Macki Mohamed, Syeda Sbaa, Kerezoudis Panagiotis, Bydon Ali, Witham Timothy F, Sciubba Daniel M, Wolinsky Jean-Paul, Bydon Mohamad, Gokaslan Ziya
Department of Neurosurgery, Henry Ford Hospital, Detroit, MI 48202, USA; Johns Hopkins Spinal Biomechanics and Surgical Outcomes Laboratory, Baltimore, MD 21287, USA.
Johns Hopkins Spinal Biomechanics and Surgical Outcomes Laboratory, Baltimore, MD 21287, USA.
J Clin Neurosci. 2016 Oct;32:99-103. doi: 10.1016/j.jocn.2016.03.025. Epub 2016 Jul 7.
The objective of this independent study is to determine the impact of recombinant human bone morphogenetic protein 2 (rhBMP-2) on reoperation for pseudarthrosis and/or instrumentation failure. A nested case-control study of first-time posterolateral, instrumented fusion of the lumbar spine for degenerative spinal disease was undertaken. Cases of reoperation for pseudoarthrosis and/or instrumentation failure were assigned to controls, who did not experience the primary outcome measure at the time of reoperation. Cases and controls were matched on number of interspaces fused and inclusion of interbody. Predictors of reoperation for pseudoarthrosis and/or instrumentation failure were assessed with a conditional logistical regression controlling for rhBMP-2, age, obesity, and smoking. Of the 448 patients, 155 cases of reoperation for pseudoarthrosis and/or instrumentation were matched with 293 controls. Twenty-six percent of first-time surgeries included rhBMP-2, which was statistically more commonly used in the control cohort (33.11%) versus the case cohort (12.90%) (Unadjusted odds ratio [ORunadj]=0.28) (95% confidence interval [CI]: 0.16-0.49). Following a multivariate analysis controlling for age, obesity, and smoking, the rhBMP-2 recipients incurred a 73% lower odds of reoperation for pseudoarthrosis and/or instrumentation failure (95% CI, 0.15-0.48). Neither sarcomatous nor osseous neoplasm was detected in the study population. Mean follow up did not differ between the cases (81.57±standard deviation [SD] 4.98months) versus controls (74.75±2.49month) (ORunadj=1.01) (95% CI: 1.00-1.01). rhBMP-2 in lumbar fusion constructs protects against reoperation for pseudoarthrosis and/or instrumentation failure. However, the decision to include fusion supplements should be weighted between surgical determinants and clinical outcomes.
这项独立研究的目的是确定重组人骨形态发生蛋白2（rhBMP-2）对假关节形成和/或内固定失败再手术的影响。我们对因退行性脊柱疾病首次进行腰椎后路器械融合术开展了一项巢式病例对照研究。将因假关节形成和/或内固定失败而进行再手术的病例与对照组进行匹配，对照组在再手术时未出现主要结局指标。病例组和对照组在融合节段数量和椎间融合器使用情况方面进行匹配。通过条件逻辑回归分析评估假关节形成和/或内固定失败再手术的预测因素，并对rhBMP-2、年龄、肥胖和吸烟进行控制。在448例患者中，155例因假关节形成和/或内固定失败而进行再手术的病例与293例对照组进行了匹配。首次手术中有26%使用了rhBMP-2，在对照组（33.11%）中使用rhBMP-2在统计学上比病例组（12.90%）更常见（未调整优势比[ORunadj]=0.28）（95%置信区间[CI]：0.16-0.49）。在对年龄、肥胖和吸烟进行多因素分析后，接受rhBMP-2治疗的患者因假关节形成和/或内固定失败而进行再手术的几率降低了73%（95%CI，0.15-0.48）。在研究人群中未检测到肉瘤或骨肿瘤。病例组（81.57±标准差[SD]4.98个月）与对照组（74.75±2.49个月）的平均随访时间无差异（ORunadj=1.01）（95%CI：1.00-1.01）。腰椎融合结构中使用rhBMP-2可预防因假关节形成和/或内固定失败而进行的再手术。然而，是否使用融合补充剂的决定应在手术因素和临床结果之间进行权衡。
