
the event has no temporal relationship with the use of the investigational device, 
or the procedures related to application of the investigational device. 
 
Possible:  
The relationship with the use of the investigational device or comparator, or the 
relationship with procedures, is weak but cannot be ruled out completely. 
Alternative causes are also possible (e.g. an underlying or concurrent illness/ 
clinical condition or/and an effect of another device, drug or treatment). Cases 
where relatedness cannot be assessed, or no information has been obtained 
should also be classified as possible. 
 
 
 

 
 
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Probable:  
The relationship with the use of the investigational device or comparator, or the 
relationship with procedures, seems relevant and/or the event cannot be 
reasonably explained by another cause. 
 
Causal Relationship (Definitely Related):  
The serious adverse event is associated with the investigational device, 
comparator or with procedures beyond reasonable doubt. 
 
Note: Complications caused by concomitant treatments not imposed by the 
clinical investigation plan are considered not related. Similarly, several routine 
diagnostic or patient management procedures are applied to patients regardless 
of the clinical investigation plan. If routine procedures are not imposed by the 
clinical investigation plan, complications caused by them are also considered not 
related. 
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 a 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.  

 
 
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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 reported adverse 
event.  
XIII. Monitoring 
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, IRB approval of the study protocol, and the study Informed Consent.  

 
 
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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 visits 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 will be 
documented using the Monitoring Visit Log. 
XIV. Risk Analysis 
This PMCF 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 the FastFrame External Fixation System are similar to those of the historical 
standard, the XtraFix® External Fixation System by Zimmer, Inc., when used for 
the same clinical indication or purpose. These risks are either general surgical 
risks or risks associated with the subject procedure/study device; however, 
unanticipated adverse events can occur.  
XV. Statistical Methods 
 
General Statistical Methods 
Statistical methodology will consist of summarizing collected data 
descriptively. Categorical data (i.e., gender or race) will be summarized using 
counts and percentages, and 95% 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 will be summarized using a Kaplan-Meier method and 
presented with rates (as percentages) and confidence intervals. 
 

 
 
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Sample Size 
Calculation of sample size is based on previously published literature involving 
longitudinal data collection on temporary external fixation. Assuming a power 
level of 80% and an alpha level of significance of 0.05 (α = 0.05), calculations 
were performed in order to determine the sample size needed for study 
significance using the following hypothesis test: 
 
The hypothesis will be tested by the exact binomial test: 
H0: E1 – E0 ≤ - δE 
Ha: E1 – E0 > - δE 
where:  
E0 = 95%, the expected success rate 
E1 = the success rate in the FastFrame System treatment group  
δE = 0.10, non-inferiority margin 
 
In addition, one-sided 95% exact confidence Interval (CI), lower limit of the 
success rate, will be calculated. 
 
Based on the hypothesis test above, 60 subjects will provide approximately 
80% power for the one-sided exact binomial test at 0.05 significant level. The 
sample size was calculated using SAS for Windows version 9.4. 
 
It was determined that the complication rate of devices comparable to the 
FastFrame External Fixation System is approximately 5%. Utilizing this figure, 
the power, and alpha level of significance, a sample size total (without any 
subjects becoming lost to follow-up) of 60 was obtained. Finally, in order to 
maintain a sample size large enough for statistical significance an estimated, 
90% subject return rate is assumed for the duration of the device exchange 
follow-up visits. These lost to follow-up patients increase the sample size 
requirements to 66 subjects (after rounding up). 
 
Visit 
Subjects remaining in the study 
Baseline 
66 
Follow-Up 
60 
 

 
 
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XVI. Quality Control & Quality Assurance 
The study is conducted in accordance with the Declaration of Helsinki and the ISO 
14155:2020 and Regulation (EU) 2017/745.  
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 subjects 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. 
XVII. Suspension or Premature Termination of the Clinical 
Investigation 
A description of the criteria and arrangements for suspension or premature 
termination of the whole clinical investigation, of the clinical investigation in one or 
more investigation sites, or for individual subjects. Include the following, as 
applicable: 
• Criteria for access to and breaking the blinding/masking code in the case of 
suspension or premature termination of the clinical investigation. 
• Requirements for subject follow-up. 
XVIII. Vulnerable Populations 
Patients that are within one or more vulnerable populations, including children, 
prisoners, pregnant women, and handicapped or mentally disabled persons, are 
to be excluded from this study. 

 
 
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XIX. Amendments to the Clinical Investigation Plan 
All amendments shall be agreed with the Sponsor and Investigator(s) and be 
recorded with a justification for the amendment. Approval of the IRB 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 will 
be documented in the document history.  
XX. 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. 
XXI. Document History 
Revision 
Number 
Date 
Description of Change 
Person in Charge of 
Change 
0 
02 Dec 2019 
Initial Release 
Madison Murphy 
0.1 
24 Mar 2020 
Corrected typo in table within 
Section IV. Data Collection 
Overview 
Madison Murphy 
1 
16 Sep 2020 
Replaced radiograph 
requirements with photographs 
of the device.  
 
Deleted Radiographic 
Assessment CRF requirement.  
 
Rewrote Informed Consent 
sections.  
 
Updated Record Retention and 
Adverse Event section to 
Regulation (EU) 2017/745 
requirements. 
Madison Murphy 
XXII. References 
1Fragomen, Austin T., and S. Robert Rozbruch. “The Mechanics of External 

 
 
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Fixation.” HSS Journal, vol. 3, no. 1, 2006, pp. 13–29., doi:10.1007/s11420-006-9025-0.    
2Giannoudis, Peter V, et al. “Damage Control Orthopaedics: Lessons Learned.” Injury, 
vol. 40, 2009, doi:10.1016/j.injury.2009.10.036.                                                                    
3Halvorson, Jason J., et al. “Orthopaedic Management in the Polytrauma 
Patient.” Frontiers of Medicine, vol. 6, no. 3, 2012, pp. 234–242., doi:10.1007/s11684-
012-0218-2.