Testing criteria for spinal implants: recommendations for the standardization of in vitro stability testing of spinal implants |
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Authors: | H-J Wilke K Wenger L Claes |
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Institution: | (1) Department of Orthopaedic Research and Biomechanics, University of Ulm, Helmholtzstrasse 14, D-89081 Ulm, Germany Tel. +49-731-502 3481; Fax +49-731-502 3498; e-mail: wilke@sirius.medizin.uni-ulm.de; WWW http://lyra.medizin.uni-ulm.de, DE |
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Abstract: | New implants and new surgical approaches should be tested in vitro for primary stability in standardized laboratory tests
in order to decide the most appropriate approach before being accepted for clinical use. Due to the complex and still unknown
loading of the spine in vivo a variety of different test loading conditions have been used, making comparison of the results
from different groups almost impossible. This recommendation was developed in a series of workshops with research scientists,
orthopedic and trauma surgeons, and research and development executives from spinal implant companies. The purpose was to
agree on in vitro testing conditions that would allow results from various research groups to be compared. This paper describes
the recommended loading methods, specimen conditions, and analysis parameters resulting from these workshops.
Received: 23 June 1997 Revised: 12 November 1997 Accepted: 23 December 1997 |
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Keywords: | Spine Biomechanics Implant testing In vitro testing Test standard |
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