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临床试验/NCT02247778
NCT02247778Unknown不适用

Outcome of Mini-incision-technique for Treatment of Midshaft Fractures of the Clavicle

Technical University of Munich1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
area of paresthetic skin

研究概览

简要总结

Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7 to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of this incision secondary problems like prolonged fracture healing, paresthesia of supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a mini-incision technique using an average incision length of 4cm.

The aim of this study is to analyzed whether secondary problems following plate osteosynthesis of the clavicle correlate mit the length of the surgical access.

详细描述

Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7 to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of this incision secondary problems like prolonged fracture healing, paresthesia of supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a mini-incision technique using an average incision length of 4cm.

The aim of this study is to analyzed whether secondary problems following plate osteosynthesis of the clavicle correlate mit the length of the surgical access. Therefore a prospective observational protocol was chosen.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •all patients with fractures of the clavicle and indication for operative intervention using plate osteosynthesis ability to sign informed consent

排除标准

  • •all other patients

研究组 & 干预措施

conventional plate osteosynthesis

Active Comparator

Standard procedure

干预措施: conventional plate osteosynthesis (Procedure)

mini-incision-type osteosynthesis

Active Comparator

mini-incision

干预措施: mini-incision-type osteosynthesis (Procedure)

结局指标

主要结局

area of paresthetic skin

时间窗: 12 month

次要结局

  • Postoperative shoulder function(12 month)
  • Time to fracture healing(12 month)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Chlodwig Kirchhoff

PD DR. med. Chlodwig Kirchhoff

Technical University of Munich

研究点 (1)

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