ISRCTN ISRCTN45883421
DOI https://doi.org/10.1186/ISRCTN45883421
Secondary identifying numbers 07/S0801/116
Submission date
27/10/2009
Registration date
07/12/2009
Last edited
02/10/2017
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 Douglas Wardlaw
Scientific

Orthopaedic Department
Woodend Hospital
Eday Road
Aberdeen
AB15 6XS
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleColles Fracture Brace prospective randomised study
Study acronymCFB Study
Study objectivesTreatment by a fracture brace will have a better outcome than standard care.
Ethics approval(s)North of Scotland Research Ethics Committee, 26/02/2008, ref: 07/S0801/116
Health condition(s) or problem(s) studiedColles fracture
InterventionApplication of plaster of paris (POP) cast, brace or surgery.

Total duration of follow-up: 2 years
Intervention typeProcedure/Surgery
Primary outcome measureClinical and radiological outcome at 6 months
Secondary outcome measuresClinical outcome at 2 years
Overall study start date16/11/2009
Completion date16/05/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants340
Key inclusion criteria1. Both males and females, aged 18 and over
2. Colles fracture requiring treatment
Key exclusion criteria1. Compared fracture
2. Previous fracture
3. Unable to give informed consent
Date of first enrolment16/11/2009
Date of final enrolment16/05/2012

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Woodend Hospital
Aberdeen
AB15 6XS
United Kingdom

Sponsor information

NHS Grampian (UK)
Hospital/treatment centre

Research and Development
Foresterhill House Annexe
Foresterhill
Aberdeen
AB25 2ZB
Scotland
United Kingdom

Website http://www.nhsgrampian.org
ROR logo "ROR" https://ror.org/00ma0mg56

Funders

Funder type

Other

Local funding from endowments (derek.angus@nhs.net)

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

Editorial Notes

02/10/2017: No publications found, verifying study status with principal investigator.