Purpose: The purpose of this study is to demonstrate if the intra-articular injection of a new viscoelastic Hydrogel (Hymovis) is superior to Placebo (phosphate buffered saline \[PBS\] in subjects with symptomatic osteoarthritis of the knee.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
800
Hymovis Intra-articular injection
Placebo Intra-articular injection
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain sub-score
WOMAC A Pain sub-score
Time frame: 26 weeks
Responder Analysis
Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria
Time frame: 26 weeks
WOMAC Function
WOMAC C Function sub-score
Time frame: 26 Weeks
Visual Analog Scale (VAS) WOMAC Pain
Question A1 of WOMAC Pain sub-score
Time frame: 26 Weeks
WOMAC Global Score
Time frame: 26 Weeks
WOMAC Stiffness sub-score
WOMAC C stiffness sub-score
Time frame: 26 Weeks
Rescue Medication Usage Pill Count, Failure Outcome
Time frame: 26 Weeks
Patient Global Analysis
Time frame: 26 Weeks
Clinician Responder Analysis
Time frame: 26 Weeks
SF Health Outcome
Time frame: 26 Weeks
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