Clinical trial NCT03181425: Magnetic Resonance Imaging Diffusion Tensor Tractography for Early Osteoarthritis Assessment
Official title: Evaluation of Magnetic Resonance Imaging Diffusion Tensor and Knee Cartilage Tractography Reconstructions for the Study of Early Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: Knee cartilage
Early Osteoarthritis
MRI tractography
Diffusion Tensor Imaging
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Clinical Investigation Centre for Innovative Technology Network
First posted: 2017-06-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with knee arthoplasty indication

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Refusal to sign a non-objection form

Primary outcomes:
measure: 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).
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of the MRI tractography reconstructions in the assessment of early osteoarthritis using a qualitative parameter of visual information obtained from APM maps.
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted-Anisotropy Fraction (TW-FA) obtained from APM maps.
timeFrame: 6 months
measure: Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted -Fibre Orientation Distribution (TW-FOD) obtained from APM maps.
timeFrame: 6 months
measure: Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis by using the Apparent Fibre Density (AFD) obtained from APM maps.
timeFrame: 6 months
measure: Evaluation of Optical Coherence Tomography (OCT) in the assessment of early osteoarthritis.
timeFrame: 6 months
measure: Sub-group analysis, according to the selected Anisotropy Fraction (FA) cutoff, to assess the MRI tractography reconstructions in the assessment of early osteoarthritis.
timeFrame: 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Orthopedic Surgery Department, University Hopital Grenoble Alpes
Study officials:
affiliation: Clinical Investigation Centre for Innovative Technology Network, University Hopital, Grenoble
name: Alexandre Moreau-Gaudry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: