Clinical trial NCT03650673: A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis Symptoms
Official title: A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand Osteoarthritis
Keywords: Hand osteoarthritis
Prospective cohort
Cartilage
Mobility
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Primary outcomes:
measure: Radiographic progression judged by the number of joints whose KL index has evolved
timeFrame: 2 years
Secondary outcomes:
measure: The number of painful / swollen or deformed joints in the hands.
timeFrame: 2 years
measure: The location of painful / swollen or deformed joints in the hands.
timeFrame: 2 years
measure: The intensity of pain over the last 48 hours
timeFrame: 2 years
measure: The activity of the disease over the last 48 hours
timeFrame: 2 years
measure: The aesthetic impact of osteoarthritis of the hands
timeFrame: 2 years
measure: The number of consumption of care in the month preceding the visit
timeFrame: 2 years
measure: The number of hand surgery during follow-up 56/5000 The number of a hand surgery during follow-up
timeFrame: 2 years
measure: The grip force measured by a dynamometer
timeFrame: 2 years
measure: The impact on pain and function on the hand measured by the AUSCAN questionnaire
timeFrame: 2 years
measure: The impact on pain and function on the hand measured by the COCHIN functional index
timeFrame: 2 years
measure: The impact on pain and function on the hand measured by a 6-minute walk test
timeFrame: 2 years
measure: The impact on pain and function measured the IPAQ International Physical Activity Questionnaire
timeFrame: 2 years
measure: The professional impact measured by the WPAI questionnaire which measures the deficiencies of paid work and unpaid work over the last 7 days
timeFrame: 2 years
measure: Impact on quality of life measured by the Health Assessment Questionnaire (HAQ)
timeFrame: 2 years
measure: The impact on the quality of life measured by the SF-36 questionnaire
timeFrame: 2 years
measure: The impact on the quality of life measured by the EQ-5D-3L questionnaire (https://euroqol.org)
timeFrame: 2 years
measure: The Impact on Quality of Life Measured by the Michigan Hand Outcome Questionnaire (MHQ)
timeFrame: 2 years
measure: The psychological impact of pain measured by the HAD questionnaire (Hospital Anxiety and Depression)
timeFrame: 2 years
measure: The aesthetic impact of osteoarthritis of the hands with the Michigan Hand Outcome Questionnaire
timeFrame: 2 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Department of Rheumatology, CHU Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Yves-Marie PERS, MD
role: PRINCIPAL_INVESTIGATOR
References: