A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis Symptoms

Study Overview
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Brief Summary
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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).

Official Title
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A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis

Conditions
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Hand Osteoarthritis

Intervention / Treatment
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* Diagnostic Test: Identification of subgroups of patients with early AD with risk of progression


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diagnostic Test: Identification of subgroups of patients with<br> | Diagnostic Test: Identification of subgroups of patients with early AD with risk of progression<br>* Clinical examination with questionnaires, Biological collection, Imaging (radiography, densitometry, ultrasound, and MRI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic progression judged by the number of joints whose KL index has evolved | Evaluation of prognostic role of imaging factors in x-ray progression of early onset hand osteoarthritis | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of painful / swollen or deformed joints in the hands. | Photographs of the patients' hands will be taken at each visit. | 2 years | 
| The location of painful / swollen or deformed joints in the hands. | Photographs of the patients' hands will be taken at each visit. | 2 years | 
| The intensity of pain over the last 48 hours | The intensity of pain over the last 48 hours will be assessed by the patient at each visit on a visual analogue scale (VAS). EVA pain (visual analogue scale over 100 mm): one-dimensional measurement of the intensity of pain. EVA pain is a continuous scale consisting of a horizontal line from 0 (no pain) to 100 mm (maximum pain) | 2 years | 
| The activity of the disease over the last 48 hours | The activity of the disease over the last 48 hours will be evaluated at each visit by the patient and the doctor on a visual analog scale from 0 (no pain) to 100 mm (maximum pain) | 2 years | 
| The aesthetic impact of osteoarthritis of the hands | The aesthetic impact of osteoarthritis of the hands will be evaluated at each visit by the patient on a visual analog scale from 0 (no pain) to 100 mm (maximum pain) | 2 years | 
| The number of consumption of care in the month preceding the visit |  | 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 | The impact on pain and function measured by the AUSCAN questionnaire. This is a functional index including 15 questions with a specific orientation to osteoarthritis of the hands, assessing pain / stiffness and function. The score varies from 0 to 60. Fill in the questionnaire: 7 min | 2 years | 
| The impact on pain and function on the hand measured by the COCHIN functional index | The impact on pain and function measured by the COCHIN functional index wich is oriented towards AD. It includes 18 questions, ranging from 0 to 5, and is particularly interested in the impact of osteoarthritis of the hands on the daily activities (cooking, clothing, hygiene, office ...) of the patient. The score varies from 0 to 90. Questionnaire filling time: 5 min | 2 years | 
| The impact on pain and function on the hand measured by a 6-minute walk test | The impact on pain and function measured by a 6-minute walk test that characterizes an overall assessment of functional ability to exercise. The patient is asked to walk as much as possible for 6 minutes (round trip in a 30m corridor), the pace of walking is freely chosen (ATS Recommendations, 2002) | 2 years | 
| The impact on pain and function measured the IPAQ International Physical Activity Questionnaire | The short version with 7 questions will be used | 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 | The WPAI questionnaire is an instrument for measuring deficiencies in paid work and unpaid work over the last 7 days. It measures absenteeism, presenteeism as well as the deficiencies of unpaid activity due to a health problem. It contains 6 questions and has already been used during AD | 2 years | 
| Impact on quality of life measured by the Health Assessment Questionnaire (HAQ) | The Health Assessment Questionnaire (HAQ) is a measure of quality of life in health. The questionnaire is designed to be completed by the patient himself, without the help of a doctor. We will use an adaptation of the HAQ, the Modified Health Assessment Questionnaire (MHAQ), as in the Kwok et al. Study, with 8 questions about the function of the hand. The score ranges from 0 to 3. The average score reported in osteoarthritis studies is 0.8. It is 0.49 in the global population. | 2 years | 
| The impact on the quality of life measured by the SF-36 questionnaire | The SF-36 questionnaire assesses the quality of life. It is a validated international questionnaire. It consists of 36 items evaluating 8 dimensions. It can be used in health economics studies as a variable in the calculation of a Quality Adjusted Life Year (QALY) to determine the cost-effectiveness of a health intervention. Fill in the questionnaire: 10 min. | 2 years | 
| The impact on the quality of life measured by the EQ-5D-3L questionnaire (https://euroqol.org) | This score varies between 0 and 1: 0 represents death, and 1 the best quality of life possible. So, this score indicates the decrease in quality of life compared to an optimal state of health. The more desirable a health state, the higher the score associated with it. Negative scores are possible if the subject perceives a state of health worse than death. The EQ-5D-3L includes the following five dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension has 3 levels: absence of problems, presence of problems and extreme problems. Questionnaire filling time: 5 min | 2 years | 
| The Impact on Quality of Life Measured by the Michigan Hand Outcome Questionnaire (MHQ) | It is an international questionnaire validated with 6 items, which assesses the aesthetic impact of osteoarthritis of the hands. The questionnaire includes the function of the overall hand, the activities of daily life, the pain, the work, the appearance of the hands and the satisfaction of the patient with the functionality of his hands. In the ladder pain, a high score indicates more intense pain, while in the rest of the items, a better score reveals better hand functionality. Duplicate filling time: 15 min. | 2 years | 
| The psychological impact of pain measured by the HAD questionnaire (Hospital Anxiety and Depression) | This questionnaire assesses the psychological impact of the patient. It consists of 14 questions with 4 possible answers. This score makes it possible to differentiate a level of anxiety and a level of depression according to the answers. Each sub-scale varies from 0 to 21. Questionnaire filling time: 5 min | 2 years | 
| The aesthetic impact of osteoarthritis of the hands with the Michigan Hand Outcome Questionnaire | The aesthetic impact of osteoarthritis of the hands will be evaluated at each visit by the patient with the help of the Michigan Hand Outcome Questionnaire. It is an international questionnaire validated with 6 items, which assesses the aesthetic impact of osteoarthritis of the hands. The questionnaire includes the function of the overall hand, the activities of daily life, the pain, the work, the appearance of the hands and the satisfaction of the patient with the functionality of his hands. In the ladder pain, a high score indicates more intense pain, while in the rest of the items, a better score reveals better hand functionality. Duplicate filling time: 15 min (MHQ) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hand osteoarthritis, Prospective cohort, Cartilage, Mobility