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

24. august 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiesteder

  • Egypt
    • Sohag Governorate
      • Sohag, Sohag Governorate, Egypt, 82749

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Fremgangsmåte: 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.
Aktiv komparator: 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.
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Radiological Union
Tidsramme: 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
Tidsramme: At 6 months
Proportion of participants demonstrating radiological fracture union during postoperative follow-up.
At 6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Coronal and Sagittal Alignment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

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Sponsor

Sohag University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juli 2026

Primær fullføring (Antatt)

30. juni 2027

Studiet fullført (Antatt)

30. juni 2027

Datoer for studieregistrering

Først innsendt

20. august 2026

Først innsendt som oppfylte QC-kriteriene

20. august 2026

Først lagt ut (Faktiske)

24. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SOH-MED-2026-001

Plan for individuelle deltakerdata (IPD)

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Nei

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