The primary objective is to determine whether Durolane is non-inferior to methylprednisolone, as assessed by level of pain, when each are given as single intra-articular injections for the relief of pain, in the treatment of symptomatic osteoarthritis of the knee at 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
442
single intraarticular injection
Alberta Bone & Joint Health Institute
Calgary, Alberta, Canada
Pain level and responder rate
Time frame: up to 12 weeks
WOMAC stiffness score
Will be assessed at each clinic visit
Time frame: 26 weeks blinded phase + 26 weeks OLE
WOMAC physical function
Will be assessed at each clinic visit
Time frame: 26 weeks blinded phase + 26 weeks OLE
Functional assessment
Will be assessed at each clinic visit
Time frame: 26 weeks blinded phase + 26 weeks OLE
Safety assessment (Adverse Events)
Will be assessed at each clinic visit using standard questions
Time frame: 26 weeks blinded phase + 26 weeks OLE
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