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
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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 |
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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Patellar Tendon (PT)
ACL reconstruction using a patellar tendon autograft
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Procedure: Patellar Tendon
Patellar Tendon autograft
Other Names:
|
Active Comparator: Hamstring (HT)
ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft
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Procedure: Hamstring Tendon
Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Other Names:
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Active Comparator: Double-Bundle (DB)
ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft
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Procedure: Double-Bundle
Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Other Name: Double-bundle ST/G graft
|
- Anterior Cruciate Ligament Quality of Life (ACL-QOL) outcome [ Time Frame: Baseline, 3 and 6 months, 1, 2, 5 and 10 years post-operatively ]
- 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 ]

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Ages Eligible for Study: | 14 Years to 50 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Canada, Alberta | |
University of Calgary Sport Medicine Centre | |
Calgary, Alberta, Canada, T2N 1N4 |
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 |