Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0523163139
Study information
Scientific title
A comparison study of internal versus external rotation immobilisation for primary anterior shoulder dislocation
Acronym
Study hypothesis
Not provided at time of registration
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
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Musculoskeletal Diseases: Shoulder dislocation
Intervention
Arm [A] external rotation
Arm [B] internal rotation
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
To assess rate of re dislocation per technique of splinting
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2005
Overall trial end date
01/05/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 20-40 years old
2. Traumatic dislocations
3. First time dislocations
4. No associated fractures of the region
5. No associated rotator cuff tears
6. No co morbidity that affect general health
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
75 patients per group
Participant exclusion criteria
1. Recurrent disclocation
2. Unable to co operate for physiotherapy and/or follow up
3. Co morbidity
4. Associated fracture or rotator cuff injury
5. Significant ipsilateral injury
6. Open injuries
7. Neurological disease
8. Collagen disease
9. Pregnancy
10. Unfit for surgery
Recruitment start date
01/01/2005
Recruitment end date
01/05/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Good Hope Hospital NHS Trust
Birmingham
B75 7RR
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
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
Good Hope 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