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Intra-articular Hyaluronate Injection Superior to Buffered Saline to Treat Osteoarthritis of the Knee: Presented at OARSI

By Louise Gagnon

MONTREAL -- September 18, 2009 -- The administration of an intra-articular injection of hyaluronate (Gel-200) did not produce an increased incidence of adverse events compared with phosphate buffered saline (PBS) to treat osteoarthritis (OA) of the knee, according to data from a randomised, controlled trial presented here at the 2009 World Congress of the Osteoarthritis Research Society International (OARSI).

Herbert S. Baraf, MD, Arthritis and Rheumatism Associates, Wheaton, Maryland, and George Washington University, Washington, DC, noted patients in the trial could not have a comparable level of disease in both knees.

"The knee that was injected had to be substantially worse than the other knee," said Dr. Baraf in an interview on September 12. "They could not have equally severe disease."

Patients were excluded from the trial if they had severe deformity of the knee, as witnessed by x-ray, had received a hip or knee replacement, or had cortisone injections within 1 month of the start of the study, noted Dr. Baraf.

A total of 375 patients made up the intent-to-treat population, with 247 receiving the hyaluronate injection and 128 receiving PBS, and the per protocol population comprised 229 patients receiving hyaluronate and 115 receiving PBS. Patients had a mean age of 60.5 years and the majority were female. The mean disease duration ranged from 2.5 to 3.4 years.

There were statistically significant differences in Western Ontario and McMaster Universities (WOMAC) pain scores across weeks 1 through 13, favouring the hyaluronate therapy over PBS.

Investigators found no allergic reactions or device-related side effects. In addition, there was no statistically significant difference in the incidence of side effects within 24 hours of injection between the 2 arms of the study, according to Dr. Baraf, adding it is noteworthy that there was an absence of pseudosepsis.

"There is sometimes a risk of pseudoseptic reactions, characterised by swollen and tender knee joint after 1 or a series of injections," said Dr. Baraf. "We didn't find any pseudosepsis."

He cautioned that pseudosepsis might occur when a broader and larger population is exposed to this viscosupplement.

Funding for this study was provided by Seikagaku Corporation.

[Presentation title: Effectiveness and Safety of a Single Intra-articular Injection of Gel-200, a New Cross-Linked Formulation of Hyaluronic Acid (HA) in the Treatment of Symptomatic Osteoarthritis (OA) of the Knee. Abstract 326]

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