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Completed

NCT Number: NCT02787096

Dynamic Knee Laxity Measurement Coupled to MRI in Cases of Suspected Partial Anterior Cruciate Ligament Tear

Anterior cruciate ligament (ACL) tear is frequent, but the diagnosis of partial tears is difficult. Standard MRI may be used but is of limited diagnostic value. The present study aimed to evaluate the diagnostic interest of dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon - Hôpital Edouard Herriot Pavillon B Radiologie

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • knee injury requiring MRI examination
  • accepting to participate
  • covered by a health care insurance system

Exclusion criteria

  • MRI contraindication
  • pregnancy
  • patient included in another study potentially affecting the results
  • protected patients

Treatment and study plan

LaxIRM

Device

Dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear

Primary outcomes

  1. Anterior tibial translation (ATT) measurement

    Time frame: 1 year after the baseline MRI-scan

    Time Frame : 1 year after the baseline MRI-scan a follow-up MRI is performed if the patient did not had surgery.

    ATT is calculated as the difference between the distance from the tangent to the condyle to the tangent to the posterior aspect of the tibial plateau in the stress position and in resting conditions. ATT is measured for the medial and the lateral compartment respectively and the final ATT is the average of medial and lateral ATT.

Secondary outcomes

  1. Degree of laxity

    Time frame: 1 year after the baseline MRI-scan

    1 year after the baseline MRI-scan a follow-up MRI is performed if the patient did not had surgery.

    Laxity of the torn ligament is defined using a visual scale with the following grading : 0 : No laxity. Grade 1: moderate laxity. Grade 2: severe laxity.

  2. Femorotibial rotation (FTR) value

    Time frame: 1 year after the baseline MRI-scan

    1 year after the baseline MRI-scan a follow-up MRI is performed if the patient did not had surgery.

    FTR= arc tan ((ATT lateral-ATT medial)/(slice thickness*number of sagittal slices))*180/π

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: LaxIRM

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jun 1, 2016
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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