ISRCTN ISRCTN25187648
DOI https://doi.org/10.1186/ISRCTN25187648
Secondary identifying numbers N0185146326
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
25/04/2014
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 A Hudson
Scientific

Henshears Farm
Roborough
Plymouth
PL6 7BH
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo compare two accepted means of treatment of torus (buckle) fractures in children in an attempt to show if either is superior.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedInjury, Occupational Diseases, Poisoning: Buckle fractures
InterventionPatients 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 typeOther
Primary outcome measureIf the double Tubigrip treatment proves to be superior, it will be both quicker to apply and cheaper.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/03/2001
Completion date31/01/2004

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit2 Years
Upper age limit12 Years
SexNot Specified
Target number of participants100
Key inclusion criteria100 children aged 2 - 12 years.
Key exclusion criteriaAngulated and greenstick fractures, previous fractures of the same wrist, other significant injuries, unable to attend for review.
Date of first enrolment01/03/2001
Date of final enrolment31/01/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Henshears Farm
Plymouth
PL6 7BH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Plymouth Hospitals NHS Trust (UK), Own Account NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan