Magnetic Resonance Imaging Diffusion Tensor Tractography for Early Osteoarthritis Assessment

NCT03181425 | Completed

• 1 other identifier: DCIC1614
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Osteoarthritis

Keywords

Knee cartilage; Early Osteoarthritis; MRI tractography; Diffusion Tensor Imaging

Outcome Measures

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).

  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).

  6 months

Secondary Outcomes (7)

• 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

• 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

• 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

• 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

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

  6 months

Study Arms (1)

Imaging assessment

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with knee arthoplasty indication

You may qualify if:

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

You may not qualify if:

• Refusal to sign a non-objection form

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Clinical Investigation Centre for Innovative Technology Network: collaborator

Study Sites (1)

Orthopedic Surgery Department, University Hopital Grenoble Alpes

Grenoble, 38043, France

Location

Related Links

• Clinical Investigation Centre for Innovative Technology Network website

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Alexandre Moreau-Gaudry, MD, PhD

  Clinical Investigation Centre for Innovative Technology Network, University Hopital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start: October 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 6, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)