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Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®

RecruitingNA

Sponsor: Massachusetts General Hospital

Conditions: Lateral Ankle Instability, Chronic Lateral Ankle Instability, Brostrom Procedure, ATFL, Anterior Talofibular Ligament

Interventions: Standard Brostrom Repair, Brostrom repair with augmentation

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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).

Locations (2)

Boston, Massachusetts, United States
Boston, Massachusetts, United States