Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis. (RHIZ'ART)
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ClinicalTrials.gov Identifier: NCT03431584 |
Recruitment Status :
Completed
First Posted : February 13, 2018
Last Update Posted : February 8, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rhizarthrosis | Drug: infiltration of corticosteroids Drug: infiltration of corticosteroids and hyaluronic acid | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis. |
Actual Study Start Date : | May 11, 2018 |
Actual Primary Completion Date : | May 28, 2021 |
Actual Study Completion Date : | December 16, 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Infiltration of corticosteroids |
Drug: infiltration of corticosteroids
infiltration of corticosteroids |
Experimental: Infiltration of corticosteroids and hyaluronic acid |
Drug: infiltration of corticosteroids and hyaluronic acid
infiltration of corticosteroids and hyaluronic acid |
- Analogical visual scale of pain (VAS) [ Time Frame: 3 month post infiltration ]Analogical visual scale of pain (VAS) To 0mm (no pain) form 100mm (maximum pain imaginable)
- Progression of pain to activity at protocol follow-up visits [ Time Frame: 1 month, 6 month, and 12 month post infiltration ]Analogical visual scale of pain (VAS)
- Progression of pain at rest at protocol follow-up visits [ Time Frame: Base-line,1 month, 3month, 6 month, and 12 month post infiltration ]Analogical visual scale of pain (VAS)
- Comparison of pain between M0 and M3, by weekly collection on a patient book [ Time Frame: 3 month post infiltration ]Analogical visual scale of pain (VAS)
- Evolution of the fhand unction with Cochin Hand Function Scale [ Time Frame: 1 month, 6 month, and 12 month post infiltration ]Cochin Hand Function Scale
- Evolution of the grip and opposition force [ Time Frame: 1 month, 3 month, 6 month, and 12 month post infiltration ]dynamometer mesures
- Ultrasound appearance of lesions [ Time Frame: Baseline and 3 month post infiltration ]ultrasound b-mode and Doppler - gradation of OMERACT
- Comparison of infiltration pain [ Time Frame: the day of infiltration ]Analogical visual scale of pain (VAS)
- Patient's feelings about the evolution of his pain [ Time Frame: 3 month post infiltration ]Verbal Scale of global evolution
- Need for new infiltrations [ Time Frame: over the 12 months of follow-up ]Number of corticosteroid infiltrations
- Use of analgesics and NSAIDs [ Time Frame: over the 12 months of follow-up ]Use of analgesics and NSAIDs
- Need for surgical procedure [ Time Frame: over the 12 months of follow-up ]Number of patient requiring a surgical procedure
- Number of days off work [ Time Frame: over the 12 months of follow-up ]Number of days off work

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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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
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431584
France | |
CH Cholet | |
Cholet, France, 49300 | |
CHD Vendée | |
La Roche-sur-Yon, France, 85925 | |
CH Le Mans | |
Le Mans, France, 72037 | |
CHU Nantes | |
Nantes, France, 44000 |
Responsible Party: | Centre Hospitalier Departemental Vendee |
ClinicalTrials.gov Identifier: | NCT03431584 |
Other Study ID Numbers: |
CHD 046-17 |
First Posted: | February 13, 2018 Key Record Dates |
Last Update Posted: | February 8, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Hyaluronic Acid |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents |