跳至主要内容
临床试验/NCT06046404
NCT06046404
招募中
不适用

Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department

Maasstad Hospital1 个研究点 分布在 1 个国家目标入组 134 人2023年5月8日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Wrist Fractures
发起方
Maasstad Hospital
入组人数
134
试验地点
1
主要终点
daily pain scores
状态
招募中
最后更新
11个月前

概览

简要总结

The investigators test the efficacy of closed reduction in displaced distal radial fractures in the emergency department.

详细描述

in a multicenter cluster randomized trial the investigators aim to include 134 patients with displaced distal radial fractures awaiting surgery and randomize between closed reduction followed by plaster casting and plaster casting alone. Primairy outcomes are pain in the days leading up to surgery and postoperative hand- and wrist function. Secondary outcomes are length of stay in the emergency department, length of surgey, return to work and complications.

注册库
clinicaltrials.gov
开始日期
2023年5月8日
结束日期
2025年7月
最后更新
11个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Maasstad Hospital
责任方
Sponsor

入排标准

入选标准

  • displaced distal radial fracture eligible for surgery

排除标准

  • ISS traumascore \>16
  • open fracture
  • multiple fractures in ipsilateral extremety
  • neurovascular damage
  • previous injury in the same wrist
  • inability to complete questionnaires

结局指标

主要结局

daily pain scores

时间窗: usually 2-10 days

pain reported in the days awaiting surgery on the visual analog scale (VAS) scoring from 0 to 10 where 0 equals no pain and 10 the worst pain imaginable.

次要结局

  • Number of complications(1 year)
  • function(6 weeks, 3, 6 and 12 months)
  • Wrist mobility(6 weeks and 3 months)
  • quality of life in EQ5D5L(1 year)
  • length of stay in emergency department(baseline)

研究点 (1)

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