Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Clinical Trial Comparing Three Methods for Anterior Cruciate Ligament Reconstruction: Patellar Tendon, Quadruple Semitendinosus/Gracilis and Double-Bundle Semitendinosus/Gracilis Grafts.

Conditions
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Anterior Cruciate Ligament Rupture, Deficiency of Anterior Cruciate Ligament, Chronic Instability of Knee, Anterior Cruciate Ligament Injury

Intervention / Treatment
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* Procedure: Patellar Tendon
* Procedure: Hamstring Tendon
* Procedure: Double-Bundle


Participation Criteria
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Eligibility Criteria
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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 Repair 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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patellar Tendon (PT)<br>ACL reconstruction using a patellar tendon autograft | Procedure: Patellar Tendon<br>* Patellar Tendon autograft<br>* Other names: BTPB graft;|
| Active Comparator: Hamstring (HT)<br>ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft | Procedure: Hamstring Tendon<br>* Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft<br>* Other names: ST/G graft;|
| Active Comparator: Double-Bundle (DB)<br>ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft | Procedure: Double-Bundle<br>* Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft<br>* Other names: Double-bundle ST/G graft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome | 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. | Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures | 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. | Minimum 2-year Follow-up, and 5-Year Follow-up | 
| Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade | 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). | Baseline, 1, 2 and 5 years post-operatively | 
| Mean International Knee Documentation Committee (IKDC) Subjective Score | Patient-reported health-related outcome measure with a score between 0 and 100. A higher score represents a better outcome. | Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively | 
| Number of Participants With Each Pivot Shift Grade | 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. | Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively | 
| Proportion of Patients With Moderate or Severe Kneeling Pain | 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. | Baseline, 2 and 5 years post-operatively | 
| Knee Laxity as Measured by the KT Arthrometer | Mean side-to-side differences, as measured using the KT-1000 Arthrometer instrument at 30lbs/134N forces to objectively measure knee laxity. | Baseline, 1 and 2 years post-operatively | 
| Mean Tegner Activity Level | Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10)) | Baseline, 6 months, 1 and 2 years post-operatively | 
| Return to Pre-injury Tegner Activity Level | 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)). | 1, 2 and 5 years post-operatively | 
| Cincinnati Occupational Rating Scale | 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. | Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively | 
| Skin-to-Skin Operative Times | Skin-to-skin operative times (in minutes) for each ACL reconstruction procedure | During surgery | 
| Radiographic (X-ray) Changes | The analysis for the radiographic assessment data is currently ongoing, to provide a comparison of baseline, 2- and 5-year post-operative x-rays. | Baseline, 2 and 5 years post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior Cruciate Ligament (ACL) Reconstruction, Patellar Tendon, Hamstring Tendon, Double-Bundle, Autograft