Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0185146326
Study information
Scientific title
Acronym
Study hypothesis
To compare two accepted means of treatment of torus (buckle) fractures in children in an attempt to show if either is superior.
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Injury, Occupational Diseases, Poisoning: Buckle fractures
Intervention
Patients will be randomised into two groups one of which will receive the standard treatment (plaster of paris) and the other the trial treatment (double Tubigrip). The parents will then be given a prospective diary to complete and the patient will be reviewed in the A&E clinic at approximately 3 weeks to assess the patient and discuss the completed diary prior to discharge from clinical follow up.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
If the double Tubigrip treatment proves to be superior, it will be both quicker to apply and cheaper.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2001
Overall trial end date
31/01/2004
Reason abandoned
Eligibility
Participant inclusion criteria
100 children aged 2 - 12 years.
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Angulated and greenstick fractures, previous fractures of the same wrist, other significant injuries, unable to attend for review.
Recruitment start date
01/03/2001
Recruitment end date
31/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Henshears Farm
Plymouth
PL6 7BH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Plymouth Hospitals NHS Trust (UK), Own Account NHS R&D Support Funding
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