Optimal timing for femoral fracture fixation in multiple trauma patients

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000478415

Enrollment

Registered

2007-09-21

Start date

2007-08-27

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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

Study design

Allocation

Randomised controlled trial

Intervention model

Single group

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to -2147483648 No limit

Healthy volunteers

Inclusion criteria

• 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 - 2 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 criteria

• 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)

Outcome results