It is a post-license, multicenter, randomized, single blind, controlled study comparing a single injection of Cingal® (study arm) with a single injection of Monovisc® (control arm).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Intra-articular injection
Intra-articular injection
Site 04
Barrie, Ontario, Canada
Site 03
Hamilton, Ontario, Canada
Site 02
Kanata, Ontario, Canada
Site 05
Laval, Quebec, Canada
Site 01
Québec, Quebec, Canada
Compare the local pain reduction after a single injection of Cingal® or Monovisc® over a 6 weeks period in patients with osteoarthritis of the knee assessed with the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 6 weeks post injection
Compare the maximum pain reduction by treatment arm
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 6 weeks post injection
Compare the time to maximum pain reduction by treatment arm
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 6 weeks post injection
Change in stiffness and physical function
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 6 weeks post injection
Overall change of WOMAC score
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 6 weeks post injection
Time to maximum WOMAC score reduction
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 6 weeks post injection
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