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Elastic Nailing With Kirschner Wires Versus Plate Fixation for Distal Tibial Fractures in Adolescents

2026年8月24日 更新者：Mohamed Sabry Farghaly、Sohag University

Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires Versus Plate Fixation in the Treatment of Distal Tibial Metaphyseal-diaphyseal Junction Fractures in Adolescents

This prospective randomized controlled trial will compare two surgical methods for treating distal tibial metaphyseal-diaphyseal junction fractures in adolescents aged 10 to 16 years. Participants will be randomly assigned in a 1:1 ratio to receive either elastic stable intramedullary nailing supplemented by Kirschner wires or plate fixation. The study will compare fracture healing, radiological alignment, time to full weight-bearing, functional outcomes, and treatment-related complications. Participants will be followed at 2 weeks, 6 weeks, 3 months, and 6 months after surgery.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Distal tibial metaphyseal-diaphyseal junction fractures in adolescents can be difficult to treat because of the short distal fragment, proximity to the growth plate, and tendency toward displacement and malalignment. Elastic stable intramedullary nailing is minimally invasive and preserves the fracture biology, but fixation of the short distal fragment may be less stable. Supplementary Kirschner wires may improve rotational and angular stability. Plate fixation provides stable fixation and good control of alignment but may require greater soft-tissue dissection.

This study will be conducted at the Department of Orthopaedics Surgery, Sohag University Hospital. Eligible adolescents with displaced or unstable distal tibial metaphyseal-diaphyseal junction fractures requiring surgical fixation will be randomly assigned to one of two treatment groups. Group A will undergo elastic stable intramedullary nailing supplemented by one or two Kirschner wires. Group B will undergo plate fixation using a distal tibial locking compression plate. Randomization will be performed using a computer-generated sequence in a 1:1 ratio.

Patients will undergo clinical and radiological follow-up at 2 weeks, 6 weeks, 3 months, and 6 months. The primary outcomes are time to radiological union and fracture union rate. Secondary outcomes include coronal and sagittal alignment, time to full weight-bearing, AOFAS Ankle-Hindfoot Score, Lower Extremity Functional Scale, and complications including malunion, delayed union, nonunion, infection, implant irritation or failure, and reoperation.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 埃及
    • Sohag Governorate
      • Sohag、Sohag Governorate、埃及、82749

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age 10-16 years.
  • Patients diagnosed with distal tibial metaphyseal-diaphyseal junction (DTDMJ) fractures.
  • Closed fractures or Gustilo-Anderson type I open fractures.
  • Acute fractures presenting within two weeks of injury.
  • Displaced or unstable fractures requiring surgical fixation.
  • Open or partially open physis, as assessed on preoperative radiographs.

Exclusion Criteria:

  • Patients younger than 10 years or older than 16 years.
  • Fractures involving the distal tibial physis (Salter-Harris fractures).
  • Intra-articular distal tibial fractures.
  • Gustilo-Anderson type II and III open fractures.
  • Pathological fractures.
  • Fractures associated with metabolic bone disease or congenital skeletal disorders.
  • Polytrauma patients requiring alternative treatment priorities.
  • Previous fracture, deformity, or surgical intervention involving the affected tibia.
  • Neurovascular injury requiring repair.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：ESIN Supplemented by Kirschner Wires
Participants assigned to this arm will undergo elastic stable intramedullary nailing using two appropriately sized elastic titanium nails inserted through medial and lateral proximal tibial metaphyseal entry points. One or two supplementary Kirschner wires will then be inserted percutaneously across the distal fragment under fluoroscopic guidance to improve rotational and angular stability.
程序：Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires
Closed reduction will be performed under fluoroscopic guidance. Two appropriately sized titanium elastic nails will be inserted through medial and lateral entry points in the proximal tibial metaphysis and advanced across the fracture into the distal fragment. One or two supplementary Kirschner wires will then be inserted percutaneously across the distal fragment under fluoroscopic guidance to enhance rotational and angular stability.
有源比较器：Plate Fixation
Participants assigned to this arm will undergo fixation with a distal tibial locking compression plate using a minimally invasive plate osteosynthesis technique or a limited open approach according to fracture characteristics. The plate will be positioned on the medial aspect of the tibia and fixed with appropriate locking and cortical screws under fluoroscopic guidance.
程序：Plate fixation
Following fracture reduction, fixation will be performed using a distal tibial locking compression plate through a minimally invasive plate osteosynthesis technique or a limited open approach according to fracture characteristics. The plate will be positioned on the medial aspect of the tibia and secured with appropriate locking and cortical screws under fluoroscopic guidance.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Time to Radiological Union
大体时间：From surgery through 6 months
Time from surgery to radiographic evidence of fracture union as assessed on follow-up anteroposterior and lateral radiographs.
From surgery through 6 months
Fracture Union Rate
大体时间：At 6 months
Proportion of participants demonstrating radiological fracture union during postoperative follow-up.
At 6 months

次要结果测量

结果测量
措施说明
大体时间
Coronal and Sagittal Alignment
大体时间：At 2 weeks, 6 weeks, 3 months, and 6 months
Radiographic assessment of coronal and sagittal alignment of the distal tibia during postoperative follow-up.
At 2 weeks, 6 weeks, 3 months, and 6 months
AOFAS Ankle-Hindfoot Score
大体时间：During postoperative follow-up through 6 months
Functional outcome assessed using the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score. The total score ranges from 0 to 100 points, including pain, function, and alignment, with higher scores indicating better outcome.
During postoperative follow-up through 6 months
Lower Extremity Functional Scale
大体时间：During postoperative follow-up through 6 months
Functional outcome assessed using the Lower Extremity Functional Scale (LEFS), a patient-reported measure evaluating difficulty with daily activities such as walking, running, and climbing stairs. The maximum score is 80 points, with higher scores indicating better lower-extremity function.
During postoperative follow-up through 6 months
Treatment-Related Complication Rate
大体时间：From surgery through 6 months
Proportion of participants experiencing treatment-related complications, including malunion, delayed union, nonunion, superficial infection, deep infection, implant irritation, implant failure, or reoperation.
From surgery through 6 months
Time to Full Weight-Bearing
大体时间：From surgery through 6 months
Time from surgery until the participant is allowed to progress to full weight-bearing based on fracture stability and radiographic evidence of healing.
From surgery through 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Sohag University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月1日

初级完成 (估计的)

2027年6月30日

研究完成 (估计的)

2027年6月30日

研究注册日期

首次提交

2026年8月20日

首先提交符合 QC 标准的

2026年8月20日

首次发布 (实际的)

2026年8月24日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月24日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SOH-MED-2026-001

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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