Open reduction and internal fixation (ORIF) versus conservative treatment of high energy clavicle fractures

ISRCTN ISRCTN00825817
DOI https://doi.org/10.1186/ISRCTN00825817
Secondary identifying numbers N0188095539
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
02/02/2017
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 Steve Bale
Scientific

Orthopaedics
Lancashire Teaching Hospitals NHS Trust
Preston
PR2 9HT
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleOpen reduction and internal fixation (ORIF) versus conservative treatment of high energy clavicle fractures
Study objectivesDoes early fixation influence outcome?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedInjury, Occupational Diseases, Poisoning: Fractures
InterventionOpen reduction and internal fixation (ORIF) versus conservative treatment
Intervention typeOther
Primary outcome measureUsing shoulder scoring system
Secondary outcome measuresNot provided at time of registration
Overall study start date01/06/1999
Completion date01/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40 patients
Key inclusion criteriaAll patients with high energy clavicle fractures
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/06/1999
Date of final enrolment01/12/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Orthopaedics
Preston
PR2 9HT
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

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

Editorial Notes

02/02/2017: No publications found in PubMed, verifying study status with principal investigator.