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New Study Reveals Effectiveness of Treatment for Osteoarthritis of the Knee

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By News Release • www.ProHealth.com • April 12, 2000


SUMMARY: A study of patients with osteoarthritis of the knee has shown that a lavage (wash) of saline one week prior to treatment with hylan G-F 20 (Synvisc®) enhances the results of the viscosupplementation process. Osteoarthritis causes changes in synovial fluid, the natural substance that provides joints with crucial shock absorption and lubrication. The goal of viscosupplementation is to reduce pain and restore lost mobility by replacing diseased fluid. This study suggests people undergoing viscosupplementation may want to try incorporation a lavage of saline before treatment.

NEW YORK, March 15 /PRNewswire/ -- A study of patients with osteoarthritis of the knee has shown that a lavage of saline one week prior to treatment with hylan G-F 20 (Synvisc®) enhances the results of the viscosupplementation process. The results were announced today at the annual meeting of the American Academy of Orthopedic Surgeons in Orlando, Florida.
Successful outcomes were seen in 79.5 percent of the group receiving the lavage/hylan G-F 20 combination therapy, as compared to 54 percent of the group receiving the hylan G-F 20 exclusively (p<0.05).

"These results are encouraging for the millions of patients suffering from osteoarthritis of the knee and facing the prospect of knee surgery," said Vijay B. Vad, M.D., assistant attending physician at the Hospital for Special Surgery in New York City and lead investigator for the study. "Clinically, we are seeing an increase in the number of patients suffering from this debilitating condition. However, with the effective combination of saline lavage and hylan G-F 20 therapy, supported by a rehabilitation program and a knee cytobrace, these patients could see pain relief and delay knee surgery for 18 to 24 months. "

About the Study
The study included 81 patients with osteoarthritis of the knee, who were followed for an average of 1.1 years. Based on patient choice, the patients were non-randomly divided into two groups. Group One (n=44, average age 64.7 years) received a single needle lavage using 500 cc's of normal saline in week one, followed by an injection of hylan G-F 20 in weeks two, three, and four. Group Two (n=37, average age 64.4 years) received a hylan G-F 20 injection in weeks one, two and, three. Both groups underwent an eight-week program simultaneously consisting of home rehabilitation exercises and a knee cytobrace to be used 15 minutes each night.
Outcome was measured using the Lysholm II questionnaire, a visual numeric pain scale, and patient satisfaction ratings from poor to excellent. A successful outcome was defined as greater than 50 percent pain reduction based on the pain scale score combined with good or excellent patient satisfaction. In Group One, successful outcomes were seen in 79.5 percent of the patients overall. Within this group, 58 percent of the Grade Four osteoarthritis patients (n=12) demonstrated successful outcomes, while 50 percent of moderate to severe patellofemoral osteoarthritis patients (n=10) displayed successful outcomes. In Group Two, successful outcomes were seen in 54 percent of patients overall, with 65 percent seen in Grade Four osteoarthritis patients (n=11), and 33 percent seen in patients with moderate to severe patellofemoral osteoarthritis.

A local adverse effect in the form of acute inflammatory reaction was observed at ten percent in both groups, with all reactions being resolved without sequelae, and with no systemic effects seen. A majority of these patients had successful outcomes.

"As people age, they want to remain active, and frequently suffer injuries to the knee and back," said Dr. Vad. "Through minimally invasive procedures, such as viscosupplementation, we can enhance the quality of life for our active, aging population. Driven by data such as these, I anticipate an increased demand for this type of medical technology in the future."
About Osteoarthritis and Viscosupplementation In 1999, some form of osteoarthritis affected more than 42 million Americans, almost one of every six people, according to the Centers for Disease Control and Prevention. Osteoarthritis, which is most prevalent in people over age 50, and most commonly affects the knee, is a leading cause of disability for older Americans. Currently, an estimated 9.5 million Americans have osteoarthritis of the knee. By 2020, with the aging of the baby boom generation, the numbers will swell: an estimated 60 million (20 percent of the population) will have arthritis, and more than 11 million will be disabled.

Osteoarthritis causes changes in synovial fluid, the natural substance that provides joints with crucial shock absorption and lubrication. The goal of viscosupplementation is to reduce pain and restore lost mobility by replacing diseased fluid.

Manufactured by Biomatrix, Inc. and marketed and distributed by Wyeth-Ayerst Laboratories, a division of American Home Products Corporation, more than 2.1 million injections of hylan G-F 20 (Synvisc) have been administered worldwide to date.

Source: Biomatrix, Inc.



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