To Assess the Safety and Effectiveness of Hyruan ONE versus a Comparator for the Treatment of Knee Osteoarthritis in Europe
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
284
For use as a symptomatic treatment of osteoarthritis (OA) of the knee
For use as a symptomatic treatment of osteoarthritis (OA) of the knee
Lubelskie Centrum Diagnostyczne
Świdnik, Poland
The change in the WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) Likert pain subscore
The WOMAC Likert Index measures 3 separate dimensions: pain, stiffness, and function. The subject will self assess the level of pain in the target knee joint for the prior 48 hours (5 questions), the level of difficulty of performing daily activities (17 questions), and the level of stiffness (2 questions) using the WOMAC Likert Questionnaire (24 total questions; 4 points/question). Each item of the WOMAC Likert Index will be assessed using the scale of 0=none, 1=a little, 2=moderate, 3=severe, 4=very severe. The aggregate total score that can result for each scale is as follows: Pain = 0-20 Stiffness = 0-8 Physical function = 0-68.
Time frame: from Baseline to 13 weeks post injection.
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