Comparison of treatment cost of knee osteoarthritis (OA) in patients treated with Synvisc® versus usual treatments as well as evaluation of safety and effectiveness of these treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
518
Standard drug treatment at the discretion of the investigator
Cost of knee OA treatment including cost of side effect related to OA treatment
Time frame: up to 274 days
Area under the curve (AUC) Lequesne index
Index of severity
Time frame: Day 1, 29, 91, 182 and 274
Assessment of Western Ontario and McMaster Universities (WOMAC) index by patient
Time frame: Day 1, 91, 182 and 274
Patient's assessment of pain on movement and rest on a visual analogue scale (VAS) through WOMAC question 1 and 3
Time frame: Day 1, 91, 182 and 274
Disease activity assessment by patient and investigator on a VAS
Time frame: Day 1, 29, 91, 182 and 274
Acute congestive OA flares assessed through a questionnaire
Time frame: Day 1, 29, 91, 182 and 274
Assessment of state of health of the patients with a quality of life questionnaire (SF 12)
Time frame: Day 1, 91, 182, 274
Final global assessment of efficacy by patient and investigator on a four-point verbal rating scale (VRS)
Time frame: Day 274
Final global assessment of tolerability by patient and investigator on a four-point VRS
Time frame: Day 274
Incidence and intensity of adverse events
Time frame: up to day 274
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Number of withdrawals due to adverse event
Time frame: up to day 274