跳至主要内容
临床试验/NCT01589692
NCT01589692已完成不适用

A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures. The Wrist and Radius Injury Surgical Trial (WRIST)

University of Michigan46 个研究点 分布在 3 个国家目标入组 304 人开始时间: 2012年4月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
304
试验地点
46
主要终点
Michigan Hand Outcomes Questionnaire score

研究概览

简要总结

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 24-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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have an unstable DRF for which surgical fixation is indicated
  • o AO type A2, A3, C1, C2
  • At least one of the following radiographic criteria indicating fracture instability
  • Dorsal angulation of greater than 10°
  • Radial inclination angle of less than 15°
  • Radial shortening of greater than 3mm
  • Patients with the ability to read and understand English (to complete study questionnaires)
  • Community-dwelling patients
  • Patients 60 years of age or older

排除标准

  • Patients who have suffered open DRFs
  • Patients with bilateral DRFs
  • Patients with associated upper extremity fractures or ligament injuries (including ulnar styloid fracture, TFCC and wrist ligament injuries) requiring repair at the time of DRF fixation
  • Multi-trauma patients
  • Patients with prior DRF on the same wrist
  • Patients with comorbid conditions prohibiting surgery
  • Patients with neurologic disorders that affect hand, wrist or arm sensation or movement
  • Patients who have a history of dementia, Alzheimer's Disease or other serious psychiatric disorders
  • Patients with current substance abuse
  • Patients who do not agree to be randomized
  • Patients who have DRFs that are not equally suited for each procedure (i.e. severely comminuted fractures)

研究组 & 干预措施

Internal Fixation

Experimental

Open Reduction and Internal Fixation: Internal fixation with a volar locking plating system

干预措施: Open Reduction and Internal Fixation (Procedure)

External Fixation

Experimental

External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.

干预措施: External Fixation (Procedure)

Pinning

Experimental

Percutaneous pinning with any number of Kirschner wires

干预措施: Percutaneous Pinning (Procedure)

No Surgery

Active Comparator

Closed Reduction and casting: Closed reduction and immobilization with a cast and/or splint

干预措施: Closed Reduction and casting (Procedure)

结局指标

主要结局

Michigan Hand Outcomes Questionnaire score

时间窗: 12months

upper-extremity questionnaire

次要结局

  • Change in Rapid Assessment of Physical Activity score(pre-injury and 24months)
  • Hand function(12months)
  • SF-36 score(12months)
  • complications(12months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Kevin C. Chung

Charles B. G. de Nancrede Professor of Surgery

University of Michigan

研究点 (46)

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