Study Comparing Arthroscopic Brostrom Repair With and Without BioBrace Implant Evaluating Early Patient Outcomes After Lateral Ankle Ligament Surgery

What this Trial Is About

Researchers are evaluating patient outcomes and functional scores before and after an all-arthroscopic Brostrom repair for lateral ankle ligament injuries. This trial compares the use of a suture anchor construct alone versus suture anchors combined with the BioBrace Implant to understand differences in recovery and function. The study is prospective, randomized, and single-center, focusing on early postoperative results and safety. Participants will be assigned to one of two groups a control group receiving the standard arthroscopic Brostrom repair using suture anchors only, and a treatment group receiving the same repair augmented with the BioBrace Implant. The procedures are performed using an all-arthroscopic Brostrom technique. Clinical evaluations are scheduled preoperatively and at multiple points postoperatively, including 1, 3, and 6 weeks, and 3, 6, and 12 months. During the study, participants will complete various patient-reported outcome measures to assess pain, function, activity levels, and safety following surgery. These assessments include the American Orthopedic Foot and Ankle Society score, Foot Function Index, Visual Analog Scale, and Karlsson-Peterson score at all scheduled visits. The study involves close monitoring from before surgery through one year after the procedure to track recovery and outcomes.

BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair