|
ISRCTN
|
ISRCTN34857372
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Distal forearm torus fractures - do they need a splint?
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0143185333
|
|
Study hypothesis
|
To demonstrate that a torus fracture, treated with no splintage at all, is not significantly more painful than one treated with splintage and allows the child to start using the limb sooner.
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Pilot Randomised Controlled Trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Injury, Occupational Diseases, Poisoning: Fractures
|
|
Participants - inclusion criteria
|
All children under 17 presenting with a torus fracture of the distal end of the radius and or ulna.
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
08/08/2006
|
|
Anticipated end date
|
08/08/2007
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
30-50 patients to be recruited in total
|
|
Interventions
|
A pilot study recruiting for 1 year, using patients randomised into two groups after x-ray diagnosis. Pain, satisfaction and treatment evaluation will be conducted at 1 week using patient and carer responses. At 4 weeks, patient's carer will do a similar evaluation again.
|
|
Primary outcome measure(s)
|
1. Difference in pain levels at weeks 1 and 4 between the 2 groups
2. Time to return to normal use of affected limb with and without splintage
3. Patient and carer satisfaction level in the 2 groups.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Hertfordshire Hospitals Research and Development Consortium (UK)
West Hertfordshire Hospitals NHS Trust
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Michelle
Jacobs
|
|
Address
|
A&E
Watford General Hospital
Vicarage Road
|
|
City/town
|
Watford
|
|
Zip/Postcode
|
WD18 0HB
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
28/09/2007
|
|
Last edited
|
21/05/2008
|
|
Date ISRCTN assigned
|
28/09/2007
|
