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ISRCTN
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ISRCTN50850043
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ClinicalTrials.gov identifier
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Public title
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Multi-centre randomised trial evaluating surgery for displaced fractures of the proximal humerus
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Scientific title
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Pragmatic multi-centre randomised trial of surgical versus non-surgical treatment for proximal fracture of the humerus in adults
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Acronym
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PROFHER
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Serial number at source
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HTA 06/404/53
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Study hypothesis
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To assess the effectiveness and cost-effectiveness of surgical versus non-surgical treatment of the majority of displaced proximal humeral fractures in adults.
Protocol can be found at http://www.hta.ac.uk/protocols/200604040053.pdf
More information can be found at http://www.hta.ac.uk/1660
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Ethics approval
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York Multi-centre Research Ethics Committee (MREC), approved on 11/03/2007 (ref: 08/H1311/12)
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Study design
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Multi-centre randomised controlled trial.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Musculoskeletal trauma of the upper limb
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Participants - inclusion criteria
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1. Aged 16 or above, male and female
2. Presenting to the participating trauma centre within 3 weeks of their injury
3. Radiologically confirmed displaced fracture of the proximal humerus involving the surgical neck
4. Surgeon would consider surgical treatment for the fracture
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Participants - exclusion criteria
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1. Open fracture
2. Cognitive impairment that would preclude participation
3. Co-morbidities precluding surgery/ anaesthesia
4. Clear indication for surgery such as severe soft-tissue compromise requiring surgery/ emergency treatment
5. Multiple injuries: Same limb fractures, other upper limb fractures
6. Pathological fractures (other than osteoporotic)
7. Terminal illness
8. Participant not resident in trauma-centre catchment area
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Anticipated start date
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01/10/2008
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Anticipated end date
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30/09/2012
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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250
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Interventions
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Participants will be randomised to one of two basic treatment interventions:
1. Surgery (fixation or joint replacement)
2. Non-surgical management (sling immobilisation)
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Primary outcome measure(s)
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Oxford Shoulder Score (12-item condition-specific questionnaire providing a total score based on the person's subjective assessment of pain and activities of daily living impairment) assessed at 6, 12 and 24 months via postal questionnaire.
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Secondary outcome measure(s)
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1. The 12-item short form health survey (SF-12) and Euroqol (EQ-5D) for general health status data (at 6, 12 and 24 months)
2. Complications, including surgical complications (wound infection, implant failure, shoulder dislocation, septicaemia). Duration of follow-up: 2 years
3. Early medical complications, i.e. chest infection, confirmed myocardial infarction or stroke, treated deep vein thrombosis and pulmonary embolism.
4. Mortality. Duration of follow-up: 2 years
5. Subsequent referral for operation or substantive treatment. Duration of follow-up: 2 years
6. Data for economic evaluation: NHS and societal costs
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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http://www.profher.org/
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Publications
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2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19917097
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Contact name
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Mr
Amar
Rangan
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Address
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Consultant Orthopaedic Surgeon
The James Cook University Hospital
Marton Road
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City/town
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Middlesbrough
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Zip/Postcode
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TS4 3BW
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Country
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United Kingdom
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Tel
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+44 1642 854380
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Fax
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+44 1642 854375
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Email
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amar.rangan@stees.nhs.uk
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Sponsor
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University of Teesside (UK)
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Address
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-
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City/town
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Middlesbrough
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Zip/Postcode
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TS1 3BA
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Country
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United Kingdom
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Sponsor website:
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http://www.tees.ac.uk
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Date applied
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25/03/2008
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Last edited
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10/12/2009
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Date ISRCTN assigned
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25/03/2008
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