Follow-up Study to Evaluate Safety and Performance of the Incompass Total Ankle System After Ankle Replacement Surgery

What this Trial Is About

Researchers are evaluating the safety and performance of the Incompass Total Ankle System in patients undergoing total ankle replacement surgery. The study aims to measure improvements in quality of life and pain through patient-reported outcomes and medical imaging over a standard follow-up period. The device is FDA cleared and already used routinely in ankle replacement surgeries, so no experimental treatment is involved. Participants will undergo total ankle replacement surgery using the Incompass Total Ankle System and will be followed according to the surgeons standard care. Medical imaging such as X-rays and CT scans taken during routine care will be reviewed throughout the study. The main goal is to assess improvement in the Ankle Osteoarthritis Scale score at 24 months after surgery, along with other measures of safety, reoperation rates, radiographic assessments, physical and mental health questionnaires, and satisfaction with the ankle replacement. During the study, participants will complete questionnaires and undergo routine imaging at baseline, 6 months, 1 year, 2 years, and up to 10 years post-surgery. Researchers will monitor adverse events, survivorship of the implant, and functional outcomes over this period. The study is expected to enroll about 200 subjects over three years and continue follow-up for up to 10 years.

A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System