Arthroscopic Broström repair with BioBrace augmentation for lateral ankle ligament injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, prospective randomized (1:1) trial enrolls adults undergoing primary all-arthroscopic Broström repair and randomizes them to standard suture-anchor repair or suture anchors plus the BioBrace implant. Clinical and patient-reported outcome measures for pain, function, activity, and safety are collected at baseline and at 1, 3, and 6 weeks, and at 3, 6, and 12 months postoperatively. The primary approach compares functional scores and complications between the two arms to see if augmentation improves recovery or reduces recurrence. Eligibility excludes prior Broström surgery, major concomitant procedures, or conditions that would alter recovery or impair consent or follow-up.

Why it matters

Who can join: the full rules

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)

Where it's running

• Hancock Orthopedics
  Greenfield, Indiana, United States Recruiting

Study contacts

• Study coordinator: Jay Badell, DPM, MS, FACFAS
• Email: JBadell@hancockhealth.org
• Phone: 317-477-6683

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.