A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis Symptoms (NCT03650673) | Clinical Trial Compass
RecruitingNot Applicable
A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis Symptoms
France150 participantsStarted 2019-07-15
Plain-language 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).
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 administ…
What they're measuring
1
Radiographic progression judged by the number of joints whose KL index has evolved