INvestigative Kyphoplasty Efficacy and Safety Trial (INKTEST)

项目摘要 该项目的长期目标是改善对患有疟疾的病人的护理， 压缩性骨折，每年发生在多达70万美国患者中。这些痛苦的骨折 背痛相关发病率和死亡率的主要原因。从历史上看，这些骨折是用床治疗的。 休息支撑和麻醉性镇痛药脊柱增强术的出现，即，经皮注射 医疗水泥到痛苦的骨折，在20世纪90年代已被认为是一个分水岭事件，在照顾这些 患者该手术，无论是作为一个简单的针输注（称为“椎体成形术”）或临时 球囊扩张（称为“KKyphoplasty”）已在许多病例系列中显示可提供显著缓解 痛苦 椎体成形术和椎体后凸成形术的非盲随机对照试验（RCT）证实了这些早期结果 结果显示，脊柱增强优于药物治疗。然而，四个独立的，盲目的， 椎体成形术的安慰剂对照试验与不注入骨水泥的“模拟”手术相比无获益。 与椎体成形术不同，椎体后凸成形术从未在盲法试验中进行过评价。在“假”之后， 椎体成形术试验，在美国进行的椎体成形术手术数量急剧下降，而 椎体后凸成形术实际上随着时间的推移而增加。许多研究人员提出， 椎体后凸成形术上级椎体成形术，但大量比较两种手术的RCT显示， 结果的相对等价性。因此，尚不清楚椎体后凸成形术是否会提供优于 “模拟”隆乳，而椎体成形术没有。 在这项拨款申请中，我们将计划在未来进行椎体后凸成形术的随机对照试验 与模拟椎体后凸成形术但未注入骨水泥的“对照干预”相比。这种类型的研究 设计将允许我们确定观察到的椎体后凸成形术的受益是否与球囊充盈相关 和骨水泥注入或包括患者期望受益的其它因素（即，“安慰剂效应”）。

PROJECT ABSTRACT The long-term objective of this project is to improve the care of patients suffering from osteoporotic compression fractures, which occurs in up to 700,000 US patients per year. These painful fractures are a leading cause of back pain-related morbidity and mortality. Historically these fractures were treated with bed rest, bracing, and narcotic analgesics. The advent of spine augmentation, i.e., the percutaneous injection of medical cement into painful fractures, in the 1990s has been considered a watershed event in the care of these patients. The procedure, done either as a simple needle infusion (termed “vertebroplasty”) or with temporary balloon inflation (termed “KKyphoplasty”), has been shown in numerous case series to offer remarkable relief of pain. Unblinded randomized controlled trials (RCTs) of both vertebroplasty and Kyphoplasty confirmed these earlier results, showing benefit of spine augmentation over medical therapy. However, four independent, blinded, placebo controlled trials of vertebroplasty no benefit of over a “simulated” procedure without cement infusion. Unlike vertebroplasty, Kyphoplasty has never been evaluated in a blinded trial. In the aftermath of the “sham” vertebroplasty trials, the number of vertebroplasty procedures performed in the US plummeted, while Kyphoplasty procedures have actually increased over time. Numerous investigators have proposed that Kyphoplasty is superior to vertebroplasty, but numerous RCTs comparing the two procedures have shown relative equivalence in outcomes. As such, it remains unknown whether Kyphoplasty would offer benefit over a "simulated" augmentation, where vertebroplasty did not. In this grant application, we will make plans to carry out a future randomized, controlled trial of Kyphoplasty versus a “control intervention,” where Kyphoplasty is simulated but no cement infused. This type of study design will allow us to determine whether the observed benefit of Kyphoplasty is related to the balloon inflation and cement infusion or to other factors that include patient expectation of benefit (i.e., the “placebo effect”).