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脊柱肿瘤手术治疗中植入器械的临床性能:系统评价。

Clinical performance of implanted devices used in surgical treatment of patients with spinal tumors: a systematic review.

机构信息

Research Unit of Orthopaedic and Trauma Surgery, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, Roma, 00128, Italy.

Department of Orthopedics, Children's Hospital Bambino Gesù, Palidoro, Rome, 00165, Italy.

出版信息

BMC Musculoskelet Disord. 2024 Aug 19;25(1):650. doi: 10.1186/s12891-024-07623-7.

Abstract

PURPOSE

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.

CONCLUSION

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.

摘要

目的

用于转移性脊柱肿瘤手术(MSTS)的植入设备包括椎弓根螺钉、固定钢板、固定棒和椎间融合器。用于制造这些设备的材料应具有一系列特性,包括生物相容性、无毒、生物活性、低磨损率、在成像过程中低至中度的伪影发生率、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)计划和输送的最小或无负面影响以及与相邻骨融合的高能力。Ti6Al4V 合金在这些应用中具有这些理想特性的缺点是众所周知的,这为寻找可能替代当前金标准的新型生物材料开辟了研究领域。之前关于该主题的评论在其包含的研究中存在明显的缺点,例如样本量小且异质,以及缺乏成本效益分析,这些对于理解大规模应用新型材料的实际可能性非常有用。因此,本综述旨在从最新文献中收集有关这些生物材料临床性能的信息,目的是讨论哪些材料在未来可能比钛更好,特别关注安全性、伪影产生和放疗计划干扰。通过分析这些设备的临床性能,表明有很大的研究前景,需要通过具有更大样本量的前瞻性研究进一步研究,同时考虑到这些材料的生产和使用的各个方面。

方法

采用系统评价和荟萃分析的首选报告项目(PRISMA)指南来提高综述的报告质量。搜索从 2022 年 3 月至 2023 年 9 月进行。

结果

经过筛选过程,最终有 20 篇文章符合本研究的条件。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)和碳纤维螺钉和棒用于纳入的研究中。

结论

CFR-PEEK 显示出与钛植入设备相当的非劣效安全性和疗效。然而,它也有其他优点。通过减少伪影的产生,它能够提高局部肿瘤复发的检测率,并降低放疗剂量的干扰,最终改善需要辅助治疗的患者的预后。尽管如此,其缺点尚未得到充分探讨,仍需要在未来的研究中进一步研究。这并不排除 CFR-PEEK 在不久的将来可能成为钛的有效替代品的事实。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/27b8/11331752/c9b1fcc15724/12891_2024_7623_Fig1_HTML.jpg

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