NCT03650673招募中不适用
A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Radiographic progression judged by the number of joints whose KL index has evolved
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
排除标准
- 未提供
结局指标
主要结局
Radiographic progression judged by the number of joints whose KL index has evolved
时间窗: 2 years
Evaluation of prognostic role of imaging factors in x-ray progression of early onset hand osteoarthritis
次要结局
- The activity of the disease over the last 48 hours(2 years)
- The location of painful / swollen or deformed joints in the hands.(2 years)
- The intensity of pain over the last 48 hours(2 years)
- The impact on pain and function measured the IPAQ International Physical Activity Questionnaire(2 years)
- The impact on the quality of life measured by the SF-36 questionnaire(2 years)
- The number of painful / swollen or deformed joints in the hands.(2 years)
- The professional impact measured by the WPAI questionnaire which measures the deficiencies of paid work and unpaid work over the last 7 days(2 years)
- The psychological impact of pain measured by the HAD questionnaire (Hospital Anxiety and Depression)(2 years)
- The impact on pain and function on the hand measured by a 6-minute walk test(2 years)
- The number of hand surgery during follow-up 56/5000 The number of a hand surgery during follow-up(2 years)
- The grip force measured by a dynamometer(2 years)
- The impact on pain and function on the hand measured by the AUSCAN questionnaire(2 years)
- Impact on quality of life measured by the Health Assessment Questionnaire (HAQ)(2 years)
- The aesthetic impact of osteoarthritis of the hands(2 years)
- The number of consumption of care in the month preceding the visit(2 years)
- The impact on pain and function on the hand measured by the COCHIN functional index(2 years)
- The impact on the quality of life measured by the EQ-5D-3L questionnaire (https://euroqol.org)(2 years)
- The Impact on Quality of Life Measured by the Michigan Hand Outcome Questionnaire (MHQ)(2 years)
- The aesthetic impact of osteoarthritis of the hands with the Michigan Hand Outcome Questionnaire(2 years)
研究者
研究点 (2)
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