Nwachukwu Benedict U, Schairer William W, Pan Ting, Widmann Roger F, Blanco John S, Green Daniel W, Lyman Stephen, Dodwell Emily R
Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.
J Pediatr Orthop. 2017 Sep;37(6):e369-e374. doi: 10.1097/BPO.0000000000000915.
Bone morphogenetic protein (BMP) is considered off-label when used to augment spinal arthrodesis in children and adolescents. There is a paucity of longer-term information on BMP use in this population. The purpose of this study was to determine the rate of BMP utilization in pediatric spinal arthrodesis, assess factors associated with BMP use in this population, and evaluate long-term outcome.
Spinal arthrodeses in patients 18 years and younger performed in New York State between 2004 and 2014 were identified through the Statewide Planning and Research Cooperative System database. All cases had a minimum 1-year follow-up. The primary outcome was revision arthrodesis. The primary outcome, as well as short-term and longer-term complications were identified using time-to-event analysis. Multivariable Cox proportional hazards models were used to assess the association between BMP and outcomes.
Of 7312 children and adolescents who underwent spinal arthrodesis, 462 (6.7%) received BMP. Utilization spiked between 2008 and 2010 when (8.6%) of cases received BMP, but subsequently BMP use returned to pre-2008 levels (2004 to 2007: 5.3%; 2011 to 2014: 5.5%). BMP was more likely to be used in children who were older (P=0.027), white and with higher mean family income (P<0.001 for race and income). BMP was more likely to be used for revision surgery, 2 to 3 level fusions, and spondylolisthesis (P<0.001 for all). Revision rates did not differ based on BMP utilization status. Patients receiving BMP did not have increased risk of short-term complications although at 5-year follow-up, BMP was associated with a statistically significant increased risk of mechanical complications (hazard ratio 1.48; 95% confidence interval, 1.02-2.14).
Off-label use of BMP for pediatric spinal arthrodesis increased until 2008 and now appears to be decreasing. Racial/ethnic minorities and lower socioeconomic status patients are less likely to receive BMP. The rate of revision after spinal arthrodesis does not differ between those treated with and without BMP. Further long-term studies are required to delineate appropriate guidelines for BMP utilization in children.
Level III.
骨形态发生蛋白（BMP）用于增强儿童和青少年脊柱融合术时被视为超说明书用药。关于该人群使用BMP的长期信息较少。本研究的目的是确定小儿脊柱融合术中BMP的使用比例，评估与该人群使用BMP相关的因素，并评估长期疗效。
通过全州规划与研究合作系统数据库识别2004年至2014年在纽约州进行的18岁及以下患者的脊柱融合术。所有病例均至少随访1年。主要结局是翻修融合术。使用事件发生时间分析确定主要结局以及短期和长期并发症。多变量Cox比例风险模型用于评估BMP与结局之间的关联。
在7312例接受脊柱融合术的儿童和青少年中，462例（6.7%）接受了BMP。2008年至2010年期间使用率飙升，当时（8.6%）的病例接受了BMP，但随后BMP的使用恢复到2008年前的水平（2004年至2007年：5.3%；2011年至2014年：5.5%）。年龄较大（P=0.027）、白人且家庭平均收入较高的儿童（种族和收入P<0.001）更有可能使用BMP。BMP更有可能用于翻修手术、2至3节段融合术和椎体滑脱（所有P<0.001）。翻修率不因BMP使用情况而异。接受BMP的患者短期并发症风险没有增加，尽管在随访5年时，BMP与机械并发症风险在统计学上显著增加相关（风险比1.48；95%置信区间，1.02 - 2.14）。
BMP在小儿脊柱融合术中的超说明书使用在2008年之前增加，现在似乎在下降。少数种族/族裔和社会经济地位较低的患者接受BMP的可能性较小。接受BMP治疗和未接受BMP治疗的患者脊柱融合术后的翻修率没有差异。需要进一步的长期研究来制定儿童BMP使用的适当指南。
三级。
