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Elastic Nailing With Kirschner Wires Versus Plate Fixation for Distal Tibial Fractures in Adolescents

24 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Egypte
    • Sohag Governorate
      • Sohag, Sohag Governorate, Egypte, 82749

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Procedure: Elastic Stable Intramedullary Nailing Supplemented by Kirschner Wires
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.
Actieve vergelijker: 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.
Procedure: Plate fixation
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to Radiological Union
Tijdsspanne: From surgery through 6 months
Time from surgery to radiographic evidence of fracture union as assessed on follow-up anteroposterior and lateral radiographs.
From surgery through 6 months
Fracture Union Rate
Tijdsspanne: At 6 months
Proportion of participants demonstrating radiological fracture union during postoperative follow-up.
At 6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Coronal and Sagittal Alignment
Tijdsspanne: At 2 weeks, 6 weeks, 3 months, and 6 months
Radiographic assessment of coronal and sagittal alignment of the distal tibia during postoperative follow-up.
At 2 weeks, 6 weeks, 3 months, and 6 months
AOFAS Ankle-Hindfoot Score
Tijdsspanne: During postoperative follow-up through 6 months
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.
During postoperative follow-up through 6 months
Lower Extremity Functional Scale
Tijdsspanne: During postoperative follow-up through 6 months
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.
During postoperative follow-up through 6 months
Treatment-Related Complication Rate
Tijdsspanne: From surgery through 6 months
Proportion of participants experiencing treatment-related complications, including malunion, delayed union, nonunion, superficial infection, deep infection, implant irritation, implant failure, or reoperation.
From surgery through 6 months
Time to Full Weight-Bearing
Tijdsspanne: From surgery through 6 months
Time from surgery until the participant is allowed to progress to full weight-bearing based on fracture stability and radiographic evidence of healing.
From surgery through 6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sohag University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2026

Primaire voltooiing (Geschat)

30 juni 2027

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

20 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

20 augustus 2026

Eerst geplaatst (Werkelijk)

24 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

24 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SOH-MED-2026-001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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