Clinical trial Recruiting at 1 site Interventional Ages 10 to 16

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 typeInterventional
Ages10 Years to 16 Years
SexAll
Enrollment60 (estimated)
SponsorSohag University
Academic / other
Locations1 site (Sohag, Sohag Governorate)
StatusRecruiting
StartedJuly 1, 2026
Main results expectedJune 30, 2027
Study endsJune 30, 2027
Registry record updatedAugust 26, 2026
Trial IDNCT07783529 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

  • Sohag University Hospital
    Sohag, Sohag Governorate, Egypt
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.