Osteoarthritis of the Knee MedDRA version: 6.1 Level: LLT Classification code 10031165 Term: Osteoarthritis knee
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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