Overview

This trial is active, not recruiting.

Condition anterior cruciate ligament rupture
Treatment laximeter measurement
Sponsor Central Hospital, Versailles
Start date July 2015
End date January 2017
Trial size 43 participants
Trial identifier NCT02875210, P15/02_LAXIMETRIE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification bio-equivalence study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Anterior laxity of patient was measure with 4 laximeters:Telos, reference laximeter and with three other instruments called, KT-1000, GnrB and Rolimeter.
laximeter measurement

Primary Outcomes

Measure
Comparison of anterior laxity measurement between pathologic and healthy knees.
time frame: 18 months

Secondary Outcomes

Measure
Sensivity and specificity of each instrument
time frame: 18 months
Correlation between the f4 laximeters results
time frame: 18 months
Value of the ratio : pathologic (anterior knee laxity) versus healthy knee
time frame: 18 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Comparative Study of Anterior Tibial Translation Measurement by Four Different Laximeters in Anterior Cruciate Ligament Ruptures
Principal investigator Nicolas PUJOL, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Central Hospital, Versailles.