Clinical trial NCT00529958: Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Deficiency of Anterior Cruciate Ligament
Chronic Instability of Knee
Anterior Cruciate Ligament Injury
Keywords: Anterior Cruciate Ligament (ACL) Reconstruction
Patellar Tendon
Hamstring Tendon
Double-Bundle
Autograft
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Workers' Compensation Board, Alberta
First posted: 2007-09-14
Enrollment: 330
Sex: ALL
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome
timeFrame: Baseline, 3 and 6 months, 1, 2, and 5 years post-operatively
Secondary outcomes:
measure: Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures
timeFrame: Minimum 2-year Follow-up, 5-Year Follow-up, 10-Year Follow-up
measure: Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade
timeFrame: Baseline, 1, 2, 5 years post-operatively
measure: Mean International Knee Documentation Committee (IKDC) Subjective Score
timeFrame: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively
measure: Number of Participants With Each Pivot Shift Grade
timeFrame: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively
measure: Proportion of Patients With Moderate or Severe Kneeling Pain
timeFrame: Baseline, 2 and 5 years post-operatively
measure: Knee Laxity as Measured by the KT Arthrometer
timeFrame: Baseline, 1 and 2 years post-operatively
measure: Mean Tegner Activity Level
timeFrame: Baseline, 6 months, 1 and 2 years post-operatively
measure: Return to Pre-injury Tegner Activity Level
timeFrame: 1, 2 and 5 years post-operatively
measure: Cincinnati Occupational Rating Scale
timeFrame: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively
measure: Skin-to-Skin Operative Times
timeFrame: During surgery
measure: Radiographic (X-ray) Changes
timeFrame: Baseline, 2 and 5 years post-operatively
Other outcomes:
measure: Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome)
timeFrame: 2 years post-operatively
Locations:
city: Calgary
country: Canada
facility: University of Calgary Sport Medicine Centre
state: Alberta
Study officials:
affiliation: University of Calgary Sport Medicine Centre
name: Nicholas G Mohtadi, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohtadi N. Development and validation of the quality of life outcome measure (questionnaire) for chronic anterior cruciate ligament deficiency. Am J Sports Med. 1998 May-Jun;26(3):350-9. doi: 10.1177/03635465980260030201.
citation: Mohtadi NG, Chan DS, Dainty KN, Whelan DB. Patellar tendon versus hamstring tendon autograft for anterior cruciate ligament rupture in adults. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD005960. doi: 10.1002/14651858.CD005960.pub2.
citation: Mohtadi N, Barber R, Chan D, Paolucci EO. Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction. Clin J Sport Med. 2016 May;26(3):182-9. doi: 10.1097/JSM.0000000000000202.
citation: Mohtadi N, Chan D, Barber R, Oddone Paolucci E. A Randomized Clinical Trial Comparing Patellar Tendon, Hamstring Tendon, and Double-Bundle ACL Reconstructions: Patient-Reported and Clinical Outcomes at a Minimal 2-Year Follow-up. Clin J Sport Med. 2015 Jul;25(4):321-31. doi: 10.1097/JSM.0000000000000165.
citation: Mohtadi N, Chan D, Barber R, Paolucci EO. Reruptures, Reinjuries, and Revisions at a Minimum 2-Year Follow-up: A Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction. Clin J Sport Med. 2016 Mar;26(2):96-107. doi: 10.1097/JSM.0000000000000209.
citation: Mohtadi NG, Chan DS. A Randomized Clinical Trial Comparing Patellar Tendon, Hamstring Tendon, and Double-Bundle ACL Reconstructions: Patient-Reported and Clinical Outcomes at 5-Year Follow-up. J Bone Joint Surg Am. 2019 Jun 5;101(11):949-960. doi: 10.2106/JBJS.18.01322.