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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
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:
Inclusion Criteria Subjects to be included in the study must meet all of the following criteria:
Exclusion Criteria Subjects will be excluded from the study if they meet any of the following criteria:
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| 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 |
| 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 |
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Inclusion Criteria:
Subjects to be included in the study must meet all of the following criteria:
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the following criteria:
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Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY® Total Ankle System
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| Name | Affiliation | Role |
|---|---|---|
| David Townshend, MD | Northumbria Trust | Study Chair |
| Rebecca Gibson | Stryker Trauma & Extremeties | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Torbay Hospital | Torquay | Devon | TQ2 7AA | United Kingdom | ||
| Royal Bournemouth Hosptial |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 6, 2017 | Nov 8, 2017 |
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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 |
| Bournemouth |
| Dorset |
| BH7 7DW |
| United Kingdom |
| University Hairmyres Hospital | Bothwell | Scotland | G71 8BB | United Kingdom |
| RJAH Orthopaedic Hospital | Oswestry | Shropshire | SY10 7AG | United Kingdom |
| Sheffield Teaching Hospital | Sheffield | South Yorksire | S5 7AU | United Kingdom |
| North Bristol NHS Trust Southmead Hospital | Bristol | BS105NB | United Kingdom |
| Royal Infirmary of Edinburgh | Edinburgh | EH16 4SA | United Kingdom |
| Royal Devon and Exeter NHS Foundation Trust | Exeter | EX2 5DW | United Kingdom |
| Royal National Orthopaedic Hospital | Middlesex | HA7 4LP | United Kingdom |
| North Tyneside General Hospital | Newcastle upon Tyne | NE29 8NH | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG5 1PB | United Kingdom |
| Wrightington Hospital | Wigan | WN6 9EP | United Kingdom |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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