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
Results First Posted : February 20, 2019
Last Update Posted : May 19, 2021
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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.|
|Actual Study Start Date :||September 2007|
|Actual Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Patellar Tendon (PT)
ACL reconstruction using a patellar tendon autograft
Procedure: Patellar Tendon
Patellar Tendon autograft
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
Active Comparator: Double-Bundle (DB)
ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft
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 and 5 years post-operatively ]The 32-item patient-reported Anterior Cruciate Ligament Quality-of-Life (ACL-QOL) questionnaire assesses symptoms/physical complaints, work-related, sports/recreational, lifestyle and social/emotional concerns. A higher score on the 0 to 100mm visual analog scale represents better quality of life.
- Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures [ Time Frame: Minimum 2-year Follow-up, and 5-Year Follow-up ]
- COMPLETE TRAUMATIC RE-RUPTURE - defined as a consequence of an acute traumatic event resulting in a change in static stability since the most recent follow-up visit; determined clinically by a definite loss of end point on Lachman testing, increased anterior translation (>3mm) and a greater than or equal grade 2 pivot shift. Confirmed by MRI or diagnostic arthroscopy.
- PARTIAL TRAUMATIC TEARS - defined as a consequence of an acute traumatic event resulting in a suspected meniscal injury or graft tear on history, without the clinical characteristics of a "complete traumatic rerupture". Confirmed by MR or diagnostic arthroscopy.
- TRAUMATIC RE-INJURY - combined total of "complete traumatic re-ruptures" and "partial traumatic tears".
- ATRAUMATIC GRAFT FAILURES - defined in the absence of an acute traumatic event, with greater than or equal grade 2 pivot shift and/or greater than or equal to 6mm side-to-side difference on the KT arthrometer.
- Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade [ Time Frame: Baseline, 1, 2 and 5 years post-operatively ]IKDC Objective group grades: Normal (A), Nearly Normal (B), Abnormal (C), Severely Abnormal (D) The IKDC Objective Overall Group Grade is determined by the lowest grade assigned to defined objective knee examination measurements, including effusion, passive motion deficit and manual/instrumented ligament examinations (i.e. Lachman, anterior-posterior (AP) translation).
- Mean International Knee Documentation Committee (IKDC) Subjective Score [ Time Frame: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively ]Patient-reported health-related outcome measure with a score between 0 and 100. A higher score represents a better outcome.
- Number of Participants With Each Pivot Shift Grade [ Time Frame: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively ]
The Pivot Shift test is a dynamic, passive test to assess the rotational instability of the Anterior Cruciate Ligament in the knee.
Pivot shift grades include: equal/0 (negative); glide/1; clunk/2; gross/3. A positive grade indicates injury to the Anterior Cruciate Ligament.
- Proportion of Patients With Moderate or Severe Kneeling Pain [ Time Frame: Baseline, 2 and 5 years post-operatively ]Patients kneeled down on the same hard surface (i.e. clinic floor) and self-reported the pain on a scale of: none, mild, moderate or severe. The number of patients reporting moderate or severe kneeling pain were combined in the reported proportions.
- Knee Laxity as Measured by the KT Arthrometer [ Time Frame: Baseline, 1 and 2 years post-operatively ]Mean side-to-side differences, as measured using the KT-1000 Arthrometer instrument at 30lbs/134N forces to objectively measure knee laxity.
- Mean Tegner Activity Level [ Time Frame: Baseline, 6 months, 1 and 2 years post-operatively ]Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10))
- Return to Pre-injury Tegner Activity Level [ Time Frame: 1, 2 and 5 years post-operatively ]Proportion of patients returning to pre-injury levels, as measured by the Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10)).
- Cincinnati Occupational Rating Scale [ Time Frame: Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively ]The Cincinnati Occupational Rating Scale assesses the level of work-related activities, including sitting, standing, walking, squatting, climbing, lifting and carrying weighted objects. The score ranges from 0 to 100, with a lower score representing more sedentary work-related activities.
- Skin-to-Skin Operative Times [ Time Frame: During surgery ]Skin-to-skin operative times (in minutes) for each ACL reconstruction procedure
- Radiographic (X-ray) Changes [ Time Frame: Baseline, 2 and 5 years post-operatively ]The analysis for the radiographic assessment data is currently ongoing, to provide a comparison of baseline, 2- and 5-year post-operative x-rays.
- Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) [ Time Frame: 2 years post-operatively ]
All complications/adverse events that occurred within the first two-years post-operatively.
See Adverse Events section for results of this outcome.
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
|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|