UKUFF is a multi-centre randomised controlled trial to measure the clinical and cost effectiveness of different types of surgery for rotator cuff repairs
The UKUFF Trial (funded by the Department of Health’s NIHR Health Technology Assessment programme) is a multi-centre randomised controlled trial to measure the clinical and cost effectiveness of different types of surgery for rotator cuff repairs. The Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) at the University of Oxford co-ordinates the trial via OSIRIS in collaboration with the Health Services Research Unit at the University of Aberdeen, which hosts the main UKUFF website.
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 repair surgery are practiced throughout the United Kingdom.
- Arthroscopic Repair: the tear is repaired through key-hole surgery
- Open / Mini-open Repair: a longer skin incision is used to undertake the procedure under direct vision
Initially the study design incorporated a non-surgical comparator arm. 58 centres and 90 surgeons from around the UK were involved and 474 patients were recruited up until the end of 2009. An extension was granted by the study funders at the beginning of 2010, but the extended recruitment period will only apply to the surgical comparisons. Recruitment to the non-surgical arm of the study will stop. All data collected up until the end of 2009 will be included in the final analysis of the extended study version. The UKUFF study will be completed by the end of 2013.
This study is now designed to assess the two methods of surgical treatment for rotator cuff tears.
We will investigate over 180 patients, from 20 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)
- Patient is aged over 50 years
- Degenerative Rotator Cuff Tear
- Full thickness Rotator Cuff Tear
- Diagnosed using MRI or Ultrasound
- Patient able to consent
- Previous surgery on affected shoulder
- Dual shoulder pathology
- Rheumatoid arthritis/systemic disease
- Significant osteoarthritis problems
- Significant neck problems
- Cognitive impairment or language issues
Recruitment of Patients
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 or from the CLRN research support team at participating centres. Those who consent to participate will be randomised to undergo an arthroscopic repair or an open/mini-open repair. All participating patients will be placed on the NHS waiting list for surgery.