Magnetic Resonance Imaging Diffusion Tensor Tractography for Early Osteoarthritis Assessment

Completed

• Conditions: Knee Osteoarthritis

• Registration Number: NCT03181425
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

The aim of this study is the evaluation of new MRI tractography maps for early knee osteoarthritis assessment.

Detailed Description

Knee osteoarthritis (OA) is a common and chronic degenerative disease of the articular cartilage. Despite recent progress in the field of cartilage imaging, no routinely used clinical imaging modality has the ability to evaluate and monitor changes in cartilage degeneration.

More and more studies report the benefits of Magnetic Resonance (MR) diffusion tensor imaging (DTI) in the study of early knee osteoarthritis and in particular the new MRI contrasts generating the Track Weighted Imaging (TWI) technique.

This observationnal, pilot, prospective, unrandomized and uncontrolled study aim to evaluate, for the first time, the new MRI tractography maps for the assessment of early knee osteoarthritis. This study doesn't modify the medical care of the patient.

Study Timeline

• Study Start: 2016-10
• Primary Completion: 2017-04
• Study Completion: 2017-06
• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-08
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-04
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Over 18 years of age Knee prosthetic surgery indication with cartilage excision

Exclusion Criteria

Refusal to sign a non-objection form

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the MRI tractography reconstructions in the assessment of early osteoarthritis using the quantitative parameter of the average fiber lenght per voxel within a region of interest obtained from Average Pathlength Maps (APM).	6 months	Correlation between the average fiber lenght per voxel within a region of interest (APM maps) obtained from MRI tractography reconstructions of human cartilage and the gold standard of the arthrosis grade(OARSI).

Secondary Outcome Measures

Name	Time	Method
Evaluation of the MRI tractography reconstructions in the assessment of early osteoarthritis using a qualitative parameter of visual information obtained from APM maps.	6 months	Correlation between the qualitative parameter of visual information (heterogeneity, contrast density by fiber density) and the gold standard of the arthrosis grade(OARSI).
Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis by using the Apparent Fibre Density (AFD) obtained from APM maps.	6 months	Correlation between the Apparent Fibre Density (AFD) and the gold standard of arthrosis grade (OARSI).
Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted-Anisotropy Fraction (TW-FA) obtained from APM maps.	6 months	Correlation between the Track Weighted-Anisotropy Fraction (TW-FA) and the gold standard of arthrosis grade (OARSI).
Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted -Fibre Orientation Distribution (TW-FOD) obtained from APM maps.	6 months	Correlation between the Track Weighted -Fibre Orientation Distribution (TW-FOD) and the gold standard of arthrosis grade (OARSI).
Evaluation of Optical Coherence Tomography (OCT) in the assessment of early osteoarthritis.	6 months	Correlation between the qualitative parameter from OCT and the gold standard of arthrosis grade (OARSI).
Evaluation the of the MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted - Apparent Diffusion Coefficient (TW-ADC) obtained from APM maps	6 months	Correlation between the Track Weighted - Apparent Diffusion Coefficient (TW-ADC) and the gold standard of arthrosis grade (OARSI).
Sub-group analysis, according to the selected Anisotropy Fraction (FA) cutoff, to assess the MRI tractography reconstructions in the assessment of early osteoarthritis.	6 months	Correlation between the quantitative parameters previously cited and the gold standard of arthrosis grade (OARSI) for each group of Anisotropy Fraction (FA).

Trial Locations

Locations (1)

Orthopedic Surgery Department, University Hopital Grenoble Alpes; 🇫🇷 Grenoble, France