Functional Exploration of Cartilage in Patients With Osteoarthritis of the Knee Through MRI Sodium ( 23Na )

Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02885402
• Other study ID #: 2016-05
• Secondary ID: 2016-A00427-44
• Status: Not yet recruiting
• Phase: N/A
• First received: August 26, 2016
• Last updated: August 26, 2016
• Start date: October 2016
• Est. completion date: October 2020

Study information

• Verified date: August 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Jean Pierre MATTEI, MD
• Email: jean-pierre.mattei[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Osteoarthritis is a degenerative disease of hyaline cartilage not associated with an infection or an inflammatory process that affects millions of people. The first symptoms usually appear from 40-50 years and at this point, conventional radiological tests provide diagnostic elements relatively late, poorly correlated with pain relief and providing no functional information. In this context, there is a real need for imaging techniques for early detection of osteoarthritic changes in a still reversible stage for faster support and MRI appears to be the tool of choice.

Conventional proton MRI sequences already allow improved detection possibilities compared to conventional radiology and CT arthrography supplanted. They nevertheless remain insufficient to identify incipient lesions or paradoxically to the point of too advanced lesions. Due to recent technological advances, exploration MRI other nuclei such as sodium is now possible. Quantitation of sodium in the cartilage by sodium MRI allow quantifying proteoglycan loss and ultimately a gradation osteoarthritic reached.

This project's main objective is to quantify the biochemical changes (sodium content) occurring at different stages of osteoarthritis defined by clinical algofunctional scores (Lequesne) and conventional radiographic scores (Kellgren and Lawrence).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with osteoarthritis

Exclusion Criteria:

• patient with contraindication for MRI

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• MRI Sodium ( 23Na )

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of sodium released in osteoarthritis patient vs healthy volunteers		24 hours	No