Arthritis
Conditions
Brief summary
Radiation synovectomy by intra-articular injection of beta-emitting radionuclides is considered a reliable and easy-to-perform therapy without harmful side-effects for the treatment of inflammatory joint disease in many countries. The goal of this study is to demonstrate Yttrium-90 citrate colloid or Rhenium-186 sulfide synovectomy are appropriate therapeutic interventions in patients with persistent active synovitis of a joint (characterized by pain, tenderness, and effusion) which is resistant to systemic therapy and intra-articular corticosteroid injections. The primary objective will be to assess the safety of an intra-articular administration of Yttrium-90 citrate colloid or Rhenium-186 sulfide. The secondary objective will be to assess the efficacy on synovitis.
Interventions
DRUGRadiosynoviorthesis
Intraarticular administration from 111 to 222 Mbq yttrium-90 per joint
Sponsors
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* There is no age limit for RSO * Patient referred by a medical joint specialist (orthopedist, rheumatologist or internal medicine in the absence of local joint specialist) * Patient having a refractory inflammatory articular disease: * Failure of medical therapy after 6 months * Clinical signs of an active mono or oligo synovitis * Joint X-ray, echo or MR showing minimal cartilage or bone destruction * Pain limits normal activities or requires significant analgesic medication
Exclusion criteria
* Prior RSO within last 3 months in that joint * Collapse of the articular plateau or intra-articular fracture * Surgery or arthroscopy within last 6 weeks * Painful prosthesis * Joint infection, local skin infection, bacteremia * Joint puncture within last 2 weeks (increased risk of soft tissue necrosis along the needle track) * Pregnancy or breast feeding * Synovial cyst rupture * Massive hemarthrosis * Generalized synovitis defined as more than 5 uncontrolled joints by clinical examination or 3 phases bone scan * Surgical synovectomy within 6months * Cancer with bone metastases * Hypersensitivity, allergies or contraindication to the used radiopharmaceutical agent * Participation in any other ongoing clinical trial for the underlying inflammatory condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety | 3-4 days post -treatment | The safety profile will be assessed by the incidence of AEs. All the AEs will be described by system/organ class and preferred terms and overall sorted by frequency. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | Clinical response post treatment | Efficacy outcomes will be the clinical response over 1 year post treatment ( at 3, 6 and 12 months):The comparison will be done with a confidence interval approach based on a Chi²-test for each of the above secondary criterion assessed at different times during the follow-up compared to the same criterion assessed at baseline. |
Countries
Canada
Outcome results
None listed