Forearm Buckle Fracture Treatment Study
| ISRCTN | ISRCTN25187648 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25187648 |
| Protocol serial number | N0185146326 |
| Sponsor | Department of Health |
| Funder | Plymouth Hospitals NHS Trust (UK), Own Account NHS R&D Support Funding |
- 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
Scientific
Henshears Farm
Roborough
Plymouth
PL6 7BH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To 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) studied | 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 |
| Primary outcome measure(s) |
If the double Tubigrip treatment proves to be superior, it will be both quicker to apply and cheaper. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 12 Years |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | 100 children aged 2 - 12 years. |
| Key exclusion criteria | Angulated and greenstick fractures, previous fractures of the same wrist, other significant injuries, unable to attend for review. |
| Date of first enrolment | 01/03/2001 |
| Date of final enrolment | 31/01/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Henshears Farm
Plymouth
PL6 7BH
United Kingdom
PL6 7BH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |