A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis Symptoms (COARDIG)

A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis

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).

Study Overview

• Status: Recruiting
• Conditions: Hand Osteoarthritis
• Intervention / Treatment: Diagnostic test: Identification of subgroups of patients with early AD with risk of progression

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yves-Marie PERS, MD; Phone Number: +33 618993804; Email: ympers2000@yahoo.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Department of Rheumatology, CHU Montpellier
    • Contact: Michelle MOYA, CRA; Phone Number: +33 609980911; Email: michellemoya@orange.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Diagnostic Test: Identification of subgroups of patients with	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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Yves-Marie PERS, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): October 31, 2028

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Mobility; Cartilage; Prospective cohort; Hand osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: RECHMPL17_0391; 2017-A03378-45 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No