Status:
COMPLETED
Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis.
Lead Sponsor:
Centre Hospitalier Departemental Vendee
Conditions:
Rhizarthrosis
Eligibility:
All Genders
40+ years
Phase:
PHASE4
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 restin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03431584
Start Date
May 11 2018
End Date
December 16 2021
Last Update
December 2 2025
Active Locations (4)
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1
CH Cholet
Cholet, France, 49300
2
CHD Vendée
La Roche-sur-Yon, France, 85925
3
CH Le Mans
Le Mans, France, 72037
4
CHU Nantes
Nantes, France, 44000