骨形态发生蛋白会改变脊柱融合术中的手术性骨不连发生率吗？
Does bone morphogenetic protein change the operative nonunion rates in spine fusions?
作者信息
Guppy Kern H, Paxton Elizabeth W, Harris Jessica, Alvarez Julie, Bernbeck Johannes
机构信息
*Department of Neurosurgery, Kaiser Permanente Medical Group, Sacramento, CA †Department of Neurological Surgery, University of California, San Francisco, CA ‡Surgical Outcomes & Analysis Unit of Clinical Analysis, Kaiser Permanente, San Diego, CA; and §Department of Orthopaedics, Kaiser Permanente Southern California, Baldwin Park, CA.
出版信息
Spine (Phila Pa 1976). 2014 Oct 15;39(22):1831-9. doi: 10.1097/BRS.0000000000000534.
STUDY DESIGN
A retrospective cohort study with medical record review.
OBJECTIVE
To determine if there is difference in the operative nonunion rates with and without the use of bone morphogenetic protein (BMP) after spinal fusions by analyzing data from an integrated health care system's spine registry.
SUMMARY OF BACKGROUND DATA
BMP was first approved in 2002 for use in single-level anterior lumbar fusions. Follow-up studies have advocated its use in reducing the need for reoperations for nonunions. Recent studies, however, have questioned these conclusions and the usefulness of BMP in spinal fusions has been highly debated.
METHODS
We identified 9425 spinal fusion cases between 2009 and 2011 from a spine registry in a large integrated health care organization. Patient characteristics, diagnosis, operative times, length of stay, and reoperations were extracted from the registry. Reoperations for nonunions were adjudicated via medical record review. Cox regression models were used to evaluate the risk of reoperation while adjusting for confounders.
RESULTS
In our cohort, there were 5456 BMP cases and 3969 non-BMP cases. The mean age was 60.4 years (standard deviation: 12.9 yr), with the majority being females (53%). The median follow-up time was 1.2 years (interquartile range: 0.6-2.0 yr). Reoperation rates for BMP versus non-BMP nonunions for all fusion cases with follow-up of 1 year or more (1.9% vs. 2.2%) and follow-up of 2 years or more (2.3% vs. 2.6%) were not statistically significantly different. Operative nonunion rates did not reach statistical significance for different spine regions and for different fused columns (anterior only, posterior only, or combined). After controlling for differences in patient characteristics, operative times, levels fused, and spinal regions, the risk of reoperation in the BMP versus non-BMP groups was 0.67 (95% CI: 0.42-1.06).
CONCLUSION
In this large cohort of spinal fusions at all spine regions involving all fused columns with and without BMP, we found no statistically significant difference in operative nonunion rates.
LEVEL OF EVIDENCE
研究设计
一项通过病历回顾进行的回顾性队列研究。
目的
通过分析综合医疗保健系统脊柱登记处的数据，确定脊柱融合术后使用与未使用骨形态发生蛋白（BMP）时手术不愈合率是否存在差异。
背景数据总结
BMP于2002年首次获批用于单节段前路腰椎融合术。后续研究主张使用它来减少因不愈合而进行再次手术的需求。然而，近期研究对这些结论提出质疑，并且BMP在脊柱融合术中的效用一直存在激烈争论。
方法
我们从一个大型综合医疗保健机构的脊柱登记处识别出2009年至2011年间的9425例脊柱融合病例。从登记处提取患者特征、诊断、手术时间、住院时长及再次手术情况。通过病历回顾判定因不愈合而进行的再次手术。使用Cox回归模型在调整混杂因素的同时评估再次手术风险。
结果
在我们的队列中，有5456例使用BMP的病例和3969例未使用BMP的病例。平均年龄为60.4岁（标准差：12.9岁），大多数为女性（53%）。中位随访时间为1.2年（四分位间距：0.6 - 2.0年）。在所有随访1年或更长时间（1.9%对2.2%）以及随访2年或更长时间（2.3%对2.6%）的融合病例中，使用BMP与未使用BMP的不愈合再次手术率在统计学上无显著差异。不同脊柱区域和不同融合柱（仅前路、仅后路或联合）的手术不愈合率未达到统计学显著性。在控制患者特征、手术时间、融合节段和脊柱区域的差异后，使用BMP组与未使用BMP组的再次手术风险为0.67（95%置信区间：0.42 - 1.06）。
结论
在这个涉及所有脊柱区域、所有融合柱且使用与未使用BMP的大型脊柱融合队列中，我们发现手术不愈合率在统计学上无显著差异。
证据级别
3级。
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