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| 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. |
| Estimated Enrollment: | 231 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | September 2020 |
| Estimated Primary Completion Date: | November 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
|
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 |
Inclusion Criteria:
A confirmed diagnosis of anterior cruciate ligament deficiency based on all of the following:
Exclusion Criteria:
Contacts and Locations| Contact: Denise S Chan, MBT, MSc | (403) 220-8944 | dsfchan@ucalgary.ca |
| Canada, Alberta | |
| University of Calgary Sport Medicine Centre | Recruiting |
| Calgary, Alberta, Canada, T2N 1N4 | |
| Principal Investigator: Nicholas G Mohtadi, MD MSc FRCSC | |
| Principal Investigator: | Nicholas G Mohtadi, MD MSc FRCSC | University of Calgary Sport Medicine Centre |
More Information
| Responsible Party: | University of Calgary ( Denise Chan, Orthopaedic Research Coordinator ) |
| Study ID Numbers: | 20966 |
| Study First Received: | September 12, 2007 |
| Last Updated: | January 11, 2010 |
| ClinicalTrials.gov Identifier: | NCT00529958 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Anterior Cruciate Ligament (ACL) Reconstruction Patellar Tendon Hamstring Tendon Double-Bundle Autograft |
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Wounds and Injuries Disorders of Environmental Origin Rupture |