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ISRCTN
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ISRCTN18607924
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DOI
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10.1186/ISRCTN18607924
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Shoulder Arthroplasty Trial
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Scientific title
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A randomised controlled trial of total resurfacing versus hemi re-surfacing in the treatment of primary osteoarthritis of the shoulder
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Acronym
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N/A
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Serial number at source
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11130
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Study hypothesis
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A randomised controlled trial of total resurfacing versus hemi resurfacing in the treatment of primary osteoarthritis
More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11130
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Lay summary
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Not provided at time of registration
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Ethics approval
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First MREC, 30 August 2011, ref: 11/WM/0245
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Study design
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Non-randomised interventional study
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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 Disease
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Participants - inclusion criteria
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1. Patient has severe osteoarthritis of the shoulder
2. Patient is suitable for a total resurfacing of the shoulder
3. Patient is medically fit for surgery
4. Patients aged 18 years of age or older
5. Male or female participants
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Participants - exclusion criteria
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1. Patients unlikely to be able to adhere to trial procedures
2. Patients not able to provide informed consent
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Anticipated start date
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31/01/2012
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Anticipated end date
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30/04/2014
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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UK Sample Size: 30
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Interventions
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Hemi Resurfacing Arthroplasty:
The humeral head is resurfaced and the glenoid remains intact with no surgical intervention
Total Resurfacing Arthroplasty:
Total Resurfacing Shoulder Arthroplasty. The glenoid and humeral head is resurfaced.
Followed up at 12 months
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Primary outcome measure(s)
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Oxford Shoulder Score measured at baseline, 6 weeks, 3 months, 6 months and 12 months
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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NIHR Research for Patient Benefit Programme (UK) ref: PB-PG-0110-21121
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Trial website
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Publications
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Contact name
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Prof
Damian
Griffin
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Address
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University of Warwick
Clifford Bridge Road
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City/town
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Coventry
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Zip/Postcode
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CV2 2DX
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Country
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United Kingdom
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Email
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damian.griffin@warwick.ac.uk
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Sponsor
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University of Warwick (UK)
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Address
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Gibbet Hill Road
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City/town
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Coventry
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Zip/Postcode
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CV4 7AL
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Country
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United Kingdom
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Sponsor website:
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http://www2.warwick.ac.uk/
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Date applied
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12/12/2012
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Last edited
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12/12/2012
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Date ISRCTN assigned
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12/12/2012
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