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

Not Applicable

• Conditions: Anterior Cruciate Ligament Rupture

• Registration Number: NCT02875210
• Lead Sponsor: Versailles Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Status Verified: 2016-08
• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-17
• Last Update Submitted: 2016-08-17
• Study First Posted: 2016-08-23
• Last Update Posted: 2016-08-23
• Primary Completion: 2017-01
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Correlation between the f4 laximeters results	18 months	Estimate if correlation between two results increase discriminating capacity in comparison with the reference.
Sensivity and specificity of each instrument	18 months	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.
Value of the ratio : pathologic (anterior knee laxity) versus healthy knee	18 months	Compare ratio pathologic versus healthy knee obtained with each instrument to determine a possible harmonization of measurements

Trial Locations

Locations (1)

Centre Hospitalier de Versailles; 🇫🇷 Le Chesnay, France