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

Centre Hospitalier Departemental Vendee

Status and phase: Completed; Phase 4

Conditions: Rhizarthrosis

Treatments: Drug: infiltration of corticosteroids; Drug: infiltration of corticosteroids and hyaluronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03431584

CHD 046-17

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

150 participants in 2 patient groups

Infiltration of corticosteroids

Active Comparator group

Treatment:

Drug: infiltration of corticosteroids

Infiltration of corticosteroids and hyaluronic acid

Experimental group

Treatment:

Drug: infiltration of corticosteroids and hyaluronic acid