ActaVisc and ActaVisc Mx Intra-articular Injection for Pain Associated With Osteoarthritis in the Knee

A Prospective, Multi-center, Randomized, Double-blind Feasibility Study to Evaluate the Safety and Performance of ActaVisc and ActaVisc Mx Intra-articular Injection for Management of Pain Associated With Osteoarthritis in the Knee.

To evaluate the safety and performance of ActaVisc™ intra-articular injection (ActaVisc) and ActaVisc Mx, for management of pain associated with osteoarthritis in the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics

Inclusion Criteria:

• Osteoarthritis (OA) grade 2 or 3.
• Symptoms in the treatment knee for at least 12 months.
• Fully ambulatory patient.

Exclusion Criteria:

• Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.
• Generalized symptomatic OA in lower extremity joints other than the knees, inflammatory joint disease, bursitis, OA in the hips, or other condition that may interfere with study assessments.