Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction

University of Calgary

Status: Completed

Conditions: Chronic Instability of Knee; Deficiency of Anterior Cruciate Ligament; Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament Rupture

Treatments: Procedure: Patellar Tendon; Procedure: Hamstring Tendon; Procedure: Double-Bundle

Study type: Interventional

Funder types: Other

Identifiers

NCT00529958

REB15-1061 (formerly 20966)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 patients

Sex: All

Ages: 14 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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330 participants in 3 patient groups

Patellar Tendon (PT)

Active Comparator group

Description:

ACL reconstruction using a patellar tendon autograft

Treatment:

Procedure: Patellar Tendon

Hamstring (HT)

Active Comparator group

Description:

ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft

Treatment:

Procedure: Hamstring Tendon

Double-Bundle (DB)

Active Comparator group

Description:

ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft

Treatment:

Procedure: Double-Bundle