Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
07/S0801/116
Study information
Scientific title
Colles Fracture Brace prospective randomised study
Acronym
CFB Study
Study hypothesis
Treatment by a fracture brace will have a better outcome than standard care.
Ethics approval
North of Scotland Research Ethics Committee, 26/02/2008, ref: 07/S0801/116
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Colles fracture
Intervention
Application of plaster of paris (POP) cast, brace or surgery.
Total duration of follow-up: 2 years
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Clinical and radiological outcome at 6 months
Secondary outcome measures
Clinical outcome at 2 years
Overall trial start date
16/11/2009
Overall trial end date
16/05/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Both males and females, aged 18 and over
2. Colles fracture requiring treatment
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
340
Participant exclusion criteria
1. Compared fracture
2. Previous fracture
3. Unable to give informed consent
Recruitment start date
16/11/2009
Recruitment end date
16/05/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Woodend Hospital
Aberdeen
AB15 6XS
United Kingdom
Sponsor information
Organisation
NHS Grampian (UK)
Sponsor details
Research and Development
Foresterhill House Annexe
Foresterhill
Aberdeen
AB25 2ZB
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Local funding from endowments (derek.angus@nhs.net)
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