Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
02/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

Publication citations

Additional files

Editorial Notes

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