The Effect of Augmented Brostrom Repair Using Bioinductive Implant in Patients With Lateral Ankle Instability
Massachusetts General Hospital
Summary
The purpose of this investigation is to evaluate pre- and post-operative patient reported outcomes and functional scores after open non-augmented Broström repair or open Broström repair augmented with the BioBrace Implant.
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 the Broström technique. Eligible participants who meet study criteria will be enrolled and randomized into one of two study arms: Control Group: Open standard Broström repair of the lateral ankle Treatment Group: Open Broström repair of the lateral ankle using a suture-anchor construct augmented with the BioBrace® Implant. Both groups will be immobilized for 2 weeks and then will undergo standard accelerated re…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18-65 years * Chronic lateral ankle instability (\>3 months) confirmed by clinical examination (positive anterior drawer test or talar tilt \>10°) and imaging (stress X-ray or MRI). * No prior ankle surgery on the affected limb. * Willingness to follow postoperative visits and rehabilitation protocols and filling out the patient reported outcome measures (PROMs) forms. Exclusion Criteria: * BMI\>40 * Significant secondary procedures done at the time of repair, including micro-fracture, or any other treatment of osteochondral lesions of the talus or tibia. * Concomi…
Interventions
- ProcedureStandard Brostrom Repair
Standard-of-care Brostrom repair for chronic lateral ankle instability
- DeviceBrostrom repair with augmentation
Brostrom repair with BioBrace
Locations (2)
- Massachusetts General HospitalBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts