Standard ACL Reconstruction vs ACL + Lateral Extra-Articular Tenodesis Study (NCT02018354) | Clinical Trial Compass
UnknownNot Applicable
Standard ACL Reconstruction vs ACL + Lateral Extra-Articular Tenodesis Study
Belgium, Canada, United Kingdom624 participantsStarted 2014-01
Plain-language summary
The purpose of this study is to compare outcomes (failure, function, strength, range of motion and quality of life) between patients who receive the usual anterior cruciate ligament (ACL) reconstructive surgery and patients who receive anterior cruciate ligament reconstructive surgery with a lateral extra-articular tenodesis (extra tendon repair on the outside of the knee). Some studies have shown high graft failure rates (ACL re-tear) in young individuals who return to pivoting contact sports following ACL reconstruction. This study is designed to look at whether or not adding this extra tendon repair reduces the risk of graft failure in this population.
Who can participate
Age range
14 Years – 25 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:
* ACL deficient knee
* skeletally mature to 25 years of age
* 2 or more of:
* competitive pivoting sport
* grade 2 pivot shift or greater
* generalized ligament laxity - Beighton score of 4 or greater
Exclusion criteria:
* previous ACL reconstruction on either knee
* multi-ligament injury (two or more ligaments requiring surgical attention)
* symptomatic articular cartilage defect requiring treatment other than debridement
* greater than 3 degrees of asymmetric varus
* unable to complete outcome questionnaires
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.
1This trial compares standard ACL reconstruction alone to ACL reconstruction combined with a lateral extra-articular tenodesis — can you explain what the tenodesis procedure adds, and whether my specific knee instability suggests I might benefit from that combined approach?
2The primary outcome this trial is measuring is graft failure — what does graft failure mean in practical terms for recovery, and how do the failure rates in each surgical approach compare to what's already known from standard care?
3The recruitment status for this trial is listed as unknown, which means it may no longer be actively enrolling — can you check whether this study is still open, and if not, are there similar updated trials comparing these two ACL surgical techniques that I could consider?
4Since this trial is listed as Phase NA, meaning it's a surgical comparison study rather than a traditional drug trial, how does that affect what we know about the safety and long-term outcomes of adding the lateral tenodesis to my ACL reconstruction?
5Before considering this trial at all, would standard ACL reconstruction alone be the right first step for my situation, or are there factors about my knee — like the degree of instability or my activity level — that would make the combined procedure worth discussing with a specialist?
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.