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NCT Number: NCT07401095

BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair

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.

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Key information

Conditions

ATFL Ankle Ankle Injuries Anterior Talofibular Ligament Anterior Talofibular Ligament Injury Brostrom Brostrom Procedure Lateral Ankle Instability Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hancock Orthopedics

Greenfield, Indiana, 46140, United States

Location status: Recruiting

Location contact

Jay Badell, DPM, MS, FACFAS

CONTACT

[email protected]

317-477-6683

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

Brostrom repair with augmentation

Device

Brostrom repair with BioBrace

Brostrom repair without augmentation

Other

Brostrom repair without BioBrace

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jay Badell, DPM, MS, FACFAS

CONTACT

[email protected]

317-477-6683

Sponsors and collaborators

Lead sponsor

Hancock Orthopedics

Other

Collaborators

  • CONMED Corporation

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 10, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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