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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02875210

Acronym

LAXIMETRIE

Enrollment

Registered

2016-08-23

Start date

2015-07-31

Completion date

2017-06-30

Last updated

2016-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Rupture

Keywords

Anterior Cruciate Ligament, A02.835.583.512.100

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.

Interventions

PROCEDURELaximeter measurement

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
Correlation between the f4 laximeters results	18 months	Estimate if correlation between two results increase discriminating capacity in comparison with the reference.
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026