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NCT03063593
UK Infinity, Post-Market Clinical Follow-up Study
Conditions: Arthritis, Rheumatoid, Post-traumatic Osteoarthritis, Degenerative Arthritis
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Enrollment: 500
Sponsor: Stryker Trauma and Extremities
Location: Torbay Hospital Torquay Devon
Summary
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 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
Source: ClinicalTrials.gov (NCT03063593). StuddyBuddy aggregates publicly available trial information.