A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis Symptoms

NCT03650673 | Recruiting

• 2 other identifiers: RECHMPL17_03912017-A03378-45
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Hand osteoarthritis; Prospective cohort; Cartilage; Mobility

Outcome Measures

Primary Outcomes (1)

• Radiographic progression judged by the number of joints whose KL index has evolved

  Evaluation of prognostic role of imaging factors in x-ray progression of early onset hand osteoarthritis

  2 years

Secondary Outcomes (19)

• The number of painful / swollen or deformed joints in the hands.

  2 years

• The location of painful / swollen or deformed joints in the hands.

  2 years

• The intensity of pain over the last 48 hours

  2 years

• The activity of the disease over the last 48 hours

  2 years

• The aesthetic impact of osteoarthritis of the hands

  2 years

Study Arms (1)

Diagnostic Test: Identification of subgroups of patients with

OTHER

Diagnostic Test: Identification of subgroups of patients with early AD with risk of progression

Interventions

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

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

Diagnostic Test: Identification of subgroups of patients with

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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:

You may not qualify if:

• \- 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
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Department of Rheumatology, CHU Montpellier

Montpellier, 34295, France

RECRUITING

Study Officials

• Yves-Marie PERS, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yves-Marie PERS, MD

CONTACT

+33 618993804; ympers2000@yahoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 29, 2018
• Study Start: July 15, 2019
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)