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临床试验/NCT02410070
NCT02410070已完成不适用

A Comparison of Minimal Approach With Conventional Approach for Distal Radial Fractures

The Second Hospital of Qinhuangdao0 个研究点目标入组 157 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
157
主要终点
range of motion of the wrist

研究概览

简要总结

The objective of this study is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.

详细描述

The objective of this study is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.

From January 2011 to September 2012, 157 patients with distal radial fractures were allocated into group A (n=83) and B (n=74). Patients in group A were treated through a 1.5 to 2-cm long incision, and patients in group B were treated through the conventional flexor carpi radialis approach. All fractures were fixed with volar plates. Patients were assessed range of motion of the wrist, grip strength of the hand, and pronation strength of the wrist. Results were analyzed with the Statistical Package for Social Sciences 13.0. A P < 0.05 was statistically significant.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fernandez type II-IV radial fractures.

排除标准

  • Fernandez type I radial fracture.
  • Fernandez type V radial fracture.
  • Open radial fractures.
  • Surgery using K-wires or screws alone.
  • The use of external fixators.
  • multiple fractures, pathological fracture.

结局指标

主要结局

range of motion of the wrist

时间窗: 2 years

measurement of range of motion of the wrist with a goniometer, at 2 years follow-up.

次要结局

  • grip strength of the hand(2 years)
  • pronation strength of the forearm(2 years)

研究者

发起方
The Second Hospital of Qinhuangdao
申办方类型
Other
责任方
Sponsor

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