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Investigation of Sodium Hyaluronate for Treatmet of Painful Chronic Osteoarthritis of the Knee - NCT00988091-(Clinical Trial 353376)



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City:  Bellevue
State:  
WA
Zip Code:
Conditions: Osteoarthritis of the Knee
Purpose: Subjects with chronic osteoarthritis of the knee will be assigned to receive an injection of either sodium hyaluronate or buffered saline to evaluate its effectivness and safety for 26 weeks. After 26 weeks, subjects can elect to receive a second injection of soduim hyaluronate and be followed for another 26 weeks.
Study summary:
Criteria: Inclusion Criteria: - Chronic OA of target knee confirmed by ACR Criteria. - Pain due to OA in target knee present for at least 6 months. - A bilateral standing AP X-ray confirming OA of the target knee. - Ability and willingness to use only acetaminophen as the analgesic (rescue) study medication - Ability to perform procedures required of the pain index evaluations (unassisted walking 50 feet on a flat surface and going up and down stairs). - Willingness and ability to complete efficacy and safety questionnaires and ability to read and understand study instructions. - Signed Subject Informed Consent Form Exclusion Criteria: - Any major injury (including sports injuries) to the target knee within the 12 months. - Any surgery to the target knee, hip and contralateral hip within the 12 months. - Major and minor articular procedures - Inflammatory arthropathies such as rheumatoid arthritis, lupus arthropathy, or psoriatic arthritis. - Gout or calcium pyrophosphate (pseudogout) diseases of the target knee that have flared within the previous 6 months. - X-ray findings of acute fractures, severe loss of bone density, avascular necrosis, and/or severe bone or joint deformity in the target knee
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Data Source: ClinicalTrials.gov
Date Processed: April 13, 2010
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