BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair
Start Date
12/8/2025
Completion Date
12/1/2028
Summary
The purpose of this investigation is to evaluate pre- and post-operative patient reported outcomes and functional scores after an all-arthroscopic Brostrom repair using either a suture anchor construct alone or suture anchors with the BioBrace Implant.
Detailed Description
This is a single-center, prospective, randomized (1:1) interventional study investigating the use of the BioBrace® Implant in lateral ankle ligament repair procedures performed using an all-arthroscopic Broström technique. Eligible participants who meet study criteria will be enrolled and randomized into one of two study arms: Control Group: Arthroscopic Broström repair using a suture-anchor construct only. Treatment Group: Arthroscopic Broström repair using a suture-anchor construct augmented with the BioBrace® Implant. Clinical evaluations will be conducted at baseline (preoperatively), and postoperatively at 1, 3, and 6 weeks, as well as at 3, 6, and 12 months using various patient-reported outcome measures to asses pain, function, activity and safety post surgery.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Brostrom repair with augmentation
Brostrom repair without augmentation
Conditions
Locations
Hancock Orthopedics
Greenfield, Indiana 46140
United States