Study Summary

Four hundred and forty patients with knee osteoarthritis were randomized to receive a series of intra-articular diclofenac-hyaluronate conjugate (Diclofenac Etalhyaluronate) injections (DF-HA) (n=220) or placebo injections (n=220). The primary outcome of interest was the change in baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. Secondary outcomes of interest included the other WOMAC subscales, quality of life and global assessment scores. At 12 weeks follow-up, there was a significant difference in the change from baseline favoring the DF-HA group for the WOMAC pain scale. Similarly, the DF-HA had significantly greater reductions in all the WOMAC subscales, global, daily pain scores and global assessment scores at 12 weeks follow-up.