INvestigative Kyphoplasty Efficacy and Safety Trial (INKTEST)

椎体后凸成形术功效和安全性研究试验 (INKTEST)

• 批准号: 10205238
• 负责人: JEFFREY G JARVIK
• 金额: $ 18.66万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10205238
• 关键词: Adoption; Advisory Committees; Affect; American; Applications Grants; Back Pain; Bed rest; Blinded; Case Report Form; Case Series; Clinical; Clinical Trials; Compression Fracture; Coupled; Data; Devices; Elderly; Enrollment; Evaluation; Event; Fracture; Funding; Funding Mechanisms; Future; Grant; Industry; Infusion procedures; Injections; Institutional Review Boards; Intervention; Manuals; Mechanics; Medical; Medicare; Minerals; Monitor; Morbidity - disease rate; Narcotic Analgesics; National Institute of Arthritis and Musculoskeletal and Skin Diseases; Needles; Osteoporosis; Osteoporotic; Outcome; Pain; Patient Care; Patients; Placebo Effect; Population; Procedures; Protocols documentation; Public Health; Quality of life; Randomized Controlled Trials; Recording of previous events; Research; Research Design; Research Personnel; Risk; Safety; Societies; Spine surgery; Techniques; Time; U-Series Cooperative Agreements; Uncertainty; Vertebral column; base; bone; clinical center; design; efficacy trial; improved; mortality; multidisciplinary; pain reduction; pain relief; participant enrollment; patient expectation; placebo controlled trial; programs; spine bone structure; treatment effect; trial comparing

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”).

项目摘要 该项目的长期目的是改善骨质疏松患者的护理 压缩骨折每年最多发生70万名美国患者。这些痛苦的骨折是 背部疼痛相关的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，支撑和麻醉镇痛药。脊柱增强的冒险，即经皮注入 在1990年代，医疗水泥是痛苦的骨折 患者。该过程是作为简单的针输注（称为“椎体成形术”）或临时进行的。 气球通货膨胀（称为“ kkyphophoptasusty”）在许多病例系列中都显示出来 痛苦。 椎体成形术和脑膜成形术的未盲随机对照试验（RCT）证实了这些试验 结果，显示了脊柱增强的好处，而不是药物治疗。但是，四个独立，盲目， 椎体成形术的安慰剂对照试验没有水泥输注的“模拟”程序的好处。 与椎体成形术不同，在盲试验中从未评估过Kyphopplasty。在“假”之后 椎体成形术试验，在美国执行的椎体成形术程序的数量下降，而 随着时间的推移，脑臂成形术实际上已经增加了。许多调查人员提出 Kyphophopplasty优于椎体成形术，但比较这两个程序的RCT已显示出来 结果的相对等效性。因此，尚不清楚kyphophopphastuse是否会为 “模拟”增强，椎骨成形术没有。 在此赠款申请中，我们将制定计划，以进行未来的随机，对照型脑膜成形术 与“控制干预”相比，在其中模拟了Kyphopplasty，但没有水泥注入。这类研究 设计将使我们能够确定观察到的雌脑成形术的好处是否与气球通胀有关 和水泥输液或其他因素，包括患者对福利的期望（即“安慰剂效应”）。