Hand OsteoarthritisCOARDIGNCT03650673
A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis Symptoms
A study testing Identification of subgroups of patients with early AD with risk of progression in people with Hand Osteoarthritis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Identification of subgroups of patients with early AD with risk of progression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2019to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Department of Rheumatology, CHU Montpellier
Montpellier, 34295
Michelle MOYA, CRA, +33 609980911, michellemoya@orange.fr
About this study
Official title: 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).
- Conditions
- Hand Osteoarthritis
- Being tested
- Identification of subgroups of patients with early AD with risk of progression
- Keywords
- Hand osteoarthritis, Prospective cohort, Cartilage, Mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification of subgroups of patients with early AD with risk of progressionDiagnostic test
Clinical examination with questionnaires, Biological collection, Imaging (radiography, densitometry, ultrasound, and MRI)
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Test: Identification of subgroups of patients with | Other | Not described Receives: Diagnostic Test: Identification of subgroups of patients with early AD with risk of progression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (19)
The number of painful / swollen or deformed joints in the hands.
Photographs of the patients' hands will be taken at each visit.
Measured: 2 years
The location of painful / swollen or deformed joints in the hands.
Photographs of the patients' hands will be taken at each visit.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 2 years
The number of consumption of care in the month preceding the visit
Measured: 2 years
The number of hand surgery during follow-up 56/5000 The number of a hand surgery during follow-up
Measured: 2 years
The grip force measured by a dynamometer
Measured: 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
Measured: 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
Measured: 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)
Measured: 2 years
The impact on pain and function measured the IPAQ International Physical Activity Questionnaire
The short version with 7 questions will be used
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start15 Jul 2019
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves-Marie PERS, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650673
- Sponsor's protocol ID
- RECHMPL17_0391
- Other IDs
- 2017-A03378-45
- Acronym
- COARDIG
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2018
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT03650673
- Acronym / sponsor ID
- COARDIG / RECHMPL17_0391
- Conditions
- Hand Osteoarthritis
- Keywords
- Hand osteoarthritis, Prospective cohort, Cartilage, Mobility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Test: Identification of subgroups of patients with | Other | Diagnostic Test: Identification of subgroups of patients with early AD with risk of progression |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Early digital osteoarthritis must combine the clinical AND radiological 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
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identification of subgroups of patients with early AD with risk of progressionClinical examination with questionnaires, Biological collection, Imaging (radiography, densitometry, ultrasound, and MRI) | Diagnostic test | Diagnostic Test: Identification of subgroups of patients with |
Primary outcome
Radiographic progression judged by the number of joints whose KL index has evolved
Time frame: 2 years
Evaluation of prognostic role of imaging factors in x-ray progression of early onset hand osteoarthritis
19 secondary outcomes
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
The professional impact measured by the WPAI questionnaire which measures the deficiencies of paid work and unpaid work over the last 7 days
Time frame: 2 years
Impact on quality of life measured by the Health Assessment Questionnaire (HAQ)
Time frame: 2 years
The impact on the quality of life measured by the SF-36 questionnaire
Time frame: 2 years
The impact on the quality of life measured by the EQ-5D-3L questionnaire (https://euroqol.org)
Time frame: 2 years
The Impact on Quality of Life Measured by the Michigan Hand Outcome Questionnaire (MHQ)
Time frame: 2 years
The psychological impact of pain measured by the HAD questionnaire (Hospital Anxiety and Depression)
Time frame: 2 years
The aesthetic impact of osteoarthritis of the hands with the Michigan Hand Outcome Questionnaire
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Hand Osteoarthritis
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Balneotherapy in Hand Osteoarthritis
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Methotrexate in Erosive Inflammatory Hand Osteoarthritis
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Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Active, not recruitingPhase 2
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis
Osteoarthritis Hand
RecruitingPhase 2/3
Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yves-Marie PERS, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Identification of subgroups of patients with early AD with risk of progression in people with Hand Osteoarthritis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yves-Marie PERS, MD (+33 618993804, ympers2000@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic progression judged by the number of joints whose KL index has evolved (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.