United Kingdom Rotator Cuff Trial
| ISRCTN | ISRCTN97804283 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97804283 |
| Protocol serial number | HTA 05/47/02; Version 4, 25/08/10 |
| Sponsor | University of Oxford (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 22/06/2007
- Registration date
- 29/06/2007
- Last edited
- 05/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
http://www.ndorms.ox.ac.uk/clinicaltrials.php?trial=rotcuffsur
Contact information
Ms Cushla Cooper
Scientific
Scientific
Windmill Road
Headington
Oxford
OX3 7LD
United Kingdom
| Phone | +44 (0)1865 737643 |
|---|---|
| cushla.cooper@ndorms.ox.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Parallel-group randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Clinical effectiveness and cost-effectiveness of open and arthroscopic rotator cuff repair |
| Study acronym | UKUFF |
| Study objectives | 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 |
| Ethics approval(s) | 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) |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure(s) |
The UKUFF Questionnaire at 24 months after entry into study. |
| Key secondary outcome measure(s) |
Resource use measures including use and cost of health services. |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 270 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
OX3 7LD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | surgeon questionnaire results | 01/06/2012 | Yes | No | |
| Results article | complete study results | 01/10/2015 | Yes | No | |
| Protocol article | protocol | 01/05/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/12/2017: internal review.
16/10/2015: Added publication reference.
