The Optimal Conservative Management of Isolated Midshaft Clavicle Fractures

ISRCTN	ISRCTN38821485
DOI	https://doi.org/10.1186/ISRCTN38821485
Protocol serial number	N0185146336
Sponsor	Department of Health
Funder	Plymouth Hospitals NHS Trust (UK), Own Account

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Patient completed questionnaire relating to activities of daily living and pain scores. Clinical, cosmetic and radiological outcome.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/07/2003

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan