A Double-Blind, Randomized Trial of Intra-Articular injections of 20 mg of Hyalgan® for the Treatment of Knee Pain Due to Osteoarthritis (Three-injection regimen Efficacy and Duration-20 mg/2ml Dose: Tread-20): Sanofi Protocol #L-9385

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Principal Investigator

Co-Investigators

Summary

This is a multi-center trial and 150 patients will be enrolled in 5 sites with 30 patients being enrolled from HSS. The purpose of this study is to evaluate the efficacy of Hyalgan in a treatment cycle of 3 injections (20mg / 2ml) given at weekly intervals. Each patient will have a total of 10 visits over a total of 26 weeks. There will be a screening visit and then 3 weekly visits for the study injections, with 6 follow-up visits to assess joint pain and function. All medications, lab work, x-rays, and medical visits will be provided at no cost to patients who qualify. Travel reimbursement will also be available to those who qualify.

Inclusion Criteria

• Male/Female age 40 and older with knee pain for at least 6 months
• Confirmed osteoarthritis by x-ray in the past 6 months. If no x-ray done in the past 6 months, one will be provided.

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