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ISRCTN
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ISRCTN55089523
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ClinicalTrials.gov identifier
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Public title
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Self Cast Removal at the Child's Home
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Scientific title
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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
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Acronym
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SCRATCH
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Serial number at source
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N/A
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Study hypothesis
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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
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Ethics approval
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Mid and South Buckinghamshire Research Ethics Committee. Date of approval: 12/03/2008 (ref: 08/H0607/20)
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Study design
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Pragmatic, individually randomised controlled equivalence study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Upper limb fractures in children
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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30/05/2008
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Anticipated end date
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13/03/2011
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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460
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Interventions
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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
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Primary outcome measure(s)
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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%.
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Secondary outcome measure(s)
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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
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Sources of funding
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Oxford Radcliffe Hospitals NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Prof
Keith
Willett
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Address
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Kadoorie Centre
John Radcliffe Hospital
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 9DU
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Country
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United Kingdom
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Sponsor
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Oxford Radcliffe Hospitals NHS Trust (UK)
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Address
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John Racdliffe Hospital
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 9DU
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Country
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United Kingdom
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Sponsor website:
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http://www.oxfordradcliffe.nhs.uk
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Date applied
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07/08/2008
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Last edited
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13/08/2008
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Date ISRCTN assigned
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13/08/2008
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