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    Spinal Implants: Are We Evaluating Them Appropriately?

    Melkerson MN, Kirkpatrick JS, Griffith S
    Published: 2003

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    Meet the challenges and demands facing professionals in the dynamic field of spinal implants. Sections cover:

    Spinal Constructs presents developments and results associated with the application of ASTM F1717 test methods. Papers describe the clinical results from spinal constructs having marketing clearance or approval using these test methods; address device failure modes; and examine corrosion seen with explanted devices. Other papers evaluate impact on results due to gauge length used in tests; mobility or constraint of the test blocks; and use of transverse rod connections.

    Spinal Device Components, Subassemblies, and Interconnections using ASTM F1798, this section discusses test methods for new components or modifications to existing components of a construct. Papers describe the impact from application of different transverse connector designs on clinical outcomes; and evaluate impact on bench testing results due to protection of the longitudinal member, anchoring materials, gauge length, mobility or constraint of the test blocks.

    Interbody Spacers and Intervertebral Body Fusion Devices provides the latest developments and results associated with the application of ASTM F2077 test methods for intervertebral body fusion devices. Papers cover the clinical results from lumbar interbody fusion devices; the causes of some of these devices that extruded; strength testing methodologies; and the usefulness of pull-out or push-out testing for spinal cages.

    Functional Spinal Devices and/or Artificial Discs examines comparative cadaveric testing, durability testing, and alternative test methods for spinal constructs intended for posterior stabilization without fusion.

    Suggested Test Methods, Models, Fixtures, or Needed Improvements addresses today's limitations and tomorrow's concerns in spinal implants standards. Some papers describe the results from alternative models for fusion, non-fusion, or functional spinal implants; and others examine the impact on testing due to preload, block design, and material properties.

    Audience: This new publication is a valuable resource for designing engineers, surgeons, researchers, and regulatory entities who test and evaluate the appropriateness of a devices' design and materials.

    Table of Contents

    History of Isola-VSP Fatigue Testing Results with Correlation to Clinical Implant Failures

    Gauge Length and Mobility of Test Blocks Strongly Affect the Strength and Stiffness of Posterior Occipito-Cervico-Thoracic Corpectomy Constructs

    Relative 3 Dimensional Motions between End Vertebrae in a Bi-level Construct, the Effect of Fixture Constraints on Test Results

    Spinal Implant Transverse Rod Connectors: A Delicate Balance Between Stability and Fatigue Performance

    Corrosion on Spinal Implant Constructs: Should Standards Be Revised?

    Effect of Transverse Connector Design on Development of Late Operative Site Pain: Preliminary Clinical Findings

    Interconnection Strength Testing and its Value in Evaluating Clinical Performance

    Protection of the Longitudinal Member Interconnection by ASTM F 1798-97 Interconnection Mechanism and Subassemblies Standard Guide

    Clinical Relevance of Pull-out Strength Testing of Pedicle Screws

    Extrusion of Interbody Fusion Devices—Clinical Examples

    Is Push-out Testing of Cage Devices Worthwhile in Evaluating Clinical Performance?

    A Comparison of Two Strength-Testing Methodologies for Interbody Structural Allografts for Spinal Fusion

    The Influence of In Vitro Testing Method on Measured Intervertebral Disc Characteristics

    Testing of Human Cadaveric Functional Spinal Units to the ASTM Draft Standard, “Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs”

    Durability Test Method for a Prosthetic Nucleus (PN)

    Mechanical Analogue Model of the Human Lumbar Spine: Development and Initial Evaluation

    An Improved Biomechanical Testing Protocol For Evaluating Multilevel Cervical Instrumentation In A Human Cadaveric Corpectomy Model

    Influence of Preload in Flexibility Testing of Native and Instrumented Lumbar Spine Specimens

    Transverse Connectors: Clinical Objectives, Biomechanical Parameters Involved in Their Achievement, and Summary of Current and Needed In Vitro Tests

    An Evaluation of the Influence of UHMWPE Test Block Design on the Mechanical Performance of Bilateral Lumbar Corpectomy Constructs

    Vertebral Bone Density—A Critical Element in the Performance of Spinal Implants

    Author Index

    Subject Index

    Committee: F04

    DOI: 10.1520/STP1431-EB

    ISBN-EB: 978-0-8031-5480-3

    ISBN-13: 978-0-8031-3463-8