Condition category
Injury, Occupational Diseases, Poisoning
Date applied
27/10/2009
Date assigned
07/12/2009
Last edited
19/05/2015
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 Douglas Wardlaw

ORCID ID

Contact details

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

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 below 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 month

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, age 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

http://www.nhsgrampian.org

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

Publication citations

Additional files

Editorial Notes