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可扩张椎间融合器:一项为期两年的研究,评估影像学和临床结果以及患者报告的结果。

Expandable Interbody Spacers: A Two-Year Study Evaluating Radiologic and Clinical Outcomes With Patient-Reported Outcomes.

作者信息

Mulvaney Graham, Monk Steve, Clemente Jonathan D, Pfortmiller Deborah, Coric Domagoj

机构信息

Carolina Neurosurgery & Spine Associates, Charlotte, North Carolina.

Atrium Health Musculoskeletal Institute, Department of Neurological Surgery, Charlotte, North Carolina.

出版信息

Int J Spine Surg. 2020 Dec;14(s3):S31-S38. doi: 10.14444/7124. Epub 2020 Oct 29.

Abstract

BACKGROUND

Posterior and transforaminal lumbar interbody fusion (PLIF and TLIF) have gained significant popularity for management of lumbar degenerative spine over the last 3 decades. Expandable interbody spacers are a newer technology that can increase in size after placement, theoretically minimizing the operative risks of static spacers without sacrificing radiographic correction. The goal of this study is to further evaluate the radiographic and clinical outcomes of expandable spacers.

METHODS

This was a retrospective analysis of a prospective cohort that underwent elective 1- to 3-level PLIF/TLIF with expandable interbody spacers from 2014 to 2020 at a single institution. Patient-reported outcome measures (PROMs) Oswestry Disability Index and Visual Analog Scale were collected at 6 weeks, 3 months, 6 months, and 12 months. Imaging was performed at 12 months, with follow up at 24 months in case of nonunion. Retrospective outcomes were computer tomography (CT) based and Bridwell-Lenke classification of fusion, radiographic parameters, and adverse events.

RESULTS

A total of 50/53 (94.3%) otherwise eligible patients had 12-month PROMs and CT imaging for analysis. Here, 50% were obese (body mass index > 30), 58% had a smoking history, and 24% had a prior lumbar procedure. Also, 46/50 (92%) patients fused by CT criteria. Significant decrease in PROMs was seen as early as 6 weeks postoperatively. The mean change in preoperative-to-postoperative global lordosis values was 3.8° ± 15.6°. There were 4 (8%) intraoperative durotomies and 5 (10%) patients requiring reoperation for nonunion.

CONCLUSIONS

Our study demonstrates the use of expandable spacers in a high comorbidity cohort with low complications, excellent improvement in PROMs despite minimal lordotic improvement, and high rates of fusion without recombinant human bone morphogenetic protein-2 (rhBMP-2) or iliac crest bone graft.

LEVEL OF EVIDENCE

CLINICAL RELEVANCE

Expandable interbody fusion can significantly improve outcomes for degenerative lumbar spondylosis, with good safety profile, and high fusion rates.

摘要

背景

在过去30年中,后路腰椎椎间融合术(PLIF)和经椎间孔腰椎椎间融合术(TLIF)在腰椎退行性疾病的治疗中得到了广泛应用。可扩张椎间融合器是一种较新的技术,放置后可增大尺寸,理论上可将静态融合器的手术风险降至最低,同时不影响影像学矫正效果。本研究的目的是进一步评估可扩张融合器的影像学和临床疗效。

方法

这是一项对前瞻性队列的回顾性分析,该队列于2014年至2020年在单一机构接受了1至3节段的PLIF/TLIF手术,并使用了可扩张椎间融合器。在术后6周、3个月、6个月和12个月收集患者报告的结局指标(PROMs),即Oswestry功能障碍指数和视觉模拟量表。在术后12个月进行影像学检查,若出现骨不连则在24个月进行随访。回顾性结局基于计算机断层扫描(CT)以及融合的Bridwell-Lenke分类、影像学参数和不良事件。

结果

共有50/53(94.3%)名符合条件的患者有12个月的PROMs和CT影像用于分析。其中,50%为肥胖患者(体重指数>30),58%有吸烟史,24%曾接受过腰椎手术。此外,46/50(92%)的患者根据CT标准实现了融合。术后6周时,PROMs就出现了显著下降。术前至术后整体前凸值的平均变化为3.8°±15.6°。有4例(8%)术中硬脊膜切开,5例(10%)患者因骨不连需要再次手术。

结论

我们的研究表明,在高合并症队列中使用可扩张融合器并发症发生率低,尽管前凸改善不明显,但PROMs有显著改善,且在未使用重组人骨形态发生蛋白-2(rhBMP-2)或髂嵴骨移植的情况下融合率高。

证据级别

4级。

临床意义

可扩张椎间融合术可显著改善退行性腰椎疾病的治疗效果,安全性良好,融合率高。

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