| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN34857372 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0143185333 |
| Public title | Distal forearm torus fractures - do they need a splint? |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Injury, Occupational Diseases, Poisoning: Fractures |
| 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. |
| Design/methodology | Pilot Randomised Controlled Trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | All children under 17 presenting with a torus fracture of the distal end of the radius and or ulna. 30-50 patients to be recruited in total. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 08/08/2006 |
| Anticipated end date | 08/08/2007 |
| Status of trial | Completed |
| Target number of participants | 30-50 patients to be recruited in total |
| Interventions | 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. |
| 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. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Hertfordshire Hospitals Research and Development Consortium
West Hertfordshire Hospitals NHS Trust
|
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Michelle Jacobs |
| Contact details | A&E
Watford General Hospital
Vicarage Road
Watford
United Kingdom
WD18 0HB |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN34857372 |
| Date last extracted from ISRCTN register | 17/04/2008 |
