Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Endobutton vs Me… (NCT02918734) | Clinical Trial Compass
RecruitingNot Applicable
Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Endobutton vs Metal Interference Screws
Norway220 participantsStarted 2016-10
Plain-language summary
In this randomized controlled trial the investigators will compare the results after primary anterior cruciate ligament (ACL) reconstruction using two different methods for femoral fixation of a bone-patellar tendon-bone (BPTB) autograft. Interference screws have been the standard method for fixing the femoral side of BPTB grafts; however, several pitfalls have been reported. Cortical fixation with the Endobutton CL BTB Fixation System has become available and the clinical results have been described as promising; however, no randomized controlled trials comparing these two femoral fixation methods have been conducted, and there is no published data that confirms that the bone block heals in the tunnel with the newer method.
The aim of our study is to compare the outcome after primary ACL reconstruction with BPTB autografts using the Endobutton CL BTB or metal interference screw for femoral fixation.
Who can participate
Age range
18 Years – 55 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:
* Primary reconstruction of ACL ruptures
* Surgery at least 6 weeks after injury
* The patient must accept and sign the informed consent form before surgery
Exclusion Criteria:
* Medical indication for using another graft than BPTB autograft (such as history of anterior knee pain or occupations etc. requiring frequent kneeling)
* Previous major surgical procedures in the same knee
* Major additional injuries in the knee (posterior cruciate ligament, lateral collateral ligament, medial collateral ligament, sutured meniscus lesions and major cartilage lesions undergoing cartilage repair)
* Contralateral ACL injury (treated or untreated)
* Present or former serious illness that makes follow-up or rehabilitation difficult (e.g. alcohol or drug abuse, psychiatric disease)
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.