Euflexxa for the Treatment of Osteoarthritis

Exclusion Criteria

• •1. Age less than 18 years
• •2. any major injury to the target knee within the prior 12 months
• •3. any surgery to the target knee within the prior 12 months
• •4. surgery to the contralateral knee or other weight-bearing
• •5. inflammatory arthropathies
• •6. gout or pseudogout within the previous 6 months
• •7. radiographic acute fracture, severe loss of bone density, avascular necrosis, and/or severe bone or joint deformity in the target knee
• •8. osteonecrosis of either knee
• •9. fibromyalgia, pes anserine bursitis, lumbar radiculopathy, and/or neurogenic or vascular claudication
• •10. target knee joint infection or skin disorder/ infection within the previous 6 months
• •11. symptomatic OA of the hips, spine, or ankle; known hypersensitivity to acetaminophen, IA-BioHA, or phosphate-buffered saline solution
• •12. Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the study
• •13. history of immune disorders; vascular insufficiency of lower limbs or peripheral neuropathy
• •14. current treatment or treatment of cancer within the previous 2 years (excluding basal cell or squamous cell carcinoma of the skin)
• •15. active liver or renal disease
• •16. any clinically significant abnormal laboratory value \[to be defined in detail at a later point\]
• •17. any intercurrent chronic disease or condition that might interfere with the completion of the study
• •18. participation in any experimental device study within the prior 6 months or any experimental drug study within the prior month