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NCT07708584From ClinicalTrials.govRecruiting

Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®

The Effect of Augmented Brostrom Repair Using Bioinductive Implant in Patients With Lateral Ankle Instability

  • Lateral Ankle Instability
  • Chronic Lateral Ankle Instability
  • Brostrom Procedure
  • ATFL
  • Anterior Talofibular Ligament
  • Ankle
  • Bioinductive Implant

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Massachusetts General Hospital
Enrolment target
75
Started
September 2026
Main results due
June 2028
Study sites
2
Registry updated
29 September 2026

Can you take part?

  • Ages 18 years to 65 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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).

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(2)

  • Massachusetts General Hospital

    Boston, Massachusetts, United States

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, United States

    Recruiting

Showing 2 of 2 sites. 2 of the 2 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07708584. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace® | Trialion