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

手术治疗老年桡骨远端骨折的临床试验

• 批准号: 8726722
• 负责人: KEVIN C CHUNG
• 金额: $ 78.14万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-15 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8726722
• 关键词: Affect; Aftercare; Anatomy; Bone Density; Characteristics; Clinical Trials; Data; Deformity; Dissection; Distal; Economics; Elderly; Forearm Fracture; Fracture; Frequencies; Future; Generations; Goals; Hand; Health Expenditures; Healthcare; Hip region structure; Immobilization; Individual; Injury; Life; Life Style; Methods; Michigan; Motion; North America; Operative Surgical Procedures; Osteoporosis; Outcome; Patient Preferences; Patients; Pattern; Population; Public Health; Publishing; Quality of Care; Quality of life; Questionnaires; Radius Fractures; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Recording of previous events; Recovery; Research Design; Retrospective Studies; Sample Size; Self Care; Series; Severities; Socioeconomic Status; Techniques; Time; Uncertainty; United States; Woman; Wrist; arm; base; bone; cohort; cost; cost utility analysis; evidence base; experience; follow-up; functional gain; functional outcomes; functional status; human old age (65+); older patient; osteoporosis with pathological fracture; prevent; primary outcome; programs; sample fixation; treatment strategy; trend; trial comparing

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.

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和超过200年的治疗经验，老年DRF的管理仍然是有争议的。闭合复位和石膏固定是一种常用的非手术技术，但骨质疏松性骨折在老年人中很常见，经常会塌陷和移位。目前应用的三种手术技术是闭合复位和经皮穿针，有或无经皮穿针的外固定，以及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护理活动。虽然这些结果是有希望的，但没有随机对照临床试验来证明更具侵入性，可能更昂贵，钢板技术优于其他简单的方法上级。这项21个中心的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不稳定DRF的结局。次要目的是随访一组选择不接受手术的老年患者，以评价单纯闭合复位和铸造治疗的结局。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的损伤。