Elastic nailing with Kirschner wires versus plate fixation for distal tibial fractures in adolescents
Official title: Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires Versus Plate Fixation in the Treatment of Distal Tibial Metaphyseal-diaphyseal Junction Fractures in Adolescents
Run by Sohag University · NCT07783529 · Data updated 2026-11-12
This trial tests whether elastic stable intramedullary nailing with Kirschner wires works as well as plate fixation for fixing distal tibial fractures in kids aged 10 to 16.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 10 Years to 16 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag, Sohag Governorate) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | August 26, 2026 |
| Trial ID | NCT07783529 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adolescents aged 10–16 with displaced or unstable distal tibial metaphyseal-diaphyseal junction fractures requiring surgical fixation.
✕Probably not a fit
Patients with certain fracture patterns or conditions outside the eligibility criteria may not experience a benefit from either approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective randomized study compares two surgical methods for distal tibial metaphyseal-diaphyseal junction fractures in adolescents. Participants are assigned 1:1 to receive either elastic stable intramedullary nailing with Kirschner wires or plate fixation. Outcomes include fracture healing, alignment, time to full weight-bearing, functional scores, and complications, with follow-ups at 2 weeks, 6 weeks, 3 months, and 6 months. The study aims to determine which approach provides reliable fixation with favorable recovery and fewer complications. It is conducted at Sohag University Hospital, enrolling eligible adolescents with displaced or unstable DTDMJ fractures requiring surgical fixation.
Why it matters
Potential benefit: If successful, the trial could clarify which fixation method yields faster recovery and fewer complications for adolescents with distal tibial fractures.
How similar studies have gone: Previous studies in pediatric tibial fracture fixation have shown mixed results; this trial explores a direct comparison in a specific DTDMJ population.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Sohag University Hospital
Sohag, Sohag Governorate, Egypt Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.