1、STP 1431 Spinal Implants:Are We Evaluating Them Appropriately?M.N.Melkerson,M.S.;S.L.Griffith,Ph.D.;and J.S.Kirkpatrick,M.D.,editors ASTM Stock Number:STP 1431 ml ASTM International 100 Barr Harbor Drive PO Box C700 West Conshohocken,PA 19428-2959 Printed in the U.S.A.Foreword The Symposium on Spina
2、l Implants:Are We Evaluating Them Appropriately?was held in Dallas,Texas on 6-7 November 2001.ASTM International Committee F04 on Medical and Surgical Materials and Devices was its sponsor.Symposium chairmen and co-editors of this publication were Mark N.Melkerson,M.S.;John S.Kirkpatrick,M.D.;and St
3、even L.Griffith,Ph.D.iii Library of Congress Cataloging-in-Publication Data Symposium on Spinal Implants,Are We Evaluating Them Appropriately?(2001:Dallas,Tex.)Spinal implants:are we evaluating them appropriately?/M.N.Melkerson,S.L.Griffith,and J.S.Kirkpatrick,editors.p.;cm.-(STP;1431)Symposium on S
4、pinal Implants,Are We Evaluating Them Appropriately?was held in Dallas,Texas on 6-7 November 2001.Includes bibliographical references and index.ISBN 0-8031-3463-0 Spinal Implants:Are We Evaluating Them Appropriately?ASTM Stock Number:.STP1431.1.Spinal implants-Testing-Congresses.I.Melkerson,M.N.(Mar
5、k N.)1961-II.Griffith,Steven L.,1960-111.Kirkpatrick,J.S.(John S.)1958-1V.Title.V.ASTM special technical publication;1431.DNLM:1.Spine-surgeryongresses.2.Device Approvalngresses.3.Implants.Experimental-Congresses.4.Prosthesis Design-Congresses.WE 725 S9869s 2003 RD768.$847 2003 617.56059-dc21 200304
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11、ational.Printed in Bridgeport,NJ 2003 Contents FOREWORD OWRVmW SESSION I:SPINAL CONSTRUCTS History of Isola-VSP FatigueTesting Results with Correlation to Clinical Implant Failures-w.L.CARSON,M.ASHER,O.BOACHIE-ADJEI,B.AKBARNIA,R.DZIOBA,AND N.LEBWOHL Gauge Length and Mobility of Test Blocks Strongly
12、Affect the Strength and Stiffness of Posterior Occipito-Cervico-Thoracic Corpectomy Constructs-M.SLIVKA,H.SERHAN,D.SELVITELLI,AND K.TORRES Relative 3 Dimensional Motions Between End Vertebrae in a Bi-level Construct,The Effect of Fixture Constraints on Test Results-w.L.CARSON Spinal Implant Transver
13、se Rod Connectors:A Delicate Balance Between Stability and Fatigue Performance-H.SERHAN AND M.A.SLIVKA Corrosion on Spinal Implant Constructs:Should Standards be Revised?-J.s.KIRKPATRICK,R.VENUGOLOPALAN,M.BIBBS,J.E.LEMONS,AND P.BECK iii vii 17 24 34 40 SESSION II:SPINAL DEVICE COMPONENTS,SUBASSEMBLI
14、ES,AND INTERCONNECTIONS Effect of Transverse Connector Design on Development of Late Operative Site Pain:Preliminary Clinical Findings-s.M.COOK,M.ASHER,W.L.CARSON,AND S.M.LAI lnterconnectiou Strength Testing and its Value in Evaluating Clinical Performance L.M.JENSEN,S.SPRINGER,S.CAMPBELL,AND E.GRAY
15、 Protection of the Longitudinal Member Interconnection by ASTM F1798-97 lnterconnection Mechanism and Subassemblies Standard Guide-w.L.CARSON Clinical Relevance of Pull-out Strength Testing of Pedicle Screws-J.M.DAWSON,P.BOSCHERT,M.MACENSKI,AND N.RAND 47 55 63 68 V vi CONTENTS SESSION IlI:CAGES AND
16、INTERBODY FUSION DEVICES Extrusion of Interbody Fusion Devices-Clinical Examples-s.M.THEISS IS Push-out Testing of Cage Devices Worthwhile in Evaluating Clinical Perfornlance.9s.SPRINGER,S.CAMPBELL,R.HOUFBURG,A.SHINBROT,AND J.PAVLOVIC A Comparison of Two Strength-Testing Methodologies for Interbody Structural Allografts for Spinal Fusion-j.M.DAWSON,AND S.L.GRIFFITH 81 86 92 SESSION IV FUNCTIONAL SPINAL DEVICES AND/OR ARTIFICIAL DISKS The Influence ofln Vitro Testing Method on Measured Interverte
