| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN97804283 |
| Date ISRCTN assigned | 29/06/2007 |
| Local reference number(s) | HTA 05/47/02; Version 1, 01/02/2007 |
| Public title | United Kingdom Rotator Cuff Trial |
| Scientific title |
|
| Acronym | UKUFF |
| Disease/condition/study domain | Musculoskeletal Diseases |
| Study hypothesis | To assess the clinical and cost effectiveness of three treatments for rotator cuff tears - surgical (arthroscopic or open repair) versus non-surgical management. |
| Design/methodology | A parrallel-group randomised controlled trial. |
| Research ethics review | Multi-centre Research Ethics Committee (MREC), approved on 12/06/2007 (ref: 07/Q1606/49)
|
| Countries of trial | United Kingdom |
| 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 |
| Patient information material | 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 |
| Anticipated start date | 01/07/2007 |
| Anticipated end date | 30/06/2012 |
| Status of trial | Ongoing |
| Target number of participants | 690 |
| Interventions | 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. |
| Trial website | http://www.charttrials.abdn.ac.uk/ukuff |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | University of Oxford (UK) |
| Sponsor details | Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
United Kingdom
OX3 9DZ |
| Sponsor telephone | +44 1865 743004 |
| Sponsor email | heather.house@admin.ox.ac.uk |
| Sponsor website | http://www.admin.ox.ac.uk/rso |
| Contact name | Prof Andrew Carr |
| Contact details | Windmill Road
Headington
Oxford
United Kingdom
OX3 7LD |
| Contact telephone | +44 1865 227270 |
| Contact fax | +44 1865 227740 |
| Contact email | andrew.carr@ndos.ox.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN97804283 |
| Date last extracted from ISRCTN register | 17/04/2008 |
