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Recruiting NCT07708584

Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®

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

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 75
Sponsor: Massachusetts General Hospital

Location: Massachusetts General Hospital Boston Massachusetts

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.

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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07708584). StuddyBuddy aggregates publicly available trial information.