Elastic Nailing With Kirschner Wires Versus Plate Fixation for Distal Tibial Fractures in Adolescents
24 de agosto de 2026 actualizado por: Mohamed Sabry Farghaly, Sohag University
Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires Versus Plate Fixation in the Treatment of Distal Tibial Metaphyseal-diaphyseal Junction Fractures in Adolescents
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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Sohag Governorate
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Sohag, Sohag Governorate, Egipto, 82749
- Reclutamiento
- Sohag university hospital
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Contacto:
- Mohamed S Hassan, M.B.B.Ch.
- Número de teléfono: 01060318567
- Correo electrónico: mohamed.farghaly@med.sohag.edu.eg
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Contacto:
- Sumayya M Mohamed, M.B.B.Ch.
- Número de teléfono: 01016571202
- Correo electrónico: su5221225@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: ESIN Supplemented by Kirschner Wires
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.
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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.
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Comparador activo: Plate Fixation
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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to Radiological Union
Periodo de tiempo: From surgery through 6 months
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Time from surgery to radiographic evidence of fracture union as assessed on follow-up anteroposterior and lateral radiographs.
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From surgery through 6 months
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Fracture Union Rate
Periodo de tiempo: At 6 months
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Proportion of participants demonstrating radiological fracture union during postoperative follow-up.
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At 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Coronal and Sagittal Alignment
Periodo de tiempo: At 2 weeks, 6 weeks, 3 months, and 6 months
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Radiographic assessment of coronal and sagittal alignment of the distal tibia during postoperative follow-up.
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At 2 weeks, 6 weeks, 3 months, and 6 months
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AOFAS Ankle-Hindfoot Score
Periodo de tiempo: During postoperative follow-up through 6 months
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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.
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During postoperative follow-up through 6 months
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Lower Extremity Functional Scale
Periodo de tiempo: During postoperative follow-up through 6 months
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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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During postoperative follow-up through 6 months
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Treatment-Related Complication Rate
Periodo de tiempo: From surgery through 6 months
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Proportion of participants experiencing treatment-related complications, including malunion, delayed union, nonunion, superficial infection, deep infection, implant irritation, implant failure, or reoperation.
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From surgery through 6 months
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Time to Full Weight-Bearing
Periodo de tiempo: From surgery through 6 months
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Time from surgery until the participant is allowed to progress to full weight-bearing based on fracture stability and radiographic evidence of healing.
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From surgery through 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de julio de 2026
Finalización primaria (Estimado)
30 de junio de 2027
Finalización del estudio (Estimado)
30 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
20 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de agosto de 2026
Publicado por primera vez (Actual)
24 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SOH-MED-2026-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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