About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Concomitant deltoid ligament insufficiency.
Any worker's compensation case or any subject with a history of infection of the ankle predating the ankle repair. Current orthopedic issues, not related to the ankle, that prevented the patient from performing the functional tests.
Trial design
Treatments tested in this trial
- Standard Brostrom Repair
- Brostrom repair with augmentation
Treatment groups
Sponsors and collaborators
Massachusetts General Hospital
Lead sponsor
CONMED Corporation
Collaborator