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Clinical Trials/NCT02875210
NCT02875210
Unknown
Not Applicable

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

Versailles Hospital1 site in 1 country43 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Rupture
Sponsor
Versailles Hospital
Enrollment
43
Locations
1
Primary Endpoint
Comparison of anterior laxity measurement between pathologic and healthy knees.
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
June 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Versailles Hospital
Responsible Party
Principal Investigator
Principal Investigator

Nicolas Pujol

Investigator coordinator

Versailles Hospital

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.

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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

Study Sites (1)

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