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

RecruitingNAAges 10 Years - 16 YearsAllSohag University
NCT07783529 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires
  • Plate fixation
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Where

1 site
Sohag University Hospital
Sohag, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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