Hylan G-F 20 Improves Hip Osteoarthritis: A Prospective Randomized Study As Published In The June 2010 Edition Of The Physician And Sportsmedicine

In a prospective, randomized, multicenter, double-blind trial of 313 patients, investigators 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 (OA). Hip OA is the second most common type of large joint OA. Although nonsurgical treatment options (eg, exercise, activity modifications, walking aids, topical agents, analgesics, nonsteroidal anti-inflammatory drugs [NSAIDs]) are available, these treatments may only be modestly effective, and patients who are not yet candidates for hip arthroplasty often experience pain and limited function. Hylan G-F 20 is currently approved for treatment of knee OA in the United States but not for hip OA, although it is available for shoulder, hip, knee, and ankle pain OA in Europe.

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 was administered 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. 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. Investigators concluded that hylan G-F 20 is an appropriate option for treating hip OA.

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