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

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Tear
• Interventions: Device: LaxIRM

• Registration Number: NCT02787096
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-05-09
• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-06-01
• Primary Completion: 2017-07-13
• Study Completion: 2017-07-13
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-22
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
laxIRM	LaxIRM	Patients will have dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear

Primary Outcome Measures

Name	Time	Method
Anterior tibial translation (ATT) measurement	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 Outcome Measures

Name	Time	Method
Degree of laxity	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.
Femorotibial rotation (FTR) value	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

Trial Locations

Locations (1)

Hospices Civils de Lyon - Hôpital Edouard Herriot Pavillon B Radiologie; 🇫🇷 Lyon, France