Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
SCRATCH
Study hypothesis
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
Mid and South Buckinghamshire Research Ethics Committee. Date of approval: 12/03/2008 (ref: 08/H0607/20)
Study design
Pragmatic, individually randomised controlled equivalence study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
30/05/2008
Overall trial end date
13/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
460
Participant 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
Recruitment start date
30/05/2008
Recruitment end date
13/03/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Kadoorie Centre
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
Oxford Radcliffe Hospitals NHS Trust (UK)
Sponsor details
John Racdliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Oxford Radcliffe Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list