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Not Yet RecruitingPhase 2ACTRN12607000478415

Optimal timing for femoral fracture fixation in multiple trauma patients

Sponsor

The Alfred

Enrollment

40 participants

Start Date

Aug 27, 2007

Study Type

Interventional

Conditions

Multi-system trauma with femoral shaft fracture

Summary

It is not known at what time definitive femoral shaft intramedullary nailing (IMN) should be performed to result in fewer complications for the patient. The trial will investigate the optimal timing of femoral shaft IMN in a single-centre phase II randomised trial. The null hypothesis is that there is no difference in organ dysfunction outcomes between multitrauma patients having a femoral shaft fracture nailed immediately (within 24 hours) or nailed 3-6 days later secondary to external fixation.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria16

  • Fractured femoral shaft with a blunt mechanism of injury, suitable for intramedullary nailing
  • AND
  • Significant injury to another body region
  • post-injury pre-intubation Glasgow Coma Scale (GCS) 3 – 12
  • multiple facial fractures
  • chest trauma (> 2 rib fractures, mediastinal injury, pulmonary contusion, aortic injury, sternal fracture)
  • abdominal trauma (need for laparotomy/embolisation)
  • spine or spinal cord trauma
  • or more long bone fracture’s (or the presence of bilateral femoral shaft fractures)
  • pelvic ring fracture
  • need for urgent surgery/procedure including:
  • craniotomy
  • external ventricular drain (EVD)/intracranial pressure (ICP)
  • thoracotomy
  • planned spinal fixation
  • planned pelvic fixation

Exclusion Criteria3

  • Peri-prosthetic femoral shaft fractures
  • Medical contraindication to surgery (e.g., intracranial pressure (ICP) > 25, hypothermic, coagulopathic, acidotic)
  • Surgeon or anaesthetist judges that the patient is too unstable for the intramedullary nailing procedure (e.g., risk of disturbing contained solid-organ injuries or aortic disruptions by changes in patient position or by movement during the femoral nailing procedure)

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Interventions

Damage Control Orthopaedics (DCO) – primary fixation using an external fixator followed by secondary definitive intramedullary nailing between 3 (i.e., greater than 48 hours) and 6 days post-injury

Damage Control Orthopaedics (DCO) – primary fixation using an external fixator followed by secondary definitive intramedullary nailing between 3 (i.e., greater than 48 hours) and 6 days post-injury

Locations(1)

Australia

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ACTRN12607000478415