Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis. (RHIZ'ART)

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 Overview

• Status: Completed
• Conditions: Rhizarthrosis
• Intervention / Treatment: Drug: infiltration of corticosteroids; Drug: infiltration of corticosteroids and hyaluronic acid

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Cholet, France, 49300
    • Ch Cholet
  • La Roche-sur-Yon, France, 85925
    • CHD Vendee
  • Le Mans, France, 72037
    • CH Le Mans
  • Nantes, France, 44000
    • CHU Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

  • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analogical visual scale of pain (VAS)	Analogical visual scale of pain (VAS) To 0mm (no pain) form 100mm (maximum pain imaginable)	3 month post infiltration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of pain to activity at protocol follow-up visits	Analogical visual scale of pain (VAS)	1 month, 6 month, and 12 month post infiltration
Progression of pain at rest at protocol follow-up visits	Analogical visual scale of pain (VAS)	Base-line,1 month, 3month, 6 month, and 12 month post infiltration
Comparison of pain between M0 and M3, by weekly collection on a patient book	Analogical visual scale of pain (VAS)	3 month post infiltration
Evolution of the fhand unction with Cochin Hand Function Scale	Cochin Hand Function Scale	1 month, 6 month, and 12 month post infiltration
Evolution of the grip and opposition force	dynamometer mesures	1 month, 3 month, 6 month, and 12 month post infiltration
Ultrasound appearance of lesions	ultrasound b-mode and Doppler - gradation of OMERACT	Baseline and 3 month post infiltration
Comparison of infiltration pain	Analogical visual scale of pain (VAS)	the day of infiltration
Patient's feelings about the evolution of his pain	Verbal Scale of global evolution	3 month post infiltration
Need for new infiltrations	Number of corticosteroid infiltrations	over the 12 months of follow-up
Use of analgesics and NSAIDs	Use of analgesics and NSAIDs	over the 12 months of follow-up
Need for surgical procedure	Number of patient requiring a surgical procedure	over the 12 months of follow-up
Number of days off work	Number of days off work	over the 12 months of follow-up

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2018
• Primary Completion (Actual): May 28, 2021
• Study Completion (Actual): December 16, 2021

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: CHD 046-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No