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Active Not Recruiting
NCT04594993
INFINITY™ With ADAPTIS™ Technology Study
Conditions: Arthritis, Rheumatoid
Sex: All
Ages: 22 Years – N/A
Healthy volunteers: No
Enrollment: 200
Sponsor: Stryker Trauma and Extremities
Location: OrthoArizona Foot and Ankle Institute Gilbert Arizona
Summary
INFINITY™ with ADAPTIS™ Technology Total Ankle Replacement Follow-up (ITAR2) - 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 200 patients with up to 13 sites
Eligibility Criteria
Inclusion Criteria:
* Be over 22 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;
* Willing and able to attend the requested follow-up visits;
* A clinical decision has been made to use INFINITY™ with ADAPTIS™ Technology Total Ankle System replacement prior to enrollment.
Exclusion 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 (NCT04594993). StuddyBuddy aggregates publicly available trial information.
