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

NCT07783529 | Recruiting

• 1 other identifier: SOH-MED-2026-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Distal tibial fracture; Metaphyseal-diaphyseal junction; Adolescent fractures; Elastic stable intramedullary nailing; Kirschner wires; Plate fixation

Outcome Measures

Primary Outcomes (2)

• Time to Radiological Union

  Time from surgery to radiographic evidence of fracture union as assessed on follow-up anteroposterior and lateral radiographs.

  From surgery through 6 months

• Fracture Union Rate

  Proportion of participants demonstrating radiological fracture union during postoperative follow-up.

  At 6 months

Secondary Outcomes (5)

• Coronal and Sagittal Alignment

  At 2 weeks, 6 weeks, 3 months, and 6 months

• Time to Full Weight-Bearing

  From surgery through 6 months

• AOFAS Ankle-Hindfoot Score

  During postoperative follow-up through 6 months

• Lower Extremity Functional Scale

  During postoperative follow-up through 6 months

• Treatment-Related Complication Rate

  From surgery through 6 months

Study Arms (2)

ESIN Supplemented by Kirschner Wires

EXPERIMENTAL

Participants assigned to this arm will undergo elastic stable intramedullary nailing using two appropriately sized elastic titanium nails inserted through medial and lateral proximal tibial metaphyseal entry points. One or two supplementary Kirschner wires will then be inserted percutaneously across the distal fragment under fluoroscopic guidance to improve rotational and angular stability.

Procedure: Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires

Plate Fixation

ACTIVE COMPARATOR

Participants assigned to this arm will undergo fixation with a distal tibial locking compression plate using 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 fixed with appropriate locking and cortical screws under fluoroscopic guidance.

Procedure: Plate fixation

Interventions

Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires PROCEDURE

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.

ESIN Supplemented by Kirschner Wires

Plate fixation PROCEDURE

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.

Plate Fixation

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Sohag Governorate, 82749, Egypt

RECRUITING

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedics Resident, Sohag University Hospitals

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)