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

Phase 1

• Conditions: Osteoarthritis of the Knee; MedDRA version: 6.1Level: LLTClassification code 10031165Term: Osteoarthritis knee

• Registration Number: EUCTR2009-015849-22-GB
• Lead Sponsor: Salford Royal Foundation NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-17
• Study Completion: 2014-12-11
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br><br>;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