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

Launched by STRYKER TRAUMA AND EXTREMITIES · Oct 9, 2024

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Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects between and including the age of 18-75 at the time of surgery.
• • 2. Subjects who were diagnosed with lateral ankle instability by physician clinical assessment.
• • 3. Subjects who will undergo a modified Bröstrom procedure for an ATFL repair with or without FLEXBAND augmentation device (does not require an isolated repair).
• • 4. Subjects that are able to understand, complete and sign the Consent Form.
• 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.