Distal forearm torus fractures - do they need a splint?
| ISRCTN | ISRCTN34857372 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34857372 |
| Secondary identifying numbers | N0143185333 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 19/10/2011
- 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
Not provided at time of registration
Contact information
Dr Michelle Jacobs
Scientific
Scientific
A&E
Watford General Hospital
Vicarage Road
Watford
WD18 0HB
United Kingdom
Study information
| Study design | Pilot Randomised Controlled Trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| 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(s) | Not provided at time of registration |
| 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 |
| Primary outcome measure | 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 study start date | 08/08/2006 |
| Overall study end date | 08/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 17 Years |
| Sex | Not Specified |
| Target number of participants | 30-50 patients to be recruited in total |
| Participant inclusion criteria | All children under 17 presenting with a torus fracture of the distal end of the radius and or ulna. |
| 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
- England
- United Kingdom
Study participating centre
A&E
Watford
WD18 0HB
United Kingdom
WD18 0HB
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Hertfordshire Hospitals Research and Development Consortium (UK)
No information available
West Hertfordshire Hospitals NHS Trust
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
