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

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Tear
• Intervention / Treatment: Device: LaxIRM

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69437
    • Hospices Civils de Lyon - Hôpital Edouard Herriot Pavillon B Radiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: laxIRM; Patients will have dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear	Device: LaxIRM; Dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior tibial translation (ATT) measurement	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.	1 year after the baseline MRI-scan

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of laxity	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.	1 year after the baseline MRI-scan
Femorotibial rotation (FTR) value	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	1 year after the baseline MRI-scan

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Jean-Baptiste PIALAT, MD, PhD, Hospices Civils de Lyon

Publications and helpful links

General Publications

• Pialat, Jean-Baptiste and Ltaief-Boudrigua, A. and Peyron, C. and Arion, S. and Manera, L. and Barta, A. Imagerie du genou : variantes à connaître, pièges à éviter. 44e Congrès thématique de la Société d'Imagerie Musculo-Squelettique - Le Genou. 2017-06-23/2017-06-24
• Lavigne, Joris and Stacoffe, Nicolas and Heidelberg, Damien and Pialat, Jean-Baptiste. 50 cas cliniques en radiologie pédiatrique ostéoarticulaire. Journées Francophones de Radiologie Diagnostique et Interventionnelle (JFR 2018) - 2018-10-12/2018-10-15

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2012
• Primary Completion (Actual): July 13, 2017
• Study Completion (Actual): July 13, 2017

Study Registration Dates

• First Submitted: May 26, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimated): June 1, 2016

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: dynamic knee laxity measurement; laxi-MRI; partial anterior cruciate ligament tear
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: 2011-685

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO