Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
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	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	330 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, 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.
Study Start Date :	September 2007
Actual Primary Completion Date :	December 2010
Estimated Study Completion Date :	December 2020

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Patellar Tendon (PT); ACL reconstruction using a patellar tendon autograft	Procedure: Patellar Tendon; Patellar Tendon autograft; Other Names: Bone-patellar tendon-bone graft; BTPB graft
Active Comparator: Hamstring (HT); ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft	Procedure: Hamstring Tendon; Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft; Other Names: Single-bundle hamstring graft; ST/G graft
Active Comparator: Double-Bundle (DB); ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft	Procedure: Double-Bundle; Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft; Other Name: Double-bundle ST/G graft

Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. Incidence of Traumatic ACL Re-ruptures and Atraumatic Graft Failures [ Time Frame: 2, 5 and 10 years post-operatively ]
2. Knee laxity as measured by the KT arthrometer [ Time Frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years ]
3. Radiographic (x-ray) changes using the International Knee Documentation Committee (IKDC) grading recommendations [ Time Frame: 2, 5 and 10 years post-operatively ]
4. Pivot Shift [ Time Frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years post-operatively ]
5. Complications of the surgical procedure [ Time Frame: 3 and 6 months, 1, 2, 5 and 10 years ]
6. Surgical times for each procedure [ Time Frame: Surgery ]
7. Return to pre-injury activity level as measured by the Tegner Activity Scale [ Time Frame: 6 months, 1, 2, 5 and 10 years ]
8. IKDC Subjective Score and Overall Group Grade [ Time Frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years ]
9. 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

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Ages Eligible for Study:	14 Years to 50 Years (Child, Adult)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

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.

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.

Other 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.

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;(9):CD005960. doi: 10.1002/14651858.CD005960.pub2. Review.

Responsible Party:	Dr. Nicholas Mohtadi, Clinical Professor and Orthopaedic Surgeon, University of Calgary
ClinicalTrials.gov Identifier:	NCT00529958 History of Changes
Other Study ID Numbers:	20966
First Posted:	September 14, 2007
Last Update Posted:	August 19, 2016
Last Verified:	August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Dr. Nicholas Mohtadi, University of Calgary:

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

Additional relevant MeSH terms:

Rupture; Anterior Cruciate Ligament Injuries; Wounds and Injuries; Knee Injuries; Leg Injuries