Elastic Nailing With Kirschner Wires Versus Plate Fixation for Distal Tibial Fractures in Adolescents
24 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Sohag Governorate
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Sohag, Sohag Governorate, Egypte, 82749
- Recrutement
- Sohag university hospital
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Contact:
- Mohamed S Hassan, M.B.B.Ch.
- Numéro de téléphone: 01060318567
- E-mail: mohamed.farghaly@med.sohag.edu.eg
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Contact:
- Sumayya M Mohamed, M.B.B.Ch.
- Numéro de téléphone: 01016571202
- E-mail: su5221225@gmail.com
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Time to Radiological Union
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Coronal and Sagittal Alignment
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
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Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juillet 2026
Achèvement primaire (Estimé)
30 juin 2027
Achèvement de l'étude (Estimé)
30 juin 2027
Dates d'inscription aux études
Première soumission
20 août 2026
Première soumission répondant aux critères de contrôle qualité
20 août 2026
Première publication (Réel)
24 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SOH-MED-2026-001
Plan pour les données individuelles des participants (IPD)
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NON
Informations sur les médicaments et les dispositifs, documents d'étude
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