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Completed

NCT Number: NCT03181425

Magnetic Resonance Imaging Diffusion Tensor Tractography for Early Osteoarthritis Assessment

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopedic Surgery Department, University Hopital Grenoble Alpes

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Refusal to sign a non-objection form

Treatment and study plan

Primary outcomes

  1. 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).

    Time frame: 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 outcomes

  1. Evaluation of the MRI tractography reconstructions in the assessment of early osteoarthritis using a qualitative parameter of visual information obtained from APM maps.

    Time frame: 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).

  2. 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

    Time frame: 6 months

    Correlation between the Track Weighted - Apparent Diffusion Coefficient (TW-ADC) and the gold standard of arthrosis grade (OARSI).

  3. Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted-Anisotropy Fraction (TW-FA) obtained from APM maps.

    Time frame: 6 months

    Correlation between the Track Weighted-Anisotropy Fraction (TW-FA) and the gold standard of arthrosis grade (OARSI).

  4. Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis using the Track Weighted -Fibre Orientation Distribution (TW-FOD) obtained from APM maps.

    Time frame: 6 months

    Correlation between the Track Weighted -Fibre Orientation Distribution (TW-FOD) and the gold standard of arthrosis grade (OARSI).

  5. Evaluation of MRI tractography reconstructions in the assessment of early osteoarthritis by using the Apparent Fibre Density (AFD) obtained from APM maps.

    Time frame: 6 months

    Correlation between the Apparent Fibre Density (AFD) and the gold standard of arthrosis grade (OARSI).

  6. Evaluation of Optical Coherence Tomography (OCT) in the assessment of early osteoarthritis.

    Time frame: 6 months

    Correlation between the qualitative parameter from OCT and the gold standard of arthrosis grade (OARSI).

  7. Sub-group analysis, according to the selected Anisotropy Fraction (FA) cutoff, to assess the MRI tractography reconstructions in the assessment of early osteoarthritis.

    Time frame: 6 months

    Correlation between the quantitative parameters previously cited and the gold standard of arthrosis grade (OARSI) for each group of Anisotropy Fraction (FA).

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Clinical Investigation Centre for Innovative Technology Network

Registry information

Official study title

Evaluation of Magnetic Resonance Imaging Diffusion Tensor and Knee Cartilage Tractography Reconstructions for the Study of Early Osteoarthritis

Acronym: TRACTILAGE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2017
Registry last updated
Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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