An interventional study of Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires and Plate fixation in Distal Tibial Fracture, Tibial Fracture and Fracture Fixation, Intramedullary, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 10 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Sohag University · Not applicable, Interventional, and Treatment
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.
Distal tibial metaphyseal-diaphyseal junction fractures in adolescents can be difficult to treat because of the short distal fragment, proximity to the growth plate, and tendency toward displacement and malalignment. Elastic stable intramedullary nailing is minimally invasive and preserves the fracture biology, but fixation of the short distal fragment may be less stable. Supplementary Kirschner wires may improve rotational and angular stability. Plate fixation provides stable fixation and good control of alignment but may require greater soft-tissue dissection.
This study will be conducted at the Department of Orthopaedics Surgery, Sohag University Hospital. Eligible adolescents with displaced or unstable distal tibial metaphyseal-diaphyseal junction fractures requiring surgical fixation will be randomly assigned to one of two treatment groups. Group A will undergo elastic stable intramedullary nailing supplemented by one or two Kirschner wires. Group B will undergo plate fixation using a distal tibial locking compression plate. Randomization will be performed using a computer-generated sequence in a 1:1 ratio.
Patients will undergo clinical and radiological follow-up at 2 weeks, 6 weeks, 3 months, and 6 months. The primary outcomes are time to radiological union and fracture union rate. Secondary outcomes include coronal and sagittal alignment, time to full weight-bearing, AOFAS Ankle-Hindfoot Score, Lower Extremity Functional Scale, and complications including malunion, delayed union, nonunion, infection, implant irritation or failure, and reoperation.
135 studies on the registry are indexed under Tibial Fractures; 37 are open to participants now.
This study's planned enrollment of 60 is close to the median of 65 across 91 interventional studies indexed under Tibial Fractures.
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Exclusion Criteria:
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
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
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.
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.
Time to Radiological Union
Time from surgery to radiographic evidence of fracture union as assessed on follow-up anteroposterior and lateral radiographs.
Time frame: From surgery through 6 months
Fracture Union Rate
Proportion of participants demonstrating radiological fracture union during postoperative follow-up.
Time frame: At 6 months
Coronal and Sagittal Alignment
Radiographic assessment of coronal and sagittal alignment of the distal tibia during postoperative follow-up.
Time frame: At 2 weeks, 6 weeks, 3 months, and 6 months
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.
Time frame: From surgery through 6 months
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.
Time frame: During postoperative follow-up through 6 months
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.
Time frame: During postoperative follow-up through 6 months
Treatment-Related Complication Rate
Proportion of participants experiencing treatment-related complications, including malunion, delayed union, nonunion, superficial infection, deep infection, implant irritation, implant failure, or reoperation.
Time frame: From surgery through 6 months
Plan to share: No
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Started Jul 2026 (actual). Primary completion is estimated for Jun 2027, 11 months after the start.
Of 39 interventional studies with no phase under Tibial Fractures, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 80. This study's planned 11 months is below that.
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