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

Primary Purpose

Anterior Cruciate Ligament Rupture

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Laximeter measurement
Sponsored by
Versailles Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anterior Cruciate Ligament Rupture focused on measuring Anterior Cruciate Ligament, A02.835.583.512.100

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Centre Hospitalier de Versailles

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with anterior cruciate ligament rupture

Arm Description

Anterior laxity of patient was measure with 4 laximeters:Telos, reference laximeter and with three other instruments called, KT-1000, GnrB and Rolimeter.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
Correlation between the f4 laximeters results
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
Compare ratio pathologic versus healthy knee obtained with each instrument to determine a possible harmonization of measurements

Full Information

First Posted
August 11, 2016
Last Updated
August 17, 2016
Sponsor
Versailles Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02875210
Brief Title
Comparative Study of Anterior Tibial Translation Measurement by Four Laximeters in Anterior Cruciate Ligament Ruptures
Acronym
LAXIMETRIE
Official Title
Comparative Study of Anterior Tibial Translation Measurement by Four Different Laximeters in Anterior Cruciate Ligament Ruptures
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture
Keywords
Anterior Cruciate Ligament, A02.835.583.512.100

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient with anterior cruciate ligament rupture
Arm Type
Experimental
Arm Description
Anterior laxity of patient was measure with 4 laximeters:Telos, reference laximeter and with three other instruments called, KT-1000, GnrB and Rolimeter.
Intervention Type
Procedure
Intervention Name(s)
Laximeter measurement
Primary Outcome Measure Information:
Title
Comparison of anterior laxity measurement between pathologic and healthy knees.
Description
Collect and compare differential values of anterior laxity between pathologic and healthy knee obtained by four different laximeters (Telos, KT-1000, GnrB and Rolimeter)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Sensivity and specificity of each instrument
Description
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.
Time Frame
18 months
Title
Correlation between the f4 laximeters results
Description
Estimate if correlation between two results increase discriminating capacity in comparison with the reference.
Time Frame
18 months
Title
Value of the ratio : pathologic (anterior knee laxity) versus healthy knee
Description
Compare ratio pathologic versus healthy knee obtained with each instrument to determine a possible harmonization of measurements
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas PUJOL, MD
Organizational Affiliation
Central Hospital of Versailles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de Versailles
City
Le Chesnay
ZIP/Postal Code
78150
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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