Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis.

NCT03431584 | Completed Phase 4 Results DMC

• 1 other identifier: CHD 046-17
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Infiltration of corticosteroids

ACTIVE COMPARATOR

Drug: infiltration of corticosteroids

Infiltration of corticosteroids and hyaluronic acid

EXPERIMENTAL

Drug: infiltration of corticosteroids and hyaluronic acid

Interventions

infiltration of corticosteroids DRUG

infiltration of corticosteroids

Infiltration of corticosteroids

infiltration of corticosteroids and hyaluronic acid DRUG

infiltration of corticosteroids and hyaluronic acid

Infiltration of corticosteroids and hyaluronic acid

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Known allergy to any of the products (corticosteroids or hyaluronic acid) including its excipients (methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl alcohol)
• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (4)

CH Cholet

Cholet, 49300, France

Location

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

CH Le Mans

Le Mans, 72037, France

Location

CHU Nantes

Nantes, 44000, France

Location

Related Publications (2)

• 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.

  PMID: 30782680 BACKGROUND

• 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.

  PMID: 39892589 RESULT

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Grégoire CORMIER
• Organization: Centre Hospitalier Departemental Vendée

gregoire.cormier@ght85.fr

251446197

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 13, 2018
• Study Start: May 11, 2018
• Primary Completion: May 28, 2021
• Study Completion: December 16, 2021
• Last Updated: December 2, 2025
• Results First Posted: September 29, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)