Condition category
Injury, Occupational Diseases, Poisoning
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
19/10/2011
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 Michelle Jacobs

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0143185333

Study information

Scientific title

Acronym

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

Not provided at time of registration

Overall trial start date

08/08/2006

Overall trial end date

08/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

All children under 17 presenting with a torus fracture of the distal end of the radius and or ulna.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

30-50 patients to be recruited in total

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

08/08/2006

Recruitment end date

08/08/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

A&E
Watford
WD18 0HB
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
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

Hertfordshire Hospitals Research and Development Consortium (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

West Hertfordshire Hospitals NHS Trust

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

No publication intended as of 19/10/2011

Publication citations

Additional files

Editorial Notes