Self Cast Removal at the Child's Home

ISRCTN	ISRCTN55089523
DOI	https://doi.org/10.1186/ISRCTN55089523
Protocol serial number	N/A
Sponsor	Oxford Radcliffe Hospitals NHS Trust (UK)
Funder	Oxford Radcliffe Hospitals NHS Trust (UK)

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

Kadoorie Centre
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom

Study information

Primary study design	Interventional
Study design	Pragmatic, individually randomised controlled equivalence study
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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%.
Key secondary outcome measure(s)	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
Completion date	13/03/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	16 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Kadoorie Centre

Oxford
OX3 9DU
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes