Efficacy and Safety of EUFLEXXA® for Treatment of Painful Osteoarthritis of the Knee

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)

Article specifications

This Double-Blind, Randomized, Saline-Controlled clinical trial was published in 2009 in Seminars in Arthritis and Rheumatism (IF 2009: 4.498) by American orthopedics. 588 patients with chronic knee OA were randomized to either intra-articular (IA) injections of 1% sodium hyaluronate (n= 293) or intra- articular buffered saline (n= 295) injection weekly for 3 weeks. primary efficacy outcome was subject recorded difference in least-squares means between IA-Bio HA and IA-SA in subjects change from baseline to week 26 following a 50-foot walk test, measured via 100-mm visual analog scale (VAS). Secondary outcome measures included Osteoarthritis Research Society International responder index, Western Ontario McMaster University Osteoarthritis Index VA 3.1 subscales, patient global assessment, rescue medication, and health-related quality of life (HRQoL) by the SF-36. Safety was assessed by monitoring and reporting vital signs, physical examination of the target knee following injection, adverse events, and concomitant medications. Of the 5 products available in the United States, the MW, molecular structure, and sourcing of the HA differ substantially. IA-BioHA has an MW range between 2.4 and 3.6 MDa, the highest MW of any of the non-crosslinked products available.

 

Results

The results of the study showed that hyaluronic acid was more effective in decreasing pain in 26 weeks which is sustained for 6 months. They also said that hyaluronic acid was well tolerated, with no joint effusions.