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A RCT Comparing Three Methods for Anterior Cruciate Ligament Reconstruction
This study is currently recruiting participants.
Study NCT00529958   Information provided by University of Calgary
First Received: September 12, 2007   Last Updated: February 17, 2009   History of Changes

September 12, 2007
February 17, 2009
September 2007
September 2010   (final data collection date for primary outcome measure)
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 ]
Anterior Cruciate Ligament Quality of Life (ACL-QOL) outcome [ Time Frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years post-operatively ]
Complete list of historical versions of study NCT00529958 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Incidence of Traumatic ACL Re-ruptures and Atraumatic Graft Failures [ Time Frame: 2, 5 and 10 years post-operatively ]
  • Knee laxity as measured by the KT arthrometer [ Time Frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years ]
  • Radiographic (x-ray) changes using the International Knee Documentation Committee (IKDC) grading recommendations [ Time Frame: 2, 5 and 10 years post-operatively ]
  • Pivot Shift [ Time Frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years post-operatively ]
  • Complications of the surgical procedure [ Time Frame: 3 and 6 months, 1, 2, 5 and 10 years ]
  • Surgical times for each procedure [ Time Frame: Surgery ]
  • Return to pre-injury activity level as measured by the Tegner Activity Scale [ Time Frame: 6 months, 1, 2, 5 and 10 years ]
  • IKDC Subjective Score and Overall Group Grade [ Time Frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years ]
  • Work-related outcomes using the Cincinnati Occupational Rating Scale [ Time Frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years post-operatively ]
 
A RCT Comparing Three Methods for Anterior Cruciate Ligament Reconstruction
A Randomized Clinical Trial Comparing Three Methods for Anterior Cruciate Ligament Reconstruction: Patellar Tendon, Quadruple Semitendinosus/Gracilis and Double-Bundle Semitendinosus/Gracilis Grafts.

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.

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.

 
Interventional
Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment
  • ACL Rupture
  • ACL Deficiency
  • Knee Instability
  • Anterior Cruciate Ligament Injury
  • Procedure: Patellar Tendon
  • Procedure: Hamstring Tendon
  • Procedure: Double-Bundle
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
231
September 2020
September 2010   (final data collection date for primary outcome measure)

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

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
Both
14 Years to 50 Years
Yes
Contact: Denise S Chan, MBT (403) 220-8944 dsfchan@ucalgary.ca
Canada
 
NCT00529958
Denise Chan, Orthopaedic Research Coordinator, University of Calgary
20966
University of Calgary
Workers' Compensation Board - Alberta
Principal Investigator: Nicholas G Mohtadi, MD MSc FRCSC University of Calgary Sport Medicine Centre
University of Calgary
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP