Condition category
Injury, Occupational Diseases, Poisoning
Date applied
07/08/2008
Date assigned
13/08/2008
Last edited
27/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Keith Willett

ORCID ID

Contact details

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

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 measures

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

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

http://www.oxfordradcliffe.nhs.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes