Biocompatibility of Co-Cr-Ni Alloys

366 Pages·1988·7.03 MB·English

by  Bernard Bloch (auth.)

Biocompatibility
of Co-Cr-N i Alloys
NATO ASI Series
Advanced Science Institutes Series
A series presenting the results of activities sponsored by the NATO Science Committee,
which aims at the dissemination of advanced scientific and technological knowledge,
with a view to strengthening links between scientific communities.
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A Life Sciences Plenum Publishing Corporation
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and Physical Sciences Dordrecht, Boston, and London
o
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Volume 158-Biocompatibility of Co-Cr-Ni Alloys
edited by Hartmut F. Hildebrand and Maxime Champy
Series A: Life Sciences
Biocom pati bi Ii ty
of Co-Cr-N i Alloys
Edited by
Hartmut F. Hildebrand
Institute of Occupational Medicine
Li lie, France
and
Maxime Champy
University Hospital Center of Strasbourg
Strasbourg, France
Plenum Press
New York and London
Published in cooperation with NATO Scientific Affairs Division
Proceedings of a NATO Advanced Research Workshop on
Biological Incidences of Co-Cr-Ni Alloys Used in
Orthopaedic Surgery and Stomatology,
held September 3D-October 4, 1985,
in Bischenberg Obernay, France
Library of Congress Cataloging in Publication Data
NATO Advanced Research Workshop on Biological Incidences of Co-Cr-Ni Alloys
Used in Orthopedic Surgery and Stomatology (1985: Bischenberg, France)
Biocompatibility of Co-Cr-Ni alloys I edited by Hartmut F. Hildebrand and
Maxime Champy.
p. cm.-(NATO ASI series. Series A, Life sciences; vol. 158)
"Proceedings of a NATO Advanced Research Workshop of Biological In
cidences of Co-Cr-Ni Alloys Used in Orthopedic Surgery and Stomatology, held
September 3D-October 4, 1985, in Bischenberg Obernay, France"-T.p. verso.
"Published in cooperation with NATO Scientific Affairs Division."
Includes bibliographies and index.
ISBN-13: 978-1-4612-8067-5 e-ISBN-13: 978-1-4613-0757-0
DOl: 10.1007/978-1-4613-0757-0
1. Cobalt-chromium-nichel alloys-Biocompatibility-Congresses. 2. Im
plants, Artificial-Congresses. I. Hildebrand, Hartmut F. II. Champy, Maxime. III.
North Atlantic Treaty Organization. Scientific Affairs. IV. Title. V. Series: NATO
ASI series. Series A, Life sciences; v. 158.
[DNLM: 1. Biocompatible Materials-congresses. 2. Chromium
Alloys-adverse effects-congresses. 3. Dental Implantation-congresses. 4.
Implants, Artificial-congresses. QT 34 N2788b 1985J
R857.C63N37 1985
61D'.28-dc19
DNLMIDLC 88-38501
for Library of Congress CIP
© 1988 Plenum Press, New York
Softcover reprint of the hardcover 1s t edition 1988
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233 Spring Street, New York, N.Y. 10013
All rights reserved
No part of this book may be reproduced, stored in a retrieval system.
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microfilming, recording, or otherwise, without written permission from the Publisher
PREFACE
For several years now scientific and medical sLaff have recognised the risks of toxicity of
certain metals contained in alloys used in Lhe manufacture of biomaterials protheses,
implants, and artificial organs. A number or scientific and industrial research centres have
focussed their investigations in this direction and international societies and commissions
have organised meetings with specialists from complementary disciplines in attendance in
attempts to guage the importance of biological risks and to determine the toxicity of certain
metals, with the aim of establishing preventive measures and guidelines.
In the last century great efforts have been made to reduce unwanted biological effects
caused by orthopaedic implants. The problems of pain and infection were overcome and the
development of modern technology has resulted in a convincing decrease in corrosion
problems and mechanical failure, such that ostosynthesis and endoprosthesis have rapidly
progressed beyond the level of tentative investingation.llowever, a number of problems still
remain to be solved, such as the influence of the material type on the healing process and its
relative speed.
The increasing use of cobalt-,chromium-and nickel-containing alloys in surgical and dental
implants has raised various questions concerning the biological consequences of chronic
internal release of these elements in the human body. A total of 55 delegates representing
16 countries heard presentations of fundamental aspects, local and remote tissue response,
immunopathology, clinical aspects, and manufacturing qual ity control issues.
The discussion was energetic and heated at limes, with informal conversations stretching
far into the evenings. A workshop held on the final day drew several widely-supported
conclusions. It was generally agreed that there was considerable evidence for unfavourable
biological reaction to these alloys, reactions associated primarily with the nickel content of
such alloys. The most common such responses are of an immunological nature, sometimes
requiring device removal in order to eliminate symptoms. C\Jevertheless, it was felt that the
use of these alloys should continue in those situations where they remain the best choice,
based on their critical properties and in the absence of any reasonable alternatives.
It was agreed that comprehensive studies 011 clinical epidemiology and device retrieval and
analysis are needed to better identify the magnitude 01' clinical problems and to try to
distinguish between the effects of the various alloys ill usc. There is a great need for
improved data-gathering systems and clinical tests, especially in illlIllunolgy where is
considerable doubt as to the safety and accuracy of the conventional skin (patch) test.
Finally, the delegates were pleased by the evidence of the growing number of well
structUl'ed, interdisciplinary research groups in many countries which are currently
addressing the problems of biological respon,;cs to implants.
H. F. HILDEBRAND and M. CIIAMPY
v
ACKNOWLEDGEMENTS
The authors and editors gratefully acknowledge
the World Gold Council for the financial
support allowing the printing of the colour
plates.
CONTENTS
The International Standards Organization Technical Committee
on Surgical Implant~
B. BLOCH ............. .
FUNDAMENTAL ASPECTS
Carcinogenic Risks of Metal Implants and Prostheses
F W. SL'N DERMAN Jr ... . . . . . . . . . . . .. 11
The Toxicity of Chromium in the Zero and Trivalent Form
U. GLASEI{ 21
Measurement of the Uptake ofChromiulll
J) SII APCO'l'T 31
Analy~is of Cobalt, Chromium and Nickel in Biological Materials
State of the Art
M. STOEPPLER 45
Phenomenology of the Trace Element Burdening of the iluman Organism
by the In-Bod.v Corrosion ofCo-Cr-Ni-Alloys as Revealed by Neutron
J\rti vation Analysis
It MICHI':L, I". LOEI{, M. NOLTE, M. REICH andJ. ZILKENS 59
Ch,tirmen Summary: Fundamental Aspects
FW. SL'NDERMA!\: Jr. and M. STOEPPLER 77
TISSUE RESPONSE
In vivo Corrosion ora Cobalt-Base Alloy and its Biological Consequences
J. BLACK 83
[{elation between Metal Corrosion and Electrical Polarization
S SINGH and liS RANU 101
III vitro and in vivo Cellular I{esponse to Semi-Precious and Amorphous Alloys
P GUIHALDENQ. II. MAZILU';, J. BRUGmARO, M. BOUVIER
and II. MAGLOIRE 107
vii
Nickel and Chromium in the Human Body
A Review and a Research Proposal
J.A.IIELSEN .................... . . .. 119
Orthopaedic Implants and Corrosion Products
Ultrastructural and Analytical Studies of 65 Patients
II.F. HILDEBRAND, P. OSTAPCZUK,J.F. MERCIER, M. STOEPPLER,
B.ROUMAZEILLEandJ.DECOULX .. . ....................... 133
Histochemical, Electron Microscopic and Microanalytic Investigations
of1'issue Surrounding Ni·Cr·Allenthesis in Maxillo·Facial Surgery
E. DIELERT and E. FISCHER·BRANDIES 155
Measurement of Nickel and Chromium at the Site of Metallic Dental Implants
A. GARUET, M. SIMONOFF, B. BERDED, Y LLABADOR, F.X. MICIIELET
and P.l<'. CAITUCOLI .................... 161
III vitro Evaluation of the Biocompatihility of a Ni·Cr·Alloy (Wiron 88)
An Ultrastructural Study
P. EXBI{A YAT, M.L. COUBLE, D. HARTMANN and II. MAGLOIRE 175
Chairmen Summary: Tissue Response
J. BLACK and D.F. WILLIAMS ........ . 183
IMMUNOP ATHOLOGY
Fundamental Aspects of Contact Sensitivity to Nickel
C. BENEZRA and M.l". LEROY ......... . .. ..... 187
Total I lip Arthroplasties and Allergy to Metals
F I.EYNADlERand F. LANGLAIS 193
"Jickel, Chromium, Cobalt Dental Alloys and Allergic Reactions An Overview
I I.F. HILDEBRAND, C. VERON and P. MARTIN 201
Allergic Contact Stomatitis from Ni·Alloys
A Ilistological, Immunohistological and Electrochemical Relation
L.A.J. van LOON, P.W. van ELSAS, PYX DUYSTERS, J.D. BOS
anuC.L. DAVIDSON.. . ....................... . 213
Immunological Aspects of Contact Hypersensitivity to Nickel
and Chromium in Dental Alloys
K.J.J. VREEBURG, K. de GROOT, C.K.H. v.d. BURG and IU. SCHEPER. ...... 225
Chairmen Summary: Immunopathology
C. B/<;NEZRA and K. MERRITT .......... . .. ... 235
CLINICAL ASPECTS
Analysis of'l'otal Joint Replacements (!lip and Knee)
H. BLOCH ........... . ....... . ... 241
Aspects of the Failure of the Implanted Systems in Orthopedicsand Traumatology
Y. ANDRIANE, F. BURNY, J. QUINTIN and M. DONKERWOLCKE ............ 249
viii
Clinical Intolerance to Prosthesis Material Including Metallic Implants
M. DONAZZAN, M. CHANAVAZ, L. DURET, C. VERON
and J.P. FERNANDEZ ..... . 267
Clinical Aspects on the Corrosion of Dental Alloys
RSQREMARK 275
The Influence ofIntraoperalive Forming Procedures on Corrosion
ofNi-Cr Alloys
E. FISCIIER-BRANDmS and E. DIELERT ......... . 287
Pilot Study of Allergic Effects ofCo-Cr-Ni Alloys among Dental Technicians
D. CHOUDAT, F. VALLENTIN, P. BIWCHARD, T. BEI{RIAU
and J. PROTEA U . . . . . . . . . . 293
Chairmen Summary: Clinical Aspects
B. BLOCH and R. SQREMARK ..... . 299
QUALITY CONTROL
The Corrosion of Dental Ni-Cr Alloys
An in vitro I<:valuation
J.M. MI~YER ... 305
Austenitic Stainless Steel S350 for Surgical Implants?
C GABBI, G. MELOTTI, E. VITA FINZI and P TRANQlJlLLI LEAL! 321
Corrosion and Bioelectrochemistry
G. MILAZZO 325
Micro-Analysis of the Composition of Dental Implants before
and after Implantation
M. SIMONOFF, B. BERDIEU, Y. LLABADOI{, A. GARUET,
P.F. CAITUCOLI and F.X. MICHELET 331
Surface Treatment of Metallic Biomaterials to Improve Biological
and Economical Compatibility
D. MUSTER, M. CIIAMPY, S. SZMUKLER, C BALTZI~GER
andC. BURGGRAF ............................ . 341
Corrosion and Protection of Surgical and Dental Metallic Implants
C. SgLLA,J.C. MARTIN,J. LECOEUR,JP BELLIER
and J.P. DA VIDAS 349
Chairman Summary: Quality Control
G. MILAZZO 363
CONCLUSIONS AND RECOMMENDATIONS
Conclusions and Recommendations 369
Contributors 373
Index 375
ix
THE INTERNATIONAL STANDARDS ORGANIZATION
TECHNICAL COMMITTEE ON SURGICAL IMPLANTS
Bernard Bloch
Chairman ISO/TC 150
Central Secretariat Geneva
INTRODUCTION
Implants have been defined as "objects or devices which
are surgically placed in the body either temporarily or
permanently for diagnostic or therapeutic purposes". This
is indeed a broad definition. Practically every surgical
procedure thus involves the use of an implant.
There is need for surgical implant standards and
assurance of their quality control. The achievements of
ISO's technical committee (TCI50) on Implants for Surgery,
are described.
SURGICAL IMPLANTS
Recent innovations in almost every branch of surgery
have been accompanied by, and often were dependent upon,
remarkable new materials and composites derived from the
fields of metallurgy, chemistry, textiles and bio-ceramics.
Processed materials of biological origin must also be
included. The surgeon, who is untrained in the materials
and engineering sciences, is justifiably bewildered by
the confusion, particularly in the polymer field, between
chemical and generic names. He is unaware of the different
properties engendered by variations in chemical formulation,
molecular weight and methods of fabrication and
sterilization. He may be unaware that "nylon" is a trade
name for polyamide and that there are many variations in
type. Or that a cobalt-chromium or titanium alloy may have
excellent qualities in tension or bending but is less
satisfactory in tension, torsion and bending--the typical
forces that exist when inserting a bone screw. He may not
know, for instance, that polyamides (such as nylon) lose
tensile strength in the tissues, and incorrect grades will
degrade. PTFE (Teflon) is hystiocytic when abraded.
Dissimilar metals, if both implanted, produce an
electromotive force and reaction. If incorrect catheter
materials are selected for intravascular and intracardiac