The Optimal Conservative Management of Isolated Midshaft Clavicle Fractures

ISRCTN ISRCTN38821485
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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesProspectively 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) studiedInjury, Occupational Diseases, Poisoning: Clavicle fractures
InterventionPatients 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 typeOther
Primary outcome measurePatient completed questionnaire relating to activities of daily living and pain scores. Clinical, cosmetic and radiological outcome.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2002
Completion date01/07/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants100
Key inclusion criteria100 patients (50 in each of the two treatment arms) with isolated closed diaphyseal (midshaft) fractures of clavicle.
Key exclusion criteria1. Age below 18 or above 65
2. Mentally incompetent
3. Not resident locally
Date of first enrolment01/04/2002
Date of final enrolment01/07/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Old Dairy
Exeter
EX5 4HP
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan