Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000478415
Ethics application status
Approved
Date submitted
24/08/2007
Date registered
21/09/2007
Date last updated
21/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimal timing for femoral fracture fixation in multiple trauma patients
Scientific title
Optimal timing for femoral fracture fixation in multiple trauma patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multi-system trauma with femoral shaft fracture 2290 0
Condition category
Condition code
Surgery 2384 2384 0 0
Other surgery
Musculoskeletal 2385 2385 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 2004 0
Treatment: Devices
Comparator / control treatment
• Early Total Care (ETC) – definitive intramedullary nailing within 24 hours of injury
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3287 0
- the incidence of adult respiratory distress syndrome (ARDS);
- the incidence of acute lung injury (ALI);
- the percentage of patients developing new organ failure using a standard and well established organ failure scoring system (Sequential Organ Failure Assessment [SOFA] score).
Timepoint [1] 3287 0
Whilst in Intensive Care Unit up to 14 days post-injury
Secondary outcome [1] 5467 0
- time on mechanical ventilation,
- the inflammatory response to surgery measured using markers for proinflammatory cytokines, including interleukin-6,
- Acute Physiology And Chronic Health Evaluation (APACHE) II and APACHE III score from first 24 hours in intensive care unit (ICU),
- ICU length of stay,
- hospital length of stay, and
- mortality.
Timepoint [1] 5467 0
up to 14 days post-injury

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 233 0
3181

Funding & Sponsors
Funding source category [1] 2546 0
Government body
Name [1] 2546 0
Transport Accident Commission
Country [1] 2546 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
Commercial Road
Prahran VIC 3181
Country
Australia
Secondary sponsor category [1] 2305 0
None
Name [1] 2305 0
Address [1] 2305 0
Country [1] 2305 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4472 0
The Alfred
Ethics committee address [1] 4472 0
Commercial Road
Prahran VIC 3181
Ethics committee country [1] 4472 0
Australia
Date submitted for ethics approval [1] 4472 0
Approval date [1] 4472 0
22/12/2006
Ethics approval number [1] 4472 0
257/06

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28001 0
Address 28001 0
Country 28001 0
Phone 28001 0
Fax 28001 0
Email 28001 0
Contact person for public queries
Name 11158 0
Adam Dowrick
Address 11158 0
NTRI - The Alfred
PO Box 315
Prahran VIC 3181
Country 11158 0
Australia
Phone 11158 0
+61 3 9076 8035
Fax 11158 0
+61 3 9076 8811
Email 11158 0
A.Dowrick@alfred.org.au
Contact person for scientific queries
Name 2086 0
Adam Dowrick
Address 2086 0
NTRI - The Alfred
PO Box 315
Prahran VIC 3181
Country 2086 0
Australia
Phone 2086 0
+61 3 9076 8035
Fax 2086 0
+61 3 9076 8811
Email 2086 0
A.Dowrick@alfred.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.