BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair

NCT07401095 | Recruiting FDA Device

• 1 other identifier: ABBB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this investigation is to evaluate pre- and post-operative patient reported outcomes and functional scores after an all-arthroscopic Brostrom repair using either a suture anchor construct alone or suture anchors with the BioBrace Implant.

Conditions

ATFL; Lateral Ankle Instability; Anterior Talofibular Ligament; Anterior Talofibular Ligament Injury; Brostrom Procedure; Brostrom; Ankle

Keywords

BioBrace; The BioBrace Implant; BioBrace Implant; ATFL; Lateral Ankle Instability; CONMED; Ankle; Ankle Injury

Outcome Measures

Primary Outcomes (4)

• American Orthopedic Foot and Ankle Society score (AOFAS)

  The AOFAS Score is a clinician-based assessment tool that evaluates pain, function, and alignment in patients with foot and ankle disorders. It provides a composite score ranging from 0 to 100, with higher scores indicating better function. The system includes region-specific scales (e.g., ankle-hindfoot, midfoot, hallux) and combines both patient-reported symptoms and objective clinician findings

  Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months

• Foot Function Index (FFI)

  The Foot Function Index (FFI) is a patient-reported questionnaire used to assess how foot conditions affect pain, disability, and activity limitation. It includes 23 items rated on a 0-10 scale, with higher scores indicating greater impairment in foot function.

  Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months

• Visual Analog Scale (VAS)

  The Visual Analog Scale (VAS) is a tool used to measure the intensity of pain or other subjective symptoms. It consists of a 10-cm line labeled "no pain" at one end and "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 100.

  Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months

• Karlsson-Peterson score

  The Karlsson-Peterson Score is a functional ankle assessment tool that evaluates symptoms such as pain, swelling, instability, stiffness, stair-climbing ability, running ability, work/activity level, and need for support, producing a total score up to 100, with higher scores indicating better ankle function.

  Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months

Study Arms (2)

Control - Repair Only Group

SHAM COMPARATOR

Procedure: Standard of care Brostrom repair.

Other: Brostrom repair without augmentation

BioBrace Augment Group

EXPERIMENTAL

Brostrom repair with BioBrace

Device: Brostrom repair with augmentation

Interventions

Brostrom repair with augmentation DEVICE

Brostrom repair with BioBrace

BioBrace Augment Group

Brostrom repair without augmentation OTHER

Brostrom repair without BioBrace

Control - Repair Only Group

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age at the time of surgery.
• Able to read, understand and sign the informed consent form.
• Willing to be available to attend each protocol required visit and complete the study required questionnaires.
• Scheduled to undergo primary, arthroscopic Brostrom repair.

You may not qualify if:

• Previous Brostrom surgery.
• Concomitant procedures that would change the post operative course/recovery (i.e. total ankle replacement, OCD repair, foot/ankle osteotomies) as determined by the Investigator.
• Currently participating or plans to enroll in another clinical trial during this study that would affect the outcomes of this study as determined by the Investigator.
• History of non-compliance with medical treatment or clinical trial participation.
• The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant with protocol required follow-up.
• Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study.
• Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.
• Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)

Sponsors & Collaborators

• Hancock Orthopedics: lead
• CONMED Corporation: collaborator

Study Sites (1)

Hancock Orthopedics

Greenfield, Indiana, 46140, United States

RECRUITING

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Central Study Contacts

Jay Badell, DPM, MS, FACFAS

CONTACT

317-477-6683; JBadell@hancockhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: December 8, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-01

Locations

US (1)