RhizarthrosisPhase 4RHIZ'ARTNCT03431584
Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis.
A Phase 4 study testing infiltration of corticosteroids and infiltration of corticosteroids and hyaluronic acid in people with Rhizarthrosis, run by Centre Hospitalier Departemental Vendee at 4 sites in France.
Trial summary
The rhizarthrosis, or the degenerative osteoarthritis of the trapezo-metacarpal joint, is a frequent degenerative osteoarthritis. The treatment associates not pharmacological measures, such as resting relative of the joint, the orthosis of rest, glazing and pharmacological measures such analgesic, anti-inflammatory… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Rhizarthrosis
- What is being tested?
- infiltration of corticosteroids and infiltration of corticosteroids and hyaluronic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesFrance
- Study dates
- 11 May 2018to 16 Dec 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, ≥ 40 years
- Pain located at the root of the thumb (near the wrist) and awakened by direct pressure and movement
- Pain resistant to well-conducted medical treatment, with analgesics, NSAIDs, icing with pain (analog visual scale) ≥ 4 for more than 3 months
- Radiological findings (kapandji face + profile incidence) typical of rhizarthrosis, stage II or III of Eaton and Litter, with at least 2 of the following 5 radiological elements observed on the trapeziometacarpal joint:
- marginal osteophyte
- pinching of the joint space
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- sclerosis of the subchondral space
- subchondral kyst
- absence of osteopenia
- Patient with the ability to understand the protocol and signed informed consent
- Patient receiving social security
Who cannot join
- Known allergy to any of the products (corticosteroids or hyaluronic acid) including its excipients (methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl alcohol)
- Change of analgesic treatment within 4 weeks before inclusion.
- Patients with symptomatic bilateral rhizarthrosis
- Scaphoid-trapezial arthrosis
- Local or general infection
- Severe coagulation disorders, ongoing anticoagulant therapy
Show all 19Show fewer
- severe and / or uncontrolled hypertension
- Earlier local surgery
- Associated inflammatory rheumatism
- Tendinopathy of De Quervain, thumb to jump associated
- Infiltrations earlier than 6 months
- Diabetes imbalanced
- Live vaccines
- Severe water and / or sodium retention (hypernatremia), particularly in cases of heart failure, decompensated liver failure (edema and ascites failure)
- Pregnant or lactating women
- Immunocompromised or hemodialysis patients
- Patients under guardianship, trusteeship, or deprived of liberty
- Patients participating in another clinical research protocol involving a drug or medical device
- Patients unable to follow the protocol, according to the judgment of the investigator
Trial locations and contacts
4 sites in 1 country.
France4 sites
CH Cholet
Cholet, 49300
CHD Vendée
La Roche-sur-Yon, 85925
CH Le Mans
Le Mans, 72037
CHU Nantes
Nantes, 44000
About this study
The rhizarthrosis, or the degenerative osteoarthritis of the trapezo-metacarpal joint, is a frequent degenerative osteoarthritis.
The treatment associates not pharmacological measures, such as resting relative of the joint, the orthosis of rest, glazing and pharmacological measures such analgesic, anti-inflammatory not steroidal per bones or premises, even infiltrations cortisone or by hyaluronic acid.
No study has, for the moment, tested the interest of the combination of cortisone and hyaluronic acid in rhizarthrosis. In view of the current publications, we propose to carry out a study on two arms, with corticosteroids in reference arm; the experimental arm is the combination of hyaluronic acid and cortisone.
- Conditions
- Rhizarthrosis
- Being tested
- infiltration of corticosteroids, infiltration of corticosteroids and hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infiltration of corticosteroidsDrug
infiltration of corticosteroids
infiltration of corticosteroids and hyaluronic acidDrug
infiltration of corticosteroids and hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| Infiltration of corticosteroids | Active comparator | Not described Receives: Drug: infiltration of corticosteroids |
| Infiltration of corticosteroids and hyaluronic acid | Experimental | Not described Receives: Drug: infiltration of corticosteroids and hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analogical Visual Scale of Pain (VAS)
Analogical visual scale of pain (VAS) To 0 cm (no pain) form 10 cm (worst pain imaginable)
Measured: 3 month post infiltration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start11 May 2018
- Primary completion28 May 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RhizarthrosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431584
- Sponsor's protocol ID
- CHD 046-17
- Acronym
- RHIZ'ART
- Status last verified
- Nov 2025
- First submitted
- 6 Feb 2018
- Last updated
- 2 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cormier G, Le Goff B, Denis A, Varin S, Auzanneau L, Dimet J, Le Thuaut A. Corticosteroids injections versus corticosteroids with hyaluronic acid injections in rhizarthrosis: the randomised multicentre RHIZ'ART trial study protocol. BMJ Open. 2019 Jan 9;9(1):e022553. doi: 10.1136/bmjopen-2018-022553.
PubMed 30782680Cormier G, Denis A, Leske C, Varin S, Dimet J, Planche L, Le Goff B. Improvement of rhizarthrosis pain management with the infiltration of hyaluronic acid and corticosteroids versus corticosteroids alone. Joint Bone Spine. 2025 Jul;92(4):105849. doi: 10.1016/j.jbspin.2025.105849. Epub 2025 Jan 30.
PubMed 39892589
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis.
- ClinicalTrials.gov ID
- NCT03431584
- Acronym / sponsor ID
- RHIZ'ART / CHD 046-17
- Conditions
- Rhizarthrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 11 May 2018 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Posted 29 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rhizarthrosis, or the degenerative osteoarthritis of the trapezo-metacarpal joint, is a frequent degenerative osteoarthritis.
The treatment associates not pharmacological measures, such as resting relative of the joint, the orthosis of rest, glazing and pharmacological measures such analgesic, anti-inflammatory not steroidal per bones or premises, even infiltrations cortisone or by hyaluronic acid.
No study has, for the moment, tested the interest of the combination of cortisone and hyaluronic acid in rhizarthrosis. In view of the current publications, we propose to carry out a study on two arms, with corticosteroids in reference arm; the experimental arm is the combination of hyaluronic acid and cortisone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infiltration of corticosteroids | Active comparator | Drug: infiltration of corticosteroids |
| Infiltration of corticosteroids and hyaluronic acid | Experimental | Drug: infiltration of corticosteroids and hyaluronic acid |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults, ≥ 40 years
- Pain located at the root of the thumb (near the wrist) and awakened by direct pressure and movement
- Pain resistant to well-conducted medical treatment, with analgesics, NSAIDs, icing with pain (analog visual scale) ≥ 4 for more than 3 months
- Radiological findings (kapandji face + profile incidence) typical of rhizarthrosis, stage II or III of Eaton and Litter, with at least 2 of the following 5 radiological elements observed on the trapeziometacarpal joint:
- Patient with the ability to understand the protocol and signed informed consent
Key exclusion criteria (19 listed)
- Known allergy to any of the products (corticosteroids or hyaluronic acid) including its excipients (methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl alcohol)
- Change of analgesic treatment within 4 weeks before inclusion.
- Patients with symptomatic bilateral rhizarthrosis
- Scaphoid-trapezial arthrosis
- Local or general infection
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 |
|---|---|---|
| infiltration of corticosteroidsinfiltration of corticosteroids | Drug | Infiltration of corticosteroids |
| infiltration of corticosteroids and hyaluronic acidinfiltration of corticosteroids and hyaluronic acid | Drug | Infiltration of corticosteroids and hyaluronic acid |
Primary outcome
Analogical Visual Scale of Pain (VAS)
Time frame: 3 month post infiltration
Analogical visual scale of pain (VAS) To 0 cm (no pain) form 10 cm (worst pain imaginable)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30782680Cormier G, Le Goff B, Denis A, Varin S, Auzanneau L, Dimet J, Le Thuaut A. Corticosteroids injections versus corticosteroids with hyaluronic acid injections in rhizarthrosis: the randomised multicentre RHIZ'ART trial study protocol. BMJ Open. 2019 Jan 9;9(1):e022553. doi: 10.1136/bmjopen-2018-022553.
- Results publication: PubMed 39892589Cormier G, Denis A, Leske C, Varin S, Dimet J, Planche L, Le Goff B. Improvement of rhizarthrosis pain management with the infiltration of hyaluronic acid and corticosteroids versus corticosteroids alone. Joint Bone Spine. 2025 Jul;92(4):105849. doi: 10.1016/j.jbspin.2025.105849. Epub 2025 Jan 30.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing infiltration of corticosteroids and infiltration of corticosteroids and hyaluronic acid in people with Rhizarthrosis, run by Centre Hospitalier Departemental Vendee at 4 sites 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 11 inclusion and 19 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: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analogical Visual Scale of Pain (VAS) (time frame: 3 month post infiltration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03431584, which also lists 2 linked publications.
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 2 Dec 2025.