Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0185146336
Study information
Scientific title
Acronym
Study hypothesis
Prospectively how do the clinical, radiological and functional outcomes of two well established methods of immobilising clavicle fractures compare? One method immobilises the arm on the affected side whereas the other (figure of eight shoulder bandage) leaves both arms free and may therefore interfere less with activities of daily living.
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: Clavicle fractures
Intervention
Patients fulfulling inclusion criteria will be given an information leaflet in casualty. Those agreeing to enter the trial will be randomised by opening an envelope to either the sling or shoulder brace group. They will be followed up in the fracture clinic at 3 & 8 weeks and x-rayed as normal but will complete a short questionnaire at the end of each week and answer a short questionnaire at their 8 week clinic visit.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Patient completed questionnaire relating to activities of daily living and pain scores. Clinical, cosmetic and radiological outcome.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2002
Overall trial end date
01/07/2003
Reason abandoned
Eligibility
Participant inclusion criteria
100 patients (50 in each of the two treatment arms) with isolated closed diaphyseal (midshaft) fractures of clavicle.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
1. Age below 18 or above 65
2. Mentally incompetent
3. Not resident locally
Recruitment start date
01/04/2002
Recruitment end date
01/07/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Old Dairy
Exeter
EX5 4HP
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Plymouth Hospitals NHS Trust (UK), Own Account
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