This trial is active, not recruiting.

Conditions anterior cruciate ligament rupture, deficiency of anterior cruciate ligament, chronic instability of knee, anterior cruciate ligament injury
Treatments patellar tendon, hamstring tendon, double-bundle
Sponsor University of Calgary
Collaborator Workers' Compensation Board, Alberta
Start date September 2007
End date December 2010
Trial size 330 participants
Trial identifier NCT00529958, 20966


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
(Active Comparator)
ACL reconstruction using a patellar tendon autograft
patellar tendon Bone-patellar tendon-bone graft
Patellar Tendon autograft
(Active Comparator)
ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft
hamstring tendon Single-bundle hamstring graft
Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft
(Active Comparator)
ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft
double-bundle Double-bundle ST/G graft
Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft

Primary Outcomes

Anterior Cruciate Ligament Quality of Life (ACL-QOL) outcome
time frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years post-operatively

Secondary Outcomes

Incidence of Traumatic ACL Re-ruptures and Atraumatic Graft Failures
time frame: 2, 5 and 10 years post-operatively
Knee laxity as measured by the KT arthrometer
time frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years
Radiographic (x-ray) changes using the International Knee Documentation Committee (IKDC) grading recommendations
time frame: 2, 5 and 10 years post-operatively
Pivot Shift
time frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years post-operatively
Complications of the surgical procedure
time frame: 3 and 6 months, 1, 2, 5 and 10 years
Surgical times for each procedure
time frame: Surgery
Return to pre-injury activity level as measured by the Tegner Activity Scale
time frame: 6 months, 1, 2, 5 and 10 years
IKDC Subjective Score and Overall Group Grade
time frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years
Work-related outcomes using the Cincinnati Occupational Rating Scale
time frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years post-operatively

Eligibility Criteria

Male or female participants from 14 years up to 50 years old.

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 Research 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

Additional Information

Official title A Randomized Clinical Trial Comparing Three Methods for Anterior Cruciate Ligament Reconstruction: Patellar Tendon, Quadruple Semitendinosus/Gracilis and Double-Bundle Semitendinosus/Gracilis Grafts.
Principal investigator Nicholas G Mohtadi, MD MSc FRCSC
Description Following an ACL injury, the knee is predisposed to chronic instability, further damage to the meniscal and chondral structures in the knee, osteoarthritis and an impaired quality of life. The successful treatment of an ACL deficient knee aims to preserve the intact meniscus and chondral structures, and to provide a functionally stable knee so that patients can return to pre-injury activities and restore their quality of life. The current standard of care for ACL deficient knees is with a surgical ACL reconstruction procedure. A Cochrane Review was done and demonstrated that the existing literature is controversial. To date, no existing trial has used validated patient-based outcome assessment, accounted for the critical differences between acute and chronic ACL deficiency or used modern techniques to ensure randomization concealment and a sufficient sample size to avoid type II error. The existing information does not define graft failure or re-ruptures, involve long-term follow-up to address osteoarthritis development, nor compare outcomes between single- and double-bundle reconstructive techniques. The current standard includes either a patellar tendon or quadruple semitendinosus/gracilis tendon autograft reconstruction. The newest option is a double-bundle semitendinosus/gracilis graft. This option attempts to restore the complex ACL anatomy by using two separate tendon components to reconstruct the ACL. This study will measure disease-specific quality of life at short- and long-term post-operative intervals (1, 2, 5 and 10 years). Additional secondary outcomes, including the incidence of traumatic re-ruptures and graft failures, will also be compared between treatment groups.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Calgary.