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

Anterior Cruciate Ligament Tear Clinical Trial

— LaxIRM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787096
• Other study ID #: 2011-685
• Status: Completed
• Phase: N/A
• Start date: May 9, 2012
• Est. completion date: July 13, 2017

Study information

• Verified date: August 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: July 13, 2017
• Est. primary completion date: July 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Tear

Intervention

Device:
• LaxIRM
Dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hôpital Edouard Herriot Pavillon B Radiologie	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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/p	1 year after the baseline MRI-scan