Comparative Study of Anterior Tibial Translation Measurement by Four Laximeters in Anterior Cruciate Ligament Ruptures

Study Overview
=================
Brief Summary
-----------------
Actually, there are several laximeters for measuring anterior tibial translational in case of anterior cruciate ligament rupture. The most commonly used are telos, KT-1000, GnrB and Rolimeter. Results of these instrumented tests, which expressed in differential (millimeters values), have a bad correlation between them and so are not comparable in current literature. The aim of this study was to compare results of these tests and establish a ratio (pathologic knee laxity/ healthy knee laxity) to reduce differences between each instrumented test.

Official Title
-----------------
Comparative Study of Anterior Tibial Translation Measurement by Four Different Laximeters in Anterior Cruciate Ligament Ruptures

Conditions
-----------------
Anterior Cruciate Ligament Rupture

Intervention / Treatment
-----------------
* Procedure: Laximeter measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obtaining a written informed consent of the patient, Affiliated with a Medicare (or rightful beneficiary), Disponibility of the patient, Patients ≥ 18 ans, Anterior cruciate ligament rupture concerned only one knee of the patient. Exclusion Criteria: Patient is in the exclusion period for another study, Patient is under judicial protection, guardianship, or curators, Eligible patients who are refused to sign consent, It is impossible to give clear informations to the patient, Pregnant women, Nursing mother, Patient which has been already operate of the other knee, Patient present ligament lesions associated.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with anterior cruciate ligament rupture<br>Anterior laxity of patient was measure with 4 laximeters:Telos, reference laximeter and with three other instruments called, KT-1000, GnrB and Rolimeter. | Procedure: Laximeter measurement<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of anterior laxity measurement between pathologic and healthy knees. | Collect and compare differential values of anterior laxity between pathologic and healthy knee obtained by four different laximeters (Telos, KT-1000, GnrB and Rolimeter) | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensivity and specificity of each instrument | Determine sensivity and specificity of each instrument test to highlight a cruciate ligament rupture and find the better test. Evaluations are using the 4 following devices: Telos ©, KT-1000 ©, Rolimeter, and GnrB. | 18 months | 
| Correlation between the f4 laximeters results | Estimate if correlation between two results increase discriminating capacity in comparison with the reference. | 18 months | 
| Value of the ratio : pathologic (anterior knee laxity) versus healthy knee | Compare ratio pathologic versus healthy knee obtained with each instrument to determine a possible harmonization of measurements | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anterior Cruciate Ligament, A02.835.583.512.100