BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair
United States40 participantsStarted 2025-12-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
American Orthopedic Foot and Ankle Society score (AOFAS)
Timeframe: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months
2
Foot Function Index (FFI)
Timeframe: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months
3
Visual Analog Scale (VAS)
Timeframe: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months
4
Karlsson-Peterson score
Timeframe: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months
. 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)