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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects between and including the age of 18-75 at the time of surgery.
. 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).
. Subjects that are able to understand, complete and sign the Consent Form.
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 major bone debridement, synovectomies, and bone spur/osteophyte removals are allowed).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. Subjects undergoing a Calcaneal osteotomy.
. Subjects requiring major additional tendon surgery (i.e., peroneal tendon repair or tenodesis).
. Neuropathy.
. Subjects with diabetes, who, in the opinion of the investigator, are not sufficiently controlled.
. BMI greater than 40 kg/m2.
. Subjects with active Worker's Compensation Cases