A Study to Compare Two Techniques for the Reconstruction of the Anterior Cruciate Ligament

Study Overview
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Brief Summary
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This is a prospective and randomized trial to compare two different techniques used in normal practice for the reconstruction of the anterior cruciate ligament in arthroscopy. The experimental group (group 1) will undergo a reconstruction technique where semitendinosus and gracilis will preserve their insertion at the level of the hamstring whereas in the control group (group 2) the semitendinosus and gracilis tendons will be disengaged from their insertion on the hamstring .

Official Title
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A Randomized Controlled Trial to Evaluate the Graft Ligamentization and Integration in the Reconstruction of the Anterior Cruciate Ligament With or Without Detachment of Hamstring Tendon Tibial Insertion

Conditions
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Complete Tear, Knee, Anterior Cruciate Ligament

Intervention / Treatment
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* Procedure: ACL reconstruction preserving insertion
* Procedure: ACL reconstruction detaching insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 55 MRI confirmed primary and total ACL injury of traumatic origin Indication for ACL reconstruction in arthroscopy Written informed consent Active and non-sedentary lifestyle Exclusion Criteria: Complex meniscal injuries Cartilage lesions of sizes> 2 cm2 Other ligamentous lesions Axis deviations greater than 10° Rheumatic, neuromuscular or general systemic diseases Prevention of injured knee traumas treated surgically Difficulties in compliance in following the rehabilitation programs Obesity (BMI ≥ 30) Neoplastic diseases, metabolic diseases, inflammatory and systemic diseases, autoimmune diseases, immunocompromised patients

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: insertion preserving<br>ACL reconstruction preserving insertion | Procedure: ACL reconstruction preserving insertion<br>* Anterior cruciate ligament reconstruction with semitendinosus and gracilis, preserving their insertion at the level of the hamstring.<br>|
| Active Comparator: insertion detaching<br>ACL reconstruction detaching insertion | Procedure: ACL reconstruction detaching insertion<br>* Anterior cruciate ligament reconstruction with semitendinosus and gracilis tendons completely detached from their insertion at the hamstring.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft integration by the Signal / Noise Quotient (SNQ) at 6 months | Signal intensity of the graft evaluated by the Signal / Noise Quotient (SNQ) during MRI 3 Tesla | 6 months after ACL reconstruction intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft integration by the Signal / Noise Quotient (SNQ) at 3 and 12 months | Signal intensity of the graft evaluated by the Signal / Noise Quotient (SNQ) during MRI 3 Tesla | 3, 12 months after ACL reconstruction intervention | 
| Right anatomical graft position | Evaluation of right anatomical graft position by MRI 3 TESLA | 12 months after ACL reconstruction intervention | 
| Anterior tibial translation | Anterior tibial translation will be measured in millimeters using the arthrometer Rolimeter | 3, 6, 12 months after ACL reconstruction intervention | 
| Anterior knee joint instability | Anterior knee joint instability will be measured by the device KiRA (Kinematic Rapid Assessment) by the parameters of the pivot-shift test | 3, 6, 12 months after ACL reconstruction intervention | 
| IKDC (International Knee Documentation Committee) questionnaire | Test to evaluate post-surgery instability with a scores range from 0 points to 100 points; patients report symptoms, sports and daily living activities | 3, 6, 12 months after ACL reconstruction intervention | 
| Tegner activity scale | Test to evaluate post-surgery instability with a scores range from 0 points to 10 points; patients describe their current level of activity and that before injury. | 3, 6, 12 months after ACL reconstruction intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arthroscopy