Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0649183954
Study information
Scientific title
Acronym
Study hypothesis
Does splintage in external rotation following anterior shoulder dislocation reduce the incidence of recurrent dislocation?
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: Shoulder dislocation
Intervention
Patients presenting to fracture clinic with a first time shoulder dislocation are randomised to either current practice (use of sling) or use of an external rotation splint. Treatment otherwise is identical.
Queen Elizabeth Hospital NHS Trust study also ongoing at East Kent Hospitals which now makes it a dual centre study. Both local and central ethical approval has been gained for this.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The only outcome measure needed is the incidence of recurrent dislocation.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2005
Overall trial end date
01/11/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Patients aged 16-40 presenting to our hospital with a first time anterior shoulder dislocation.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Target: 50. As of Sep'07: 38.
Participant exclusion criteria
1. Age less than 16 or more than 40
2. Patients unable to give informed consent
3. All vulnerable groups (mental illness, prisoners etc) and patients with an associated fracture requiring operative intervention
Recruitment start date
01/11/2005
Recruitment end date
01/11/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Orthopaedic Consultant
London
SE18 4QH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
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
Queen Elizabeth 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