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ISRCTN
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ISRCTN97804283
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ClinicalTrials.gov identifier
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Public title
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United Kingdom Rotator Cuff Trial
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Scientific title
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Acronym
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UKUFF
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Serial number at source
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HTA 05/47/02; Version 1, 01/02/2007
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Study hypothesis
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To assess the clinical and cost effectiveness of three treatments for rotator cuff tears - surgical (arthroscopic or open repair) versus non-surgical management.
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Ethics approval
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Multi-centre Research Ethics Committee (MREC), approved on 12/06/2007 (ref: 07/Q1606/49)
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Study design
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A parrallel-group 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 Diseases
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Participants - inclusion criteria
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1. Aged 50 years or older
2. Suffer from degenerative rotator cuff tear
3. Have full thickness rotator cuff tear
4. Tear diagnosed using Magnetic Resonance Imaging (MRI) or ultrasound scan
5. Patient able to consent
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Participants - exclusion criteria
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1. Previous surgery on affected shoulder
2. Dual shoulder pathology
3. Significant problems in other shoulder
4. Rheumatoid arthritis / systemic disease
5. Significant osteoarthritis problems
6. Significant neck problems
7. Cognitive impairment or language issues
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Anticipated start date
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01/07/2007
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Anticipated end date
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30/06/2012
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Status of trial
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Ongoing
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Patient information material
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Patient Information Sheet version 5 dated 15/11/2007 is available for download from https://viis.abdn.ac.uk/HSRU/UKUFF/Site/Public/Downloads.aspx
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Target number of participants
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690
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Interventions
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Each participant will be randomised to one of the following arms:
Arm 1: Arthroscopic surgery
Arm 2: Open surgery
Arm 3: “Rest then Exercise” Programme
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Primary outcome measure(s)
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The UKUFF Questionnaire at 24 months after entry into study.
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Secondary outcome measure(s)
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Resource use measures including use and cost of health services.
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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.charttrials.abdn.ac.uk/ukuff
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Publications
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Contact name
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Prof
Andrew
Carr
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Address
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Windmill Road
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 7LD
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Country
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United Kingdom
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Tel
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+44 1865 227270
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Fax
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+44 1865 227740
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Email
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andrew.carr@ndos.ox.ac.uk
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Sponsor
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University of Oxford (UK)
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Address
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Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 9DZ
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Country
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United Kingdom
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Tel
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+44 1865 743004
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Email
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heather.house@admin.ox.ac.uk
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Sponsor website:
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http://www.admin.ox.ac.uk/rso
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Date applied
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22/06/2007
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Last edited
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29/01/2008
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Date ISRCTN assigned
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29/06/2007
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