Splintage In External Rotation For Anterior Glenohumeral Dislocation: A Prospective, Randomised & Controlled Study
| ISRCTN | ISRCTN41070054 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41070054 |
| Protocol serial number | N0649183954 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | Queen Elizabeth Hospital NHS Trust (UK) |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 27/06/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
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
Contact information
Mr Nick Nicolaou
Scientific
Scientific
Orthopaedic Consultant
Queen Elizabeth Hospital NHS Trust
Stadium Road
Woolwich
London
SE18 4QH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
The only outcome measure needed is the incidence of recurrent dislocation. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 50 |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Orthopaedic Consultant
London
SE18 4QH
United Kingdom
SE18 4QH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
