Study of Intra-articular Injections vs Placebo in Patients With Pain From Osteoarthritis of the Knee

Exclusion Criteria

• •1. Known hypersensitivity or allergy to any of the components of Traumeel or Zeel
• •2. Known hypersensitivity or allergy to acetaminophen.
• •3. Has body mass index (BMI) \>38 kg/m2.
• •4. Avoidance of, or aversion to, nonprescription medications.
• •5. Clinical symptoms of meniscal instability or significant valgus/ varus that requires corrective osteotomy
• •6. Any major injury or surgery to the target knee in the prior 12 months.
• •7. One or a combination of the following co-morbidities:
• •1. other inflammatory arthropathies, gout or pseudogout within previous 6 months
• •2. avascular necrosis
• •3. severe bone or joint deformity in target knee
• •4. osteonecrosis of either knee
• •5. fibromyalgia
• •6. pes anserine bursitis
• •7. lumbar radiculopathy with referred pain to either knee
• •8. neurogenic or vascular claudication
• •9. significant anterior knee pain due to diagnosed isolated patella-femoral syndrome in the target knee
• •10. target knee joint infection or skin disorder/infection to the area surrounding the knee within previous 6 months
• •11. current treatment or treatment of cancer within the previous 2 years (excluding basal cell or squamous cell carcinoma of the skin)
• •8. Participated in any experimental drug or device study within the prior one (1) month and/or IA injections six (6) months.
• •9. Referred pain from other joints
• •10. Significantly debilitating concurrent infection(s)
• •11. Significant ligamentous instability
• •12. Any prior viscosupplementation therapy (in target knee) within 6 months prior to Screening
• •13. Systemic or IA injection of corticosteroids in any joint within 3 months of enrollment
• •14. Therapy with oral hyaluronic acid products, and/or oral pharmaceutical products containing glucosamine and/or chondroitin sulphate and/or diacerein
• •15. Therapy with opioids within the last 90 days including intra-dermal delivery systems (patches)
• •16. Therapy with autologous stem cells
• •17. Therapy with coumarins such as warfarin, Coumadin; heparin and derivative substances including low molecular weight heparin, synthetic pentasaccharide inhibitors of factor Xa such as fondaparinux and idraparinux; direct factor Xa inhibitors such as rivaroxaban and apixaban; direct thrombin inhibitors such as hirudin, lepirudin, bivalirudin, argatroban and dabigatran.
• •18. Concomitant inflammatory or other rheumatologic, neurological or cardiovascular diseases which could affect the evaluation of knee pain
• •19. Ongoing litigation for workers compensation for musculoskeletal injuries or disorders
• •20. Use of alcohol of more than 4 drinks per day
• •21. Clinically important axial deviation (varus, valgus) greater than 15 degrees
• •22. Concomitant severe OA of the hip or other joints, which might interfere with the assessments required by the study
• •23. Painful knee conditions other than OA (e.g., Paget's disease)
• •24. Hemiparesis of lower limbs
• •25. Significant planned surgery to lower limbs, which might interfere with the patient's ability to comply with study requirements
• •26. Presence of serious gastrointestinal, renal, hepatic, pulmonary, cardiovascular, neurological disease that might interfere with the outcome of the study or the patient's ability to comply with study requirements
• •27. Presence of infections and/or skin diseases in the area of the injection site such as psoriasis
• •28. Females who are pregnant or breast-feeding or not using recognized effective contraceptive measures. Females of childbearing potential (including those less than one year post-menopausal) must agree to maintain reliable birth control throughout the study.
• •29. Clinically significant abnormal laboratory values.
• •30. Patients who are likely to be non-compliant or uncooperative during the study.