Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®

NCT07708584 | Recruiting DMC FDA Device

• 1 other identifier: 2026P000101
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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

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

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Pain VAS

  The pain VAS (Visual Analog Scale) is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients. It consists of a line marked from 0 to 10, with 0 representing "no pain" at one end and 10 "worst imaginable pain" at the other; patients mark their pain level on the line, which is then measured to provide a numerical score from 0 to 10.

  From enrollment to the last follow-up at 12 months

• PROMIS Scale v2.0 - Pain Intensity 3a

  The PROMIS Scale v2.0 - Pain Intensity 3a scale utilizes a 3-question questionnaire to assess patients' pain experiences over the previous 7 days. The items include the intensity of pain at its worst, the intensity of pain on average, and the level of pain right now. The items are scored on a scale from "Had no pain" to "Very severe".

  From enrollment to the last follow-up at 12 months.

• NIH Toolbox Pain Interference CAT Ages 18 v3.0

  The NIH Toolbox Pain Interference CAT Ages 18 v3.0 is a computerized adaptive test that evaluates how much pain has interfered with and affected a person's life and daily activities over the previous 7 days. The questions are generated dynamically based on previous answers. Results are reported as a T-score. A higher T-score indicates a greater degree of pain interference.

  From enrollment to the last follow-up at 12 months.

• PROMIS Scale v1.2 - Global Mental 2a

  The PROMIS Scale v1.2 - Global Mental 2a is a two-question questionnaire assessing participants' mental health, mood, ability to think, and satisfaction with social activities and relationships. The questions are scored from "Excellent" to "Poor".

  From enrollment to the last follow-up at 12 months.

• PROMIS Scale v1.2 - Global Physical 2a

  The PROMIS Scale v1.2 - Global Physical 2a is a two-question questionnaire designed to assess a participant's overall physical well-being. The participants are asked to rate their physical health on a scale from "Excellent" to "Poor" and their ability to carry out physical activities of daily living on a scale from "Completely" to "Not at all".

  From enrollment to the last follow-up at 12 months.

• Foot and Ankle Outcome Score (FAOS)

  The Foot and Ankle Outcome Score (FAOS) is a 42-item questionnaire with 5 subscales: symptoms (5 items), stiffness (2 items), pain (9 items), daily living (17 items), sports and recreational activities (5 items), and quality of life (4 items). Each question is graded on a 5-point scale (none, mild, moderate, severe, and extreme problems).

  From enrollment to the last follow-up at 12 months.

• Foot and Ankle Ability Measure Scored

  The Foot and Ankle Ability Measure Scored tool has two sections. The first section asks participants to rate their difficulty completing activities of daily living on a scale from "No difficulty" to "Unable to do" over 21 different questions along with a rating their current level of function from 0 to 100, with 100 being their prior level of function. The second section asks participants to rate their difficulty in participating in sports activities on a scale from "No difficulty at all" to "Unable to do" over 7 different questions along with a rating their current level of function during sport activities from 0 to 100, with 100 being their prior level of function.

  From enrollment to last follow-up at 12 months.

• Clinical Assessment

  Clinicians will assess participants during their follow-up appointments. The clinicians will measure an anterior drawer test, range of motion assessment, hindfoot alignment, wound/incision assessment, complications assessment, and a physical activity assessment.

  From enrollment to the last follow-up at 12 months.

Secondary Outcomes (1)

• Return to Activity

  From baseline until participants report full return to activity or until last follow-up at 12 months.

Study Arms (2)

Standard Brostrom Repair (SBR)

OTHER

Standard-of-care Brostrom repair

Procedure: Standard Brostrom Repair

Augmented Brostrom Repair (ABR)

EXPERIMENTAL

Brostrom repair augmented with BioBrace

Device: Brostrom repair with augmentation

Interventions

Standard Brostrom Repair PROCEDURE

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

Standard Brostrom Repair (SBR)

Brostrom repair with augmentation DEVICE

Brostrom repair with BioBrace

Augmented Brostrom Repair (ABR)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• CONMED Corporation: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Central Study Contacts

Soheil Ashkani-Esfahani, MD MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Foot & Ankle Research and Innovation Laboratory (FARIL); Assistant Professor, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

US (2)