BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair
Recruiting now · Not applicable
Conditions studied: ATFL, Lateral Ankle Instability, Anterior Talofibular Ligament, Anterior Talofibular Ligament Injury, Brostrom Procedure, Brostrom, Ankle
In brief
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.
Key facts
- Study ID
- NCT07401095
- Run by
- Hancock Orthopedics
- People needed
- 40
- Starts
- 2025-12-08
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-02-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Hancock Orthopedics — Greenfield, Indiana, United States (enrolling)
Full record on ClinicalTrials.gov
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