跳至主要内容
临床试验/NCT02114840
NCT02114840Unknown不适用

Preservation vs (Repair or Not Repair) Pronator Quadratus in the Volar Plating of Distal Radial Fracture. Randomized Controlled Clinical Trial

Universidad de La Frontera2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Pronosupination strength

研究概览

简要总结

The purpose of this study is to determine pronator quadrutus preservation have clinical impact following volar plate fixation

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fractures of distal radius with instability (Aofoundation.org)
  • Age between 15-75 años
  • Informed consent approval for ethical comitte

排除标准

  • Previos surgery of the hand, wrist or forearm
  • Inflammatory arthropathy
  • Carpal tunel syndrome
  • Sensory or mixed neuropathy
  • Bilater wrist fracture
  • Functional deficits of ipsilateral extremity
  • Functional deficits of contralateral extremity
  • Complications after surgery with motor deficit
  • Disease that can evolve with neuropathy during study time

结局指标

主要结局

Pronosupination strength

时间窗: Up to 12 month

Pronosupination strength

Proprioception

时间窗: Up to 12 month

Proprioception

Clinical impact in dairy life

时间窗: Up to 12 month

Clinical impact in dairy life with a functional score

次要结局

  • Infection after surgery(Up to 12 month)
  • Ischaemic time surgery(Up to 12 month)
  • Proprioception evolution after surgery(Up to 12 month)
  • Flexor tendon rupture(Up to 12 month)
  • Pronosupination strenght evolution(Up to 12 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristian Ricardo Correa Valencia

MD, Traumatologist/Orthopedic Surgeon

Universidad de La Frontera

研究点 (2)

Loading locations...

相似试验