Open Broström repair with BioBrace augmentation for chronic ankle instability
Official title: The Effect of Augmented Brostrom Repair Using Bioinductive Implant in Patients With Lateral Ankle Instability
Run by Massachusetts General Hospital · NCT07708584 · Data updated 2026-11-12
This study tests whether adding the BioBrace implant to a standard Broström repair improves outcomes for adults with chronic lateral ankle instability.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Status | Recruiting |
| Started | September 2026 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT07708584 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-65 with chronic lateral ankle instability (>3 months) suitable for open Broström repair and no prior ankle surgery on the affected side.
✕Probably not a fit
Individuals with BMI over 40, additional ankle pathologies requiring other procedures, or contraindications to the proposed rehabilitation may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, prospective, randomized trial comparing open Broström repair alone to open Broström repair augmented with the BioBrace implant in adults with chronic lateral ankle instability. Participants are randomly assigned 1:1 and followed for 12 months, with assessments at baseline, 2 weeks, 2 months, 6 months, and 12 months, plus biweekly checks on return to sport and activity. Both groups follow immobilization for 2 weeks and then standard rehabilitation, with PROMs used to measure pain, function, satisfaction, activity, and safety. The study aims to determine if BioBrace augmentation provides superior patient-reported and functional outcomes compared with the standard repair.
Why it matters
Potential benefit: If successful, BioBrace augmentation could improve pain relief, function, and return-to-activity timelines after Broström repair.
How similar studies have gone: Prior similar approaches have shown promise in enhancing ligament repair stability, but this exact BioBrace augmentation in Broström procedures is being evaluated in this randomized trial.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
-
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Soheil Ashkani-Esfahani, MD MPH
- Email: sashkaniesfahani@mgh.harvard.edu
- Phone: 510-850-6056
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Arthroscopic Broström repair with BioBrace augmentation for lateral ankle ligament injuries
This trial will test whether adding the BioBrace implant to suture-anchor arthroscopic Broström repair helps adults with ATFL and lateral ankle instability recover better than suture anchors alone.
-
Functional biomechanics after augmentation repair for chronic lateral ankle instability
This study tests how the foot and leg move after augmentation repair for chronic lateral ankle instability in people who stay active or play sports.
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Dynamic Neuromuscular Stability Exercises With or Without Rhythmic Auditory Stimulation for Lateral Ankle Sprain
This study tests if Dynamic Neuromuscular Stabilization (DNS) with or without rhythmic auditory cues helps badminton players recover balance and function after a lateral ankle sprain.
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Comparing two methods for repairing rotator cuff tears using BioBrace®
This study is testing if using BioBrace® for repairing large rotator cuff tears helps patients recover better and feel stronger compared to traditional repair methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.