BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair

February 10, 2026 updated by: Hancock Orthopedics

Early Outcomes With and Without Use of a Novel Reinforced Bioinductive Implant in Arthroscopic Brostrom Repair: A Prospective Randomized Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, prospective, randomized (1:1) interventional study investigating the use of the BioBrace® Implant in lateral ankle ligament repair procedures performed using an all-arthroscopic Broström technique. Eligible participants who meet study criteria will be enrolled and randomized into one of two study arms:

Control Group: Arthroscopic Broström repair using a suture-anchor construct only.

Treatment Group: Arthroscopic Broström repair using a suture-anchor construct augmented with the BioBrace® Implant.

Clinical evaluations will be conducted at baseline (preoperatively), and postoperatively at 1, 3, and 6 weeks, as well as at 3, 6, and 12 months using various patient-reported outcome measures to asses pain, function, activity and safety post surgery.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Indiana
      • Greenfield, Indiana, United States, 46140
        • Recruiting
        • Hancock Orthopedics
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Previous Brostrom surgery.
  2. 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.
  3. 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.
  4. History of non-compliance with medical treatment or clinical trial participation.
  5. 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.
  6. Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study.
  7. Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.
  8. Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control - Repair Only Group
Procedure: Standard of care Brostrom repair.
Other: Brostrom repair without augmentation
Brostrom repair without BioBrace
Experimental: BioBrace Augment Group
Brostrom repair with BioBrace
Device: Brostrom repair with augmentation
Brostrom repair with BioBrace

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Orthopedic Foot and Ankle Society score (AOFAS)
Time Frame: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months
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)
Time Frame: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months
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)
Time Frame: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months
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
Time Frame: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hancock Orthopedics

Collaborators

CONMED Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABBB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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