Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0185131394
Study information
Scientific title
Acronym
Study hypothesis
To ascertain whether aspiration of traumatic elbow effusions reduces pain, increases mobility and quality of life?
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: Traumatic elbow effusion
Intervention
Randomly assigned to aspiration or not.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Parameters of pain, mobility and quality of life will be assessed on presentation, after treatment, one day, one week and 3 months.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2003
Overall trial end date
01/10/2007
Reason abandoned
Eligibility
Participant inclusion criteria
150 patients with traumatic elbow effusions, or type 1/2 radial head fractures.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
150
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2003
Recruitment end date
01/10/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Accident and Emergency Dept
Plymouth
PL6 8DH
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
Government
Funder name
Plymouth Hospitals 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