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

NCT ID: NCT02875210

Last Updated: 2016-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-06-30

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.

Conditions

Anterior Cruciate Ligament Rupture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patient with anterior cruciate ligament rupture

Anterior laxity of patient was measure with 4 laximeters:Telos, reference laximeter and with three other instruments called, KT-1000, GnrB and Rolimeter.

Group Type: EXPERIMENTAL

Laximeter measurement

Intervention Type: PROCEDURE

Interventions

Laximeter measurement

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Versailles Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nicolas Pujol

Investigator coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicolas PUJOL, MD

Role: PRINCIPAL_INVESTIGATOR

Central Hospital of Versailles

Locations

Centre Hospitalier de Versailles

Le Chesnay, , France

Countries

France

Other Identifiers

P15/02_LAXIMETRIE

Identifier Type: -

Identifier Source: org_study_id