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
Eligibility
Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Primary Outcome Measure survivorship at 10 years — 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.
Trial sites (12)
Facility
City
Region
Status
Torbay Hospital
Torquay
Devon
Royal Bournemouth Hosptial
Bournemouth
Dorset
University Hairmyres Hospital
Bothwell
Scotland
RJAH Orthopaedic Hospital
Oswestry
Shropshire
Sheffield Teaching Hospital
Sheffield
South Yorksire
Nottingham University Hospitals NHS Trust
Nottingham
United Kingdom
North Bristol NHS Trust Southmead Hospital
Bristol
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh
United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter
United Kingdom
Royal National Orthopaedic Hospital
Middlesex
United Kingdom
North Tyneside General Hospital
Newcastle upon Tyne
United Kingdom
Wrightington Hospital
Wigan
United Kingdom
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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