Wong David A, Kumar Anant, Jatana Sanjay, Ghiselli Gary, Wong Katherine
Advanced Center for Spinal Microsurgery, Presbyterian St. Luke's Medical Center, Denver, CO, USA.
Spine J. 2008 Nov-Dec;8(6):1011-8. doi: 10.1016/j.spinee.2007.06.014. Epub 2007 Nov 26.
Bone morphogenetic protein-2 (BMP-2) (Infuse) has been approved for use in anterior lumbar fusion in conjunction with an LT cage. However, off-label use is seen with anterior cervical fusion, posterior lumbar interbody fusion (PLIF), and transforaminal lumbar interbody fusion (TLIF). The Federal Food and Drug Administration trial of BMP-2 in a PLIF application was halted because of a high incidence of ectopic bone forming in the neural canal (75%). The authors did not find a correlation between ectopic bone and increased leg pain. They concluded that the ectopic bone was a radiographic phenomenon and not associated with clinical findings. Complications using BMP in the cervical spine have been reported. Heretofore, there has not been a similar warning voiced for use of BMP in a lumbar PLIF or TLIF.
The purpose was to report five cases of ectopic bone in the canal associated with PLIF/TLIF off-label use of BMP-2 potentially contributing to abnormal neurologic findings.
STUDY DESIGN/SETTING: This is an observational cohort study of patients referred to a tertiary care private medical center.
This was a retrospective chart review of patients referred to a tertiary spine institute with complications after surgery where BMP-2 had been used in an off-label PLIF or TLIF application. Patient demographics, operating room (OR) notes from the index BMP surgery, imaging studies, and current clinical status were reviewed.
Five cases of ectopic bone in the spinal canal with potential neurologic compromise were identified.
It does appear that ectopic bone in the spinal canal associated with BMP-2 use in PLIF or TLIF may contribute to symptomatic neurologic findings in rare cases. Revision surgeries are difficult. This article challenges a previous publication, which concluded that the high incidence of ectopic bone was of no clinical significance. Isolating BMP anteriorly in the disc space using layered barriers of bone graft between the BMP and the annular defect may reduce the incidence of ectopic bone in the spinal canal. Surgeons need to weigh the benefits versus risks of any technology used off label when making treatment decisions with their patients.
骨形态发生蛋白-2（BMP-2）（Infuse）已被批准与LT椎间融合器联合用于前路腰椎融合术。然而，其在颈椎前路融合术、后路腰椎椎间融合术（PLIF）和经椎间孔腰椎椎间融合术（TLIF）中存在非适应证使用的情况。美国食品药品监督管理局关于BMP-2用于PLIF的试验因神经根管内异位骨形成的发生率较高（75%）而停止。作者未发现异位骨与腿痛增加之间存在关联。他们得出结论，异位骨是一种影像学现象，与临床症状无关。已有关于在颈椎使用BMP的并发症报道。在此之前，对于在腰椎PLIF或TLIF中使用BMP尚未发出类似警告。
报告5例与PLIF/TLIF非适应证使用BMP-2相关的椎管内异位骨病例，这些异位骨可能导致异常神经学表现。
研究设计/研究地点：这是一项对转诊至三级私立医疗中心患者的观察性队列研究。
这是一项对转诊至三级脊柱研究所且在非适应证PLIF或TLIF应用中使用BMP-2后出现手术并发症患者的回顾性病历审查。审查了患者人口统计学资料、初次BMP手术的手术室记录、影像学检查以及当前临床状况。
确定了5例椎管内存在异位骨且可能有神经功能损害的病例。
在PLIF或TLIF中使用BMP-2相关的椎管内异位骨在罕见情况下似乎可能导致有症状的神经学表现。翻修手术困难。本文对之前一篇得出异位骨高发生率无临床意义结论的出版物提出了质疑。使用骨移植分层屏障将BMP隔离于椎间盘间隙前方，可能会降低椎管内异位骨的发生率。外科医生在与患者做出治疗决策时，需要权衡任何非适应证使用技术的利弊。
