The Optimal Conservative Management of Isolated Midshaft Clavicle Fractures
ISRCTN | ISRCTN38821485 |
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DOI | https://doi.org/10.1186/ISRCTN38821485 |
Secondary identifying numbers | N0185146336 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 25/04/2014
- 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 N Talbot
Scientific
Scientific
The Old Dairy
Fore Street
Silverton
Exeter
EX5 4HP
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | Prospectively how do the clinical, radiological and functional outcomes of two well established methods of immobilising clavicle fractures compare? One method immobilises the arm on the affected side whereas the other (figure of eight shoulder bandage) leaves both arms free and may therefore interfere less with activities of daily living. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Injury, Occupational Diseases, Poisoning: Clavicle fractures |
Intervention | Patients fulfulling inclusion criteria will be given an information leaflet in casualty. Those agreeing to enter the trial will be randomised by opening an envelope to either the sling or shoulder brace group. They will be followed up in the fracture clinic at 3 & 8 weeks and x-rayed as normal but will complete a short questionnaire at the end of each week and answer a short questionnaire at their 8 week clinic visit. |
Intervention type | Other |
Primary outcome measure | Patient completed questionnaire relating to activities of daily living and pain scores. Clinical, cosmetic and radiological outcome. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/04/2002 |
Completion date | 01/07/2003 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Not Specified |
Target number of participants | 100 |
Key inclusion criteria | 100 patients (50 in each of the two treatment arms) with isolated closed diaphyseal (midshaft) fractures of clavicle. |
Key exclusion criteria | 1. Age below 18 or above 65 2. Mentally incompetent 3. Not resident locally |
Date of first enrolment | 01/04/2002 |
Date of final enrolment | 01/07/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Old Dairy
Exeter
EX5 4HP
United Kingdom
EX5 4HP
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Plymouth Hospitals NHS Trust (UK), Own Account
No information available
Results and Publications
Intention to publish date | |
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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 |