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临床试验/NCT01122628
NCT01122628已完成不适用

Long Term Follow Up Study Into The Use Of The DVR-A Locking Plate In The Treatment Of Distal Radial Fractures

Norfolk and Norwich University Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2010年5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
136
试验地点
1
主要终点
Pain

研究概览

简要总结

The surgical treatment of wrist fractures (distal radius bone) has been changed by the introduction of a new plate design, the locking plate. This results in improved fixation and stabilisation of the fracture fragments allowing early movement.

This type of plate has been increasingly used throughout the world but questions have been raised regarding the potential complications of the surgery, particularly nerve and tendon injury. The Norfolk and Norwich Hospital has treated over 250 distal radial fractures with this type of plate. The investigators plan to recall these patients to asses their long term function, general satisfaction and radiological results.

研究设计

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

入排标准

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

入选标准

  • Treatment between Jan 2005 and March 2009

排除标准

  • Unable to consent

结局指标

主要结局

Pain

时间窗: One year or more post surgery

A patient administered visual analogue scale numbered 1-10. A mark can be placed anywhere along the line with a score of 0 indicating no pain and 10 the worst pain imaginable

DASH score

时间窗: One year or more post surgery

Disability of arm shoulder and hand score. This is a patient administered validated score

次要结局

  • Range of motion(One year or more post surgery)
  • Radiographic appearance(One year or more post surgery)
  • Grip Strength(One year or more post surgery)
  • Pain(One year or more post surgery)
  • EQ 5D(More than one year post surgery)
  • Complications(One year or more post surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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