Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability

Exclusion Criteria

• •1. Significant secondary procedures done at the time of repair, including significant osteochondral lesions and/or significant microfracture of the talus or tibia that warrant modifying the typical lateral ligament repair post-op rehab protocol (minor microfractures and OCD lesions that do not warrant major bone debridement, synovectomies, and bone spur/osteophyte removals are allowed).
• •2. Any concomitant orthopedic procedure that will extend the post-op rehabilitation (e.g., casting/immobilization) beyond the routinely prescribed rehab protocol following an ATFL reconstructive procedure.
• •3. Subjects undergoing a Calcaneal osteotomy.
• •4. Subjects requiring major additional tendon surgery (i.e., peroneal tendon repair or tenodesis).
• •5. Neuropathy.
• •6. Subjects with diabetes, who, in the opinion of the investigator, are not sufficiently controlled.
• •7. BMI greater than 40 kg/m2.
• •8. Subjects with active Worker's Compensation Cases
• •9. Any subject with a history of infection of the ankle predating the ankle repair.
• •10. Subjects with a systemic ligament laxity disorder (i.e., Ehlers-Danlos Syndrome).
• •11. Any orthopedic issue outside of the ankle that the Investigator feels may impede functional endpoint outcome measures.
• •12. Subjects who have a medical history that would likely make the subject an unreliable research participant.
• •13. Subjects that are nursing or pregnant at the time of surgery.
• •14. Subjects with physician assessed untreated alcohol or substance abuse at the time of screening.
• •15. Subjects who are currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening.