Hydros and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis

A Multi-center, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Hydros and Hydros-TA Joint Therapies for Management of Pain Associated With Osteoarthritis in the Knee

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.

Inclusion Criteria:

• Have radiographic evidence within the prior 6 months, as shown in the radiology reports, of OA grade 2 or 3 using Kellgren-Lawrence Grading for OA.
• Symptoms in the index knee for at least 12 months.
• Fully ambulatory Subject (ability to perform a 15 meters walk test).
• Male and female Subjects 40 through 85 years of age.

Exclusion Criteria:

• BMI >40 kg
• Secondary OA (acute knee injury, rheumatoid arthritis, gout, history of joint infection, osteonecrosis, chronic fibromyalgia) or other chronic autoimmune disease.
• Intra articular steroid therapy in last 3 months
• Intra articular viscosupplementation in last 6 months