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

NCT07783529 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-26

No results posted yet for this study

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.

Conditions

  • Distal Tibial Fracture
  • Tibial Fracture
  • Fracture Fixation, Intramedullary
  • Fracture Fixation, Internal
  • Bone Plates
  • Adolescents

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07783529 on ClinicalTrials.gov