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活性钛椎间融合器能否加速或增强脊柱融合?文献回顾与临床试验设计。

Can activated titanium interbody cages accelerate or enhance spinal fusion? a review of the literature and a design for clinical trials.

机构信息

Departments of Neurological Surgery, The Ohio State University Wexner Medical Center, Columbus, OH, USA.

Department of Neurosurgery, College of Medicine, University of Kentucky, Lexington, KY, USA.

出版信息

J Mater Sci Mater Med. 2021 Dec 18;33(1):1. doi: 10.1007/s10856-021-06628-1.

Abstract

While spinal interbody cage options have proliferated in the past decade, relatively little work has been done to explore the comparative potential of biomaterial technologies in promoting stable fusion. Innovations such as micro-etching and nano-architectural designs have shown purported benefits in in vitro studies, but lack clinical data describing their optimal implementation. Here, we critically assess the pre-clinical data supportive of various commercially available interbody cage biomaterial, topographical, and structural designs. We describe in detail the osteointegrative and osteoconductive benefits conferred by these modifications with a focus on polyetheretherketone (PEEK) and titanium (Ti) interbody implants. Further, we describe the rationale and design for two randomized controlled trials, which aim to address the paucity of clinical data available by comparing interbody fusion outcomes between either PEEK or activated Ti lumbar interbody cages. Utilizing dual-energy computed tomography (DECT), these studies will evaluate the relative implant-bone integration and fusion rates achieved by either micro-etched Ti or standard PEEK interbody devices. Taken together, greater understanding of the relative osseointegration profile at the implant-bone interface of cages with distinct topographies will be crucial in guiding the rational design of further studies and innovations.

摘要

虽然过去十年中脊柱椎间融合器的选择已经多样化,但在探索生物材料技术在促进稳定融合方面的潜在比较方面,相对较少的工作已经完成。微刻蚀和纳米结构设计等创新在体外研究中显示出了据称的益处,但缺乏描述其最佳实施方式的临床数据。在这里,我们批判性地评估了支持各种市售椎间融合器生物材料、形貌和结构设计的临床前数据。我们详细描述了这些改良所带来的骨整合和骨诱导益处,重点介绍聚醚醚酮(PEEK)和钛(Ti)椎间植入物。此外,我们还描述了两项随机对照试验的原理和设计,这些试验旨在通过比较 PEEK 或活化 Ti 腰椎椎间融合器的融合结果来解决现有临床数据不足的问题。利用双能计算机断层扫描(DECT),这些研究将评估具有不同形貌的椎间融合器的相对植入物-骨整合和融合率。总之,在指导进一步研究和创新的合理设计方面,更深入地了解具有不同形貌的融合器在植入物-骨界面处的相对骨整合特征将至关重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4c76/8684547/abf2941655c0/10856_2021_6628_Fig1_HTML.jpg

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