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Clinical Effects of Intraarticular Injection of High Molecular Weight Hyaluronan (Orthovisc®) in Osteoarthritis of the Knee: A Randomized, Controlled, Multicenter Trial
DAVID NEUSTADT, JACQUES CALDWELL, MARY BELL, JOHN WADE, and JOSEPH GIMBEL
ABSTRACT. Methods. A randomized, arthrocentesis-controlled, multicenter trial. Patients (n = 372) were randomized to 4 weekly HMW hyaluronan injections (O4, n = 128), 3 weekly HMW hyaluronan injections followed by one arthrocentesis (O3A1, n = 120), or 4 arthrocenteses without injection (control group, A4, n = 124). All patients had knee OA, as determined by Kellgren-Lawrence (K-L) grade, and Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score ≥ 200 mm and < 400 mm in index knee and < 150 mm in contralateral knee. The primary outcome measure was the proportion of patients achieving a 20% relative and 50 mm absolute improvement from baseline in WOMAC pain score at Weeks 8, 12, 16, and 22 post-baseline in the index knee. Secondary outcomes were Patient Global score, Investigator Global score, and Pain on Standing score. Results. The evaluable subgroup consisted of patients with K-L grade 2 or 3 at baseline. The comparison of O4 versus A4 for the primary outcome approached, but did not reach, significance in the evaluable subgroup: 76% of O4 patients had ≥ 20% improvement in WOMAC pain score at Week 8 compared to 62% of A4 patients. More O4 patients had ≥ 40% improvement in WOMAC pain score compared to A4. The effectiveness of the 3-injection regimen (O3A1) was masked by a possible placebo effect from the needle injection procedure in the A4 (control) group. No differences between groups were observed with respect to incidence of adverse events. Conclusion. Our findings indicate that HMW hyaluronan is safe and seems to be effective in the treatment of mild to severe OA of the knee. (J Rheumatol 2005;32:1928-36) Key Indexing Terms:
OSTEOARTHRITIS
From the Department of Medicine, Section on Rheumatic Diseases, University of Louisville School of Medicine, Louisville, Kentucky; BioniCare Technologies, Sparks, Maryland, USA; Division of Rheumatology, Department of Medicine, Sunnybrook Health Sciences Center, University of Toronto, Toronto, Ontario; Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; and Arizona Research Center, Phoenix, Arizona, USA. Supported in part by a grant from Anika Therapeutics, Inc., Woburn, Massachusetts, USA. D. Neustadt, MD, Clinical Professor of Medicine, University of Louisville School of Medicine; J. Caldwell, MD, University of Florida, BioniCare Technologies; M. Bell, MD, Head, Division of Rheumatology, Department of Medicine, Sunnybrook and Women's College Health Sciences Centre, Associate Professor, Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Toronto; J. Wade, MD, Department of Medicine, University of British Columbia; J. Gimbel, MD, Medical Director, Arizona Research Center. Address reprint requests to Dr. D. Neustadt, University of Louisville School of Medicine, 234 East Gray Street, Suite 328, Louisville, KY 40202. E-mail: md@davidhneustadt.com Accepted for publication April 15, 2005. |