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

Rhizarthrosis Clinical Trial

— RHIZ'ART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03431584
• Other study ID #: CHD 046-17
• Status: Completed
• Phase: Phase 4
• Start date: May 11, 2018
• Est. completion date: December 16, 2021

Study information

• Verified date: January 2022
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 16, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Rhizarthrosis

Intervention

Drug:
• infiltration of corticosteroids
infiltration of corticosteroids
• infiltration of corticosteroids and hyaluronic acid
infiltration of corticosteroids and hyaluronic acid

Locations

Country	Name	City	State
France	CH Cholet	Cholet
France	CHD Vendée	La Roche-sur-Yon
France	CH Le Mans	Le Mans
France	CHU Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

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