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脱矿骨基质用于腰椎器械融合术的疗效、成本及并发症:与重组人骨形态发生蛋白-2的比较

Efficacy, Cost, and Complications of Demineralized Bone Matrix in Instrumented Lumbar Fusion: Comparison With rhBMP-2.

作者信息

Eleswarapu Ananth, Rowan F Andrew, Le Hai, Wick Joseph B, Roberto Rolando F, Javidan Yashar, Klineberg Eric O

机构信息

University of California Davis, Sacramento, CA, USA.

出版信息

Global Spine J. 2021 Oct;11(8):1223-1229. doi: 10.1177/2192568220942501. Epub 2020 Aug 4.

Abstract

STUDY DESIGN

Retrospective cohort study.

OBJECTIVES

To evaluate demineralized bone matrix as an adjunct for instrumented lumbar spine fusion compared with recombinant human bone morphogenetic protein-2 (rhBMP-2).

METHODS

Clinical and radiographic review was performed of 43 patients with degenerative spine disease treated with posterolateral spinal fusion with or without posterior or transforaminal lumbar interbody fusion. Final analysis included sixteen patients treated with demineralized bone matrix (DBM; Accell Evo3, SeaSpine) compared with a retrospective matched group of 21 patients treated with rhBMP-2 (rhBMP-2, Infuse, Medtronic). All patients were followed for 24 months. Fusion was evaluated by computed tomography and/or x-ray. Clinical outcomes included visual analogue scale (VAS), Oswestry Disability Index (ODI), and Short Form 12 (SF-12).

RESULTS

Overall fusion rate, including posterolateral and/or interbody fusion, was 100% for both groups, though the fusion rates in the posterolateral space alone were 93.5% and 100% for the DBM and rhBMP-2 groups, respectively. Clinical outcomes were similar between groups, with the DBM group showing greater improvement in ODI. The rhBMP-2 group showed higher rates of radiographic complications with 7 of 21 patients (33.3%) demonstrating either adjacent level fusion or ectopic bone formation, compared with zero in the DBM group. Average biologic cost per level was $1522 for DBM and $3505 for rhBMP-2.

CONCLUSIONS

DBM and rhBMP-2 demonstrated similar radiographic and clinical outcomes in instrumented lumbar fusions. rhBMP-2 was associated with higher rates of radiographic complications and significantly higher costs.

摘要

研究设计

回顾性队列研究。

目的

评估脱矿骨基质作为器械辅助腰椎融合术的辅助材料与重组人骨形态发生蛋白-2(rhBMP-2)相比的效果。

方法

对43例接受后外侧脊柱融合术(有或无后路或经椎间孔腰椎椎间融合术)治疗的退行性脊柱疾病患者进行临床和影像学回顾。最终分析包括16例接受脱矿骨基质(DBM;Accell Evo3,SeaSpine)治疗的患者,并与回顾性匹配的21例接受rhBMP-2(rhBMP-2,Infuse,美敦力)治疗的患者组进行比较。所有患者均随访24个月。通过计算机断层扫描和/或X线评估融合情况。临床结果包括视觉模拟量表(VAS)、奥斯威斯功能障碍指数(ODI)和简明健康调查问卷(SF-12)。

结果

两组的总体融合率(包括后外侧和/或椎间融合)均为100%,尽管仅后外侧间隙的融合率在DBM组和rhBMP-2组中分别为93.5%和100%。两组的临床结果相似,DBM组在ODI方面改善更大。rhBMP-2组的影像学并发症发生率更高,21例患者中有7例(33.3%)出现相邻节段融合或异位骨形成,而DBM组为零。DBM每节段的平均生物成本为1522美元,rhBMP-2为3505美元。

结论

在器械辅助腰椎融合术中,DBM和rhBMP-2的影像学和临床结果相似。rhBMP-2与更高的影像学并发症发生率和显著更高的成本相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d003/8453673/e68ad14ddaed/10.1177_2192568220942501-fig1.jpg

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