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European multidisciplinary consensus statement on the use and monitoring of metal-on-metal bearings for total hip replacement and hip resurfacing - 19/04/13

Doi : 10.1016/j.otsr.2013.01.005 
F. Hannemann a, b, A. Hartmann a, J. Schmitt b, c, J. Lützner a, A. Seidler c, P. Campbell d, C.P. Delaunay e, H. Drexler f, H.B. Ettema g, E. García-Cimbrelo h, H. Huberti i, K. Knahr j, J. Kunze k, D.J. Langton l, W. Lauer m, I. Learmonth n, C.H. Lohmann o, M. Morlock p, M.A. Wimmer q, L. Zagra r, K.P. Günther a,
a University Hospital Carl Gustav Carus Dresden, Orthopaedics, Fetscherstr. 74, 01307 Dresden, Germany 
b Centre for Evidence-Based Health Care, Fetscherstr. 74, 01307 Dresden, Germany 
c University of Dresden, Occupational and Social Medicine, Fetscherstr. 74, 01307 Dresden, Germany 
d Orthopaedic Hospital/UCLA, Implant Retrieval Laboratory, 2400 S. Flower Street, Los Angeles, California 90007, USA 
e Orthopaedics, clinique de l’Yvette, 67-71, route de Corbeil, 91160 Longjumeau, France 
f University Erlangen-Nuremberg, Occupational, Social and Environmental Medicine, Schillerstr. 25/29, 91054 Erlangen, Germany 
g Isala Klinieken, Orthopaedic Surgery and Traumatology, Groot Weezenland 20, 8011 JW Zwolle, Netherlands 
h Hospital la Paz, Orthopaedics, Pez Austral 13, 5°A, 28007 Madrid, Spain 
i German Osteoarthritis Society, PO box 11 05 51, 60040 Frankfurt/Main, Germany 
j Orthopaedic Hospital Vienna-Speising, Speisinger Str. 109, 1130 Vienna, Austria 
k University of Technology Hamburg-Harburg, Chemical Analysis Laboratory, 21071 Hamburg, Germany 
l University Hospital of North Tees, Joint Replacement Unit, Hardwick, Stockton-on-Tees TS19 8PE, UK 
m Federal Institute for Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, Germany 
n Bristol Implant Research Centre, Southmead Hospital, Westbury-on-Trym, Bristol BS 10 5NB, UK 
o University Hospital Magdeburg, Orthopaedics, Leipziger Str. 44, 39120 Magdeburg, Germany 
p University of Technology Hamburg-Harburg, Institute of Biomechanics, 21071 Hamburg, Germany 
q Rush University Medical Center, Section of Tribology, 1653 W. Congress Parkway, Chicago, Illinois 60612, USA 
r IRCCS Galeazzi Orthopaedic Institute, via R. Galeazzi nr. 4, 20161 Milan, Italy 

Corresponding author. Tel.: +49 0 351 458 3137.

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Summary

Introduction

There is an ongoing debate about the optimal use of metal-on-metal (MoM) bearings in total hip replacement, since there are uncertainties about local and systemic adverse effects due to wear and corrosion of these bearings. Despite various national recommendations, efforts to achieve international harmonization of specific evidence-based recommendations for best practice are still lacking.

Hypothesis

An international consensus study group should be able to develop recommendations on the use and monitoring of MoM bearings, preferably at the European level, through a multidisciplinary approach, by integrating the perspectives of various stakeholders.

Materials and methods

Twenty-one experts representing three stakeholder groups and eight countries participated in this European consensus study, which consisted of a consensus meeting, subsequent structured discussion, and consensus voting.

Results

The current statement defines first of all benefits, local and systemic risks, as well as uncertain issues related to MoM bearings. Safety assessment after implantation of MoM comprises all patients. A closer follow-up is recommended for large head MoM (≥36mm) and resurfacing. In these implants basic follow-up should consist of x-rays and metal ion measurement of cobalt in whole blood, performed with GF-AAS or ICP-MS. Clinical and/or radiographic abnormality as well as elevated ion levels needs additional imaging (ultrasound, CT-scan and/or MARS-MRI). Cobalt values less than 2μg/L are probably devoid of clinical concern, the threshold value for clinical concern is expected to be within the range of 2–7μg/L.

Discussion

This is the first multinational, interdisciplinary, and multiprofessional approach for developing a recommendation for the use and monitoring of MoM bearings in total hip replacement. The current recommendations are in partial agreement with previous statements regarding the extent of follow-up and imaging techniques. They however differ from previous communications regarding measurement of metal ions and especially the investigated medium, technique, and eventual threshold levels.

Level of evidence

Level V, expert opinion/agreement conference.

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Keywords : Metal-on-metal bearing, MoM, Recommendation, Consensus study, Total hip replacement, Hip resurfacing


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Vol 99 - N° 3

P. 263-271 - mai 2013 Retour au numéro
Article précédent Article précédent
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