Osteoarthritis of the Knee Clinical Trial
Official title:
A Prospective, Multi-center, Randomized, Double-blind Feasibility Study to Evaluate the Safety and Performance of Hydros Joint Therapy and Hydros-TA Joint Therapy for Management of Pain Associated With Osteoarthritis in the Knee
The purpose of this study is to evaluate the safety and performance of Hydros Joint Therapy (Hydros) and Hydros-TA Joint Therapy (Hydros-TA) for treatment of pain from osteoarthritis of the knee, in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.
The objective of the study is to evaluate Hydros and Hydros-TA treated subject for reduction
of osteoarthritis symptoms, compared to a commercial control, as assessed by the WOMAC
Osteoarthritis Index.
The WOMAC Osteoarthritis Index is a validated assessment instrument that is
self-administered and designed to subjectively elicit patient symptoms of osteoarthritis in
the knee in the areas of pain, stiffness, and physical function. The WOMAC Osteoarthritis
Index with its Pain Subscale has been used extensively as an effectiveness endpoint in
clinical trials of viscosupplements.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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