CompletedNot Applicable

Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction

Canada330 participantsStarted 2007-09

Plain-language summary

The purpose of this randomized clinical trial is to determine the difference in quality of life outcome at two years, in patients undergoing an Anterior Cruciate Ligament (ACL) reconstruction procedure with either a patellar tendon, quadruple hamstring tendon or a double-bundle hamstring tendon autograft.

Who can participate

Age range

14 Years – 50 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: A confirmed diagnosis of anterior cruciate ligament deficiency based on all of the following: * History of a traumatic injury episode * Physical examination findings of increased anterior translation of the tibia on the femur (Lachman test and/or anterior drawer test) * A positive pivot shift test * X-rays showing skeletal maturity (ie: tibial tubercle fused) and no fractures. (NB: Magnetic resonance imaging is not required) * Age 14-50 years old Exclusion Criteria: * Patients with combined ligament deficiencies (Posterior Cruciate, Medial and/or Lateral Collateral deficiency.) (NB: Grade 1 side to side differences (ie. \< 5mm) on valgus, varus or posterior stress testing will not be considered exclusions) * Intra-operative identification of International Cartilage Repair Society (ICRS) Grade 4 chondral lesion of \> 1 cm ² \[61\] * Previous ligament surgery on the affected or contralateral knees * Cases involving litigation or Worker's Compensation * Confirmed connective tissue disorder (ie: Ehlers-Danlos, Marfans) * X-ray showing that tibial physis is not fused

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

Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome

Timeframe: Baseline, 3 and 6 months, 1, 2, and 5 years post-operatively

Trial details

NCT IDNCT00529958

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-12

Results submitted2017-11-07

View on ClinicalTrials.gov More Anterior Cruciate Ligament Rupture trials