A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis Symptoms

Официальное название

A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis

Обзор

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).

Вмешательства

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

Первичные конечные точки

• Radiographic progression judged by the number of joints whose KL index has evolved [Срок оценки: 2 years]

Вторичные конечные точки (12)

• The number of painful / swollen or deformed joints in the hands. [Срок оценки: 2 years]
• The location of painful / swollen or deformed joints in the hands. [Срок оценки: 2 years]
• The intensity of pain over the last 48 hours [Срок оценки: 2 years]
• The activity of the disease over the last 48 hours [Срок оценки: 2 years]
• The aesthetic impact of osteoarthritis of the hands [Срок оценки: 2 years]
• The number of consumption of care in the month preceding the visit [Срок оценки: 2 years]
• The number of hand surgery during follow-up 56/5000 The number of a hand surgery during follow-up [Срок оценки: 2 years]
• The grip force measured by a dynamometer [Срок оценки: 2 years]
• The impact on pain and function on the hand measured by the AUSCAN questionnaire [Срок оценки: 2 years]
• The impact on pain and function on the hand measured by the COCHIN functional index [Срок оценки: 2 years]
• The impact on pain and function on the hand measured by a 6-minute walk test [Срок оценки: 2 years]
• The impact on pain and function measured the IPAQ International Physical Activity Questionnaire [Срок оценки: 2 years]

Критерии участия

Критерии включения

\- 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 1 центр

• Department of Rheumatology, CHU Montpellier — Montpellier

Идентификаторы

NCT: NCT03650673 · RECHMPL17_0391 · 2017-A03378-45

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗