We compared the efficacy and safety of intra-articular
hylan G-F 20 with
methylprednisolone acetate (MPA) for treating symptomatic Kellgren-Lawrence grade (KLG) 2 or 3
hip osteoarthritis in a prospective, randomized, multicenter, double-blind trial (N = 313). Two
injections of
hylan G-F 20 were administered 2 weeks apart (n = 150), or 1 injection of 40 mg MPA and 1
sham injection 2 weeks later (n = 155). The Western Ontario and McMaster Universities
Arthritis Index (WOMAC) (total and subscale), clinician observations, and patient global assessments were collected at baseline and at weeks 4, 8, 12, 16, 20, and 26 (intent-to-treat population was analyzed; n = 305). Responder rates were assessed by WOMAC domain A, and criteria were established by the Outcome Measures in Rheumatology Clinical Trials-
Osteoarthritis Research Society International (OMERACT-OARSI). At week 26, WOMAC A improved by 16.6 mm for
hylan G-F 20 versus 13.6 mm for MPA. Response rates were higher with
hylan G-F 20 versus MPA in patients with more advanced disease (KLG 3) and were similar between
hylan G-F 20 and MPA in patients with less advanced disease (KLG 2). Adverse events were similar between groups and between patients with KLG 2 or 3.
Hylan G-F 20 provided clinically meaningful improvements in
pain and function, comparable with those of MPA, with good safety and tolerability. Thus, we conclude it is an appropriate option for treating
hip osteoarthritis.