CClinicalTrials.gg
Status unknownNCT02875210LAXIMETRIEUpdated Aug 23, 2016

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

An interventional study of Laximeter measurement in Anterior Cruciate Ligament Rupture, sponsored by Versailles Hospital. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-23.

Sponsored by Versailles Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Anterior Cruciate Ligament Rupture

Keywords

  • Anterior Cruciate Ligament
  • A02.835.583.512.100
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In context

Rupture

558 studies on the registry are indexed under Rupture; 98 are open to participants now.

This study's enrollment of 43 is below the median of 72 across 335 interventional studies indexed under Rupture.

Browse Rupture studies →

Lead sponsor

Versailles Hospital is the lead sponsor of 74 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureLaximeter measurement
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What researchers measure

Primary outcomes

  1. 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)

    Time frame: 18 months

Secondary outcomes

  1. 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.

    Time frame: 18 months

  2. Correlation between the f4 laximeters results

    Estimate if correlation between two results increase discriminating capacity in comparison with the reference.

    Time frame: 18 months

  3. 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

    Time frame: 18 months

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Study locations

1 site
  • Centre Hospitalier de Versailles
    Le Chesnay, 78150, France
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02875210
Lead sponsor
Versailles Hospital
Responsible party
Nicolas Pujol (Investigator coordinator, Versailles Hospital) — Principal investigator
First posted
Aug 23, 2016
Start date
Jul 2015
Primary completion
Jan 2017 (estimated)
Completion
Jun 2017 (estimated)
Last update
Aug 23, 2016

Study contacts

Nicolas PUJOL, MD
principal investigator · Central Hospital of Versailles

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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