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临床试验/NCT05631951
NCT05631951进行中(未招募)不适用

Bone Transport Through Induced Membrane Technique Versus Conventional Bone Transport Technique in Management of Bone Defects of Lower Limbs

Ain Shams University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
1
主要终点
complications rate

研究概览

简要总结

This is a prospective randomised controlled comparative study comparing bone transport through induced membrane (BTM) and conventional bone transport (BT) in management of bone defects in infected non united fractures of long bones of lower limbs (femur, tibia) as regard clinical, functional outcomes and possible complications.

详细描述

A prospective randomised controlled study was conducted at Ain shams university hospitals. A total of 30 patients with infected non united fractures of long bones of lower limbs (femur and tibia) were divided randomly into 15 patients treated by bone transport through induced membrane technique (BTM) (Group A) and 15 patients treated by conventional bone transport technique (BT) (Group B)

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
None

入排标准

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

入选标准

  • Sex: both sexes.
  • Age:18-60 yrs old.
  • Lesion: tibial or femoral bone defects (>4 cm)
  • Defects resulting from infected non-united fractures

排除标准

  • Pathological and congenital defects
  • Aseptic traumatic bone defects
  • Defects less than 4 cm
  • Multiple defects Pediatric age group

结局指标

主要结局

complications rate

时间窗: through study completion, an average of 1 year

number of complications in each group

additional operations

时间窗: through study completion, an average of 1 year

number of additional operations in each group

External fixation time

时间窗: through study completion, an average of 1 year

time from the initial application of the fixator until removal of fixator (in months)

Association for the Study and Application of the Method of Ilizarov (ASAMI) Scoring System

时间窗: through study completion, an average of 1 year

scoring system for bone and functional results

External fixation index

时间窗: through study completion, an average of 1 year

calculated by dividing the EFT (months) by the bone defect size (centimeters)

Docking time

时间窗: through study completion, an average of 1 year

time taken (months) from end of bone transport till union of docking site (both with and without bone graft)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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