Lower Extremity Fixation In Neuropathic Patients Study
Conditions: Neuropathy, Charcot; Disease (Etiology)
Sponsor: Stryker Trauma and Extremities

Lower Extremity Fixation In Neuropathic Patients Study (FINS) CIP Version 3
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Lower Extremity Fixation In Neuropathic Patients Study 
(FINS) Clinical Investigation Plan
CLINICAL INVESTIGATION TITLE: 
ABBREVIATED CLINICAL 
INVESTIGATION TITLE: 
DEVICE NAME: 
CLINICAL INVESTIGATION 
DESIGN: 
INDICATIONS: 
CLINCIAL INVESTIGATION PLAN 
PHASE: 
SPONSOR: 
INVESTIGATORS: 
COMPLIANCE STATEMENT: 
CONFIDENTIALITY STATEMENT: 
VERSION: 
DATE: 
NCT04607044

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Sponsor Approval Page
APPROVERS
Role
Name
Signature
Date
Medical Expert
Clinical Research 
Head (CRH)
Regulatory Affairs
(RA)
Statistician

Lower Extremity Fixation In Neuropathic Patients Study (FINS) CIP Version 3
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Table of Contents
1.
LIST OF ABBREVIATIONS .................................................................................... 4 
2.
SYNOPSIS ............................................................................................................. 5 
3.
GENERAL INFORMATION AND ADMINISTRATIVE STRUCTURE ......................... 6 
4 
PRODUCT INFORMATION.................................................................................... 6 
5 
RISKS AND BENEFITS .......................................................................................... 7 
6 
INTRODUCTION ................................................................................................... 7 
7 
CLINICAL INVESTIGATION DESIGN ..................................................................... 8 
8 
OBJECTIVE ........................................................................................................... 8 
9 
SELECTION OF CLINICAL INVESTIGATION POPULATION ................................... 9 
10 CLINICAL INVESTIGATION EVALUATIONS, PROCEDURES AND ASSESSMENTS .11 
11 STATISTICAL CONSIDERATIONS ........................................................................12 
12 CLINICAL INVESTIGATION PLAN DEVIATIONS ..................................................15 
13 ADVERSE EVENTS ...............................................................................................15 
14 REOPERATIONS ..................................................................................................17 
15 ETHICS ................................................................................................................17 
16 DATA COLLECTION PROCESS .............................................................................18 
17 CLINICAL INVESTIGATION MONITORING ..........................................................18 
18 DATA HANDLING AND RECORD KEEPING ..........................................................18 
19 REPORTS ............................................................................................................18 
20 PUBLIC REGISTRATION ......................................................................................18 
21 COMPLETION OF THE CLINICAL INVESTIGATION .............................................18 
22 ESSENTIAL DOCUMENTS ....................................................................................19 
23 PUBLICATION POLICY ........................................................................................19 
24 REFERENCES .......................................................................................................19 
25 CLINICAL INVESTIGATION PLAN SIGNATURE PAGE ..........................................21 
26 DOCUMENT VERSION HISTORY .........................................................................22 

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1. List of Abbreviations
Acronym 
Definition 

Lower Extremity Fixation In Neuropathic Patients Study (FINS) CIP Version 3
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2. Synopsis
Primary Endpoint: 
 
Secondary Endpoints: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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3. General Information and Administrative Structure 
 
 
 
 
4 Product Information 

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5
Risks and Benefits
 
6 Introduction 
 

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7
Clinical Investigation Design
 
8 Objective 
 

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o 
 
o 
 
 
 
 
 
 
 
 
 
9 Selection of Clinical Investigation Population 
 
 
 
 
o 
o 
o 
o 
o 

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o 
o 
 
 
 
 
 
 
 
 
 
 
 
 

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10 Clinical Investigation Evaluations, Procedures and Assessments 
 
 
 

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d. 
 
11 Statistical Considerations 

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11.1 
 
 
 
 

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12 Clinical Investigation Plan Deviations 
 
13 Adverse Events 
An Adverse Event (AE) 
 
A Serious Adverse Event (SAE) 
 
 
o 
o 
o 
o 
 
An Adverse Device Effect 
 
An Incident
 
A Serious Adverse Device Effect 

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A Serious Incident
o 
o 
o 
 
An Unanticipated Adverse Device Effect (UADE) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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14  Reoperations 
15 Ethics 
 
 
 

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16 Data Collection Process
17 Clinical Investigation Monitoring 
18 Data Handling and Record Keeping 
19 Reports 
20 Public Registration 
21 Completion of the Clinical Investigation 

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22 Essential Documents 
23 Publication Policy 
24 References 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54&showFR=1
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56&showFR=1

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25 Clinical Investigation Plan Signature Page

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26 Document Version History