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Investigating the efficacy of allograft cellular bone matrix for spinal fusion: a systematic review of the literature
Neurosurgical Focus ( IF 3.3 ) Pub Date : 2021-06-01 , DOI: 10.3171/2021.3.focus2179
Ryan R. Diaz , Amey R. Savardekar , Jared R. Brougham , Danielle Terrell , Anthony Sin

OBJECTIVE

The use of allograft cellular bone matrices (ACBMs) in spinal fusion has expanded rapidly over the last decade. Despite little objective data on its effectiveness, ACBM use has replaced the use of traditional autograft techniques, namely iliac crest bone graft (ICBG), in many centers.

METHODS

In accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, a systematic review was conducted of the PubMed, Cochrane Library, Scopus, and Web of Science databases of English-language articles over the time period from January 2001 to December 2020 to objectively assess the effectiveness of ACBMs, with an emphasis on the level of industry involvement in the current body of literature.

RESULTS

Limited animal studies (n = 5) demonstrate the efficacy of ACBMs in spinal fusion, with either equivalent or increased rates of fusion compared to autograft. Clinical human studies utilizing ACBMs as bone graft expanders or bone graft substitutes (n = 5 for the cervical spine and n = 8 for the lumbar spine) demonstrate the safety of ACBMs in spinal fusion, but fail to provide conclusive level I, II, or III evidence for its efficacy. Additionally, human studies are plagued with several limiting factors, such as small sample size, lack of prospective design, lack of randomization, absence of standardized assessment of fusion, and presence of industry support/relevant conflict of interest.

CONCLUSIONS

There exist very few objective, unbiased human clinical studies demonstrating ACBM effectiveness or superiority in spinal fusion. Impartial, well-designed prospective studies are needed to offer evidence-based best practices to patients in this domain.



中文翻译:

研究同种异体细胞骨基质对脊柱融合的疗效:文献系统评价

客观的

在过去十年中,同种异体细胞骨基质 (ACBM) 在脊柱融合中的应用迅速扩大。尽管几乎没有关于其有效性的客观数据,但在许多中心,ACBM 的使用已经取代了传统的自体移植技术,即髂嵴骨移植 (ICBG)。

方法

根据 PRISMA(系统评价和元分析的首选报告项目)指南,对 PubMed、Cochrane 图书馆、Scopus 和 Web of Science 数据库在 2001 年 1 月至2020 年 12 月,客观评估 ACBM 的有效性,重点是当前文献中的行业参与程度。

结果

有限的动物研究 (n = 5) 证明了 ACBM 在脊柱融合中的功效,与自体移植相比,融合率相等或更高。使用 ACBM 作为骨移植扩张器或骨移植替代物的临床人体研究(颈椎 n = 5,腰椎 n = 8)证明了 ACBM 在脊柱融合中的安全性,但未能提供结论性的 I、II 或III 证明其有效性的证据。此外,人体研究受到几个限制因素的困扰,例如样本量小、缺乏前瞻性设计、缺乏随机化、缺乏对融合的标准化评估以及存在行业支持/相关利益冲突。

结论

很少有客观、公正的人类临床研究证明 ACBM 在脊柱融合中的有效性或优越性。需要公正的、精心设计的前瞻性研究,为该领域的患者提供基于证据的最佳实践。

更新日期:2021-06-01
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