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

Phase 4

Completed

• Conditions: Rhizarthrosis
• Interventions: Drug: infiltration of corticosteroids; Drug: infiltration of corticosteroids and hyaluronic acid

• Registration Number: NCT03431584
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-13
• Study Start: 2018-05-11
• Primary Completion: 2021-05-28
• Study Completion: 2021-12-16
• Status Verified: 2022-01
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infiltration of corticosteroids	infiltration of corticosteroids	-
Infiltration of corticosteroids and hyaluronic acid	infiltration of corticosteroids and hyaluronic acid	-

Primary Outcome Measures

Name	Time	Method
Analogical visual scale of pain (VAS)	3 month post infiltration	Analogical visual scale of pain (VAS) To 0mm (no pain) form 100mm (maximum pain imaginable)

Secondary Outcome Measures

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

Trial Locations

Locations (4)

CHU Nantes; 🇫🇷 Nantes, France

CH Cholet; 🇫🇷 Cholet, France

CH Le Mans; 🇫🇷 Le Mans, France

CHD Vendée; 🇫🇷 La Roche-sur-Yon, France