A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures

描述(由申请人提供)：在美国，每年有超过30万65岁以上的人患有桡骨远端骨折(DRF)。尽管这种损伤的频率很高，而且有200多年治疗DRF的经验，但老年DRF的管理仍然存在争议。闭合复位和铸型是一种经常使用的非手术技术，但骨质疏松性骨折在老年人中很常见，经常发生塌陷和移位。目前应用的三种手术技术是闭合复位经皮穿针、外固定加或不加经皮穿针、掌侧锁定钢板内固定。初步证据表明，锁定钢板固定可以使老年患者更快地移动手和手腕，以便更快地恢复自我护理活动。尽管这些结果是有希望的，但还没有随机对照临床试验来证明更具侵入性、可能更昂贵的钢板技术优于其他更简单的方法。这项21中心随机对照试验的具体目的是比较这三种手术技术在治疗老年人不稳定DRF方面的结果。第二个目标是跟踪一组选择不做手术的老年患者，以评估仅通过闭合复位和铸型治疗后的结果。这项临床试验是手外科领域最雄心勃勃的研究，它汇集了北美大多数领先的中心，收集循证数据，以指导未来在不断增长的老年人口中治疗这种普遍存在的损伤。

DESCRIPTION (provided by applicant): In the United States, over 300,000 individuals over age 65 suffer from distal radius fractures (DRFs) each year. Despite the frequency of this injury and over 200 years of experience treating DRFs, management of elderly DRFs is still controversial. Close reduction and casting is a nonsurgical technique that is frequently used, but osteoporotic fractures, common in the elderly, often collapse and displace. The three currently applied surgical techniques are close reduction and percutaneous pinning, external fixation with or without percutaneous pinning, and internal fixation with volar locking plating. Preliminary evidence indicates that locking plate fixation can permit elderly patients to move their hands and wrists much sooner in order to return to self-care activities more quickly. Although these outcomes are promising, there is no randomized controlled clinical trial to demonstrate that the more invasive, and perhaps more costly, plating technique is superior to the other simpler approaches. The specific aim of this 21-center randomized controlled trial is to compare outcomes of these three surgical techniques in treating unstable DRFs in the elderly. The secondary aim is to follow a cohort of elderly patients who choose not to have surgery to evaluate outcomes following treatment by close reduction and casting alone. This clinical trial is the most ambitious study in hand surgery by assembling most of the leading centers in North America to collect evidence-based data to guide future treatment of this prevalent injury in the growing elderly population.