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The MOVE-C Cervical Artificial Disc – Design, Materials, Mechanical Safety

机译:移动C颈椎人工圆盘 - 设计,材料,机械安全

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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.
机译:目的:今天市场上有各种颈椎椎间盘假体。它们可以细分为具有球形和插座设计和植入物的植入物,植入芯芯,它们在植入物的端板之间捕获并使用各种护套密封。具有铰接表面的植入物主要是金属金属或金属on-On-UHMWPE设计,因此不允许轴向阻尼。本研究的目的是提供Move-C颈椎间盘假体的机械安全性和性能数据,该假体与铰接表面和柔性芯相结合。材料和方法:Move-C由TiAl6v4制成的颅骨和尾部金属板组成。颅骨是罐装在其铰接表面上的罐子。尾部具有固定的聚碳酸酯 - 聚氨酯(PCU)芯。罐涂层是为了优化钛端板的磨损行为,而PCU核心旨在允许可逆轴向变形,预定的中性区域和所有平面中的渐进式负载变形曲线。结果:进行各种标准测试程序(例如,ISO 18192-1和ASTM F2364)和非标准机械测试以证明植入物的机械安全性。由于新的植入式设计,磨损和蠕变测试被认为是最重要的。 PCU的磨损率最高为每百万次数1.54毫克。该值在其他宫颈椎间盘假肢(0.53至2.59毫克/百万次循环)的UHMWPE磨损率范围内。同样在蠕变缓解试验中,显示了一定量的剩余变形但没有失效的定性生理行为。结论:移动-C宫颈椎间盘假体的机械安全显示与其他宫颈椎间盘假体相媲美。由于PCU磨损颗粒在其他位置比交联的UHMWPE颗粒的生物活性较少,因此与其他假体相比,体内的磨损失效可能不那么频繁。然而,这将必须在进一步的研究中显示。

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