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04 February 2012
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| [ Print-friendly version ] |
| United Kingdom Rotator Cuff Trial |
| ISRCTN | ISRCTN97804283 |
| ClinicalTrials.gov identifier | |
| Public title | United Kingdom Rotator Cuff Trial |
| Scientific title | |
| Acronym | UKUFF |
| Serial number at source | HTA 05/47/02; Version 4, 25/08/10 |
| Study hypothesis |
Current information as of 21/10/10:
Initial information at time of registration: To assess the clinical and cost effectiveness of three treatments for rotator cuff tears - surgical (arthroscopic or open repair) versus non-surgical management. Please note that as of 21/10/10 this record has been updated to reflect changes in the trial protocol from a 3-arm to a 2-arm trial. More details can be found in the relevant fields with the above update date. Please also note that the anticipated end date of the trial has been extended from 30/06/12 to 31/12/13. More details at http://www.hta.ac.uk/project/1551.asp Protocol available at http://www.hta.ac.uk/protocols/200500470002.pdf |
| Lay summary | |
| Ethics approval |
Current information as of 21/10/10:
Multi-centre Research Ethics Committee (MREC) approved on the 15th of April 2010 (ref: 07/Q1606/49) Initial information at time of registration: Multi-centre Research Ethics Committee (MREC) approved on the 12th of June 2007 (ref: 07/Q1606/49) |
| Study design | Parallel-group randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Musculoskeletal Diseases |
| Participants - inclusion criteria |
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 |
| Participants - exclusion criteria |
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 |
| Anticipated start date | 01/07/2007 |
| Anticipated end date | 31/12/2013 |
| Status of trial | Ongoing |
| Patient information material | Patient Information Sheet version 6 dated 19/01/2010 is available for download from https://viis.abdn.ac.uk/HSRU/UKUFF/Site/Public/DownloadPage.aspx |
| Target number of participants | As of 21/10/10: 270 (at time of registration: 690) |
| Interventions |
Current information as of 21/10/10:
Each participant will be randomised to one of the following arms: Arm 1 - Open/mini-open surgery Arm 2 - Arthroscopic surgery Initial information at time of registration 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 |
| Primary outcome measure(s) | The UKUFF Questionnaire at 24 months after entry into study. |
| Secondary outcome measure(s) | Resource use measures including use and cost of health services. |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | http://www.charttrials.abdn.ac.uk/ukuff |
| Publications | |
| Contact name | Ms Cushla Cooper |
| Address |
Windmill Road
Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 7LD |
| Country | United Kingdom |
| Tel | +44 (0)1865 737643 |
| Fax | +44 (0)1865 227671 |
| cushla.cooper@ndorms.ox.ac.uk | |
| Sponsor | University of Oxford (UK) |
| Address |
Clinical Trials and Research Governance
Manor House John Radcliffe Hospital Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 9DZ |
| Country | United Kingdom |
| Tel | +44 1865 743004 |
| heather.house@admin.ox.ac.uk | |
| Sponsor website: | http://www.admin.ox.ac.uk/rso |
| Date applied | 22/06/2007 |
| Last edited | 21/10/2010 |
| Date ISRCTN assigned | 29/06/2007 |
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| © 2012 ISRCTN unless otherwise stated. | |
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