BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament 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)