NCT03650673 A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis Symptoms
| NCT ID | NCT03650673 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Hand Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2019-07-15 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2019-07-15 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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: The presence of the achievement of at least one PPI and / or IPD. Presence of at least two of the following three criteria: pinching, marginal subchondral condensation, marginal osteophyte Erosion on radiography is not an exclusion criteria \- Consent form signed Exclusion criteria: * 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
Contact & Investigator
Yves-Marie PERS, MD
PRINCIPAL INVESTIGATOR
University Hospital, Montpellier
Frequently Asked Questions
Who can join the NCT03650673 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Hand Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03650673 currently recruiting?
Yes, NCT03650673 is actively recruiting participants. Contact the research team at ympers2000@yahoo.fr for enrollment information.
Where is the NCT03650673 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT03650673 clinical trial?
NCT03650673 is sponsored by University Hospital, Montpellier. The principal investigator is Yves-Marie PERS, MD at University Hospital, Montpellier. The trial plans to enroll 150 participants.