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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

Sponsor: Massachusetts General Hospital · Participants: 75 · Started: 2026-09

Contact the study team

Official record on ClinicalTrials.gov — NCT07708584

Locations in the U.S.

MassachusettsBrigham 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.