跳至主要内容
临床试验/NCT04632745
NCT04632745Unknown不适用

A Prospective Randomized Evaluation of Splinting and Casting for Distal Radius Fractures in the Elderly

Rothman Institute Orthopaedics2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年11月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
110
试验地点
2
主要终点
Fracture treatment outcome

研究概览

简要总结

Distal radial fractures are the most common fracture of the upper extremity in adults, with a higher incidence in those 65 years of age or older. In 2009, Karl et al demonstrated that there are 25.42 distal radial fractures in this age group per 10,000 person-years in the US. Despite the frequency of distal radius fractures, there is still debate over the best method of treatment. In contrast to younger patients, patients who are 65 years or older appear to have acceptable functional outcomes and treatment satisfaction regardless of the presence of malalignment on radiographic imaging.Therefore, nonsurgical management has been shown to be a viable treatment option.

The purpose of this study is to compare non-operative treatment with a removable splint versus a short arm cast for distal radial fractures in patients who are 65 years of age or older who are indicated for non-operative fracture treatment.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients greater than 65 years old with isolated distal radius fracture amenable to non-operative treatment

排除标准

  • Patients younger than 65 years old
  • Open fractures (Gustilo Grade 2 or 3)
  • Pathologic fractures
  • Multiple fractures in the upper or lower extremities
  • Fracture indicated for surgical repair of the distal radius for any reason
  • Lack of health insurance
  • Inability to provide consent to the study

结局指标

主要结局

Fracture treatment outcome

时间窗: 6 weeks

The rate of successful outcomes of participants who are treated for a distal radius fracture nonsurgically by splinting compared to participants who are treated by casting

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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