A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis Symptoms

NCT ID: NCT03650673

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2028-10-31

Brief Summary

The late-stage forms of degenerative osteoarthritis (OA) are very debilitating and less affordable to therapy. The main objective is to identify early onset symptoms of hand OA patients through imaging techniques (such as ultrasound and MRI). Our primary endpoint is to specify patients with high risk of radiological profression (X-ray).

Conditions

Hand Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Diagnostic Test: Identification of subgroups of patients with

Group Type: OTHER

Identification of subgroups of patients with early AD with risk of progression

Intervention Type: DIAGNOSTIC_TEST

Clinical examination with questionnaires, Biological collection, Imaging (radiography, densitometry, ultrasound, and MRI)

Interventions

Identification of subgroups of patients with early AD with risk of progression

Clinical examination with questionnaires, Biological collection, Imaging (radiography, densitometry, ultrasound, and MRI)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Early digital osteoarthritis must combine the clinical AND radiological definition.

Clinical definition:

At least one of the following 4 criteria: Pain or stiffness or swelling or deformity of a digital joint (IPP and / or IPD) A breach of at least one PPI and / or IPD Age under 60 at the time of the first symptoms Clinical symptoms have been changing for less than 3 years

Radiographic definition:

Exclusion Criteria

• Consent form signed

• patients suffering from rheumatoid arthritis, rheumatoid psoriasis or any other inflammatory rheumatism
• patients suffering from metabolic diseasis such as gout, hemochromatosis, Wilson's disease; or from congenital disease such as displasie, osteogenesis,
• Presence of advanced radiographic osteoarthritis based in Kellgreen Lawrence score (=4) in one joint among the 10 previous sites.
• Not able to provide a sample of blood for any reasons
• MRI contraindication
• Being in exclusion period determined by another previous study
• Subject non affiliated to social insurance
• Pregnant or lactating women
• Vulnerable people based in L1121-5 article of CSP
• Elderly subject or protected subjects disabled to give their consent
• Subjects private of freedom by court or administrative order

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yves-Marie PERS, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Department of Rheumatology, CHU Montpellier

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Yves-Marie PERS, MD

Role: CONTACT

ympers2000@yahoo.fr

+33 618993804

Facility Contacts

Michelle MOYA, CRA

Role: primary

michellemoya@orange.fr

+33 609980911

Other Identifiers

2017-A03378-45

Identifier Type: REGISTRY

Identifier Source: secondary_id

RECHMPL17_0391

Identifier Type: -

Identifier Source: org_study_id