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Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®
Recruiting
The Effect of Augmented Brostrom Repair Using Bioinductive Implant in Patients With Lateral Ankle Instability
Who can join
Ages 18 to 65 · All sexes
Full eligibility criteria
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. * 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. * Concomitant osteochondral lesions, significant degenerative changes, or severe varus/valgus deformity, neuromuscular disorders or non-adherence concerns. * Pregnant * Diagnosis of Ehlers-Danlos Syndrome or other connective tissue / hyperlaxity disorder. * Prior revision ankle ligament surgery on the affected limb (any revision Broström or lateral ligament reconstruction).
About the study
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.
What is being tested
- Standard Brostrom Repair (procedure)
- Brostrom repair with augmentation (device)
Sponsor: Massachusetts General Hospital · Participants: 75 · Started: 2026-09
Contact the study team
- Soheil Ashkani-Esfahani, MD MPH · Phone: 510-850-6056
Official record on ClinicalTrials.gov — NCT07708584
Locations in the U.S.
| Massachusetts | Brigham and Women's Hospital, Boston Massachusetts General Hospital, Boston |
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.