Comparison of Bone-patellar Tendon-bone and Patellar Tendon-bone Grafts in ACL Reconstruction (NCT07475351) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of Bone-patellar Tendon-bone and Patellar Tendon-bone Grafts in ACL Reconstruction
Spain110 participantsStarted 2026-01-01
Plain-language summary
The purpose of this randomized study is to compare donor site morbidity and clinical and functional outcomes of both surgery techniques (bone-patellar tendon-bone (BPTB) graft versus bone-patellar tendon without patellar bone plug (PT) graft) for anterior cruciate ligament reconstruction (ACLR) in athletes. The main questions it aims to answer are:
* Does PT graft reduce donor site morbidity compared to the standard BPTB graft?
* Does PT technique provide clinical and functional results comparable to the BPTB technique? Researchers will compare the incidence of complications and clinical and functional outcomes between the BPTB and PT grafts groups.
Patients will:
* Undergo ACLR surgical intervention using one of the two assigned techniques (BPTB or PT)
* Follow a two-year assessment program, including visits at three, eight, 12 and 24 months after surgery.
Who can participate
Age range
12 Years – 40 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:
* Time for injury to surgery of less than six months.
* Active athletes (federated or recreational)
* Patellar tendon length \> 42mm measured by MRI.
* Age between 12 and 40 years old
* Genders eligible for Study: both
Exclusion Criteria:
* Previous surgery or history of ligamentous knee injuries.
* Concomitant knee ligament injury
* Major meniscal injury (more than 50% of the lateral or medial meniscus)
* Chondral injury greater than Outerbridge Grade I-II
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
Donor Site Morbidity
Timeframe: At 3, 8, 12 and 24 months after surgery