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
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
- 否
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))
