Effect of Tunnel Placements on Clinical and MRI Findings Two Years After ACL Reconstruction With DB Technique

Study Overview
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Brief Summary
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Purpose: To find out whether the clinical and MRI findings two years after anterior cruciate ligament (ACL) reconstruction were associated with each other so that MRI-based graft invisibility in the anteromedial (AM) graft would have an impact on anteroposterior stability of the knee, and MRI-based posterolateral (PL) graft invisibility on rotational stability of the knee. Methods: 75 patients. One experienced orthopaedic surgeon performed all double-bundle (DB) ACL reconstructions. Two independent examiners made the clinical examinations at the two-year follow-up: clinical examination of the knee, KT-1000, International Knee Documentation Committee (IKDC) and Lysholm knee evaluation scores and IKDC functional score. The MRI evaluations were made by two musculoskeletal radiologists separately and the means of these measurements were used.

Official Title
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Effect of Tunnel Placements on Clinical and MRI Findings Two Years After Anterior Cruciate Ligament Reconstruction With Double-Bundle Technique

Conditions
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Anterior Cruciate Ligament Rupture

Intervention / Treatment
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* Procedure: Double-bundle ACL reconstruction
* Device: Magnetic resonance imaging (MRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary ACL reconstruction, closed growth plates Exclusion Criteria: ligament injury to the opposite knee
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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Double-bundle ACL reconstruction<br>Double-bundle ACL reconstruction | Procedure: Double-bundle ACL reconstruction<br> <br> |
| Other: Magnetic resonance imaging (MRI)<br>MRI of the ACL double-bundle reconstructed knee was done at 2 years after surgery. | Device: Magnetic resonance imaging (MRI)<br>* MRI sequences were as follows: sagittal T1-weighted, proton density (PD)-weighted and T2-weighted fast spin echo (FSE) images with 4 mm slice and 1 mm gap, coronal T1-weighted and fat-saturated T2-weighted FSE images with 4 mm slice and 1 mm gap, axial fat saturated PD FSE images with 4 mm slice and 1 mm gap and oblique sagittal and oblique coronal T1 FSE images along AM graft plane with 3 mm slice and 0.3 mm gap.<br>* Other names: The interpretation of the images was made with the Impax DS 3000 workstation (Agfa HealthCare, Mortsel, Belgium);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The location of the ACL grafts in the insertion site in the femur and in the tibia reported as percentages | The measurements of the graft location from the MRI were made by two musculoskeletal radiologists separately and the means of these measurements were used. In brief, first the centers of the tunnels were measured from sagittal images referring to the Blumensaat's line and to the posterior femoral condyle. Then these were divided with the maximum diameters of the femoral condyle parallel to and perpendicular to the Blumensaat's line. In the tibial side, the centers of the tunnels were measured from the anterior edge of the tibial plateau and then divided with the maximum diameter of the plateau, which was measured from the sagittal view. | 2 years after surgery | 
| The visibility of the ACL grafts measured from the MRI | Two musculoskeletal radiologists made the interpretation of the images separately and the means of these measurements were used. A graft was considered visible when intact graft fibers were seen. The graft was considered partially visible when only few graft fibers were seen. The graft was considered invisible when no graft fibers were seen. | 2 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KT-1000 measurement (mm) of the knees of 61 patients | KT-1000 measurements were reported as millimeters. | 2 years after surgery | 
| International Knee Documentation Committee (IKDC) functional score | IKDC functional score was used to evaluate knee functions (IKDC scale: 0-10). Full function without any limitations was scored as 10, while zero indicated that those patients were unable to perform their daily activities. | 2 years after surgery | 
| Lysholm knee evaluation score | Patients completed the Lysholm knee score, which measures subjective functions e.g. squatting and running. The scale is 0-100, 100 being perfect functioning of the knee. | 2 years after surgery | 
| Clinical evaluation of the knees on the basis of International Knee Documentation Committee (IKDC) examination form | The clinical evaluation was performed on the basis of IKDC knee examination form, which gives the final score A-D. A being normal, B nearly normal, C abnormal and D severely abnormal. | 2 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Anterior cruciate ligament reconstruction, Double-bundle, Graft location