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An open label study of intra-articular steroid injection in the management of symptomatic knee OA - TArgeting Synovitis in Knee OA (TASK) V1.0

An open label study of intra-articular steroid injection in the management of symptomatic knee OA - TArgeting Synovitis in Knee OA (TASK) V1.0

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-015849-22-GB
Enrollment
120
Registered
2010-03-17
Start date
2010-01-27
Completion date
Unknown
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee MedDRA version: 6.1 Level: LLT Classification code 10031165 Term: Osteoarthritis knee

Interventions

Trade Name: Depomedrone Product Name: Depomedrone Pharmaceutical Form: Injection*

Sponsors

Salford Royal Foundation NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age 40 years and over Symptomatic Knee OA (moderate knee pain or discomfort lasting 48 hours in the past 2 weeks and/or KOOS score of 7 and above) Within the last 24 months - Radiological (X-ray) evidence of grade 2 or more OA; evidence of significant OA on MRI scan; documented evidence of at least grade 2 arthritis on arthroscopy. Ambulatory Able and willing to comply with intervention and follow up 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Secondary OA - septic arthritis, gout History of inflammatory arthritis Previous knee surgery or arthroscopy within 6 months Previous intra-articular Ostenil or steroid injection within 3 months Inability to comply with the study procedures Pregnancy Chronic Kidney Disease (eGFR <=44) Concurrent life threatening disease Implants which prohibit safe use of MRI (eg.Cochlear implants) Known hypersensitivity to Depomedrone or any components of its excipients Systemic infection (unless specific anti infective therapy is employed)

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine i) whether clinical response to intra-articular steroids in knee OA correlates with a decrease in size and a decrease in perfusion of the synovium. and ii) whether relapse of symptoms after intra-articular steroids is associated with recurrence of synovitis. ;Secondary Objective: To evaluate whether there is a subgroup of patients with inflammatory osteoarthritis (based on characteristics assessed at baseline) who respond better and for longer periods to intraarticular (I.A.) steroids than those without inflammatory osteoarthritis.;Primary end point(s): Change in knee pain

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026