UK Infinity, Post-Market Clinical Follow-up Study

Study Overview
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Brief Summary
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Study Title UK Post-Market Clinical Follow-Up Of The INFINITY® Total Ankle System 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 500 with 10 sites

Detailed Description
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Study Title UK Post-Market Clinical Follow-Up Of The INFINITY® Total Ankle System 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 500 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 pain and social interaction for quality of life measures from pre-op through 10 years post operatively; assessed by EuroQol (EQ5D5L). 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 self-reported pain-free function scores from pre-op through 10 years post-operatively, assessed by the Manchester Oxford Foot Questionnaire (MOXFQ) walking/standing scores. 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 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 / witnessed verbal consent) Willing and able to attend the requested follow-up visits; Subjects determined by the Investigator to be an appropriate candidate for the INFINITY® Total Ankle System 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

Official Title
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UK Multi-Centre, Observational, Post-Market Clinical Follow-up of the INFINITY® Total Ankle System

Conditions
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Arthritis, Rheumatoid, Post-traumatic Osteoarthritis, Degenerative Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects to be included in the study must meet all of the following criteria: Be 21 years of age 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 / witnessed verbal consent) Willing and able to attend the requested follow-up visits; Subjects determined by the Investigator to be an appropriate candidate for the INFINITY® Total Ankle System 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

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 |
| --- | --- | --- |
| Primary Outcome Measure survivorship 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 performance/survivorship at up to 10 years. | 10 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ5D-EuroQol-questionnaire | Compare the improvement in self-reported pain and social interaction for quality of life measures | From pre-op through 10 years | 
| Ankle Osteoarthritis Score (AOS)-questionnaire | Self-reported to compare pain and functional improvement, which is a visual analogue scale specifically designed as a modification of the Foot function Index | From Pre-op through 10 years | 
| Manchester Oxford Foot Questionnaire (MOXFQ)-questionnaire | Compare the improvement in self-reported pain-free function scores (walking/standing scores) | From Pre-op through 10 years | 
| Radiographic evaluation-physician reported questionnaire | identify and assess the implant for component loosening and/or subsidence, any osteolysis and/or cyst formation | From Pre-op through 10 years |