study of evaluating the duration of efficacy of one intra articular injection of sodium hyaluronate 2.0% in patients with painful osteoarthritis of the knee

Conditions: Osteoarthritis Patient

Summary: a pilot, open, randomised, controlled, add-on study evaluating the duration of efficacy of one intra articular injection of sodium hyaluronate 2.0% in patients with painful osteoarthritis of the knee


Eligibility criteria:
inclusion criteria: 1. patients of both genders between 40 and 70 years of age; 2. primary tibiofemoral osteoarthritis of the knee according to american college of rheumatology criteria; 3. pain ≥ 4 on a 10 point scale for at least two out of five subscores of the womac section a at baseline; 4. radiologically ascertained grade ii or iii severity knee osteoarthritis on the kellgren-lawrence scale; 5. having given signed informed consent. exclusion criteria: 1. secondary knee osteoarthritis, including: * septic arthritis; * inflammatory joint disease; * gout; * recurrent episodes of pseudogout; * paget's disease of bone; * articular fracture; * ochronosis; * acromegaly; * haemochromatosis; * wilson's disease; * primary osteochondromatosis. 2. clinical signs of acute flare (pain, warm, erythema, effusion of signal knee) at baseline; 3. axial deviation \> 15 degrees in valgus or varus on a standing x-ray; 4. clinically significant medio-lateral or antero-posterior instability; 5. rapid destructive arthritis, evolving arthritis requiring surgery within the coming year; 6. significant injury to the signal knee within 6 months prior to baseline; 7. complete loss of range of motion; 8. painful knee conditions other than osteoarthritis (e.g., sudeck's atrophy, intra-articular neoplasm, villonodular synovitis); 9. necrosis of one of the femur condyles; 10. history or evidence of gout, chondrocalcinosis; 11. peripheral neuropathy; 12. concomitant rheumatic disease: * fibromyalgia; * rheumatoid arthritis; * collagen diseases; * psoriatic arthritis and other seronegative spondylarthropathies (e.g., ankylosing spondylitis); * metabolic and crystal-induced arthropathies; * other osteopathies. 13. contraindications to intra-articular injection according to investigator's judgement (e.g., local infection at injection site, generalised infection with possible bacteraemia); 14. skin disease in the area of injection; 15. severe coagulopathy, ongoing anticoagulation therapy; 16. accompanying oa of the hip of sufficient severity to interfere with the assessment of the signal knee; 17. disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the signal knee; 18. poor general health interfering with compliance or assessment; 19. concomitant disease/ailment other than knee oa requiring the regular use of the patient's normal analgesic medicine; 20. initiation of chronic treatment with antihistaminics, glucocorticoids, antidepressants or tranquilisers, within less than 3 months prior to baseline; 21. use of assistive devices other than a cane (walking stick); 22. surgery of the signal knee other than arthroscopy; 23. arthroscopy of the signal knee within one year prior to baseline; 24. treatment with symptomatic slow acting drug for oa (sysadoa, i.e., chondroitin sulfate, diacerein, glucosamine, piascledine), unless the patient has been on a stable dose for at least 4 months prior to baseline; 25. intra-articular depocorticosteroid injection into the signal knee within 3 months prior to baseline; 26. intra-articular sh injection into the signal knee within 6 months prior to baseline; 27. ascertained hypersensitivity to any product used in the study (sh, paracetamol, diclofenac, omeprazole) or to similar compounds; 28. pregnant or lactating female; 29. female of childbearing potential without adequate contraceptive methods; 30. participation in a drug clinical trial within 3 months prior screening; 31. patients who, in the judgement of the investigator, will not comply with the protocol.