NCT03277989

INFINITY™Total Ankle Replacement Follow-up

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 155 (actual)
• Sponsor: Stryker Trauma and Extremities · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The primary outcome measure of this post-market clinical observational study is to collect data relating to the INFINITY™ Total Ankle System survivorship at 10 years. The secondary outcome measures are to characterize the improvements after implantation over a 10 year period using patient reported outcome measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments (X-Rays) The outcome measures collected in this study will be analyzed and reported as required for local, regional, and country requirements (i.e., regulatory authorities and notified bodies).

Conditions

• Arthritis, Rheumatoid

Timeline

• Start date: 2017-10-09
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2017-09-11
• Last updated: 2025-02-14
• Results posted: 2025-02-14

Locations

9 sites across 1 country: United States