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

August 17, 2016 updated by: Nicolas Pujol, Versailles Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Chesnay, France, 78150
        • Centre Hospitalier de Versailles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Laximeter measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of anterior laxity measurement between pathologic and healthy knees.
Time Frame: 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)
18 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Versailles Hospital

Investigators

  • Principal Investigator: Nicolas PUJOL, MD, Central Hospital of Versailles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P15/02_LAXIMETRIE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anterior Cruciate Ligament Rupture

Clinical Trials on Laximeter measurement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe