A double-blind, randomized, saline-controlled study of the efficacy and safety of EUFLEXXA for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX trial)

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研究概要

588 patients diagnosed with Kellgren-Lawrence grade II-II knee osteoarthritis were randomized to receive three weekly intra-articular injections of either hyaluronic acid (EUFLEXXA; Ferring Pharmaceuticals, Inc.) or saline placebo. The purpose of this study was to compare changes in pain, function and patient global assessment between the two groups. Follow-up was performed for 26 weeks following the first injection. Results indicated that intra-articular injection of the hyaluronic acid product led to greater improvement in pain after walking 50 feet (primary endpoint) at 26 week follow-up when compared to saline injections. Significantly greater improvement in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function scores after 26 weeks was also noted, but not in WOMAC pain and stiffness subscores.