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Recruiting NCT03650673

A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis Symptoms

No phase Interventional Hand Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Identification of subgroups of patients with early AD with risk of progression.
Who it may be relevant to
Registry conditions: Hand Osteoarthritis. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis

Overview

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).

Interventions

  • Diagnostic test Identification of subgroups of patients with early AD with risk of progression
    Clinical examination with questionnaires, Biological collection, Imaging (radiography, densitometry, ultrasound, and MRI)

Primary outcome measures

  • Radiographic progression judged by the number of joints whose KL index has evolved [Time frame: 2 years]
Secondary outcome measures (12)
  • The number of painful / swollen or deformed joints in the hands. [Time frame: 2 years]
  • The location of painful / swollen or deformed joints in the hands. [Time frame: 2 years]
  • The intensity of pain over the last 48 hours [Time frame: 2 years]
  • The activity of the disease over the last 48 hours [Time frame: 2 years]
  • The aesthetic impact of osteoarthritis of the hands [Time frame: 2 years]
  • The number of consumption of care in the month preceding the visit [Time frame: 2 years]
  • The number of hand surgery during follow-up 56/5000 The number of a hand surgery during follow-up [Time frame: 2 years]
  • The grip force measured by a dynamometer [Time frame: 2 years]
  • The impact on pain and function on the hand measured by the AUSCAN questionnaire [Time frame: 2 years]
  • The impact on pain and function on the hand measured by the COCHIN functional index [Time frame: 2 years]
  • The impact on pain and function on the hand measured by a 6-minute walk test [Time frame: 2 years]
  • The impact on pain and function measured the IPAQ International Physical Activity Questionnaire [Time frame: 2 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

France · 1 center
  • Department of Rheumatology, CHU Montpellier — Montpellier

Identifiers

NCT: NCT03650673 · RECHMPL17_0391 · 2017-A03378-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗