INFINITY™ With ADAPTIS™ Technology Study

Running, not enrolling

Conditions studied: Arthritis, Rheumatoid

In brief

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

Key facts

Study ID

NCT04594993

Run by

Stryker Trauma and Extremities

People needed

200

Starts

2021-02-09

Expected to finish

2035-11-01

Last updated by the study team

2026-03-25

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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

• OrthoArizona Foot and Ankle Institute — Gilbert, Arizona, United States
• Eisenhower Health / Desert Orthopedic Center — Rancho Mirage, California, United States
• University of Colorado Orthopedic Research Center — Aurora, Colorado, United States
• Steadman Philippon Research Institute — Vail, Colorado, United States
• Florida Joint Care Institute — Trinity, Florida, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Hospital for Special Surgery — New York, New York, United States
• Slocum Research & Education Foundation — Eugene, Oregon, United States
• Southern Oregon Orthopedics — Medford, Oregon, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Erlanger Institute for Clinical Research — Chattanooga, Tennessee, United States
• Campbell Clinic — Germantown, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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