Abstract
A US multicenter clinical trial was undertaken to evaluate the safety and effectiveness of Hyalgan®, a defined molecular weight fraction of highly purified hyaluronic acid (500–730 kDa), prepared as a buffered solution in physiologic saline. Hyalgan is injected intra-articularly for the sustained relief of pain and joint dysfunction in osteoarthritis of the knee. This product is classified as a device according to the current ruling of the US Food and Drug Administration (FDA). However, this categorization may be questionable. Other regulatory authorities consider hyaluronic acid products as drugs because the mechanism of action appears to go beyond the mere physical function of replacing abnormal synovial fluid (“viscosupplementation”).
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Fiorentini, R., Dorsey, F.C., Segal, S.A., Moskowitz, R. (1998). A Controlled Study of Intra-Articular Hyalgan® in the Treatment of Osteoarthritis of the Knee. In: Witkin, K.B. (eds) Clinical Evaluation of Medical Devices. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-4757-2756-2_10
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DOI: https://doi.org/10.1007/978-1-4757-2756-2_10
Publisher Name: Humana Press, Totowa, NJ
Print ISBN: 978-1-61737-040-3
Online ISBN: 978-1-4757-2756-2
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