INFINITY™Total Ankle Replacement Follow-up
Conditions: Arthritis, Rheumatoid
Sponsor: Stryker Trauma and Extremities

Page 1 of 25 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017
INFINITY™ Total Ankle Replacement Follow-up (ITAR) 
Protocol Number: US17-TAR-001 
Approval Date: August 10, 2017 
Version: 1 
Revision: 1 
ClinicalTrials.Gov: NCT03277989
SPONSOR 
Wright Medical Group, N.V. 
1023 Cherry Road 
Memphis, TN  38117 
Telephone: 
1.800.238.7188 
901.867.9971 
Fax: 901.290.5801 
 
 
 
 
This document contains confidential information belonging to Wright 
Medical. Except as may be otherwise agreed to in writing, by accepting or 
reviewing these materials, you agree to hold such information in confidence 
and not to disclose it to others (except where required by applicable law), nor 
to use it for unauthorized purposes. In the event of actual or suspected breach 
of this obligation, Wright Medical should be promptly notified. 

Page 2 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
Table of Contents 
ABBREVIATIONS/TERMINOLOGY ........................................................................................................ 4 
PROTOCOL SYNOPSIS ............................................................................................................................. 5 
SCHEDULE of EVENTS ............................................................................................................................. 6 
INTRODUCTION ........................................................................................................................................ 7 
STUDY OVERVIEW................................................................................................................................... 7 
Study Rationale ..................................................................................................................................... 7 
Part Numbers and Brief Descriptions of Configurations ..................................................................... 7 
Indications for Use (IFU) ..................................................................................................................... 8 
Risks and Benefits ................................................................................................................................. 9 
STUDY DESIGN ......................................................................................................................................... 9 
Primary and Secondary Endpoints ....................................................................................................... 9 
Planned visits and Follow-Up Time Points ........................................................................................ 10 
SITE/SUBJECT SELECTION ................................................................................................................... 10 
Study Design Summary ....................................................................................................................... 11 
Informed Consent ............................................................................................................................... 12 
Screening ............................................................................................................................................ 12 
Point of Enrollment ............................................................................................................................ 12 
Study Duration, Subject Participation and Estimated Enrollment Period ......................................... 13 
Subject Withdrawal or Discontinuation ............................................................................................. 13 
Device Failure .................................................................................................................................... 13 
Procedures and Case Report Forms................................................................................................... 13 
Operative Procedure Information ...................................................................................................... 13 
Patient Reported Outcome Measures (PROMS) ................................................................................ 14 
Surgeon-completed Radiographic Report .......................................................................................... 15 
STATISTICAL CONSIDERATION ......................................................................................................... 16 
Sample Size ......................................................................................................................................... 16 
Demographics ..................................................................................................................................... 16 
ADVERSE EVENTS ................................................................................................................................. 16 
Overview ............................................................................................................................................. 16 
Adverse Event Data Collection and Reporting ................................................................................... 17 
Adverse Event (AE) ............................................................................................................................. 17 
Serious Adverse Event (SAE) .............................................................................................................. 17 
Adverse Event Status Updates (AE) .................................................................................................... 17 
Recording and Reporting Adverse Events – Investigator & Sponsor Responsibilities ...................... 18 
DATA MANAGEMENT .............................................................................................................................. 19 

Page 3 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
Overview ............................................................................................................................................. 19 
Participant Confidentiality ................................................................................................................. 19 
Monitoring Plan ................................................................................................................................. 19 
Amendments to Study Protocol ........................................................................................................... 20 
Deviations from Study Protocol ......................................................................................................... 20 
STUDY ETHICS ........................................................................................................................................ 20 
Institutional Review Board/Ethical Review Committee ...................................................................... 20 
Statements of Compliance .................................................................................................................. 21 
Financial Disclosures ......................................................................................................................... 21 
Sponsor Discontinuation Criteria....................................................................................................... 21 
STUDY COMPLETION ............................................................................................................................ 21 
Subject Enrollment Completion .......................................................................................................... 21 
Study Closeout Activities .................................................................................................................... 21 
REFERENCES 23 
APPENDIX 
24 
Instructions for Use (IFU), INFINITY™ Surgical Technique ............................................................ 24 
Case Report Forms ............................................................................................................................. 25 
  
 
 
 

Page 4 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
 
ABBREVIATIONS/TERMINOLOGY 
 
 
Arthroplasty is a surgical procedure to restore the integrity and function of a joint. A joint can be restored by 
resurfacing the bones; an artificial joint (prosthesis) may also be used. Osteoarthritis (OA) or degenerative joint 
disease is a loss of the cartilage or cushion in a joint, and is the most common reason for arthroplasty  
 
COFAS - Canadian Orthopaedic Foot & Ankle Society 
 
Good Manufacturing Practice (GMP) - regulations set forth by the United States Department of Health and Human 
Services by the Food and Drug Administration (FDA) under the regulations 21 CRF Parts 808, 812, 820.   
 
ICH - The International Conference on Harmonization  
ICH E6 Good Clinical Practice (GCP) 
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, 
recording, and reporting trials that involve human subjects. Compliance with GCP assures that the rights, safety, 
and well-being of trial subjects are protected and that the clinical trial data are credible. This International 
Conference on Harmonization (ICH) guidance provides a unified standard for the European Union, Japan, and the 
United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. 
IRB/EC/REC- is an Institutional Review Board, Ethical Review Committee, Research Ethical Committee - a 
committee established to review and approve research involving human subjects. The purpose of the IRB/EC/REC 
is to ensure that all human subject research be conducted in accordance with all federal, institutional, and ethical 
guidelines 
 
ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical 
investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory 
purposes.  The principles set forth in ISO 14155:2011also apply to all other clinical investigations and should be 
followed as far as possible, depending on the nature of the clinical investigation and the requirements of national 
regulations. 
ISO 14155:2011 also specifies general requirements intended to protect the rights, safety and well-being of human 
subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the 
responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, 
regulatory authorities and other bodies involved in the conformity assessment of medical devices. 
Osteolysis - pathological destruction or disappearance of bone tissue. 
 
Subsidence- sinking or settling in bone, as of a prosthetic component of a total joint implant. 

Page 5 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
PROTOCOL SYNOPSIS 
 
Study Title 
 The INFINITY™ Total Ankle Replacement  Follow-up (ITAR) 
Study Design 
 Prospective, multi-site, multi-year post-market clinical follow-up study 
Study Group 
Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with 
INFINITY™ Total Ankle System 
N Subjects 
200 with 10 sites 
Follow-Up 
Schedule 
Subject enrollment will consist of a Pre-operative, Operative, 6 months, 1 yr., 2 yr., 5yr., 7 
yr., 10 yr., and an unscheduled visit as needed. 
Primary 
Objective 
Evaluate the long-term survivorship of the INFINITY™ implant over 10 years 
Secondary 
Objective(s) 
Secondary objectives assessed will be to: 
• Identify and assess the implant for component loosening and/or subsidence, any osteolysis 
and/or cyst formation through radiographic evaluation early and throughout the lifetime of 
the implant.  
• Compare the improvements in self-reported physical, mental, and social health measures 
from pre-op through 10 years post operatively; assessed by PROMIS® Global Health. 
• Compare pain and functional improvement in the Ankle Osteoarthritis Score (AOS), 
which is a visual analogue scale specifically designed as a modification of the Foot 
Function Index. 
• Compare the improvement in patient/physician reported function scores from pre-op 
through 10 years post-operatively, assessed by the FAOS questionnaire. 
• Compare satisfaction of total ankle replacement post operatively utilizing a four point 
scale 
• Identify and report the safety of the implant in terms of complications and adverse events. 
Inclusion 
Criteria 
Subjects to be included in the study must meet all of the following criteria: 
• Be 21 years of age or older at the time of surgery;  
• Diagnosed with unilateral and/or bilateral ankle joint disease; 
• Diagnosed with ankle joint damage from rheumatoid arthritis, post-traumatic, or 
degenerative arthritis; 
• Willing and able to consent to participate (written, informed consent;  
• Willing and able to attend the requested follow-up visits; 
• A clinical decision has been made to use INFINITY™ Total Ankle System replacement 
prior to enrollment in the research. 
Exclusion 
Criteria 
Subjects will be excluded from the study if they meet any of the following criteria: 
• Subjects with an ankle condition, as determined by the investigator, to be an inappropriate 
candidate for a total ankle replacement; 
• Subjects requiring revision total ankle replacement of the ankle being considered for study 
 
 
 
 
 
 
 
 

Page 6 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
SCHEDULE of EVENTS  
 
 
 
 
 
 
 
 
 
 
 
Procedures 
Pre-op 
Op. 
6 mo 
+/-30 
days 
1 yr 
+/-60 
days 
2 yr 
+/-60 
days 
5 yr 
+/-60 
days 
7 yr 
+/-60 
days 
10 yr 
+/-60 
days 
Study 
Close 
Informed Consent 
X 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
 
 
 
 
 
Medical 
History/Demographics 
X 
 
 
 
 
 
 
 
 
Operative (Surgical) 
procedure/device  
 
X 
 
 
 
 
 
 
 
PROMIS Global Health 
X 
 
X 
X 
X 
X 
X 
X 
 
Ankle Osteoarthritis Score 
(AOS) 
X 
 
X 
X 
X 
X 
X 
X 
 
FAOS Questionnaire 
X 
 
X 
X 
X 
X 
X 
X 
 
Total Ankle Replacement 
Satisfaction  
 
 
X 
X 
X 
X 
X 
X 
 
Radiographic Assessment 
(Investigator requirement)  
X 
 
X 
X 
X 
X 
X 
X 
 
Adverse Event Assessment 
 
 
X 
X 
X 
X 
X 
X 
 
End of Study 
 
 
 
 
 
 
 
 
X 
Surgical Intervention1 
 
 
 
 
 
 
 
 
 
*Sponsor-approved 
Unscheduled Visit 2 
 
 
 
 
 
 
 
 
 
 
1&2 These are not scheduled time point events but will be observed for throughout study participation. 
 
 
 
 
 
 
 
 
 
 
 

Page 7 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
INTRODUCTION 
 
Wright Medical introduced the INFINITY™, total ankle system, for use in total ankle arthroplasty replacement 
(TAR) in the United States in 2013 and in Canada and Europe in 2014. The INFINITY™ Total Ankle System is a 
fixed-bearing, bone-sparing total ankle prosthesis that restores mobility to a failing ankle joint. It encompasses three 
components (i.e., tibial tray, tibial insert, and talar dome).  
 
The INFINITY™ Total Ankle System is indicated in patients with ankle joints damaged by severe rheumatoid, 
post-traumatic, or degenerative arthritis, as well as for patients with a failed previous ankle surgery.  Its intended 
use is to give patients limited mobility by reducing pain, restoring alignment and replacing the flexion and extension 
in the ankle joint.   
 
The technological features of the INFINITY™ Total Ankle System are similar to the predicate devices (INBONE® 
Total Ankle System, DePuy Agility™, INBONE® II Total Ankle System), which have all been cleared through the 
510K process with the FDA, with regard to design and materials. The goal of the design was to limit the amount of 
bone resection and soft tissue dissection required for ankle arthroplasty; hence the overall profile of the 
INFINITY™ Total Ankle System was significantly reduced along with the incision length required to perform the 
surgical procedure. 
 
Currently, there has been little data published characterizing the use of the INFINITY™ Total Ankle System. This 
study’s data collection will begin early in the utilization and implantation of the product and the data will allow for 
the filling of this gap in knowledge, support the long-term data collection, as well as the product’s use and 
performance.  
 
STUDY OVERVIEW 
Study Rationale 
The primary outcome measure of this post-market clinical observational study is to collect data relating to the 
INFINITY™ Total Ankle System survivorship at 10 years. The secondary outcome measures are to characterize the 
improvements after implantation over a 10 year period using patient reported outcome measures related to quality of 
life, pain and functional improvements, safety of the implants, as well as radiographic assessments (X-Rays) 
 
The outcome measures collected in this study will be analyzed and reported as required for local, regional, and 
country requirements (i.e., regulatory authorities and notified bodies).  
 
Part Numbers and Brief Descriptions of Configurations  
All configurations and sizes listed in the table below can be included in the study. These products are manufactured 
according to ICH GCP in accordance with applicable Good Manufacturing Practice (GMP) and with the ISO 
14155:2011: through relevant manufacturing and related validation processes. 

Page 8 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
Part No. 
Description 
Part No. 
Description 
INFINITY™ Poly Insert 
INFINITY™ Tibial Component 
33651106 
POLY INSERT, SZ1/1+  6MM 
33650001 
Tibial tray SZ1 STD 
33651108 
POLY INSERT, SZ1/1+  8MM 
33650002 
Tibial tray SZ2 STD 
33651110 
POLY INSERT, SZ1/1+ 10MM 
33650003 
Tibial tray SZ3 STD 
33651112 
POLY INSERT, SZ1/1+ 12MM 
33650004 
Tibial tray SZ4 STD 
33652206 
POLY INSERT, SZ2        6MM 
33650005 
Tibial tray SZ5 STD 
33652208 
POLY INSERT, SZ2        8MM 
33650013 
Tibial tray SZ3 Long 
33652210 
POLY INSERT, SZ2      10MM 
33650014 
Tibial tray SZ4 Long 
33652212 
POLY INSERT, SZ2     12MM 
33650015 
Tibial tray SZ5 Long 
33653206 
POLY INSERT, SZ2     +6MM 
INFINITY™ Talar Component 
33653208 
POLY INSERT, SZ2    +8MM 
33630021 
              Talar Dome SZ 1 
33653210 
POLY INSERT, SZ2  +10MM 
33630022 
              Talar Dome SZ 2 
33653212 
POLY INSERT, SZ2 +12MM 
33630023 
              Talar Dome SZ 3 
33653306 
POLY INSERT, SZ3     6MM 
33630024 
              Talar Dome SZ 4 
33653308 
POLY INSERT, SZ3     8MM 
33630025 
              Talar Dome SZ 5 
33653310 
POLY INSERT, SZ3   10MM 
INBONE® II Talar Component 
33653312 
POLY INSERT, SZ3   12MM 
220220901 
Talar Dome SZ 1 SULCUS 
33654307 
POLY INSERT, SZ3 + 7MM 
220220902 
Talar Dome SZ 2 SULCUS 
33654309 
POLY INSERT, SZ3 + 9MM 
220220903 
Talar Dome SZ 3 SULCUS 
33654311 
POLY INSERT, SZ3 11MM 
220220904 
Talar Dome SZ 4 SULCUS 
33654313 
POLY INSERT, SZ3 13MM 
220220905 
Talar Dome SZ 5 SULCUS 
33654406 
POLY INSERT, SZ4 6MM 
INBONE® II Talar Stem 
33654408 
POLY INSERT, SZ4 8MM 
200347901 
TALAR STEM 10MM 
33654410 
POLY INSERT, SZ4 10MM 
200347902 
TALAR STEM 14MM 
33654412 
POLY INSERT, SZ4 12MM 
 
 
33655407 
POLY INSERT, SZ4 +7MM 
 
 
33655409 
POLY INSERT, SZ4 +9MM 
 
 
33655411 
POLY INSERT, SZ4 +11MM 
 
 
33655413 
POLY INSERT, SZ4 +13MM 
 
 
33655506 
POLY INSERT, SZ5 6MM 
 
 
33655508 
POLY INSERT, SZ5 8MM 
 
 
33655510 
POLY INSERT, SZ5 10MM 
 
 
33655512 
POLY INSERT, SZ5 12MM 
 
 
 
 
Indications for Use (IFU) 
Indications for use in patients with ankle joints damaged by: 
• 
Severe rheumatoid arthritis; 
• 
Post-traumatic, or; 

Page 9 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
• 
Degenerative arthritis; 
• 
Additionally, for patients with a failed previous ankle surgery 
Risks and Benefits 
Benefits 
The clinical benefit to the INFINITY™ Total Ankle System is to give a patient improvement in mobility by 
reducing pain, restoring alignment and replacing the flexion and extension in the ankle joint.   
 
Risks   
There are no additional risks anticipated, specific to participating in this study. The study is not examining any 
experimental procedures and participation in the study is not predicted to affect the medical treatment received by 
enrolled subjects. The INFINITY™ Total Ankle does not pose additional risks compared to other standard total 
ankle systems when used for the same clinical application. The risks of ankle replacement include intra-operative 
complications such as peri-prosthetic fracture, neurovascular damage and tendon injury. Early post-operative 
problems include infection, wound healing problems, deep vein thrombosis, and peri-prosthetic fracture. Late 
complications include infection, peri-prosthetic fracture, loosening, implant failure, ongoing pain. These risks are 
comparable to those in alternative implants and alternative surgical procedures. 
 
STUDY DESIGN 
 
The selected design is a multi-center, non-randomized, prospective study of 200 subjects in the US with ten 
investigational sites and a potential for more as needed to meet the enrollment requirements. The study subjects 
included are those with ankle joints damaged by severe rheumatoid arthritis, post-traumatic disease, and 
degenerative arthritis and implanted with the INFINITY™ Total Ankle System.  
Primary and Secondary Endpoints 
The primary endpoint is a survivorship rate at 10 years as defined with a Kaplan Meier survivorship analysis.  
Secondary endpoints identify, assess and compare functional improvements or deviations collected through 
investigator observation and patient self-reporting, and include: 
 
• 
Identification and assessment of the implant through radiographic assessment for component loosening 
and/or subsidence, any osteolysis and/or cyst formation early and throughout the lifetime of the implant.  

Page 10 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
• 
Comparison of improvements in self-reported physical, mental, and social health measures from pre-op 
through 10 years post operatively; assessed by PROMIS®. 
• 
Comparison of pain and functional improvement from pre-op through 10 years in the AOS which is a 
visual analogue scale specifically designed as a modification of the Foot function Index. 
• 
Comparison of the improvements in patient/physician reported function scores from pre-op through 10 
years post-operatively, assessed by FAOS scores. 
• 
Compare satisfaction of total ankle replacement post operatively utilizing a four point scale 
• 
Identification and reporting on the safety of the implant in terms of complications and adverse events. 
Planned visits and Follow-Up Time Points 
Subjects will be seen prospectively at the following intervals Pre-Op, Operative, 6 months, 1, 2, 5, 7, and 10 years. 
If there are special circumstances where the subjects require a visit outside the windows of the established visits, the 
investigator may seek approval from Wright Medical for an acceptance of an“ unscheduled visit” and it will be 
determined if the data will be included and analyzed. 
 
SITE/SUBJECT SELECTION 
 
Clinical Research Sites will be identified to participate in the study based on current experience, and training in the 
use of the INFINITY™ Total Ankle System and according to ICH GCP guidelines and ISO 14155: 2011 which 
states; qualified by education, training and experience to perform his or her respective task(s). It is the expectation 
the surgeon will adhere to and follow the INFINITY™ Surgical Technique and have knowledge of the 
contraindications as provided in the Instructions for Use (IFU). (See Appendix A). 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Page 11 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
Study Design Summary 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Yes eligible
NO 
Informed Consent  
Patient given time to consider 
participation in study  
1. Patient Screening Log Completed 
 
2. Review ICF with patient 
 
3. CONSENT patient  
AND 
Review of routinely collected X-Rays 
Collect Baseline Data 
PROMIS®, AOS, FAOS 
Surgical Procedure 
Using INFINITY™ TOTAL ANKLE SYSTEM 
(Patient Enrolment) 
Intraoperative  
Complications 
Complete Adverse Event CRF 
Complete Intraoperative CRF 
PATIENT FOLLOW-UP 
(6months,1yr,2yrs,5yrs,7yrs,10yrs) 
Collect PROMIS®, AOS, FAOS, Total Ankle Replacement Satisfaction 
& 
Review of collected X-Rays 
 
 
STUDY COMPLETION 
Exclude from further 
research participation 
Assess eligibility for implantation with INFINITY™ 
TOTAL ANKLE SYSTEM 

Page 12 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
 
Informed Consent 
Prior to any conducting any protocol required data collection, including evaluations and questionnaires, written 
informed consent must be obtained from the subject in compliance with 21 CFR Part 50. 
 
Subjects will be recruited based on interest in participating in the study. All subjects will be consented by an 
appropriately trained clinician or research nurse using the IRB/EC/REC approved consent form in order to 
participate in the study and prior to any data collection, or any study procedure. The study clinician or research 
nurse will assess whether the patient can give informed consent or not during the consent process. The potential 
participant must be allowed ample time to review the informed consent and should be allowed to take the time  to 
read, review, ask questions, and receive answers as well as being fully informed of all aspects of the study before a 
decision is made to participate. The source documentation will include a statement of the consent process and 
include details of the person taking consent for study participation.  
Screening 
Subjects with interest in participating in the study, after signing the informed consent document, will then be invited 
to participate if they meet the Inclusion Criteria.  
Point of Enrollment 
Subjects will be considered enrolled in the study when they have: 
• 
Been informed of all aspects of the study and have signed Informed Consent document  
• 
Acknowledged the appropriate patient data release information (included in the Informed Consent 
document) 
• 
Satisfied the Inclusion/Exclusion Criteria 
• 
Implanted with the Device 
 
Investigators should document subject enrollment by completing the screening and enrollment logs located within 
the trial master file. The Source documentation should clearly state that all inclusion and exclusion criteria have 
been met and the patient data release and informed consent documents have been signed and appropriately dated  
prior to any study related activity,  
 
The investigative sites will be assigned three digit a site code ***, and at enrollment the subject will be assigned a 
sequential subject identification number corresponding to the order the subject was enrolled (i.e. the first subject 
enrolled at each site will be site number *** followed by subject identifier 001). The assigned codes will be used to 
identify the subject on all case report forms. All investigative sites will be provided protocol training of the during 
the site initiation visits. Investigative sites will be provided paper case report forms/booklets, which may be used as 
source documentation, these must signed by the individual completing the form; i.e., coordinator, patient, or 
investigator. 
 

Page 13 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
Study Duration, Subject Participation and Estimated Enrollment Period 
The total study duration from , first patient, first visit, (FPFV) to last patient, last visit (LPLV) is expected to be 12 
years, with a recruitment period of 24 months The investigator/investigative site must make every reasonable 
attempt to contact the patients to complete all scheduled post-operative visits within the visit window. In instances 
where the individual cannot be reached, the investigator/investigative site will document at least two attempts to 
contact the patient via phone/mail and one certified letter for each time point. Due to the length of this study and the 
risk of lost to follow-up potential, if a subject has an inability to and, for some unforeseen reason cannot be seen on 
the hospital site, patient reported outcome measure case report forms may be completed remotely by post or 
telephone and returned to the investigative site/investigator for review and submission. If this process is applied it 
must documented and reported to Wright accordingly.  
Subject Withdrawal or Discontinuation 
Subjects maintain the right to discontinue their participation in the study at any point without penalty or loss of 
benefit to which the subject is otherwise entitled per ICH E6 4.8.10(m) guidelines. Although, a subject is not 
obliged to give his or her reason(s) for withdrawing prematurely from this study, the investigator should make a 
reasonable effort to ascertain the reason(s), while fully respecting the subject’s rights per ICH E6 4.3.4 guidelines. 
Device Failure 
Subjects will be considered a treatment failure, and will be withdrawn from the study if any sections of the device 
(tibial or talar metal components) have been removed at any time during their participation. This should be reported 
onto the adverse event form. In addition, any surgical intervention during study participation that relates to their 
total ankle replacement will be reported on the surgical intervention case report form.  
Procedures and Case Report Forms 
Subject medical history and demographic information will be collected and recorded onto the demographic case 
report form.  The following information will be collected on these forms: 
• 
Date of birth   
• 
Gender  
 
• 
Height  
 
• 
Weight  
• 
BMI calculation  
• 
Smoking status 
• 
Status of other joints that affect ambulation ( i.e., knee replacement, contralateral arthritis and/or ankle 
replacement)  
• 
Concomitant health conditions (diabetes and other medical conditions, etc.) 
Operative Procedure Information 
The information related to the subject’s operation will be collected and recorded according to the Operative 
Information Case Report Forms. The following operative information related to the primary TAR procedure will be 
documented on these forms: 
• 
Primary diagnosis  
• 
Any previous surgery to index joint 
• 
Date of operation 
• 
Site location 

Page 14 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
• 
Surgical approach  
o 
Instrumentation type (standard) or (additional approved INFINITY™ instrumentation) 
o 
List concomitant operative procedures such as tendon/deltoid lengthening or other reconstructive 
process required to make final implantation correct  
• 
Cement use 
• 
Intraoperative complications (to be collected on the Adverse Event Case Report Form) 
• 
Product description and eight-digit product code for all components implanted 
Patient Reported Outcome Measures (PROMS) 
 
The standard care pathway for patients undergoing Total Ankle Replacement includes the collection of Patient 
Reported Outcome Measures (PROMS), in some institutions. The study aims to use this data, wherever possible, 
to fulfill the secondary outcome measures of the study and avoid duplication of data collection. As there is some 
variance nationally regarding the questionnaires which are used for PROMS data collection, participants may be 
required to supplement one or more of the following questionnaires for the purposes of the research study:    
 
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that 
evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general 
population and with individuals living with chronic conditions. 
• 
PROMIS Scale v1.2 - Global Health 
 
The Foot and Ankle Outcome Score (FAOS) is a self-report measure that evaluates symptoms and functional 
limitations in individuals with generalized foot and ankle disorders. Items for the Foot and Ankle Outcome Score 
were adapted from the Knee Injury and Osteoarthritis Outcome Score. The FAOS is composed of the following 5 
subscales: pain (9 items), other symptoms (7 items), activities of daily living (7 items), sports and recreational 
activities (5 items), and foot and ankle-related quality of life (4 items). 
 
 Ankle Osteoarthritis Score (AOS) is a reliable, validated, visual analog based, disease specific self-administered 
instrument designed specifically to measure disability and pain from ankle osteoarthritis. Both Pain and Disability 
components are used to calculate the total score. The score is from zero to one hundred with a lower score 
indicating more normal function. The minimally important difference for the AOS score is not known. 
 
Total Ankle Replacement Satisfaction, this study will be evaluating the patient’s satisfaction with their total ankle 
replacement post operatively (6months,1yr,2yrs,5yrs,7yrs,10yrs) utilizing a four point scale. 
 

Page 15 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
Surgeon-completed Radiographic Report  
This report includes usual standard of care pre-operative radiographs will include a standing AP and lateral film of 
the ankle. Arthritis can be assessed by CT if available but, not required 
for this study.         
 
Coronal plane deformity should be measured in degrees as the angle 
between a line perpendicular to the anatomical axis of the tibia and a 
line drawn along the top of the talar dome see (see figure) and recorded 
as either varus or valgus. 
 
 
 
 
The Canadian Orthopaedic Foot and Ankle Society (COFAS) end-stage arthritis classification should be identified 
and recorded as: 
 
Type 1: Isolated ankle arthritis 
Type 2: Ankle arthritis with intra-articular varus or valgus deformity or a tight heel cord, or both 
o 
intra-articular ankle varus or valgus alignment* was defined as the angle of the proximal talar 
surface (talar tilt) to the lateral border of 
o 
 the tibia in the distal diaphysis and metaphyseal region more than 10 degrees on the AP 
weightbearing ankle views 
Type 3: Ankle arthritis with hindfoot deformity, tibial malunion, midfoot abductus or adductus, supinated midfoot, 
plantar flexed first ray, etc.  
o 
hindfoot deformity defined as the angle between the lateral border of the calcaneus and the long 
axis of the tibia on the AP view of the ankle (varus more than 5 degrees, valgus more than 10 
degrees) 
o 
Tibial deformity defined as an angulation between the lateral border of the tibia more than 10 
degrees on the AP view of the ankle** 
Type 4: Types 1, 2, and 3 plus subtalar, calcaneocuboid, or talonavicular arthritis*** 
 
The post-operative radiographic evaluations will be to assess, record, and report migration, loosening, subsidence of 
the device, any osteolysis and cyst formation.  
 
* Greater than 10 degrees (defined as the angle between a line perpendicular to the anatomical axis of the tibia and a line drawn along the top of 
the talar dome see (see figure) and recorded as either varus or valgus) 
 
** If the patient has required staged surgical correction of deformity as part of the management of ankle arthritis (within 18 months of TAR), this 
should be considered a type 3. However, if the patient has undergone historic corrective surgery then the current foot position should be used for 
the purpose of COFAS grading (ie if fully corrected then can be Grade 1). 
 
*** this would include patients with prior arthrodesis of the subtalar, calcaneocuboid, or talonavicular joints 

Page 16 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
 
STATISTICAL CONSIDERATION 
Sample Size 
The total sample size is 200 subjects. The sample size was not calculated using statistical methods. A non-
parametric statistical analysis for survivorship using the Kaplan-Meier will be applied to determine the implant 
survivorship.  
 
Mechanical survivorship for total hip and knee replacement is currently thought to be approximately 10 years.  This 
benchmark for long-term data collection is not only relevant  to the safety and survivorship of the implant but, also 
to provide assurances that for the introduction of new implants, a data collection plan is in place for ongoing 
evaluations and reporting.   
 
The information gained from this data collection will be analyzed at times based on potential publication periods 
around 2,  5, and 7 years with a final analysis after all subjects haven completed all follow-up requirements at the 10 
year final visit. In addition, at time points determined by the investigators and/or Wright Medical will be evaluated 
as needed or required for additional analysis of data for reporting and/or publication purposes will be done 
throughout the study.  
Demographics  
Descriptive statistics will be applied for the demographic data of all subjects. Pre to post-operative comparisons will 
be made for all outcome measures at the specific data collection time points. Summary statistics for continuous 
variables may include subject count, mean, standard deviation, minimum and maximum values.  
 
ADVERSE EVENTS 
Unanticipated Adverse Device Effect (UADE), 
Serious Adverse Events (SAE’s) & ADVERSE EVENTS (AE’s) 
 
Overview 
Procedural and device related events will be described and collected on the AE form. It is the responsibility of the 
operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the 
manufacturer/sponsor. (See appendix A) The number of subjects experiencing each adverse event percentage or 
proportion of the total number of subjects experiencing each adverse event will also be reported. All adverse events 
shall be reported in an interim and/or final report of the clinical investigation. All device deficiencies related to the 
identity, quality, durability, reliability, safety or performance of the investigational medical device shall be 
documented throughout the clinical investigation and appropriately managed by the sponsor.   
 
Potential intraoperative and early postoperative complications, related to all total ankle replacements may include: 
• 
pain; 
• 
sudden drop in blood pressure intra-operatively due to the use of bone cement; 
• 
damage to blood vessels; 

Page 17 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
• 
temporary or permanent nerve damage resulting in pain or numbness of the affected limb; 
• 
cardiovascular disorders including venous thrombosis, pulmonary embolism, or myocardial infarction. 
• 
hematoma; 
• 
delayed wound healing; and 
• 
deep wound infection (early or late) which may necessitate removal of the prosthesis.  
• 
rarely an arthrodesis of the involved joint or amputation of the limb may be required. 
 
 
Potential, late postoperative complications can include: 
• 
pain; 
• 
bone fracture by trauma or excessive loading, particularly in the presence of poor bone stock; 
• 
peri-articular calcification or ossification, with or without impediment to joint mobility; and 
• 
inadequate range of motion due to improper selection or positioning of components or peri-articular 
calcification. 
Adverse Event Data Collection and Reporting  
The following definitions from 21 CFR.   
Adverse Event (AE) 
Adverse event means any untoward medical occurrence associated with the use of an intervention in humans, 
whether or not considered intervention-related  
Serious Adverse Event (SAE)  
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of either the investigator 
or sponsor, it results in any of the following outcomes: 
• 
death, or 
• 
a life-threatening adverse event, or 
• 
inpatient hospitalization or prolongation of existing hospitalization, or 
• 
a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions 
Adverse Event Status Updates (AE) 
The Investigator will follow up subjects who experience an AE until it is either resolved, determined to be chronic, 
stable, or, until the subject’s participation in the study ends.  
Prior to completion of the study, the Investigator will complete the Adverse Event Status Update Case Report Form 
to document any AE’s previously reported as ongoing.   
 
 
 
 
 

Page 18 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
Recording and Reporting Adverse Events – Investigator & Sponsor Responsibilities 
 
Recording and Reporting Adverse Events - Investigator Responsibilities 
The Investigator will: 
• 
Record protocol required AE’s together with an assessment as recorded in the Adverse Event Case Report 
Forms; 
• 
Supply Wright Medical, upon their request, with any additional information related to the safety reporting 
of a particular AE  
 
Recording and Reporting Adverse Events - Wright Medical Responsibilities 
Wright Medical is responsible for the classification of AEs and ongoing safety evaluation of the study and will: 
• 
review the Investigator’s assessment of all AEs; determine and document, in writing, the seriousness of the 
adverse event and relationship of the adverse event to the implanted components. 
 
In case of disagreement between Wright Medical and the Investigator, Wright Medical shall: 
• 
communicate both opinions to concerned parties; and 
• 
as required, ensure that the IRB/EC/REC and regulatory authorities are informed or significant new 
information involving the product during the study. 
 
Recording and Reporting Serious Adverse Events (SAE’s) – (Immediately Reportable) Investigator Responsibilities 
• 
The investigator must report the following events to the Sponsor within 24 hours after learning of the 
event, regardless of relationship to study, using the appropriate SAE reporting form and guidelines; 
• 
The investigator must report new significant follow-up information for these events to the Sponsor within 
24 hours after becoming aware of the information. New significant information includes the following:  
• 
New signs or symptoms or a change in the diagnosis.  
• 
Significant new diagnostic test results.  
• 
Change in causality based on new information. 
• 
Change in the event/s outcome, including recovery.  
• 
Additional narrative information on the clinical course of the event.  
 
Recording and Reporting Serious Adverse Events (SAE’s) – Wright Medical Sponsor Responsibilities 
• 
SAEs must be summarized on the annual report to the IRB/EC/REC 
 
Recording and Reporting Unanticipated Adverse Device Effect (UADE)– Wright Medical Sponsor Responsibilities 
Definition - An adverse reaction that is both unexpected (not consistent with the applicable product 
information) and also meets the definition of a Serious Adverse Event/Reaction 
 
• 
UADEs must be reported to the IRB/EC/REC in accordance with  GCP guidelines i.e. 7 or 15 days 
 
 

Page 19 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
 
DATA MANAGEMENT 
Overview 
All information will be collected according to the protocol and defined case report forms.  Investigator subject 
records (e.g. medical records, imaging reports, surgical notes or, paper case report form booklets) will be considered 
source documents for the study. This information will be entered by the site through a website provided by Wright 
Medical. Data will be received by Wright Medical through the electronic data capture system.  The Investigator 
must allow Wright Medical or its representative’s access to the subject files. This access includes inspection of 
records. 
 
In order to facilitate potential site monitoring visits, the investigator is required to keep records, including the 
identity of all participating subjects, all original signed Informed Consent Documents, and source documents.  
These records must be retained by the Investigating site according to local regulations as specified in the Clinical 
Trial Agreement.   
 
If the Investigator relocates, retires, or for any reason withdraws from the study, Wright Medical should be notified 
ahead of time. The study records must then be transferred to an acceptable designee (another investigator, 
institution, or Wright Medical). The investigator must obtain Wright Medical’s written permission before disposing 
of any records. 
Participant Confidentiality 
The study team will ensure that the participants’ anonymity is maintained.  The participants will be identified only 
by study number on the electronic CRF.  All documents will be stored securely and only accessible by study staff 
and authorized personnel.  To ensure confidentiality, none of the data stored or transferred electronically will 
contain personal identifiers. 
Monitoring Plan 
There is a need for on-site monitoring before, during, and after the clinical study. The sponsor may determine that 
remote monitoring (without visiting the site), in conjunction with procedures such as investigator’s documented 
training, meetings, and extensive written guidance or telephone communication, can assure appropriate conduct of 
the clinical study. With the study data being provided to Wright via the remote electronic data capture system, there 
is an opportunity to review data in a real time manner at Wright Medical and not only reviewed during an on-site 
visit.  The study will be monitored by Wright Medical or its authorized representatives in accordance with the 
internal procedures of Wright Medical.  The frequency of the visits will be determined by Wright and scheduled 
early on with at least a minimum of each quarter based on enrollment and the number of active follow-up visits at 
each site. This may vary based on the enrollment and data collected at the sites, any compliance concerns and need 
for additional training and oversight.  
Prior to study initiation, each clinical study site will be inspected by Wright Medical or its authorized 
representative. Additionally, each site will have an initiation visit to ensure Investigator(s) and study personnel: 

Page 20 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
• 
have the appropriate knowledge, experience, and equipment necessary to comply with the study 
requirements 
• 
fully understand all aspects of the study including the study protocol and data collection methods 
• 
Fully understand the procedures related to subject selection 
Upon study commencement, regular monitoring visits will be conducted to ensure: 
• 
ongoing compliance with the study protocol; 
• 
ongoing compliance with any conditions of approval of the reviewing IRB/EC/REC; 
• 
maintenance of complete study and regulatory records 
• 
continued acceptability of the site’s facilities  
Source documents and Investigator site files will be reviewed during the monitoring visits, including, but is not 
limited to: 
• 
reviewing case report forms for accuracy and completeness; 
• 
verifying timely and accurate data collection (in comparison with the source documentation); 
• 
reviewing and resolving missing or inconsistent study data; 
• 
verifying the investigational site maintains all required source documents, supporting medical records, and 
signed Informed Consent Documents; and 
• 
verifying the investigational site maintains documentation and reports for any AEs  
 
Monitors will evaluate and summarize the results of each visit in a written report that identifies any repeated data 
problems and providing specific recommendations for the resolution of noted deficiencies. 
Amendments to Study Protocol 
Amendments cannot be made to the study protocol without the written consent of Wright Medical.  Additionally, 
amendments to the study protocol must be approved by the IRB/EC/REC prior to their implementation. 
Deviations from Study Protocol 
Investigators should not deviate from the study protocol except to deliver emergency care or to eliminate an 
immediate hazard to the subject.  Deviations should be reported by completing the Protocol Deviation Case Report 
Form.  Investigators must report all deviations from the study protocol to Wright Medical or its designated 
representatives.  Additionally, any deviations found during monitoring visits must also be reported to Wright 
Medical or its designated representatives.  All deviations with the potential to affect subject safety, rights, or well-
being will also be reported to the IRB/EC/REC as soon as possible; based on the IRB/EC/REC requirements within 
the jurisdiction with each site.  
 
STUDY ETHICS 
 
Institutional Review Board/Ethical Review Committee  
It is the responsibility of the principal investigator at each participating site to obtain prospective approval of the 
study protocol, protocol amendments, patient information sheets, Informed Consent documents, and any other 

Page 21 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
relevant documents, if applicable, from the IRB/EC/REC.  All correspondence with the IRB/EC/REC should be 
retained in the Investigator Master site File. Copies of IRB/EC/REC approvals must be forwarded to Wright 
Medical or its designated representative prior to enrolling subjects. The Investigator must immediately report to 
Wright Medical or its designated representative if the IRB/EC/REC withdraws its approval of the study for any 
reason.  
Statements of Compliance 
This study will be conducted in accordance with 21 CFR Part 11, 50, 54, 56, and the ethical principles originating 
from the Declaration of Helsinki, GCPs, and in compliance with local regulatory requirements. This study will be 
registered with ClinicalTrials.gov. 
Financial Disclosures  
All Investigators must complete, sign and date the Financial Disclosure form prior to their participation in the 
clinical study.  Each Investigator must notify Wright Medical or its designated representative if any relevant 
changes occur during the course of the study and for one year following the completion of the study.  Copies of the 
Financial Disclosure form for each Investigator will be maintained in the sponsor’s investigational files. 
Sponsor Discontinuation Criteria 
Wright Medical reserves the right to terminate a non-performing site.  Reasons for considering early termination or 
suspension of an individual site may include, but are not limited to: 
• 
Site non-compliance with study protocol or failure to comply with government or local regulations 
• 
Failure to submit data in a timely manner 
• 
Failure to comply with or act upon findings 
• 
Failure to maintain pace to complete enrollment  
 
Wright Medical reserves the right to discontinue the study at any time and will notify each investigator immediately 
at the time of such a decision. Formal documentation will be provided to the investigators to notify their 
IRB/EC/REC, research institutions. After such a decision, the Investigator must contact all participating subjects to 
notify them of this decision and its impact on their follow-up.   
STUDY COMPLETION 
Subject Enrollment Completion 
Individual subject enrollment will be considered complete once the subject has completed all of their clinical visits 
and outcome measurements required by the study protocol. The investigator should then complete the Study 
Completion Case Report Form.   
Study Closeout Activities 
The study will be considered complete once the last subject at the last active site has completed their clinical visits 
and all outcome measurements required by the study protocol.  Additionally, the following activities must be 
completed at each site before the study is considered complete: 
• 
All essential documents are complete and up to date 
• 
The Investigator has completed and submitted all required case report forms 

Page 22 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
• 
Arrangements are made for archiving and record retention 
 
All IRB’s/EC/REC’s have been notified of the conclusion of the study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Page 23 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
REFERENCES 
 
 
Cody EA, Mancuso CA, Burket JC, et al. Patient factors associated with higher expectations from foot and ankle 
surgery. Foot Ankle Int. 2017 May;38(5):472-478. 
 
Cody EA, Mancuso CA, MacMahon A, et al. Development of an expectations survey for patients undergoing foot 
and ankle surgery. Foot Ankle Int. 2016 Dec;37(12):1277-1284. 
 
Coetzee, J. Castro, M. Accurate measurement of ankle range of motion after total ankle arthroplasty, Clinical 
Orthopaedics and Related Research No 424, pp. 27-31. 2004 Lippincott & Wilkins. 
 
Domsic RT, Saltzman CL. Ankle osteoarthritis scale. Foot Ankle Int. 1998; 19:466-471. 
 
Henricson A, Carlsson A˚, Rydholm U. What is a revision of total ankle replacement? 
Foot Ankle Surg 2011; 17:99–102. 
 
Hung M, Clegg DO, Greene T, Saltzman CL. Evaluation of the PROMIS physical function item bank in 
orthopaedic patients. J Orthop Res. 2011 Jun;29(6):947-953. 
 
Golightly YM, DeVellis RF, Nelson AE, et al. Psychometric properties of the foot and ankle outcome score in a 
community-based study of adults with and without osteoarthritis. Arthritis Care & Res. 2014 Mar;66(3)395-403. 
 
Kofoed H.  Ankle replacement revision (editorial). Foot Ankle Surg 2013; 19:69. 
 
Krause FG, Di Silvestro M, Penner MJ, et al. Inter- and intraobserver reliability of the COFAS end-stage ankle 
arthritis classification system. Foot Ankle Int. 2010; 31:103-108. 
 
Roos EM, Brandsson S, Karlsson J. Validation of the foot and ankle outcome score for ankle ligament 
reconstruction. Foot Ankle Int. 2001 Oct;22(10):788-794. 
 
Flint WW, Macias DM, Jastifer JR, et al. Plantar Plate Repair for Lesser Metatarsophalangeal Joint Instability. Foot 
Ankle Int. 2017 Mar;38(3):234-242. 
 
 
 
 

Page 24 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
APPENDIX 
Instructions for Use (IFU), INFINITY™ Surgical Technique 
 
 
 

Page 25 of 25 
 
Protocol Version 1 
Wright Medical Technology Inc. 
10-Aug-2017 
 
Case Report Forms