Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Brostrom Repair, Brostrom repair with augmentation.
- Who it may be relevant to
- Registry conditions: Lateral Ankle Instability, Chronic Lateral Ankle Instability, Brostrom Procedure, ATFL. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Augmented Brostrom Repair Using Bioinductive Implant in Patients With Lateral Ankle Instability
Overview
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.
Detailed description
This is a single-center, prospective, randomized (1:1) interventional study investigating the use of the BioBrace® Implant in lateral ankle ligament repair procedures performed using the Broström technique. Eligible participants who meet study criteria will be enrolled and randomized into one of two study arms:
Control Group: Open standard Broström repair of the lateral ankle
Treatment Group: Open Broström repair of the lateral ankle using a suture-anchor construct augmented with the BioBrace® Implant.
Both groups will be immobilized for 2 weeks and then will undergo standard accelerated rehabilitation protocols (early weight-bearing and sport-specific training) unless they are not tolerated which will lead to using traditional standard protocols.
Clinical evaluations will be conducted at baseline (preoperatively), and postoperatively at 2 weeks, 2 months, 6 months, and 12 months using various patient-reported outcome measures to asses pain, function, satisfaction, activity and safety post surgery. Participants will also receive biweekly (every 2 weeks) electronic questionnaires assessing return to sport and return to daily/recreational activity. These biweekly assessments will continue until the participant reports full return to their preoperative level of activity or sport. Participants who do not reach preoperative activity/sport level will continue receiving biweekly questionnaires through the 1 year final visit.
Interventions
- Procedure Standard Brostrom Repair
Standard-of-care Brostrom repair for chronic lateral ankle instability - Device Brostrom repair with augmentation
Brostrom repair with BioBrace
Primary outcome measures
- Pain VAS [Time frame: From enrollment to the last follow-up at 12 months]
- PROMIS Scale v2.0 - Pain Intensity 3a [Time frame: From enrollment to the last follow-up at 12 months.]
- NIH Toolbox Pain Interference CAT Ages 18 v3.0 [Time frame: From enrollment to the last follow-up at 12 months.]
- PROMIS Scale v1.2 - Global Mental 2a [Time frame: From enrollment to the last follow-up at 12 months.]
- PROMIS Scale v1.2 - Global Physical 2a [Time frame: From enrollment to the last follow-up at 12 months.]
- Foot and Ankle Outcome Score (FAOS) [Time frame: From enrollment to the last follow-up at 12 months.]
- Foot and Ankle Ability Measure Scored [Time frame: From enrollment to last follow-up at 12 months.]
- Clinical Assessment [Time frame: From enrollment to the last follow-up at 12 months.]
Secondary outcome measures (1)
- Return to Activity [Time frame: From baseline until participants report full return to activity or until last follow-up at 12 months.]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Massachusetts General Hospital — Boston
- Brigham and Women's Hospital — Boston
Identifiers
NCT: NCT07708584 · 2026P000101