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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infiltration of corticosteroids | Active Comparator |
| |
| Infiltration of corticosteroids and hyaluronic acid | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infiltration of corticosteroids | Drug | infiltration of corticosteroids |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Analogical Visual Scale of Pain (VAS) | Analogical visual scale of pain (VAS) To 0 cm (no pain) form 10 cm (worst pain imaginable) | 3 month post infiltration |
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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
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
Patient receiving social security
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Cholet | Cholet | 49300 | France | |||
| CHD Vendée |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30782680 | Background | 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. | |
| 39892589 | Result |
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150 patients were randomised, 1 patient was excluded from follow-up after infiltration before the first visit at M1 and was not analysed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Infiltration of corticosteroids and hyaluronic acid | infiltration of corticosteroids and hyaluronic acid: infiltration of corticosteroids and hyaluronic acid |
| FG001 | Infiltration of corticosteroids |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2019 |
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| infiltration of corticosteroids and hyaluronic acid |
| Drug |
infiltration of corticosteroids and hyaluronic acid |
|
| La Roche-sur-Yon |
| 85925 |
| France |
| CH Le Mans | Le Mans | 72037 | France |
| CHU Nantes | Nantes | 44000 | France |
| Cormier 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. |
infiltration of corticosteroids: infiltration of corticosteroids
| COMPLETED |
|
| NOT COMPLETED |
|
One patient was lost to follow-up after infiltration and was not included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Infiltration of Corticosteroids | infiltration of corticosteroids: infiltration of corticosteroids |
| BG001 | Infiltration of Corticosteroids and Hyaluronic Acid | infiltration of corticosteroids and hyaluronic acid: infiltration of corticosteroids and hyaluronic acid |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Analogical Visual Scale of Pain (VAS) | Analogical visual scale of pain (VAS) To 0 cm (no pain) form 10 cm (worst pain imaginable) | Posted | Least Squares Mean | 95% Confidence Interval | centimeter | 3 month post infiltration |
|
|
|
Through study completion, , an average of 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infiltration of corticosteroids | infiltration of corticosteroids: infiltration of corticosteroids | 1 | 76 | 16 | 76 | 13 | 76 |
| EG001 | Infiltration of corticosteroids and hyaluronic acid | infiltration of corticosteroids and hyaluronic acid: infiltration of corticosteroids and hyaluronic acid | 0 | 73 | 11 | 73 | 10 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| OVARIAN CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| PYOGENIC GRANULOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| PELVIC FRACTURE | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| DEEP VEIN THROMBOSIS | Vascular disorders | Systematic Assessment |
| ||
| JOINT ARTHROPLASTY | Surgical and medical procedures | Systematic Assessment |
| ||
| TRAPEZIECTOMY | Surgical and medical procedures | Systematic Assessment |
| ||
| CARPAL TUNNEL SYNDROME | Nervous system disorders | Systematic Assessment |
| ||
| PYREXIA | General disorders | Systematic Assessment |
| ||
| CATARACT | Eye disorders | Systematic Assessment |
| ||
| PANCREATITIS | Gastrointestinal disorders | Systematic Assessment |
| ||
| ALCOHOL ABUSE | Psychiatric disorders | Systematic Assessment |
| ||
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| TENOSYNOVITIS STENOSANS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grégoire CORMIER | Centre Hospitalier Departemental Vendée | 251446197 | +33 | gregoire.cormier@ght85.fr |
| Sep 9, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 4, 2019 | Aug 21, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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