A multicentre randomised controlled study of primary femoral fixation versus delayed definitive femoral fixation in patients with multiple trauma

ISRCTN	ISRCTN78578486
DOI	https://doi.org/10.1186/ISRCTN78578486
Secondary identifying numbers	N0436125527

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 02/08/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr P V Giannoudis
Scientific

Academic Department of Orthopaedic Surgery
Level 5, Clinical Sciences Building
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Phone	+44 (0)113 206 7068
Email	Peter.Giannoudis@leedsth.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	A multicentre randomised controlled study of primary femoral fixation versus delayed definitive femoral fixation in patients with multiple trauma
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Injury, Occupational Diseases, Poisoning: Femoral shaft fracture
Intervention	Randomised controlled trial
Intervention type	Procedure/Surgery
Primary outcome measure	Mean ventilation
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/08/2002
Completion date	01/08/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	20
Key inclusion criteria	10-20 patients who have sustained polytrauma
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/08/2002
Date of final enrolment	01/08/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St James's University Hospital

Leeds
LS9 7TF
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Leeds Teaching Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

02/08/2016: No publications found, verifying study status with principal investigator.