Skip to main content
OpenTrials
Completed

NCT Number: NCT03431584

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CH Cholet, Cholet, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

infiltration of corticosteroids

Drug

infiltration of corticosteroids

infiltration of corticosteroids and hyaluronic acid

Drug

infiltration of corticosteroids and hyaluronic acid

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Acronym: RHIZ'ART

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 13, 2018
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.