Splintage In External Rotation For Anterior Glenohumeral Dislocation: A Prospective, Randomised & Controlled Study

ISRCTN	ISRCTN41070054
DOI	https://doi.org/10.1186/ISRCTN41070054
Secondary identifying numbers	N0649183954

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr Nick Nicolaou
Scientific

Orthopaedic Consultant
Queen Elizabeth Hospital NHS Trust
Stadium Road
Woolwich
London
SE18 4QH
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Does splintage in external rotation following anterior shoulder dislocation reduce the incidence of recurrent dislocation?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	The only outcome measure needed is the incidence of recurrent dislocation.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/11/2005
Completion date	01/11/2010

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Target: 50. As of Sep'07: 38.
Key inclusion criteria	Patients aged 16-40 presenting to our hospital with a first time anterior shoulder dislocation.
Key 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
Date of first enrolment	01/11/2005
Date of final enrolment	01/11/2010

Orthopaedic Consultant

London
SE18 4QH
United Kingdom

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Queen Elizabeth Hospital NHS Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan