Assessment of patients with midshaft clavicular fractures randomised to either conservative or operative treatment

ISRCTN ISRCTN57483251
DOI https://doi.org/10.1186/ISRCTN57483251
Secondary identifying numbers N0188119749
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
27/10/2015
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 SA Khan
Scientific

Consultant Orthopaedic Surgeon
Royal Preston Hospital
Sharoe Green Lane North
Fulwood
Preston
PR2 9HT
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAssessment of patients with midshaft clavicular fractures randomised to either conservative or operative treatment
Study objectivesTo assess which type of treatment is superior in terms of patient satisfaction (SF 12) and function (Visual Analogue Scale [VAS] and Constant scoring system).
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedInjury, Occupational Diseases, Poisoning: Clavicular fracture
InterventionRandomised to either conservative or operative treatment
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date12/12/2002
Completion date01/05/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants40 patients
Key inclusion criteriaPatients with midshaft clavicular fractures
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment12/12/2002
Date of final enrolment01/05/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Preston Hospital
Preston
PR2 9HT
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Lancashire Teaching Hospitals NHS Trust (UK)

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