Evaluation of Brostrm Repair Surgery With or Without BioBrace Implant for Adults With Chronic Lateral Ankle Instability

What this Trial Is About

This research aims to evaluate patient-reported outcomes and functional scores before and after surgery for chronic lateral ankle instability using the Brostrm repair technique. It compares the standard open Brostrm repair with a version augmented by the BioBrace Implant. The study is prospective, randomized, and interventional, focusing on adults aged 18 to 65 with confirmed chronic lateral ankle instability lasting more than 3 months. Participants will be randomly assigned to one of two groups one receiving the standard Brostrm repair surgery, and the other receiving the Brostrm repair with the addition of the BioBrace Implant. Both groups will have their ankles immobilized for 2 weeks following surgery, then follow an accelerated rehabilitation program involving early weight-bearing and sport-specific training unless this is not tolerated, in which case standard rehabilitation protocols will be used. Throughout the study, participants will be assessed before surgery and postoperatively at intervals of 2 weeks, 2 months, 6 months, and 12 months. They will complete various questionnaires measuring pain, physical and mental health, function, and satisfaction. Biweekly electronic questionnaires will track return to sport and daily activities until participants reach their preoperative activity levels or until the 12-month final visit. Clinical assessments will monitor safety and overall recovery during the year-long follow-up.

Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®