Rhizarthrosis
Conditions
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.
Interventions
DRUGinfiltration of corticosteroids
infiltration of corticosteroids
DRUGinfiltration of corticosteroids and hyaluronic acid
infiltration of corticosteroids and hyaluronic acid
Sponsors
Centre Hospitalier Departemental Vendee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analogical Visual Scale of Pain (VAS) | 3 month post infiltration | Analogical visual scale of pain (VAS) To 0 cm (no pain) form 10 cm (worst pain imaginable) |
Countries
France
Participant flow
Pre-assignment details
150 patients were randomised, 1 patient was excluded from follow-up after infiltration before the first visit at M1 and was not analysed.
Participants by arm
| Arm | Count |
|---|---|
| Infiltration of Corticosteroids infiltration of corticosteroids: infiltration of corticosteroids | 76 |
| Infiltration of Corticosteroids and Hyaluronic Acid infiltration of corticosteroids and hyaluronic acid: infiltration of corticosteroids and hyaluronic acid | 73 |
| Total | 149 |
Baseline characteristics
| Characteristic | Infiltration of Corticosteroids | Infiltration of Corticosteroids and Hyaluronic Acid | Total |
|---|---|---|---|
| Age, Continuous | 62 Years STANDARD_DEVIATION 9 | 62 Years STANDARD_DEVIATION 9 | 62 Years STANDARD_DEVIATION 9 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 62 Participants | 61 Participants | 123 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 76 | 0 / 73 |
| other Total, other adverse events | 13 / 76 | 10 / 73 |
| serious Total, serious adverse events | 16 / 76 | 11 / 73 |
Outcome results
Primary
Analogical Visual Scale of Pain (VAS)
Analogical visual scale of pain (VAS) To 0 cm (no pain) form 10 cm (worst pain imaginable)
Time frame: 3 month post infiltration
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Infiltration of corticosteroids | Analogical Visual Scale of Pain (VAS) | -1.66 centimeter |
| Infiltration of corticosteroids and hyaluronic acid | Analogical Visual Scale of Pain (VAS) | -2.65 centimeter |