Comparative efficacy and safety of two different molecular weight (MW) hyaluronans F60027 and Hylan G-F20 in symptomatic osteoarthritis of the knee (KOA). Results of a non inferiority, prospective, randomized, controlled trial.

279 patients with Kellgren-Lawrence grade II-III knee osteoarthritis were randomized to three weekly intraarticular injections of either F60027 sodium hyaluronate (Structovial; Pierre Fabre) or Hylan G-F20 (Synvisc). The primary purpose of this study was to examine if F60027 was noninferior to Hylan G-F20 for functional improvement over 24-week follow-up. Mean improvement in Lequesne Index score from baseline to 24 weeks was deemed to be noninferior in the F60027 group compared to the Hylan G-F20 group. Pain scores also did not significantly differ between groups, while rates of OMERACT-OARSI responders and treatment-emergent adverse events were similar between groups.