💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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).
💊
What it tests
- Standard Brostrom Repair
- Brostrom repair with augmentation
Massachusetts General Hospital
Boston, United States
Brigham and Women's Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky