Full Text View
Tabular View
No Study Results Posted
Related Studies
A RCT Comparing Three Methods for Anterior Cruciate Ligament Reconstruction
This study is currently recruiting participants.
Verified by University of Calgary, February 2009
First Received: September 12, 2007   Last Updated: February 17, 2009   History of Changes
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
ACL Rupture
ACL Deficiency
Knee Instability
Anterior Cruciate Ligament Injury
Procedure: Patellar Tendon
Procedure: Hamstring Tendon
Procedure: Double-Bundle

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment
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.

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: September 2020
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Patellar Tendon (PT): Active Comparator Procedure: Patellar Tendon
Patellar Tendon autograft
Hamstring (HT): Active Comparator Procedure: Hamstring Tendon
Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Double-Bundle (DB): Active Comparator Procedure: Double-Bundle
Double-Bundle Semitendinosus/Gracilis (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

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

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

Contacts
Contact: Denise S Chan, MBT (403) 220-8944 dsfchan@ucalgary.ca

Locations
Canada, Alberta
University of Calgary Sport Medicine Centre Recruiting
Calgary, Alberta, Canada, T2N 1N4
Principal Investigator: Nicholas G Mohtadi, MD MSc FRCSC            
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:
Responsible Party: University of Calgary ( Denise Chan, Orthopaedic Research Coordinator )
Study ID Numbers: 20966
Study First Received: September 12, 2007
Last Updated: February 17, 2009
ClinicalTrials.gov Identifier: NCT00529958     History of Changes
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:
Wounds and Injuries
Disorders of Environmental Origin
Rupture

ClinicalTrials.gov processed this record on November 30, 2009