Anterior Cruciate Ligament Reconstruction: Residual Rotational Laxity for Single Versus Double Bundle Techniques

Study Overview
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Brief Summary
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The main objective of this study is to compare, using MRI measures with a specialized splint, the persistent rotatory laxity after anterior cruciate ligament reconstruction using single bundle and double bundle surgical techniques, between the seventh and eighth months after surgery, and for different degrees of knee flexion (0 °, 20 °, 40 °, 60 °).

Official Title
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Reconstruction of the Anterior Cruciate Ligament: a Comparative MRI Study Evaluating Residual Rotational Laxity for Single Versus Double Bundle Surgical Techniques

Conditions
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Anterior Cruciate Ligament Injury

Intervention / Treatment
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* Procedure: Single bundle anterior cruciate ligament reconstruction
* Procedure: Double bundle anterior cruciate ligament reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is available for 24 months of follow-up The patient requires reconstruction of the anterior cruciate ligament due to rupture confirmed by MRI Exclusion Criteria: The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant The patient is breastfeeding The patient require a single bundle, KJ-type surgical technique Contra-indication for MRI scans

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single Bundle<br>These patients are operated using a single bundle technique. | Procedure: Single bundle anterior cruciate ligament reconstruction<br>* Single bundle anterior cruciate ligamentoplasty<br>|
| Experimental: Double bundle<br>These patients are operated using a double bundle technique. | Procedure: Double bundle anterior cruciate ligament reconstruction<br>* Double bundle anterior cruciate ligamentoplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual rotational laxity during MRI | Residual rotational laxity is defined as the difference between the operated knee and the non-operated knee for D, where D is the distance between the posterior tibial cortex and the center of the circle which forms the lateral femoral condyle. D will be evaluated at 4 angles of flexion (0°, 20°, 40° and 60°) and evaluated as a repeated measure. | 7-8 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lysholm score |  | 7-8 months | 
| International Knee Documentation Committee score |  | 7-8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Residual Rotational Laxity