Anterior Cruciate Ligament Rupture

Study Overview
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Brief Summary
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The assess results of Anterior Cruciate Ligament (ACL) repair with the Ligamys® surgical technique versus standard technique. The aim of the study is to compare (laxity, instability, and safety) these two types of treatment by using a prospective, randomised multicenter analysis.

Detailed Description
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The treatment of acute ruptures of the anterior cruciate ligament is surgical in some cases with ligamentoplasty technique. Contrary to the classic ligamentoplasty, the treatment with Ligamys consists of promoting heating of the ligament itself by controlling mechanical environment. It allows a dynamic stabilization of the torn Anterior Cruciate Ligament with in the 3 weekly following traumatism. These techniques may improve the recovery process, proprioceptive results, decrease morbidity of transplant harvesting and faster for the patients. It's all these issues we would like to assess with a randomised multicenter study.

Official Title
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Ligamys Technique Versus Standard Technique for the Anterior Cruciate Ligament Rupture

Conditions
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Anterior Cruciate Ligament Rupture

Intervention / Treatment
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* Device: ligamys technique
* Other: standard technique (anatomic reconstruction)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 to 35 years Primary Anterior Cruciate Ligament rupture signed patient consent surgery 21 days or less after traumatism for Ligamys technique Exclusion Criteria: infection of the operating site previous osseous disease pregnant or nursing woman.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ligamys technique<br>Ligamys technique (device) or standard technique | Device: ligamys technique<br>* Ligamys technique (device) or standard technique<br>|
| Other: standard technique<br>Ligamys technique (device) or standard technique | Other: standard technique (anatomic reconstruction)<br>* Ligamys technique (device) or standard technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring anterior knee laxity with KT 1000 arthrometer |  | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tegnér scores |  | at 12 months | 
| Lysholm scores |  | at 12 months | 
| IKDC score safety |  | at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rupture, Anterior Cruciate Ligament (ACL), Laxity knee, Instability knee