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NCT07783529
Elastic Nailing With Kirschner Wires Versus Plate Fixation for Distal Tibial Fractures in Adolescents
Conditions: Distal Tibial Fracture, Tibial Fracture, Fracture Fixation, Intramedullary, Fracture Fixation, Internal, Bone Plates, Adolescents
Sex: All
Ages: 10 Years – 16 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Sohag University
Location: Sohag University Hospital Sohag Sohag Governorate
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07783529). StuddyBuddy aggregates publicly available trial information.