Trochanteric Padding to Prevent Hip Fractures

描述：（由申请人提供）根据其频率、影响力 在生活质量和经济成本方面，髋部骨折是一个公共卫生问题， 危机的比例。研究表明，髋部骨折可以通过以下方法预防： 使用保护性转子衬垫，尽管其中一些研究 小，有潜在的偏见介绍随机疗养院或护理 家庭单元和使用的能量分流垫。裂缝仍可能发生在 这种衬垫，并且顺应性是可变的，因为这些衬垫不 特别容易穿着或舒适。我们计划进行一次随机的 能量吸收和分配的转子衬垫的对照试验 系统，以减少髋部骨折的发病率在546 NH居民如下 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州医学研究所）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募 10-14个NH和182个NH居民参加;居民将被替换为 他们在随访期间退出。这一样本量占 效应量为50%，依从率为50%。每例受试者将 可获发一套内有一个口袋及臀部护垫的防护内衣 这样每个居民都可以自己控制要保护的一面是 根据设施随机分为“右侧”或“左侧” 使得最终样品将由大致相等数量的 居民在右边和左边臀部都有保护。使用意图来 治疗分析，我们将比较有衬垫和无衬垫的髋部骨折发生率 的臀部次要目的是确定患者和设施因素 导致不坚持使用髋关节保护器。这将是 最大的临床试验，这种生物力学测试，能量吸收和 分发髋关节保护器的最大规模

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.