Recruiting

Broström Repair, BioBrace

Sponsor:

Massachusetts General Hospital

Code:

NCT07708584

Conditions

Lateral Ankle Instability

Chronic Lateral Ankle Instability

Brostrom Procedure

ATFL

Anterior Talofibular Ligament

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Standard Brostrom Repair

Brostrom repair with augmentation

Study Details

Brief summary:

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.

Conditions

Lateral Ankle Instability

Chronic Lateral Ankle Instability

Brostrom Procedure

ATFL

Anterior Talofibular Ligament

Study ID

NCT07708584

Start date

Sep, 2026

Status verified date

Aug, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Standard Brostrom Repair (SBR)

Standard-of-care Brostrom repair

experimental: Augmented Brostrom Repair (ABR)

Brostrom repair augmented with BioBrace

Interventions

Standard Brostrom Repair

Standard-of-care Brostrom repair for chronic lateral ankle instability

Brostrom repair with augmentation

Brostrom repair with BioBrace

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Soheil Ashkani-Esfahani, MD MPH

510-850-6056sashkaniesfahani@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Gregory Waryasz, MD

781-487-4338gwaryasz@mgb.org

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Christopher Miller, MD

617-525-9382cpmiller@mgb.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-08-19.