ACL Versus ALL + ACL Study

Study Overview
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Brief Summary
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The aim of the study is to show a reduction of a re-rupture rate with an ACL (antero crusader ligament) + ALL (anterolateral ligament) combined technique compared to a classical Kenneth-Jones ACL (antero crusader ligament) reconstruction technique.

Detailed Description
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The aim is to evaluate the rate of re-rupture and to analyze knee function through scores analysis as International Knee Documentation Committee Subjective Knee (IKDC), Knee injury and osteoarthritis outcome score (KOOS), Lysholm-Tegner, and by objective measurements of laximetry and rotation. This study should include 2 groups of 296 patients with isolated ACL (antero crusader ligament) with clinical rotation : operated by a conventional patellar tendon technique (first group) operated by a technique combining a ALL (anterolateral ligament) and ACL plasty for the second group

Official Title
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Assessment of the Results of Combined Anterolateral Ligament (ALL) + Antero Crusader Ligament (ACL) Plasty Compared to Classical KJ Plasty in Isolated ACL Ruptures

Conditions
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Anterior Cruciate Ligament Injury, Ligament Rupture

Intervention / Treatment
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* Procedure: ACL plasty
* Procedure: ACL + ALL plasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with total isolated antero crusader ligament (ACL) rupture who are candidates for surgical reconstruction Patients between 18 and 35 years old Patients with weekly sporting activities Patients with chronic rotatory instability with a positive pivot shift Patients who have been informed and do not object the research Exclusion Criteria: Patients with multi-ligament knee involvement Patients under 18 years old or over 35 years old Patients with a BMI of under 18.5 or over 30 Patients with any contraindication to general anaesthesia Professional sportsmen/women Patients with congenital malformation or a rheumatic disease Patients with repeated antero crusader ligament (ACL) rupture Patients with serious ligament disease in the contralateral knee Patients who refuse to take part in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: ACL plasty<br>The surgical procedure consists of a ligamentoplasty of the antero crusader ligament (ACL) with the patellar tendon according to a conventional arthroscopic procedure. | Procedure: ACL plasty<br>* standard ligamentoplasty by Kenneth Jones<br>|
| Experimental: ACL + ALL plasty<br>The surgical procedure consists of a hamstring ligamentoplasty (DIDT) of the antero crusader ligament (ACL) and anterolateral ligament (ALL) according to a published arthroscopic procedure. | Procedure: ACL + ALL plasty<br>* standard ligamentoplasty and anterolateral plasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ligament re-rupture rate | Clinical instability, laximetry, IRM | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Knee Documentation Committee Subjective Knee (IKDC) clinical score | International Knee Documentation Committee Subjective Knee allows a subjective assessment including symptoms, activity and knee function; is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0 to 100 (no limitation with activities of daily living or sports activities and the absence of symptoms) | preoperatively, 1 year and 3 years | 
| Tegner Lysholm score | Specific knee questionnaire : patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). | Preoperatively, 1 year and 3 years | 
| Rolimeter test | Antero-posterior laximetry | pre-operatively, 6 months, 1 year and 3 years | 
| KiRA test | Rotatory laximetry | preoperatively, 6 months and 3 years | 
| Knee radiography | Development of osteoarthritis signs | preoperatively and 3 years | 
| Knee injury and osteoarthritis outcome score (KOOS) clinical score | Knee injury and osteoarthritis outcome score is a specific knee questionnaire which evaluates : pain, symptoms, knee function in daily life, knee function in sport practice and quality of life. Scale : None (0) Mild Moderate Severe Extreme (4) Each subscale score is calculated independently. Calculate the mean score of the individual items of each subscale and divide by 4. Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems | preoperative, 1 year and 3 years |