跳至主要内容
临床试验/NCT03257826
NCT03257826Unknown不适用

The Effect of Percutaneous Kirschner Wire Technique in Management of Congenital Pseudarthrosis of Tibia Under One Year Old

Hunan Children's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Primary union score (range,4-12 score)

研究概览

简要总结

The aim of this study was to investigate the effect of percutaneous kirschner wire in management of Congenital Pseudarthrosis of Tibia in children younger than 1 year of age. This study was to determine the union rates of congenital pseudarthrosis in children operated before 1 year of age to identify growth abnormalities in the affected limb ,including ankle valgus,tibia valgus,and shortening.

详细描述

Currently, the timing of surgery for congenital pseudarthrosis of the tibia is a controversial issue. The investigators use percutaneous kirschner wire technique to manage the Congenital Pseudarthrosis of Tibia in children younger than 1 year of age.To investigate the effect of percutaneous kirschner wire in management of Congenital Pseudarthrosis of Tibia in children younger than 1 year of age. Bone uion rate,average time of healing, ankle valgus, limb length discrepancy, tibia axis alignment are recorded and evaluated.

研究设计

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

入排标准

年龄范围
1 Month 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • All patients did not undergo procedures
  • Patients with Crawford type IV CPT treated with Percutaneous Kirschner wire techniques
  • The age during surgery was less than 12 months old

排除标准

  • Patients with pseudarthrosis of tibia caused by trauma,infection, etc

结局指标

主要结局

Primary union score (range,4-12 score)

时间窗: 9 months post-operation

X ray score from tibia pseudarthrosis in anterior and posterior (AP )and lateral X ray. ("RUST" score:radiographic union scoring system for tibial fracture healing)

次要结局

  • Residual Deformity-proximal tibia angulation(range,0°-90°)(pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation ])
  • Residual Deformity-Limb length discrepancy(pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation)
  • Residual Deformity-ankle valgus angulation(range,0°-90°)(pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation)
  • Refracture(Cortical discontinuity)(0.5 , 1,2,3,4,5,6,7,8,9,10 years after the fracture is healed)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验