Multicentre Canadian Study to Measure the Safety and Efficacy of Radiosynoviorthesis

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.

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Key information

Conditions

Arthritis Joint Diseases Musculoskeletal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alberta Children's Hospital, Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiosynoviorthesis

Drug

Intraarticular administration from 111 to 222 Mbq yttrium-90 per joint

Other names: Yttrium-90 colloid suspension for local injection

Primary outcomes

safety

Time frame: 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 outcomes

Efficacy

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Other

Registry information

Official study title

Multicentre Canadian Study to Measure the Safety and Efficacy of Synoviorthesis Performed With Yttrium-90 or Rhenium-186 Sulfide

Acronym: RSO

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2018
First posted: Jun 11, 2012
Registry last updated: Apr 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed