Trochanteric Padding to Prevent Hip Fractures

用于预防髋部骨折的转子衬垫

• 批准号: 6431069
• 负责人: DOUGLAS P. KIEL
• 金额: $ 117.03万
• 依托单位: HEBREW REHABILITATION CENTER FOR AGED
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-30 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6431069
• 关键词: clinical trials; consumer product; hip fractures; human subject; injury prevention; nursing homes; patient oriented research; quality of life

DESCRIPTION: (provided by applicant) As measured by their frequency, influence on quality of life and economic cost, hip fractures are a public health problem of crisis proportions. Studies suggest that hip fractures may be prevented by the use of protective trochanteric padding, although some of those studies were small, had potential biases introduced by randomizing nursing homes or nursing home units, and used energy shunting pads. Fractures may still occur beneath such pads, and compliance has been variable because these pads were not particularly easy to wear or comfortable. We plan to conduct a randomized controlled trial of an energy absorbing and distributing, trochanteric padding system to reduce the incidence of hip fractures in 546 NH residents followed for an average of three years. To carry out this trial, a Coordinating Center (Maryland Medical Research Institute in Baltimore) will work with three clinical centers in Boston, Baltimore, and St. Louis that will each recruit 10-14 NHs and 182 NH residents to participate; residents will be replaced as they drop out during the follow up period. This sample size accounts for an effect size of 50 percent, and compliance rate of 50 percent. Each subject will be given a set of protective underwear containing a single pocket and hip pad so that each resident becomes his/her own control. The side to be protected is based on the randomization of facilities to be either "right" or "left-sided" such that the final sample will consist of an approximately equal number of residents with protection on the right as on the left hip. Using an intent to treat analysis, we will compare hip fracture incidence in padded and unpadded hips. The secondary aim will be to identify patient and facility factors contributing to non-adherence with the use of hip protectors. This will be the largest clinical trial of this biomechanically tested, energy absorbing and distributing hip protector ever conducted in the United States.

描述：(由申请人提供)以他们的频率、影响力衡量 在生活质量和经济成本方面，髋部骨折是一个公共健康问题 危机程度之高。研究表明，髋部骨折可以通过以下方法预防 使用保护性粗隆填充物，尽管其中一些研究是 小，有潜在的偏见，通过随机选择疗养院或护理引入 家庭单元，以及用过的能量分流垫。骨折仍可能发生在脚下 这种垫子，合规性一直是可变的，因为这些垫子不是 特别容易佩戴或舒适。我们计划进行一次随机的 一种能量吸收分配、粗隆填充物的对照试验 遵循降低546名NH居民髋部骨折发生率的系统 平均三年。为了进行这项试验，协调中心 (位于巴尔的摩的马里兰医学研究所)将与三个 波士顿、巴尔的摩和圣路易斯的临床中心将分别招聘 10-14 NHS和182名NH居民参与；居民将被替换为 他们在随访期内退学。此样本大小占 有效规模为50%，合规率为50%。每个科目都将 得到一套只有一个口袋和臀部垫的防护内衣 因此，每个居民都成为他/她自己的控制者。需要保护的一侧是 基于设施的随机性，不是“右”就是“左” 使得最终样本将由大致相同数量的 右侧和左侧臀部一样受到保护的居民。使用意图来 治疗分析，我们将比较有衬垫和无衬垫髋部骨折的发生率 臀部。次要目标将是确定患者和设施因素 导致不遵守髋关节保护器的使用。这将是 这项生物力学测试的最大临床试验，吸收能量和 分发在美国进行过的髋关节保护器。