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Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction

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ClinicalTrials.gov Identifier: NCT00529958
Recruitment Status : Active, not recruiting
First Posted : September 14, 2007
Last Update Posted : August 19, 2016
Sponsor:
Collaborator:
Workers' Compensation Board, Alberta
Information provided by (Responsible Party):
Dr. Nicholas Mohtadi, University of Calgary

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 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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 ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Other Publications:
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    Key Record Dates
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