Chapter 6-Standards Development Perspectives on the Use of Bone Graft Substitutes Based Upon Allografts

    Published: Jan 2003

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    THE DEVELOPMENT OF BONE GRAFT substitutes has had explosive growth recently. Bone graft substitutes include collagen or mineral void fillers, processed bone allografts, extracted allograft products such as demineralized bone matrix, and combination products of implants and bone morphogenetic proteins [1,2]. Bone morphogenetic protein products are in need of standardization for a number of issues including dose, concentration of product, carrier factors, and threshold of bone induction [2]. One example of the complex nature of evaluating bone graft substitutes is the recently Food and Drug Administration (FDA) approved “InFUSE”™ Bone Graft/“LT-CAGE”™ Lumbar fusion device. This product includes three components: a metallic device, a collagen sponge, and recombinant human bone morphogenetic protein-2 (rhBMP-2) [3]. The manufacturer provided basic science and clinical data from a several year, multicenter investigation in order to obtain approval for the product. Only one component of the product was subject to a standardized evaluation, and that was the cage component. The remaining components (the collagen sponge and rhBMP-2) had no standardized testing or specifications. This resulted in data that may not be comparable for future products, nor does it allow clinicians to know what key components are needed for specific clinical problems. These problems result in significant added cost to the consumer and health care system, and delays in implementing treatments that are beneficial to patients.

    Author Information:

    Tomford, WW

    Kirkpatrick, JS
    University of Alabama at BirminghamBirmingham Veterans Administration Medical Center, Birmingham, AL

    Paper ID: MONO10062M

    Committee/Subcommittee: F04.48

    DOI: 10.1520/MONO10062M

    CrossRef ASTM International is a member of CrossRef.

    ISBN10: 0-8031-3356-1
    ISBN13: 978-0-8031-3356-3