An Investigation of ReNu™ Knee Injection in Patients With Osteoarthritis

Exclusion Criteria

• •Pain medication (including nonsteroidal antiinflammatory drugs, NSAIDs) less than 15 days before injection (may take acetaminophen)
• •Receiving pain medication other than acetaminophen for conditions unrelated to osteoarthritis of the index knee
• •Regular use of anticoagulants, such as Coumadin, dabigatran or rivaroxaban; use of antiplatelet medications are not a reason for exclusion
• •History of substance abuse.
• •Failure to agree NOT to take additional knee symptom modifying drugs, other than acetaminophen, during the course of the study without reporting to the study team
• •Pregnancy or desire to become pregnant during study duration
• •Positive pregnancy test on premenopausal subject
• •Morbid obesity (defined as BMI 40 or greater)
• •Symptoms of locking, intermittent block to range of motion or loose body sensation which could indicate meniscal displacement or an intraarticular loose body
• •Corticosteroid injection into the index knee within 3 months
• •Viscosupplement injection into the index knee within 3 months
• •Knee surgery of involved index knee within 12 months
• •Knee surgery contralateral knee 6 months
• •Worker compensation
• •Acute index knee injury (injury within 3 months)
• •History of Diabetes mellitus
• •History of solid organ or hematologic transplantation
• •History of rheumatoid arthritis or other autoimmune disorder
• •Diagnosis of a non-basal cell malignancy within the preceding 5 years
• •Infection requiring antibiotic treatment within the preceding 3 months
• •Current therapy with any immunosuppressive medication, including corticosteroids at a dose \> 5 mg per day