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临床试验/NCT03240471
NCT03240471已完成不适用

Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization for Non-reduced Distal Radius Fractures: A Randomized Clinical Trial - A Feasibility Trial

Radboud University Medical Center3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
3
主要终点
Change in patient-rated wrist evaluation (PRWE) questionnaire score

研究概览

简要总结

Distal radius fracture (DRF) is a common fracture of which the incidence appears to be increasing worldwide. On average, a total of 17% of all diagnosed fractures are DRF's.

In the Dutch guideline for DRF the treatment advice for DRF, without reduction, is treatment with plaster cast or brace for one-three weeks. Despite the advice in the guideline and despite several studies from the 90's showing that plaster cast treatment of a stable DRF for one week is safe, the usual length of plaster cast treatment for stable DRF is four-six weeks. In addition, recent studies have also shown that a long period of immobilization can lead to more post traumatic pain by increasing disuse and kinesiophobia.

This evidence suggests that the usual duration (4-6 weeks) of plaster cast treatment for DRF is unnecessary.

The aim of this feasibility study is to define whether one week of plaster cast treatment is possible and can lead to better functional results, with at least the same patient satisfaction and complications. In addition, this feasibility study will be used to define the sample size of the future RCT.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 75 years
  • Isolated acute distal radius fracture
  • Closed reduction is not performed
  • Non-operative treatment with cast immobilisation
  • Understanding of Dutch language

排除标准

  • Under the age of 18 or older than 75 years
  • Multiple injured patient
  • Reduction is indicated/performed
  • Operative treatment
  • Not understanding of Dutch language

结局指标

主要结局

Change in patient-rated wrist evaluation (PRWE) questionnaire score

时间窗: Week 6, month 3, month 6 and month 12

Patient rated wrist evaluation score

次要结局

  • Pain after DRF(Baseline, week 6, month 3, month 6, month 12)
  • Change in disability of the Arm, Shoulder and Hand (DASH) questionnaire score(Week 6, month 3, month 6 and month 12)
  • Change in Short-Form 36 questionnaire score(Week 6, month 3, month 6 and month 12)
  • Complications(Duration of study (12 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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