跳至主要内容
临床试验/NCT05448053
NCT05448053Unknown不适用

Clinical and Radiographic Evaluation of Illizarov Fixation in Open Type III (A&B) Pediatric and Adolescent Tibial Shaft Fractures

Assiut University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Union of tibial fracture

研究概览

简要总结

The Ilizarov method is our usual treatment of choice for open, complex, physeal or unstable fractures and for patients in whom non-operative or other treatments have failed .

详细描述

Tibial fractures are the third most common injury involving a long bone in children. Most occur in the distal third, and approximately 10% are open.High-energy injuries with soft tissue compromise or segmental bone loss, present specific challenges. There is a significant risk of nonunion (7.5%),malunion (17%),infection (10%),and loss of reduction (32%).Many forms of treatment are available including a cast, elastic nailing, and external fixation using either a monolateral fixator, or a circular frame . In complex adult tibial fractures, evidence for the effectiveness of definitive external fixation using a circular frame continues to emerge.Fixators may be used for the correction of tibial deformities in children.Currently, only relatively small case series have been published describing their use for trauma in children and adolescents, albeit with good results.

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
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged 8-16 years old.
  • •Diagnosed to have open grade IIIA and IIIB tibial fracture according to Gustilo-Anderson fracture classification system.
  • •Fractures of the shaft of the tibia or distal tibial fractures involving the ankle joint and were complicated by bone and/or soft-tissue loss of more than 3 cm.
  • •An external fixator could be placed in the proximal lower extremity, distal lower extremity, or foot, and normal bone segments available for osteotomy.
  • •Admitted in the duration between 1st of January 2022 until end of December 2023.

排除标准

  • •Patients requiring free flap or local flap transfer to close the wound.
  • •Open grade IIIC tibial fractures (with vascular injury).
  • •Loss to follow-up.

研究组 & 干预措施

Ilizarov device

Experimental

Ilizarov fixation in open type III pediatric tibial shaft fractures

干预措施: Ilizarov (Procedure)

结局指标

主要结局

Union of tibial fracture

时间窗: 1 year

Assess Union of the fracture using radiographic union scale in tibial fracture(RUST)

次要结局

  • Determine alignment(1 year)
  • Patient reported outcome measures(1 year)

研究者

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

khaled Gamal Amir

Principal investigator

Assiut University

研究点 (1)

Loading locations...

相似试验