Optimal timing for femoral fracture fixation in multiple trauma patients

Phase 2

• Conditions: Multi-system trauma with femoral shaft fracture; Surgery - Other surgery; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12607000478415
• Lead Sponsor: The Alfred

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-09-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- the incidence of adult respiratory distress syndrome (ARDS);<br>- the incidence of acute lung injury (ALI);<br>- the percentage of patients developing new organ failure using a standard and well established organ failure scoring system (Sequential Organ Failure Assessment [SOFA] score).[Whilst in Intensive Care Unit up to 14 days post-injury]

Secondary Outcome Measures

Name	Time	Method
- time on mechanical ventilation,<br>- the inflammatory response to surgery measured using markers for proinflammatory cytokines, including interleukin-6,<br>- Acute Physiology And Chronic Health Evaluation (APACHE) II and APACHE III score from first 24 hours in intensive care unit (ICU),<br>- ICU length of stay, <br>- hospital length of stay, and<br>- mortality.[up to 14 days post-injury]