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.
Age 10-16 years. Patients diagnosed with distal tibial metaphyseal-diaphyseal junction (DTDMJ) fractures.
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.
Parallel
Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires
Procedure/SurgeryClosed 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.
Plate fixation
Procedure/SurgeryFollowing 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.
Time to Radiological Union
Time from surgery to radiographic evidence of fracture union as assessed on follow-up anteroposterior and lateral radiographs.
Fracture Union Rate
Proportion of participants demonstrating radiological fracture union during postoperative follow-up.
Coronal and Sagittal Alignment
Radiographic assessment of coronal and sagittal alignment of the distal tibia during postoperative follow-up.
Time to Full Weight-Bearing
Time from surgery until the participant is allowed to progress to full weight-bearing based on fracture stability and radiographic evidence of healing.
AOFAS Ankle-Hindfoot Score
Functional outcome assessed using the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score. The total score ranges from 0 to 100 points, including pain, function, and alignment, with higher scores indicating better outcome.
Lower Extremity Functional Scale
Functional outcome assessed using the Lower Extremity Functional Scale (LEFS), a patient-reported measure evaluating difficulty with daily activities such as walking, running, and climbing stairs. The maximum score is 80 points, with higher scores indicating better lower-extremity function.
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