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

Anterior Cruciate Ligament Rupture Clinical Trial

— LAXIMETRIE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02875210
• Other study ID #: P15/02_LAXIMETRIE
• Status: Active, not recruiting
• Phase: N/A
• First received: August 11, 2016
• Last updated: August 17, 2016
• Start date: July 2015
• Est. completion date: June 2017

Study information

• Verified date: August 2016
• Source: Central Hospital, Versailles
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : Agence Nationale de Sécurité des Médicaments (ANSM)France : Comité de Protection des Personnes (CPP)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

Procedure:
• Laximeter measurement

Locations

Country	Name	City	State
France	Centre Hospitalier de Versailles	Le Chesnay

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Versailles

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Correlation between the f4 laximeters results	Estimate if correlation between two results increase discriminating capacity in comparison with the reference.	18 months	No
Secondary	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	No