Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction - Full Text View

Sponsor:	University of Calgary
Collaborator:	Workers' Compensation Board - Alberta
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00529958

Purpose

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.

Condition	Intervention
Anterior Cruciate Ligament Rupture Deficiency of Anterior Cruciate Ligament Chronic Instability of Knee Anterior Cruciate Ligament Injury	Procedure: Patellar Tendon Procedure: Hamstring Tendon Procedure: Double-Bundle

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Knee Injuries and Disorders

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:

Anterior Cruciate Ligament Quality of Life (ACL-QOL) outcome [ Time Frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of Traumatic ACL Re-ruptures and Atraumatic Graft Failures [ Time Frame: 2, 5 and 10 years post-operatively ] [ Designated as safety issue: No ]
Knee laxity as measured by the KT arthrometer [ Time Frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years ] [ Designated as safety issue: No ]
Radiographic (x-ray) changes using the International Knee Documentation Committee (IKDC) grading recommendations [ Time Frame: 2, 5 and 10 years post-operatively ] [ Designated as safety issue: No ]
Pivot Shift [ Time Frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years post-operatively ] [ Designated as safety issue: No ]
Complications of the surgical procedure [ Time Frame: 3 and 6 months, 1, 2, 5 and 10 years ] [ Designated as safety issue: No ]
Surgical times for each procedure [ Time Frame: Surgery ] [ Designated as safety issue: No ]
Return to pre-injury activity level as measured by the Tegner Activity Scale [ Time Frame: 6 months, 1, 2, 5 and 10 years ] [ Designated as safety issue: No ]
IKDC Subjective Score and Overall Group Grade [ Time Frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years ] [ Designated as safety issue: No ]
Work-related outcomes using the Cincinnati Occupational Rating Scale [ Time Frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years post-operatively ] [ Designated as safety issue: No ]

Estimated Enrollment:	231
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2020
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Patellar Tendon (PT)	Procedure: Patellar Tendon Patellar Tendon autograft Other Names: Bone-patellar tendon-bone graft BTPB graft
Active Comparator: Hamstring (HT)	Procedure: Hamstring Tendon Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft Other Names: Single-bundle hamstring graft ST/G graft
Active Comparator: Double-Bundle (DB)	Procedure: Double-Bundle Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft Other Name: Double-bundle ST/G graft

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

Ages Eligible for Study:	14 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529958

Locations

Canada, Alberta
University of Calgary Sport Medicine Centre
Calgary, Alberta, Canada, T2N 1N4

Sponsors and Collaborators

University of Calgary

Workers' Compensation Board - Alberta

Investigators

Principal Investigator:

Nicholas G Mohtadi, MD MSc FRCSC

University of Calgary Sport Medicine Centre

More Information

Publications:

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.

Responsible Party:	Denise Chan, Orthopaedic Research Coordinator, University of Calgary
ClinicalTrials.gov Identifier:	NCT00529958 History of Changes
Other Study ID Numbers:	20966
Study First Received:	September 12, 2007
Last Updated:	February 1, 2011
Health Authority:	Canada: Health Canada

Keywords provided by University of Calgary:

Anterior Cruciate Ligament (ACL) Reconstruction
Patellar Tendon
Hamstring Tendon
Double-Bundle
Autograft

Additional relevant MeSH terms:

Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on February 09, 2012