Condition category
Injury, Occupational Diseases, Poisoning
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
27/06/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Nick Nicolaou

ORCID ID

Contact details

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

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes