An observational study in Knee Osteoarthritis, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-06.
Sponsored by University Hospital, Grenoble · Observational
The aim of this study is the evaluation of new MRI tractography maps for early knee osteoarthritis assessment.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 8 is below the median of 100 across 791 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with knee arthoplasty indication
Over 18 years of age Knee prosthetic surgery indication with cartilage excision
Exclusion Criteria:
Refusal to sign a non-objection form
All subject of the study have a knee osteoarthritis (OA) and are going to have a knee prosthetic surgery with cartilage excision. Imaging measurements are conducted on human cartilage samples (2 samples per patient are selected : healthy and severely degraded).
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).
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).
Time frame: 6 months
Evaluation of the MRI tractography reconstructions in the assessment of early osteoarthritis using a qualitative parameter of visual information obtained from APM maps.
Correlation between the qualitative parameter of visual information (heterogeneity, contrast density by fiber density) and the gold standard of the arthrosis grade(OARSI).
Time frame: 6 months
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
Correlation between the Track Weighted - Apparent Diffusion Coefficient (TW-ADC) and the gold standard of arthrosis grade (OARSI).
Time frame: 6 months
Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted-Anisotropy Fraction (TW-FA) obtained from APM maps.
Correlation between the Track Weighted-Anisotropy Fraction (TW-FA) and the gold standard of arthrosis grade (OARSI).
Time frame: 6 months
Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted -Fibre Orientation Distribution (TW-FOD) obtained from APM maps.
Correlation between the Track Weighted -Fibre Orientation Distribution (TW-FOD) and the gold standard of arthrosis grade (OARSI).
Time frame: 6 months
Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis by using the Apparent Fibre Density (AFD) obtained from APM maps.
Correlation between the Apparent Fibre Density (AFD) and the gold standard of arthrosis grade (OARSI).
Time frame: 6 months
Evaluation of Optical Coherence Tomography (OCT) in the assessment of early osteoarthritis.
Correlation between the qualitative parameter from OCT and the gold standard of arthrosis grade (OARSI).
Time frame: 6 months
Sub-group analysis, according to the selected Anisotropy Fraction (FA) cutoff, to assess the MRI tractography reconstructions in the assessment of early osteoarthritis.
Correlation between the quantitative parameters previously cited and the gold standard of arthrosis grade (OARSI) for each group of Anisotropy Fraction (FA).
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble