Distal forearm torus fractures - do they need a splint?

ISRCTN	ISRCTN34857372
DOI	https://doi.org/10.1186/ISRCTN34857372
Protocol serial number	N0143185333
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funders	Hertfordshire Hospitals Research and Development Consortium (UK), West Hertfordshire Hospitals NHS Trust

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

Dr Michelle Jacobs
Scientific

A&E
Watford General Hospital
Vicarage Road
Watford
WD18 0HB
United Kingdom

Primary study design	Interventional
Study design	Pilot Randomised Controlled Trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Injury, Occupational Diseases, Poisoning: Fractures
Intervention	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.
Intervention type	Other
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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	08/08/2007

Participant type(s)	Patient
Age group	Child
Upper age limit	17 Years
Sex	Not Specified
Target sample size at registration	50
Key inclusion criteria	All children under 17 presenting with a torus fracture of the distal end of the radius and or ulna.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	08/08/2006
Date of final enrolment	08/08/2007

A&E

Watford
WD18 0HB
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan