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临床试验/NCT04195334
NCT04195334Unknown不适用

Does Intramedullary Nail Diameter to Canal Ratio Predict the Incidence of Femoral Nonunion?

Assiut University0 个研究点目标入组 100 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
The ratio between IMN and femoral canal diameter and incidence of union objectively

研究概览

简要总结

To Detect the Relation Between the Intramedullary Nail Diameter to Canal Ratio and the Incidence of Non-union

详细描述

Femoral intramedullary nail fixation is currently considered the ''gold standard'' for treatment of femoral shaft fractures in adult population. Clinical outcomes after operative treatment of proximal femur fracture have been shown to be dependent on achieving optimal mechanical alignment and union. Patient independent risk factors associated with nonunion after intramedullary fixation includes: open fracture, undreamed intramedullary nailing, fracture comminution, non-isthmal and particularly infra-isthma fracture location and infection. Patient dependent risk factors include smoking, diabetes, nonsteroidal anti-inflammatory medications, closed head injury and delayed weight. Unreamed nailing allows for better maintenance of the endosteal circulation at the expense of smaller diameter implants; in contrast, reamed applications permit a larger diameter nail, resulting in stronger fixation constructs and earlier fracture union. After reaming, a larger diameter intramedullary nail is placed. When initially reported, this treatment resulted in high success rates.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age (20_60) years old
  • Closed fracture and open grade one
  • Midshaft fractures type3\2 according to the OA classification
  • pattern of the fracture (simple transverse,oblique ,spiral)
  • Retrograde and Antigrade nail

排除标准

  • Open fractures grade two and three.
  • patient with comorbidities eg(DM.HTN...)
  • severe osteoporosis with wide medulla .
  • patient on regular steroid therapy.
  • patient refused to be enrolled in the study

结局指标

主要结局

The ratio between IMN and femoral canal diameter and incidence of union objectively

时间窗: 6 months

We will measure union objectively using x ray (union in 3 or more cortices)

measurement of union clinically

时间窗: 6 months

we will measure the union clinically using visual analog score after 6 weeks.( Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks). then we will test if there is a relation between union and the ratio between femoral canal and IMN diameter.

次要结局

未报告次要终点

研究者

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

mina kamal

orthopedic resident doctor mina kamal kamel

Assiut University

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IMN Diameter to Femoral Canal Diameter and Union | 临床试验