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（DRFs）。尽管这种损伤很常见，而且治疗DRFs已有200多年的经验，但老年DRFs的治疗仍然存在争议。紧密复位和铸造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，经常塌陷和移位。目前应用的三种手术技术是紧密复位经皮钉钉、带或不带经皮钉钉的外固定和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他们的手和手腕，以便更快地恢复自我照顾活动。虽然这些结果很有希望，但没有随机对照临床试验来证明更具侵入性，可能更昂贵的电镀技术优于其他更简单的方法。这项21个中心随机对照试验的具体目的是比较这三种手术技术治疗老年人不稳定DRFs的结果。第二个目的是跟踪一组选择不进行手术的老年患者，以评估单独闭合复位和铸造治疗后的结果。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，以收集循证数据，指导未来治疗日益增长的老年人口中这种普遍损伤。

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. PUBLIC HEALTH RELEVANCE: The goal of this 21-center randomized controlled trial is to compare the physical, functional and quality of life outcomes of three different surgical methods for treating distal radius fractures in the elderly: close reduction and percutaneous pinning, external fixation with or without percutaneous pinning and internal fixation with volar locking plates. We will also follow a cohort of patients who opt for the non-surgical treatment, close reduction and casting, to examine and compare the same outcomes following non-surgical treatment.