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临床试验/NCT00438308
NCT00438308已完成不适用

Prospective Randomized Comparison of Early and Late Wrist Mobilization After Volar Plate Fixation of a Fracture of the Distal Radius

Massachusetts General Hospital0 个研究点目标入组 60 人开始时间: 2004年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
range of motion in degrees of the wrists

研究概览

简要总结

The purpose of the study is to compare two common ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.

详细描述

Over the last three decades, operative treatment of distal radius fractures has become increasingly common compared to non-operative treatment. Over the last 15 years there has been a trend towards more invasive, internal plate fixation of fractures of the distal radius. One argument in favor of internal fixation for these fractures is that, similar to other periarticular fractures, it would be beneficial to allow early movement of the wrist articulation. There is not, however, any data to support this statement. In fact, data regarding external fixation that either immobilizes the wrist or allows wrist motion suggest that early wrist mobilization is not as important as the overall alignment of the bone in terms of final wrist motion. This question is important in patient care and in decision-making regarding these fractures. Additionally, many companies use this claim as a marketing point in spite of the lack of evidence. We consider that good quality data is needed to determine the answer to this issue and to help to resolve the related problems described above.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Gender: Male or female
  • Age: Older than 18
  • Isolated distal radial fracture
  • Fracture treated with volar plates, stable fixation
  • Initial treatment within 4 weeks of trauma

排除标准

  • Complex fractures that require additional or different material than volar plates
  • Unstable fractures in which early mobilization is contraindicated

结局指标

主要结局

range of motion in degrees of the wrists

时间窗: 6 months

次要结局

  • DASH score(6 months)
  • Likert pain scale(6 months)
  • pinch and grip strength(6 months)
  • Gartland and Werely score(6 months)
  • and Mayo wrist score(6 months)

研究者

申办方类型
Other

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