The United Kingdom Rotator Cuff Trial (UKUFF)

The UKUFF Trial (funded by the Department of Health’s 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 Orthopaedic, Rheumatology and Musculoskeletal Sciences (NDORMS) at the University of Oxford will co-ordinate the trial in collaboration with the Health Services Research Unit at the University of Aberdeen.


Background

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.

These include:

  • Arthroscopic Repair – where the tear is repaired through key-hole surgery
  • Open/mini-Open Repair – involving a longer skin incision 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 at the end of 2009. An extension was granted by the study funders at the beginning of 2010, but the extended recruitment period only applied to the surgical comparisons. Recruitment to the non-surgical arm of the study ceased. All data collected up until the end of 2009 will be included in the final analysis of the extended study version.

Aims

This study is now designed to assess arthroscopic and open/mini-open rotator cuff repairs. UKUFF is a pragmatic randomised controlled trial.

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)

Follow up is at 8, 12 and 24 months post randomisation. There are post treatment follow ups at 2 and 8 weeks post intervention and an MRI or USS at 12 months post-surgery.

Timeline

July 2007

Start of funding

November 2007

Recruitment started

December 2009

447 patients recruited

January 2010

Protocol reconfiguration

May 2010

2 –way comparison recruitment begins – 180 patients needed

February 2012

Recruitment target met

December 2013

Follow up complete

June 2014

UKUFF Presentation to BESS

July 2014

Monograph publication


The UKUFF Team

The research team in Oxford consists of clinical staff, surgeons, physiotherapists and nurses, with research experience and expertise in shoulder care. Other members of the team include outcome analysists and health economists.

The team includes:

  • Professor Andrew Carr (Nuffield Professor of Orthopaedic Surgery, Chief Investigator)
  • Mr Jonathan Rees (Academic Consultant Orthopaedic Surgeon, Grant holder)
  • Ms Jane Moser (Specialist Physiotherapist, Grant holder)
  • Dr Jill Dawson (Outcome Analysist, Grant holder)
  • Professor Ray Fitzpatrick (Professor of Public Health & Primary Care, Grant holder)
  • Professor Alastair Gray (Professor of Health Economics, Grant holder)
  • Mrs Cushla Cooper (Trial Co-ordinator)


The UKUFF team in Aberdeen consists of statisticians and triallists who have great experience and expertise in running large randomised controlled surgical trials.

The team is as follows:

  • Professor Marion Campbell (Professor of Health Services Research, Grant holder)
  • Dr Craig Ramsay (Statistician, Grant holder)
  • Dr Hanne Bruhn (Trial Manager)

Contact Details: Cushla Cooper, UKUFF Trial Co-ordinator, t: 01865 737643, e:ukuff@ndorms.ox.ac.uk

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