Arthroscopic Broström repair with BioBrace augmentation for lateral ankle ligament injuries
Early Outcomes With and Without Use of a Novel Reinforced Bioinductive Implant in Arthroscopic Brostrom Repair: A Prospective Randomized Study
This trial will test whether adding the BioBrace implant to suture-anchor arthroscopic Broström repair helps adults with ATFL and lateral ankle instability recover better than suture anchors alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hancock Orthopedics Academic / other |
| Locations | 1 site (Greenfield, Indiana) |
| Trial ID | NCT07401095 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18+) scheduled for a primary all-arthroscopic Broström repair who can consent and commit to scheduled follow-up visits are the intended participants.
Not a fit: Patients with prior Broström surgery, major additional ankle procedures, or medical or psychiatric conditions that affect recovery or follow-up are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, BioBrace augmentation could reduce pain and instability and improve function or speed recovery after arthroscopic Broström repair.
How similar studies have performed: Small case series and nonrandomized reports have explored biologic or synthetic augmentation for lateral ankle repair, but high-quality randomized evidence on implants like BioBrace is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Greenfield, Indiana
- Hancock Orthopedics — Greenfield, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Jay Badell, DPM, MS, FACFAS
- Email: JBadell@hancockhealth.org
- Phone: 317-477-6683
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.