目的:脊柱转移性肿瘤手术(MSTS)中使用的植入装置包括椎弓根螺钉,固定板,固定杆,和体间设备。用于制造任何这些设备的材料应具有一系列特性,其中包括生物相容性,没有毒性,生物活性,低磨损率,成像过程中伪影的低至中等发生率,与皮质骨相当的拉伸强度和模量,高疲劳强度/长疲劳寿命,对放疗(RT)计划和交付的负面影响最小或没有负面影响,与相邻骨融合的能力强。Ti6Al4V合金对于这些应用在这些理想性能方面的缺点是公认的。为研究可以取代当前黄金标准的新型生物材料开辟了领域。以前发表的关于这一主题的评论在它们所包括的研究中表现出重大缺陷,比如一个小的,样本量不均匀,缺乏成本效益分析,对于理解大规模应用新材料的实际可能性非常有用。因此,这篇综述旨在从最新文献中收集有关这些生物材料的临床表现的信息,为了研究未来可能比钛更好的材料,特别注意安全,伪影产生和放射治疗计划干扰。通过分析这些装置的临床性能所显示的显著希望保证通过具有更大样本量的前瞻性研究进一步研究,还考虑到此类材料的生产和使用的每个方面。
方法:使用系统评价和Meta分析(PRISMA)指南的首选报告项目来改进评价报告。搜索时间为2022年3月至2023年9月。
结果:在筛选过程结束时,20篇文章被认为符合这项研究的条件。聚醚醚酮(PEEK),碳纤维增强聚醚醚酮(CFR-PEEK),长碳纤维增强聚合物(LCFRP),聚甲基丙烯酸甲酯(PMMA),在纳入的研究中使用了碳螺杆和棒。
结论:CFR-PEEK对钛植入器械的安全性和有效性表现不差。然而,它还有其他优点。通过减少工件的产生,它能够增加对局部肿瘤复发的检测,减少放疗剂量扰动,最终改善需要辅助治疗的患者的预后。尽管如此,其弊端尚未得到充分探索,仍需要在未来的研究中进一步研究。这并不排除CFR-PEEK在不久的将来可能是钛的有效替代品的事实。
OBJECTIVE: Implanted devices used in metastatic spine tumor surgery (MSTS) include pedicle screws, fixation plates, fixation rods, and interbody devices. A material to be used to fabricate any of these devices should possess an array of properties, which include biocompatibility, no toxicity, bioactivity, low wear rate, low to moderate incidence of artifacts during imaging, tensile strength and modulus that are comparable to those of cortical bone, high fatigue strength/long fatigue life, minimal or no negative impact on radiotherapy (RT) planning and delivery, and high capability for fusion to the contiguous bone. The shortcomings of Ti6Al4V alloy for these applications with respect to these desirable properties are well recognized, opening the field for an investigation about novel biomaterials that could replace the current gold standard. Previously published reviews on this topic have exhibited significant shortcomings in the studies they included, such as a small, heterogenous sample size and the lack of a cost-benefit analysis, extremely useful to understand the practical possibility of applying a novel material on a large scale. Therefore, this review aims to collect information about the clinical performance of these biomaterials from the most recent literature, with the objective of deliberating which could potentially be better than titanium in the future, with particular attention to safety, artifact production and radiotherapy planning interference. The significant promise showed by analyzing the clinical performance of these devices warrants further research through prospective studies with a larger sample size also taking into account each aspect of the production and use of such materials.
METHODS: The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines were used to improve the reporting of the review. The search was performed from March 2022 to September 2023.
RESULTS: At the end of the screening process, 20 articles were considered eligible for this study. Polyetheretherketone (PEEK), Carbon-fibre reinforced polyetheretherketone (CFR-PEEK), long carbon fiber reinforced polymer (LCFRP), Polymethylmethacrylate (PMMA), and carbon screw and rods were used in the included studies.
CONCLUSIONS: CFR-PEEK displays a noninferior safety and efficacy profile to titanium implanted devices. However, it also has other advantages. By decreasing artifact production, it is able to increase detection of local tumor recurrence and decrease radiotherapy dose perturbation, ultimately bettering prognosis for patients necessitating adjuvant treatment. Nonetheless, its drawbacks have not been explored fully and still require further investigation in future studies. This does not exclude the fact that CFR-PEEK could be a valid alternative to titanium in the near future.