Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT (NCT05461326) | Clinical Trial Compass
RecruitingNot Applicable
Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT
United States100 participantsStarted 2023-09-26
Plain-language summary
The choice of autograft for ACL reconstruction continues to be debated. To date, there has only be one completed randomized controlled trial with quad tendon to BTB and the tendon included a bone plug. There has been no study to date comparing an all soft tissue quad tendon to patellar tendon in a randomized controlled trial for ACL reconstruction.
Who can participate
Age range
14 Years – 65 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:
* Skeletally mature patients younger 65
* ACL insufficiency
* Scheduled to undergo autograft ACL reconstruction
* Appropriate candidate for autograft harvest
Exclusion Criteria:
* \<14 or 65\>
* Poor autograft candidate (poor tissue quality)
* Multi ligamentous reconstruction (PCL, MCL, or PLC)
* Pregnant or nursing
* High likelihood of remaining non-compliant with physical therapy regimen
* Desire to return to sport prior to 6 months
* Inability to read and write English
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 two different graft types for ACL reconstruction — the quadriceps tendon and the bone-patellar tendon-bone — what are the main differences in recovery, donor site pain, or return-to-sport timelines between these two options based on what's already known?
2The trial is measuring knee stability using a KT-1000 arthrometer as its primary outcome — does that capture everything that matters for my specific situation, like pain, function, or getting back to sports?
3Since this is listed as Phase NA, meaning it may be comparing two established surgical approaches rather than testing a brand-new treatment, how does participating in this study differ from just having standard ACL surgery outside of a trial?
4If I enroll, which graft type I receive would likely be randomly assigned — given my activity level, anatomy, or other personal factors, does my doctor have a preference for one graft over the other that I should weigh before agreeing to randomization?
5What happens to my care if I'm in the trial and one graft type ends up performing significantly better than the other — would I have access to that information during the study, and could it affect my treatment?
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.