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

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

Study information

Study designPragmatic, individually randomised controlled equivalence study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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 acronymSCRATCH
Study objectivesAn 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) studiedUpper limb fractures in children
InterventionParticipants 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 typeOther
Primary outcome measureClinical 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 measures1. 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 date30/05/2008
Completion date13/03/2011

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit2 Years
Upper age limit16 Years
SexBoth
Target number of participants460
Key inclusion criteria1. 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 criteria1. 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 enrolment30/05/2008
Date of final enrolment13/03/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Kadoorie Centre
Oxford
OX3 9DU
United Kingdom

Sponsor information

Oxford Radcliffe Hospitals NHS Trust (UK)
Hospital/treatment centre

John Racdliffe Hospital
Headington
Oxford
OX3 9DU
England
United Kingdom

Website http://www.oxfordradcliffe.nhs.uk
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan