SHAM-CONTROLLED TRIAL OF PERCUTANEOUS VERTEBROPLASTY

经皮椎体成形术的假手术对照试验

• 批准号: 6908267
• 负责人: DAVID F KALLMES
• 金额: $ 39.23万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2008-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6908267
• 关键词: analgesics; biomaterial evaluation; biotechnology; bone fracture; clinical research; cost effectiveness; functional ability; health care service utilization; human subject; human therapy evaluation; injection /infusion; osteoporosis; outcomes research; pain; patient oriented research; polymethacrylate; quality of life; questionnaires; spine injury; statistics /biometry; tissue engineering

DESCRIPTION (provided by applicant): The objective of this research protocol is to improve the quality of life for patients suffering from painful, osteoporotic vertebral compression fractures. This objective will be met by examining the clinical efficacy of percutaneous vertebroplasty for treatment of painful, osteoporotic vertebral compression fractures. Spontaneous, atraumatic compression fractures occur in more than 700,000 patients per year. Pain associated with these fractures may be excruciating, but treatment options, before the advent of percutaneous vertebroplasty, were limited. Analgesic medications, bedrest, and bracing have heretofore represented the mainstay of treatment, but each of these therapies has substantial limitations. Because of the dearth of viable treatment options for osteoporotic vertebral compression fractures, the practice of percutaneous vertebroplasty, which involves injection of polymethylmethacrylate (PMMA), or medical cement, into the fractured vertebra, has disseminated rapidly. However, evidence for the efficacy of percutaneous vertebroplasty currently is limited to uncontrolled, non-blinded, small case series. Even though high rates of success are reported, with up to 90% of patients achieving substantial pain relief, these case series have not accounted for numerous important potential biases. These biases include the natural tendency for compression fractures to heal spontaneously, regression toward the mean (wherein patients seek medical attention when pain is maximum), and the placebo effect. Also, previous studies have not used validated health outcomes scales specific for vertebroplasty, and no attempt has been made to determine the cost effectiveness of the procedure. We will perform a sham-controlled, prospective trial of percutaneous vertebroplasty in order to exclude confounding variables, such as the placebo effect, as the explanation for the apparent efficacy of vertebroplasty. Furthermore, we will validate a new, vertebroplasty-specific health outcomes instrument. Last, we will determine the cost-effectiveness of percutaneous vertebroplasty. Successful implementation of the trial will provide compelling evidence regarding the true efficacy of percutaneous vertebroplasty, to allow rationale decision-making in caring for patients suffering from painful, osteoporotic compression fractures.

描述（由申请人提供）：本研究方案的目的是改善患有疼痛性骨质疏松性椎体压缩骨折的患者的生活质量。该目标将通过检查经皮椎体成形术治疗疼痛性骨质疏松性椎体压缩骨折的临床疗效来实现。每年有超过 700,000 名患者发生自发性非创伤性压缩骨折。与这些骨折相关的疼痛可能令人难以忍受，但在经皮椎体成形术出现之前，治疗选择是有限的。迄今为止，镇痛药物、卧床休息和支具是主要的治疗方法，但这些疗法都有很大的局限性。由于缺乏针对骨质疏松性椎体压缩性骨折的可行治疗方案，经皮椎体成形术（包括将聚甲基丙烯酸甲酯 (PMMA) 或医用水泥注射到骨折椎骨中）的实践已迅速普及。然而，目前经皮椎体成形术疗效的证据仅限于不受控制、非盲法、小病例系列。尽管报道的成功率很高，高达 90% 的患者实现了显着的疼痛缓解，但这些病例系列并未考虑到许多重要的潜在偏差。这些偏差包括压缩性骨折自然愈合的自然趋势、向均值回归（患者在疼痛最严重时寻求医疗救助）以及安慰剂效应。此外，之前的研究尚未使用经验证的针对椎体成形术的健康结果量表，也没有尝试确定该手术的成本效益。我们将对经皮椎体成形术进行假手术对照、前瞻性试验，以排除混杂变量，例如安慰剂效应，作为椎体成形术明显疗效的解释。此外，我们将验证一种新的、针对椎体成形术的健康结果工具。最后，我们将确定经皮椎体成形术的成本效益。该试验的成功实施将为经皮椎体成形术的真实疗效提供令人信服的证据，以便在治疗患有疼痛性骨质疏松性压缩性骨折的患者时做出合理的决策。