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UK Infinity, Post-Market Clinical Follow-up Study

Active Not RecruitingN/A

Sponsor: Stryker Trauma and Extremities

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

Countries: United Kingdom

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 overview

Sex: ALL

Age: 21 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (12)

Torquay, Devon, United Kingdom
Bournemouth, Dorset, United Kingdom
Bothwell, Scotland, United Kingdom
Oswestry, Shropshire, United Kingdom
Sheffield, South Yorksire, United Kingdom
Bristol, United Kingdom
Edinburgh, United Kingdom
Exeter, United Kingdom
Middlesex, United Kingdom
Newcastle upon Tyne, United Kingdom
Nottingham, United Kingdom
Wigan, United Kingdom