Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0106149412
Study information
Scientific title
Acronym
Study hypothesis
To compare two methods of fixation for wrist fractures.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Injury, Occupational Diseases, Poisoning: Wrist fractures
Intervention
30 patients having their fracture treated with closed reduction and K-wire fixation
30 patients having their fracture treated with fixed-angle volar plating
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Wrist function and fracture healing
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2004
Overall trial end date
30/06/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
60 adult patients with a closed unilateral unstable distal radius fracture
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2004
Recruitment end date
30/06/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
SpR Registrar, Trauma & Orthopaedics
Cheltenham
GL53 7AN
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Gloucestershire R&D Consortium (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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20691441
Publication citations
-
Results
McFadyen I, Field J, McCann P, Ward J, Nicol S, Curwen C, Should unstable extra-articular distal radial fractures be treated with fixed-angle volar-locked plates or percutaneous Kirschner wires? A prospective randomised controlled trial., Injury, 2011, 42, 2, 162-166, doi: 10.1016/j.injury.2010.07.236.