INFINITY™Total Ankle Replacement Follow-up

Study Overview
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Brief Summary
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Study Title 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 Number of Subjects 150 with 9 sites

Detailed Description
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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).

Official Title
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INFINITY™Total Ankle Replacement Follow-up

Conditions
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Arthritis, Rheumatoid

Participation Criteria
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Eligibility Criteria
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Inclusion 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 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship of the INFINITY™ Total Ankle System at 10 years | 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. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic evaluation-physician reported questionnaire | 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. | Pre-op through 10 years | 
| PROMIS® Global Health | 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. | Pre-op through 10 years | 
| Ankle Osteoarthritis Score (AOS) | 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. | Pre-op through 10 years | 
| FAOS questionnaire | Compare the improvement in patient/physician reported function scores from pre-op through 10 years post-operatively, assessed by the FAOS questionnaire. | Pre-op through 10 years | 
| TAR satisfaction questionnaire | Compare satisfaction of total ankle replacement post operatively utilizing a four point scale | Pre-op through 10 years |