Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
25/04/2014
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 A Hudson

ORCID ID

Contact details

Henshears Farm
Roborough
Plymouth
PL6 7BH
United Kingdom

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

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

Publication citations

Additional files

Editorial Notes