Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT06829667
Eligibility Criteria:
Inclusion Criteria:
* Patients between and including the age of 14-75 at the time of surgery
* Patients who were diagnosed with lateral ankle instability by physician clinical assessment
* Patients who underwent an ATFL repair with Arthrex InternalBrace augmentation device (does not require an isolated repair)
Exclusion Criteria:
* 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 bone debridements, synovectomies, and bone spur removals are allowed)
* 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.
* Patients undergoing a Calcaneal osteotomy
* Patients with less than 6 weeks follow-up
* Patients with incomplete medical records
* Patients with Worker's Compensation Cases
* Any patient with a history of infection of the ankle predating the ankle repair
* Any orthopedic issue outside of the ankle that the Investigator feels may impede functional endpoint outcome measures.
* Patients who have a medical history that would likely make the patient an unreliable research participant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
75 Years
Study:
NCT06829667
Study Brief:
Protocol Section:
NCT06829667