Active — Not RecruitingNot Applicable

Graft Selection in Anatomic Anterior Cruciate Ligament Reconstruction

Netherlands439 participantsStarted 2017-03-06

Plain-language summary

A rupture of the anterior cruciate ligament (ACL) is a severe injury of the knee. The current gold Standard treatment for young and active patients with instability, is a surgical ACL reconstruction. However, there still is no consensus on which graft is best suited for this.The aim of the current multi-center randomized controlled trial was to investigate the hypothesis that an anatomic single bundle anterior cruciate ligament reconstruction with a (flat) quadriceps tendon autograft is at least as effective as reconstruction of the ruptured anterior cruciate ligament with a patella tendon autograft or a hamstringtendon autograft, in terms of failure, measured 2 years postoperatively. Failure is defined gedefinieerd as pathologicai laxity, complaints of knee instability in the absence of any pathological laxity and/or discontinuïty ofthe graft on MRl or arthroscopy.

Who can participate

Age range

18 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: * Patients active in sports, Tegner =/\>5 * Primary ACL rupture, evident from anamnesis (acute trauma, snapping sensation, swelling within several hours, feeling of instability), physical examination (positive Lachman test, anterior drawertest and/or pivot shift test), radiograph and MRl * Willing to comply to the suggested (nationwide standard) rehabilitation protocol, supen/ised by a NFVS registerd sport-physical therapist * \<6 months between initial trauma and surgery Exclusion Criteria: * History of knee surgery on the same side * History of tendon removal on the same side * Accompanying ligament injury ofthe knee, evident from anamnesis, physical examination, radiograph and MRl, defined as an ACL rupture in combination with a posterior cruciate ligament or collateral ligament injury, * Peroperative discovery of cartilage damage; larger than 2cm2 and more than 50% depth * Peroperative discovery of meniscus injury witch requires a meniscectomy of more than 20% or meniscus sutures * Osteoarthritis of Kellgren and Lawrence grade 2 or more, as evident from the radiograph * Severe malalignment of the leg * Tendency to form excessive scar tissue, such as arthrofibrosis * Muscular, neurological or vascular anomalies that influence healingtime or rehabilitation * Infection * Known hypersensitivity to any of the used materials * Long term relevant medication use such as prednisolone or cytostatics * Pregnancy at the time of inclusion or surgery * Known oste…

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

Physical examination ACL Failure

Timeframe: 2 years after ACL reconstruction surgery

Trial details

NCT IDNCT03073083

SponsorOrthopedisch Centrum Oost Nederland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-12

View on ClinicalTrials.gov More Anterior Cruciate Ligament Injuries trials