Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®
Recruiting
N/A
Interventional Study
Lateral Ankle Instability
Chronic Lateral Ankle Instability
Brostrom Procedure
ATFL
Anterior Talofibular Ligament
Ankle
Bioinductive Implant
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 75 (estimated)
- Sponsor
- Massachusetts General Hospital · Other
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About This Trial
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.
Trial Locations
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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…
Contacts