Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0034136470
Study information
Scientific title
Is a neutralisation plate always necessary in the treatment of unstable ankle fractures?
Acronym
Study hypothesis
To ascertain whether the avoidance of a plate will minimise soft tissue problems and lateral hardware associated pain and hence reduce the need for the removal of metalwork whilst maintaining adequate fracture fixation
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Injury, Occupational Diseases, Poisoning: Ankle fractures
Intervention
Neutralisation plate vs standard practice
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Efficacy of treatment
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2002
Overall trial end date
01/04/2005
Reason abandoned
Eligibility
Participant inclusion criteria
All adults over 18 years of age admitted to this Trust will be randomised.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/2002
Recruitment end date
01/04/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Barnsley Hospital
Barnsley
S75 2EP
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Barnsley District General Hospital 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