Contact information
Type
Scientific
Primary contact
Dr P V Giannoudis
ORCID ID
Contact details
Academic Department of Orthopaedic Surgery
Level 5
Clinical Sciences Building
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 206 7068
Peter.Giannoudis@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436125527
Study information
Scientific title
A multicentre randomised controlled study of primary femoral fixation versus delayed definitive femoral fixation in patients with multiple trauma
Acronym
Study hypothesis
This study aims to compare the effects of early primary intramedullary nailing and delayed femoral intramedullary nailing in patients who have sustained a femoral shaft fracture and multiple injuries with an injury severity score of >16. It will be in particular studying the rates of complications such as multi-organ failure and acute respiratory distress syndrome to see if there is a difference in the incidence of these between the two techniques.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Injury, Occupational Diseases, Poisoning: Femoral shaft fracture
Intervention
Randomised controlled trial
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Mean ventilation
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2002
Overall trial end date
01/08/2003
Reason abandoned
Eligibility
Participant inclusion criteria
10-20 patients who have sustained polytrauma
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
20
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/08/2002
Recruitment end date
01/08/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St James's University Hospital
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leeds Teaching Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary