跳至主要内容
临床试验/NCT05296785
NCT05296785尚未招募不适用

Management of Open Tibial Fractures With Bone Loss Using Monorail Fixator Over Intramedullary Nail

Assiut University0 个研究点目标入组 20 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
ASAMI Scoring System

研究概览

简要总结

Road traffic accidents (RTA) is the most common cause of open fractures of long bones, increase in RTA leading to increase of complex non-unions incidence. the Participants are usually undergoing multiple surgeries for healing or to eradicate infection, which in turn leading to loss of bone and soft tissues and require skin grafting, muscle pedicle graft or bone grafting. Sometimes the Participants end up with deformity, limb length discrepancy, joints stiffness, disuse osteoporosis and muscle atrophy after management

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 18-60 years old.
  • Open Grade II, Open Grade III (a & b) diaphyseal fractures of Tibia (judged after primary and/or secondary to debridement).
  • Bone defect < 10 cm.
  • Patients with Injury severity score (ISS) < 17.

排除标准

  • Massive bone defect > 10 cm.
  • Patients with ISS > 17, polytrauma patient.
  • Age < 18 years old or > 60 years old.
  • Associated vascular injury ischemic limb.

结局指标

主要结局

ASAMI Scoring System

时间窗: 1 year

excellent : active , no limping good : active with one or more of : limp , stiffness , significant pain Fair : active with at least three of the following : limping , stiffness , significant pain , reflex sympathetic syndrome Poor : Inactive Failures : Amputations

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

Hossam Eldeen Ahmed Neyaz

principle investigator

Assiut University

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