INFINITY™Total Ankle Replacement Follow-up

Stopped early

Conditions studied: Arthritis, Rheumatoid

In brief

Study Title INFINITY™Total Ankle Replacement Follow-up (ITAR) 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 150 with 9 sites

Key facts

Study ID

NCT03277989

Run by

Stryker Trauma and Extremities

People needed

155

Starts

2017-10-09

Expected to finish

2023-03-31

Last updated by the study team

2025-02-14

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be 21 years of age or older 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™ Total Ankle System replacement prior to enrollment in the research.

You may not qualify if…

• 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.

Where it is running

• Eisenhower Medical Center — Rancho Mirage, California, United States
• Orthopaedic & Spine Center of the Rockies — Fort Collins, Colorado, United States
• Illinois Bone & Joint Institute — Libertyville, Illinois, United States
• Orthopaedic Associates of Michigan, PC — Grand Rapids, Michigan, United States
• Beaumont Hospital-Royal Oak — Royal Oak, Michigan, United States
• Slocum Center for Orthopedics & Sports Medicine — Eugene, Oregon, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• UT Erlanger — Chattanooga, Tennessee, United States
• Campbell Clinic — Germantown, Tennessee, United States

Full record on ClinicalTrials.gov

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