Self Cast Removal at the Child's Home
| ISRCTN | ISRCTN55089523 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55089523 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/08/2008
- Registration date
- 13/08/2008
- Last edited
- 27/03/2013
- 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
Prof Keith Willett
Scientific
Scientific
Kadoorie Centre
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
Study information
| Study design | Pragmatic, individually randomised controlled equivalence study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial to assess the treatment of stable upper limb fractures in children, comparing traditional rigid casts with flexible casts suitable for home removal by the parent |
| Study acronym | SCRATCH |
| Study objectives | An equivalence study of stable upper limb fractures in children to ascertain whether: 1. The use of a home-removable flexible cast is clinically equivalent to the rigid cast, in the management of stable upper limb fractures in children 2. The use of a home-removable flexible cast is more cost-effective than the hospital removal of a rigid cast, in the management of stable upper limb fractures in children 3. The parent and patient are satisfied with the use and home removal of the flexible cast |
| Ethics approval(s) | Mid and South Buckinghamshire Research Ethics Committee. Date of approval: 12/03/2008 (ref: 08/H0607/20) |
| Health condition(s) or problem(s) studied | Upper limb fractures in children |
| Intervention | Participants will be randomised to one of two basic treatment interventions: 1. Traditional plaster of Paris or fibreglass rigid cast with follow-up in the fracture clinic for removal 2. Home-removable flexible cast taken off at home by the parent/ carer. They will not be observed removing the cast but an appointment in fracture clinic will be available on request if required |
| Intervention type | Other |
| Primary outcome measure | Clinical equivalence using the difference in Childhood Health Assessment Questionnaire score between pre-injury and one week post cast removal. Equivalence will be defined by a difference of less than 10%. |
| Secondary outcome measures | 1. Clinical equivalence using the difference in Childhood Health Assessment Questionnaire score between pre-injury and 6 months post cast removal 2. Cost effectiveness of flexible casts over rigid casts 3. User satisfaction of flexible casts using a modified Paediatric Quality of Life Inventory (PedsQL) Healthcare Satisfaction Questionnaire to be completed at 1 week post cast removal |
| Overall study start date | 30/05/2008 |
| Completion date | 13/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 460 |
| Key inclusion criteria | 1. All children (both males and females) with stable upper limb fracture 2. Aged between 2 and 16 years 3. Presenting within 72 hours of sustaining the injury 4. Attending with a responsible adult |
| Key exclusion criteria | 1. Fracture other than simple torus, greenstick or stable epiphyseal fracture 2. Multi-limb trauma 3. In-patient 4. Suspicion of non-accidental injury 5. Previous surgery or significant injury to affected arm 6. Developmental delay 7. Failure to thrive 8. Pre-existing musculoskeletal disease affecting the upper limb 9. On medications that influence bone metabolism 10.Live outside the hospital catchment area or will find attending for follow-up difficult |
| Date of first enrolment | 30/05/2008 |
| Date of final enrolment | 13/03/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Kadoorie Centre
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
Oxford Radcliffe Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
John Racdliffe Hospital
Headington
Oxford
OX3 9DU
England
United Kingdom
| Website | http://www.oxfordradcliffe.nhs.uk |
|---|---|
"ROR" |
https://ror.org/03h2bh287 |
Funders
Funder type
Government
Oxford Radcliffe Hospitals NHS Trust (UK)
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 |
