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ISRCTN
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ISRCTN32335957
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ClinicalTrials.gov identifier
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Public title
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Prospective randomised study of Reverse shoulder Prosthesis and Hemiarthroplasty for elderly patients with proximal humeral fractures
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Scientific title
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Acronym
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Reverse Prosthesis vs Hemiarthroplasty
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Serial number at source
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3474
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Study hypothesis
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We aim to find which of the two (Reverse Shoulder Prosthesis or Hemiarthroplasty) is the better prosthesis in the elderly patients, with a shoulder fracture and need for arthroplasty.
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Ethics approval
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Central Office for Research Ethics Committee and Liverpool Local Research Ethics Committee, received 10th October 2007 (ref: 07/Q1502/59)
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Study design
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Double blind 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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Elderly patients with shoulder fracture that require arthroplasty
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Participants - inclusion criteria
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1. Elderly patients who require arthroplasty for shoulder fracture
2. Patients agreeing to participate in the study
3. Patients who are able to give consent
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Participants - exclusion criteria
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1. Patients who are younger than 70 years
2. Poly-trauma patients
3. Multiple fractures
4. Open fracture
5. Previous operation to the shoulder
6. Dementia
7. Nerve or vessel injury
8. Unable to understand English
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Anticipated start date
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01/06/2007
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Anticipated end date
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31/05/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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120
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Interventions
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Either a Reverse Shoulder Prosthesis or a Hemiarthroplasty for the fracture. All other aspects of treatment including follow up will be the same.
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Primary outcome measure(s)
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1. Activities of daily living of American Shoulder and Elbow Surgeons (ASES)
2. Simple shoulder test
These will be measured at one year after the operation.
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Secondary outcome measure(s)
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1. 36-item Short Form health survey (SF-36)
2. University of California and Los Angeles (UCLA) scores
3. Radiological outcome
These will be measured at one year after the operation.
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Sources of funding
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Royal Liverpool and Broadgreen University Hospital NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Mr
C
Sinopidis
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Address
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Link 4Z
Royal Liverpool and Broadgreen University Hospitals
Prescot Street
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City/town
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Liverpool
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Zip/Postcode
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L7 8XP
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Country
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United Kingdom
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Sponsor
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Royal Liverpool and Broadgreen University Hospital NHS Trust (UK)
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Address
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Prescot Street
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City/town
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Liverpool
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Zip/Postcode
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L7 8XP
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Country
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United Kingdom
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Sponsor website:
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http://www.rlbuht.nhs.uk/
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Date applied
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14/03/2007
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Last edited
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23/09/2008
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Date ISRCTN assigned
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09/05/2007
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