BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair
Trial Parameters
Brief 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.
Eligibility 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 t