Back to resultsDynamic Knee Laxity Measurement Coupled to MRI in Cases of Suspected Partial Anterior Cruciate Ligament Tear (LaxIRM)
Primary Purpose
Anterior Cruciate Ligament Tear
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
LaxIRM
Sponsored by
About this trial
This is an interventional diagnostic trial for Anterior Cruciate Ligament Tear focused on measuring dynamic knee laxity measurement, laxi-MRI, partial anterior cruciate ligament tear
Eligibility Criteria
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
Sites / Locations
- Hospices Civils de Lyon - Hôpital Edouard Herriot Pavillon B Radiologie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
laxIRM
Arm Description
Patients will have dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02787096
Brief Title
Dynamic Knee Laxity Measurement Coupled to MRI in Cases of Suspected Partial Anterior Cruciate Ligament Tear
Acronym
LaxIRM
Official Title
Dynamic Knee Laxity Measurement Coupled to MRI in Cases of Suspected Partial Anterior Cruciate Ligament Tear
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 9, 2012 (Actual)
Primary Completion Date
July 13, 2017 (Actual)
Study Completion Date
July 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Tear
Keywords
dynamic knee laxity measurement, laxi-MRI, partial anterior cruciate ligament tear
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
laxIRM
Arm Type
Experimental
Arm Description
Patients will have dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear
Intervention Type
Device
Intervention Name(s)
LaxIRM
Intervention Description
Dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear
Primary Outcome Measure Information:
Title
Anterior tibial translation (ATT) measurement
Description
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.
Time Frame
1 year after the baseline MRI-scan
Secondary Outcome Measure Information:
Title
Degree of laxity
Description
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.
Time Frame
1 year after the baseline MRI-scan
Title
Femorotibial rotation (FTR) value
Description
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
Time Frame
1 year after the baseline MRI-scan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste PIALAT, MD, PhD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon - Hôpital Edouard Herriot Pavillon B Radiologie
City
Lyon
ZIP/Postal Code
69437
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dynamic Knee Laxity Measurement Coupled to MRI in Cases of Suspected Partial Anterior Cruciate Ligament Tear
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