Critical analysis of in vitro stability testing of spinal implants and proposal for standardization.

Autor:	Csernátony Z; University of Debrecen, Faculty of Medicine, Department of Orthopaedic Surgery, Laboratory of Biomechanics, Debrecen, Hungary., Manó S; University of Debrecen, Faculty of Medicine, Department of Orthopaedic Surgery, Laboratory of Biomechanics, Debrecen, Hungary., Tiba Z; Department of Aircrafts and Road Vehicles, University of Debrecen, Faculty of Engineering, Institute for Mechanical and Vehicle Engineering, Debrecen, Hungary., Husi G; Faculty of Engineering, Department of Mechatronics, University of Debrecen, Debrecen, Hungary., Jónás Z; University of Debrecen, Faculty of Medicine, Department of Orthopaedic Surgery, Laboratory of Biomechanics, Debrecen, Hungary., Váradi T; AC2T Research GmbH, Department of Advanced Chemical Analysis, Technology and Research Center, Klosterneuburg, Austria., Csámer L; University of Debrecen, Faculty of Medicine, Department of Orthopaedic Surgery, Laboratory of Biomechanics, Debrecen, Hungary., Kovács ÁÉ; University of Debrecen, Faculty of Medicine, Department of Orthopaedic Surgery, Laboratory of Biomechanics, Debrecen, Hungary.
Jazyk:	angličtina
Zdroj:	Expert review of medical devices [Expert Rev Med Devices] 2022 Mar; Vol. 19 (3), pp. 281-286. Date of Electronic Publication: 2022 Mar 21.
DOI:	10.1080/17434440.2022.2054331
Abstrakt:	Background: The American Society for Testing and Materials (ASTM), considered the gold standard worldwide, requires only testing in physiological saline solution to simulate in vivo conditions in standard testing of spinal implants. Research Design and Methods: We conducted an in vitro study to identify an industrial lubricant with characteristics that are most similar to those of biologically lubricating fat, blood, and tissue fluids. The use of such a material could standardize the results of in vitro mechanical tests for better clinical applications. Results: Our study has shown that the lubricity of physiological saline was well below that of human soft tissues and tissue fluids, and among the motor oils, Castrol GTX3 provided a testing environment similar to that of a living organism. Conclusions: With the intention of standardizing and preventing a biological hazard, we have developed a reproducible mechanical testing proposal based on our experiments, which, in addition, would allow us to avoid many misunderstandings and contingencies.
Databáze:	MEDLINE
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