INFINITY™ With ADAPTIS™ Technology Study (NCT04594993)
INFINITY™ With ADAPTIS™ Technology Total Ankle Replacement Follow-Up
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (3 items).
Location: OrthoArizona Foot and Ankle Institute — Gilbert, Arizona
Age range: 22 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (13 Sites)
- OrthoArizona Foot and Ankle Institute — Gilbert, Arizona
- Eisenhower Health / Desert Orthopedic Center — Rancho Mirage, California
- University of Colorado Orthopedic Research Center — Aurora, Colorado
- Steadman Philippon Research Institute — Vail, Colorado
- Florida Joint Care Institute — Trinity, Florida
- Loyola University Medical Center — Maywood, Illinois
- Hospital for Special Surgery — New York, New York
- Slocum Research & Education Foundation — Eugene, Oregon
- Southern Oregon Orthopedics — Medford, Oregon
- Medical University of South Carolina — Charleston, South Carolina
- Erlanger Institute for Clinical Research — Chattanooga, Tennessee
- Campbell Clinic — Germantown, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.