Chapter 17-Issues Involving Standards Development for Synthetic Material Bone Graft Substitutes

    Published: Jan 2003

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    MODERN ORTHOPEDIC SURGERY HAS become complex and technically sophisticated. Orthopedic surgeons and basic scientists have translated recent advances in chemistry, molecular biology, physiology, and biomaterials science into novel management options for their patients. In particular, the development of new synthetic bone graft substitutes (BGS) represents a rapidly evolving area. These synthetic biomaterials may be used alone, as scaffold, or as carrier for bioactive agents (proteins, antibiotics, blood derived or bone marrow derived agents, and cells). To date, most BGS materials available on the market have been classified as Bone Void Fillers (BVF) “intended to be gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure” [12]. These graft alternatives are subjected to varying degrees of regulatory scrutiny, and thus their true safety and effectiveness in patients may not be known prior to their clinical use [22]. Continuous innovation and the development of new implants raise important issues for technology testing, clinical performance, risk assessment and regulation. It is therefore not surprising that the development of standards for these implants represents an issue that increasingly confronts the professionals from industrial and health care sectors.

    Author Information:

    Agrawal, M

    Katti, DS

    Long, M
    Smith &Nephew, Inc., Memphis, TN

    Talac, R
    Mayo Clinic, Rochester, MN

    Yaszemski, MJ
    Mayo Clinic, Rochester, MN

    Paper ID: MONO10075M

    Committee/Subcommittee: F04.23

    DOI: 10.1520/MONO10075M

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