Rhizarthrosis MedDRA version: 20.0 Level: LLT Classification code 10062893 Term: Rhizarthrosis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: XEOMIN 50
Product Name: XEOMIN 50
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Intraarticular use
Sponsors
CHU de Nice
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient aged 18 and over - Patient with thumb carpometacarpal osteoarthritis objectified clinically by questionnaire and X-ray with at least 2 of the 4 following items involving the trapeziometacarpal joint : osteophytes, joint space narrowing, subchondral bone sclerosis or subchondral cysts - Patient giving his written consent - Visual analog pain scale > 4 - Patient in failure of well-conducted drug treatment including analgesics and anti-inflammatories - Patients must have stopped all corticosteroid therapy or NSAIDs within the last 48 hours - Patient affiliated to a social security scheme - Patient likely to understand the instructions of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Patient with a history of surgery of the thumb - Patient who has received corticoid and others injections in the thumb carpometacarpal acid in last 6 months - Patient who has received a botulinum toxin injection from any site in last 3 months - Patient with myasthenia gravis or Lambert Eaton disease, neuromuscular dysfunction, hypersensitivity to incobotulinumtoxin A, severe breathing disorder or severe swallowing disorder - Patient with hypersensitivity to botulinum toxin or to any of the excipients (human albumin sucrose) - Patient with infection or inflammation at the injection site concerned - Pregnant or lactating woman (a urine pregnancy test will be performed) - Patient with a history of inflammatory or crystal-associated rheumatic - Participation in another clinical trial and at least 30 days before - Any medical or psychiatric condition that may prevent the proper understanding and conduct of treatment and study (major under guardianship)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine that the botulinum toxin injection is better than the placebo injection to improve pain in symptomatic trapeziometacarpal osteoarthritis at 3 months;Secondary Objective: - Determine that the effects of a trapeziometacarpal injection of TB are superior to placebo on function (Dreiser test, Kapandji index, Jamar Hydraulic Pinch Gauge), quality of sleep and quality of life at M3 - Evaluate the tolerance of TB in rizarthrosis - Determine that the effects of a trapezo-metacarpal injection of TB are superior to placebo on rhizarthrosis pain at 8 weeks (8 weeks = M1.5) (telephone interview) - Determine that TB injection reduces the consumption of analgesic and anti-inflammatory drugs over the study period (placebo vs TB period) ;Primary end point(s): Pain assessment at 3 months;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Evaluation of the Dreiser test, quality of sleep and quality of life at 3 months - Collect side effects - Pain assessment at 8 weeks - Evaluate the use of analgesic and anti-inflammatory drugs during the study period ;Timepoint(s) of evaluation of this end point: at least 3 months after injection | — |
Countries
France
Contacts
Public ContactDRCI
CHU de Nice
Outcome results
None listed