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The Scoliosis Research Society (SRS) Morbidity and Mortality (M&M) registry is a large, potentially powerful resource in understanding risks related to rhBMP-2 use. This review of SRS registry complications associated with the use of bone morphogenetic proteins (BMPs) is particularly interesting and timely because of recent description of method-ologic shortcomings in trials of rhBMP-2. Unfortunately, the article missed opportunities to add perspective on this issue. Recent reviews have identified several serious complications of rhBMP-2 use. Not surprisingly, the SRS registry was not designed to track all these possible complications. Specifically, Carragee et al cited the incidence of osteolysis with implant subsidence, bone overgrowth, retrograde ejaculation associated with anterior lumbar interbody fusion surgery, neurologic injury risks, and infections. Williams et al discussed only the last 2, noting a high incidence of both problems with anterior cervical discectomy and fusion (ACDF) but no significant differences for other procedures. The validity of these conclusions depends on the intent of the registry, the design of the registry, the statistical analysis used in this article, and the presentation of results. We have concerns in each of these areas.
机译:脊柱侧弯研究协会(SRS)发病率和死亡率(M&M)注册表是了解与rhBMP-2使用相关风险的巨大且潜在强大的资源。这项与骨形态发生蛋白(BMP)使用相关的SRS注册表并发症的综述特别有趣且及时,因为最近对rhBMP-2试验中的方法学缺陷进行了描述。不幸的是,本文错过了就此问题发表观点的机会。最近的评论已经确定了使用rhBMP-2的一些严重并发症。毫不奇怪,SRS注册中心并非旨在跟踪所有这些可能的并发症。特别是,Carragee等人列举了骨沉着的发生率,植入物沉陷,骨骼过度生长,与前腰椎椎间融合手术相关的逆行射精,神经系统损伤的风险和感染。 Williams等人仅讨论了后2个,并指出前颈椎间盘切除术和融合术(ACDF)的两个问题的发生率均很高,但与其他手术没有显着差异。这些结论的有效性取决于注册表的目的,注册表的设计,本文中使用的统计分析以及结果的表示形式。我们在这些领域中都有关切。

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