Study of the Anatomical Direct Insertion Anterior Cruciate Ligament Reconstruction

Study Overview
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Brief Summary
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The purpose of the study is to study the effect of anatomical direct insertion ACL reconstruction compared with conventional anatomical ACL reconstruction.

Detailed Description
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The investigators divide 320 patients with ACL rupture into 4 groups, each group has 80 patients. The operation technique is different among the groups: group A: conventional anatomical double bundle acl reconstruction, group B: conventional anatomical single bundle acl reconstruction, group DA: direct insertion double bundle acl reconstruction, group DSB: direct insertion single bundle acl reconstruction. The investigators compare the results of the patients of each group at 2 years of surgery.

Official Title
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Anterior Cruciate Ligament Reconstruction (ACLR) Using Direct Insertion Technique or Traditional Technique With Single and Double Bundle Procedure.

Conditions
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Rupture of Anterior Cruciate Ligament

Intervention / Treatment
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* Procedure: direct insertion anterior cruciate ligament reconstruction
* 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: ACL rupture patients aged between 16 to 40 years Exclusion Criteria: combined severe injuries to the operated knee (additional ligament rupture, major meniscus loss, patella instability, cartilage damage >2°, pathologic leg axis deviation) any injury or surgery to the contralateral knee any infammatory or systemic disease, neuromuscular disease in the lower limbs, any recent knee infection

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 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: direct insertion single bundle ACLR<br>Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using single bundle technique. | Procedure: direct insertion anterior cruciate ligament reconstruction<br>* ACL reconstruction based on direct insertion of ACL.<br>Procedure: single bundle anterior cruciate ligament reconstruction<br>* anterior cruciate ligament reconstruction using single bundle technique<br>|
| Experimental: anatomical double bundle ACLR<br>Patients with ACL rupture undergo double bundle anterior cruciate ligament reconstruction. | Procedure: double bundle anterior cruciate ligament reconstruction<br>* anterior cruciate ligament reconstruction using double bundle technique<br>|
| Experimental: anatomical single bundle ACLR<br>Patients with ACL rupture undergo single bundle anterior cruciate ligament reconstruction. | Procedure: single bundle anterior cruciate ligament reconstruction<br>* anterior cruciate ligament reconstruction using single bundle technique<br>|
| Active Comparator: direct insertion double bundle ACLR<br>Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using double bundle technique. | Procedure: direct insertion anterior cruciate ligament reconstruction<br>* ACL reconstruction based on direct insertion of ACL.<br>Procedure: double bundle anterior cruciate ligament reconstruction<br>* anterior cruciate ligament reconstruction using double bundle technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lysholm score of the knee | Lysholm score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score | two years | 
| Tegner score of the knee | Tegner score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score | two years | 
| IKDC score of the knee | IKDC score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KT-2000 of the knee | KT-2000 of the knee was evaluated preoperatively and at 2 years post operation. | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior Cruciate Ligament Reconstruction, Direct Insertion of Anterior Cruciate Ligament