The purpose of this study is to evaluate the safety and efficacy of Hydros-TA Joint Therapy for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and long lasting pain relief for up to six months with a single IA injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
510
Unnamed facility
St Leonards, New South Wales, Australia
Unnamed facility
London, Ontario, Canada
Unnamed facility
Oshawa, Canada
Unnamed facility
Québec, Canada
Unnamed facility
Willemstad, Curacao, Netherlands Antilles
Change from baseline in the WOMAC A subscale score for the treatment knee.
Time frame: 2 weeks and 26 weeks
Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee
Time frame: 26 weeks
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