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The MOVE-C Cervical Artificial Disc – Design, Materials, Mechanical Safety
PURPOSE: There are various cervical disc prostheses on the market today. They can be subdivided into implants with a ball-and-socket design and implants with a flexible core, which is captured between the implant endplates and sealed using various sheaths. Implants with an articulating surface are m...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Dove
2020
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7524193/ https://www.ncbi.nlm.nih.gov/pubmed/33061680 http://dx.doi.org/10.2147/MDER.S270789 |
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author | Kienle, Annette Graf, Nicolas Krais, Carina Wilke, Hans-Joachim |
author_facet | Kienle, Annette Graf, Nicolas Krais, Carina Wilke, Hans-Joachim |
author_sort | Kienle, Annette |
collection | PubMed |
description | PURPOSE: There are various cervical disc prostheses on the market today. They can be subdivided into implants with a ball-and-socket design and implants with a flexible core, which is captured between the implant endplates and sealed using various sheaths. Implants with an articulating surface are mostly metal-on-metal or metal-on-UHMWPE designs and, thus, do not allow for axial damping. The aim of this study is to provide mechanical safety and performance data of the MOVE-C cervical disc prosthesis which combines both an articulating surface and a flexible core. MATERIALS AND METHODS: MOVE-C consists of a cranial and caudal metal plate made of TiAl6V4. The cranial plate is TiNbN coated on its articulating surface. The caudal plate has a fixed polycarbonate-urethane (PCU) core. The TiNbN coating is meant to optimize the wear behavior of the titanium endplate, whereas the PCU core is meant to allow for a reversible axial deformation, a pre-defined neutral zone and a progressive load-deformation curve in all planes. RESULTS: Various standard testing procedures (for example, ISO 18192–1 and ASTM F2364) and non-standard mechanical tests were carried out to prove the implant’s mechanical safety. Due to the new implant design, wear and creep testing was deemed most important. The wear rate for the PCU was in maximum 1.54 mg per million cycles. This value was within the range of the UHMWPE wear rates reported for other cervical disc prostheses (0.53 to 2.59 mg/million cycles). Also in the creep-relaxation test, a qualitatively physiological behavior was shown with a certain amount of remaining deformation but no failure. CONCLUSION: The mechanical safety of the MOVE-C cervical disc prosthesis was shown to be comparable to other cervical disc prostheses. Since PCU wear particles were elsewhere shown to be less bioactive than cross-linked UHMWPE particles, wear-related failure in vivo may be less frequent compared to other prostheses. This, however, will have to be shown in further studies. |
format | Online Article Text |
id | pubmed-7524193 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Dove |
record_format | MEDLINE/PubMed |
spelling | pubmed-75241932020-10-14 The MOVE-C Cervical Artificial Disc – Design, Materials, Mechanical Safety Kienle, Annette Graf, Nicolas Krais, Carina Wilke, Hans-Joachim Med Devices (Auckl) Original Research PURPOSE: There are various cervical disc prostheses on the market today. They can be subdivided into implants with a ball-and-socket design and implants with a flexible core, which is captured between the implant endplates and sealed using various sheaths. Implants with an articulating surface are mostly metal-on-metal or metal-on-UHMWPE designs and, thus, do not allow for axial damping. The aim of this study is to provide mechanical safety and performance data of the MOVE-C cervical disc prosthesis which combines both an articulating surface and a flexible core. MATERIALS AND METHODS: MOVE-C consists of a cranial and caudal metal plate made of TiAl6V4. The cranial plate is TiNbN coated on its articulating surface. The caudal plate has a fixed polycarbonate-urethane (PCU) core. The TiNbN coating is meant to optimize the wear behavior of the titanium endplate, whereas the PCU core is meant to allow for a reversible axial deformation, a pre-defined neutral zone and a progressive load-deformation curve in all planes. RESULTS: Various standard testing procedures (for example, ISO 18192–1 and ASTM F2364) and non-standard mechanical tests were carried out to prove the implant’s mechanical safety. Due to the new implant design, wear and creep testing was deemed most important. The wear rate for the PCU was in maximum 1.54 mg per million cycles. This value was within the range of the UHMWPE wear rates reported for other cervical disc prostheses (0.53 to 2.59 mg/million cycles). Also in the creep-relaxation test, a qualitatively physiological behavior was shown with a certain amount of remaining deformation but no failure. CONCLUSION: The mechanical safety of the MOVE-C cervical disc prosthesis was shown to be comparable to other cervical disc prostheses. Since PCU wear particles were elsewhere shown to be less bioactive than cross-linked UHMWPE particles, wear-related failure in vivo may be less frequent compared to other prostheses. This, however, will have to be shown in further studies. Dove 2020-09-25 /pmc/articles/PMC7524193/ /pubmed/33061680 http://dx.doi.org/10.2147/MDER.S270789 Text en © 2020 Kienle et al. http://creativecommons.org/licenses/by-nc/3.0/ This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). |
spellingShingle | Original Research Kienle, Annette Graf, Nicolas Krais, Carina Wilke, Hans-Joachim The MOVE-C Cervical Artificial Disc – Design, Materials, Mechanical Safety |
title | The MOVE-C Cervical Artificial Disc – Design, Materials, Mechanical Safety |
title_full | The MOVE-C Cervical Artificial Disc – Design, Materials, Mechanical Safety |
title_fullStr | The MOVE-C Cervical Artificial Disc – Design, Materials, Mechanical Safety |
title_full_unstemmed | The MOVE-C Cervical Artificial Disc – Design, Materials, Mechanical Safety |
title_short | The MOVE-C Cervical Artificial Disc – Design, Materials, Mechanical Safety |
title_sort | move-c cervical artificial disc – design, materials, mechanical safety |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7524193/ https://www.ncbi.nlm.nih.gov/pubmed/33061680 http://dx.doi.org/10.2147/MDER.S270789 |
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