Elastic Nailing With Kirschner Wires Versus Plate Fixation for Distal Tibial Fractures in Adolescents
24 de agosto de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
60
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Sohag Governorate
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Sohag, Sohag Governorate, Egito, 82749
- Recrutamento
- Sohag university hospital
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Contato:
- Mohamed S Hassan, M.B.B.Ch.
- Número de telefone: 01060318567
- E-mail: mohamed.farghaly@med.sohag.edu.eg
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Contato:
- Sumayya M Mohamed, M.B.B.Ch.
- Número de telefone: 01016571202
- E-mail: su5221225@gmail.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time to Radiological Union
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Coronal and Sagittal Alignment
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de julho de 2026
Conclusão Primária (Estimado)
30 de junho de 2027
Conclusão do estudo (Estimado)
30 de junho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
20 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de agosto de 2026
Primeira postagem (Real)
24 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
26 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SOH-MED-2026-001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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Estuda um medicamento regulamentado pela FDA dos EUA
Não
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