Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Tal… (NCT06638138) | Clinical Trial Compass
CompletedNot Applicable
Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability
United States58 participantsStarted 2023-08-22
Plain-language summary
The goal of this clinical trial is to analzye return to pre-injury activity level on study participants with lateral ankle instability undergoing a modified Bröstrom reconstruction procedure for repair of the ATFL. Study participants undergoing ATFL reconstructive procedure using the ARTELON FLEXBAND System as an augmentation device will be compared to study participants undergoing a standard modified Bröstrom procedure alone. Clinician reported safety and functional outcomes measures will be collected at baseline; and at 2-, 6-, 12-, 18 and 26-weeks and 1- and 2-years post-surgery.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
âś“. Subjects between and including the age of 18-75 at the time of surgery.
âś“. Subjects who were diagnosed with lateral ankle instability by physician clinical assessment.
✓. Subjects who will undergo a modified Bröstrom procedure for an ATFL repair with or without FLEXBAND augmentation device (does not require an isolated repair).
âś“. Subjects that are able to understand, complete and sign the Consent Form.
Exclusion criteria
âś•. 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).
âś•. 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.
âś•. Subjects undergoing a Calcaneal osteotomy.
What they're measuring
1
Primary Efficacy Endpoint
Timeframe: From 2 weeks post-surgery to 26 weeks post-surgery.
2
Primary Safety Endpoint
Timeframe: Time of surgery to 2 years post-surgery