NCT02114840Unknown不适用
Preservation vs (Repair or Not Repair) Pronator Quadratus in the Volar Plating of Distal Radial Fracture. Randomized Controlled Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Pronator quadratus preservation
Experimental
Pronator quadratus preservation
干预措施: Pronator quadratus preservation after volar plate fixation in wrist fractures (Procedure)
Pronator quadratus non repair
Active Comparator
干预措施: Pronator quadratus nonrepair after volar plate fixation in wrist fractures (Procedure)
Pronator quadratus repair after disruption
Active Comparator
干预措施: Pronator quadratus repair after volar plate fixation in wrist fractures (Procedure)
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
Cristian Ricardo Correa Valencia
MD, Traumatologist/Orthopedic Surgeon
Universidad de La Frontera
研究点 (1)
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