Details of HTA project in progress
Last updated: 31 August 2010 - Next update due: 7 September 2010
Research type: |
Primary Research (e.g. trial) |
Project title: |
The clinical and cost-effectiveness of arthroscopic versus open surgical repair for tears of the rotator cuff (UKUFF trial) |
Project ref: |
05/47/02 |
Cost: |
£1,895,440 |
Chief Investigator : |
Professor Andrew J Carr, Nuffield Professor of Orthopaedic Surgery, Nuffield Department of Orthopaedic, Rheumatology and Musculoskeletal Sciences, University of Oxford |
Project Website |
https://viis.abdn.ac.uk/HSRU/UKUFF/Site/Public/Default.aspx |
Start Date: |
July 2007 |
Estimated date of publication in HTA journal series: |
Early 2015. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
Tears of the rotator cuff are a common cause of shoulder pain in the adult population. Rotator cuff tears can be treated either surgically or non-surgically (for example by injection or home exercises). Surgery can take two main forms - an open repair or an arthroscopic repair (where the cuff is repaired using small instruments inserted through small incisions). There is wide variation in treatment practices across the UK and it is unclear which approach provides the best results for patients. In order to assess the effectiveness of the different approaches we propose to undertake a randomised controlled trial comparing arthroscopic surgery and open surgery with a non-surgical ("Rest then Exercise") approach. We know that surgeons have strong preferences regarding the surgery they are able and willing to perform and, as such, we propose that surgeons choose the randomised comparisons they feel able to contribute to (reflecting the treatments they are most uncertain about). For example surgeons could randomise to: a) arthroscopic surgery vs Rest then Exercise management only; or b) open surgery vs Rest then Exercise management only; or c) arthroscopic surgery vs open surgery vs Rest then Exercise management. It is planned that patients will be followed up for two years and will be asked about their shoulder (using a measure called the "Oxford Shoulder Score") and their general health (using "EQ5D"). Patients will also be assessed post-operatively by MRI scan as it is known that the quality of the repair can influence patient outcome. Full costs of the two surgical treatments and the non-surgical treatment will be calculated. This application has the support of the British Elbow and Shoulder Society and will take place in up to 60 centres across the UK and will involve a large group of surgeons. The research team has considerable expertise in the design and successful conduct of large scale randomised trials in Orthopaedic Surgery (notably the Knee Arthroplasty Trial - the KAT trial - currently funded by the HTA, which is one of the largest orthopaedic trials in the UK). The research team also has wide experience in the design and use of patient-based outcome scores in orthopaedic surgery. Members of the team were responsible for the design of the principal outcome measure, the Oxford Shoulder Score. The team also involves substantial experience in Health Economics and the assessment of cost-effectiveness of medical and surgical care. |
Project Abstract: |
The rotator cuff is a group of muscles that control movements within the shoulder. Tears of the rotator cuff are one of the most common causes of shoulder pain and dysfunction. The clinical evidence available regarding the natural history and the treatment of rotator cuff tears is limited and conflicting. Different methods of rotator cuff tear management are practiced throughout the United Kingdom. These include: ArthroscopicRepair - where the tear is repaired through key-hole surgery Open Repar - involving a longer skin incision to undertake the procedure under direct vision Non-Surgical Treatment - where a programme of Rest then Exercise is practiced This study was designed to assess these three methods of treatment. We will investigate over 600 patients, from 70 centres through out the United Kingdom. Information to be collected and analysed includes: Patient focused questionnaires regarding shoulder pain and function Patient focused questionnaires regarding the economic cost of the treatment Health care resources used (i.e. hospital stays, operating theatre equipment) MRI scans 12 months after the surgical repairs (to see if the repair is intact) Histological findings from tissue samples harvested during surgical repairs (to see if tissue quality influences success) Patients will be introduced to the trial by their consultant orthopaedic surgeon at his/her out-patient clinic. Patients who are interested will then receive information regarding UKUFF from the Oxford Trial office. Those who consent to participate will be randomised to undergo an arthroscopic repair or an open repair, or to complete the rest then exercise programme. All participating patients will be placed on the NHS waiting list for surgery. Those allocated to the Rest then Exercise programme will still be placed on the waiting list. However if they feel their shoulder has improved after completing the programme, they can decline surgery. A free-phone helpline will be established so patients have easy access to communicate with members of the research team in Oxford. |
NRR* number, if applicable: |
N0484193509 (*National Research Register). The National Research Register was a public database of ongoing and recently completed research projects funded by, or of interest to, the United Kingdom's National Health Service (NHS). It is now an archive of projects from early 2000 to September 2007. Search the NRR archive. |
ISRCTN* number: | ISRCTN 97804283 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN97804283 |
Project Protocol: |
Project protocol (pdf format, 268 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1551 |
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