The Optimal Conservative Management of Isolated Midshaft Clavicle Fractures

ISRCTN	ISRCTN38821485
DOI	https://doi.org/10.1186/ISRCTN38821485
Secondary identifying numbers	N0185146336

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 N Talbot
Scientific

The Old Dairy
Fore Street
Silverton
Exeter
EX5 4HP
United Kingdom

Study design	Randomised controlled trial
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

Participant type(s)	Patient
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

The Old Dairy

Exeter
EX5 4HP
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Plymouth Hospitals NHS Trust (UK), Own Account

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