Summary

A national, multi-centre pragmatic randomised controlled trial to answer the question ‘is surgical treatment of calcaneal fractures effective, as measured by patient functional outcome at two years?’

Fractures of the calcaneus, or heel bone, are an important cause of hind-foot osteoarthritis & consequent pain, loss of function, inability to work, economic loss & necessity for sub-talar fusion. Modern surgical techniques offer the opportunity to reduce these risks significantly. These techniques are becoming widespread, but do have risks, and there is an urgent need to assess the clinical effectiveness of surgery for calcaneal fractures.

The UK Heel Fracture Trial will answer the research question "is surgical treatment of calcaneal fractures effective, as measured by patient functional outcome at two years" by comparing open reduction & internal fixation with non-operative treatment of closed displaced intra-articular fractures of the calcaneus.

The trial will be set in twenty UK hospitals, and is recruiting 150 participants. The participants will be followed-up with interim outcomes measured at 6, 12 & 18 months. The principal outcome will be measured at two years following injury using validated objective & subjective measures.

Chief Investigator: Damian Griffin, Professor of Trauma and Orthopaedic Surgery

UK Heel Fracture Trial Coordinator: Miss Jaclyn Brown
Telephone: 02476 968625
Email: heelfracture@warwick.ac.uk

Address:
UK Heel Fracture Trial
Warwick Medical School
Clinical Sciences Research Institute
Clifford Bridge Road
Coventry, CV2 2DX

Other Principal Unit Participants: Matthew Costa, Senior Lecturer in Orthopaedics; Yuri Kulikov, Clinical Research Fellow in Orthopaedics; Becky Hardcastle and Katie Dunn, Research Associates.

Collaborating Investigators

• Sallie Lamb Professor of Physiotherapy and Rehabilitation, Warwick Medical School, University of Warwick and University of Oxford
• Margaret Thorogood Professor of Epidemiology, Warwick Medical School, University of Warwick
• Ewart Shaw Lecturer in Statistics, University of Warwick
• Richard Lilford Professor of Clinical Epidemiology, Department of Public Health and Epidemiology, University of Birmingham
• Ala Szczepura Professor of Health Economics, Centre for Health Services Studies, Warwick Medical School, University of Warwick
• Gillian Hundt Professor of Social Sciences in Health and Chair of School of Health and Social Studies, University of Warwick
• Matthew Costa, Senior Lecturer in Orthopaedics, Warwick Medical School

Collaborating Centres

• University Hospitals Coventry and Warwickshire NHS Trust
  M Costa, M Blakemore
• Kings College Hospital, London
  M Phillips
• Cambridge University Hospitals Foundation Trust (Addenbrooke's)
  A Robinson
• University Hospitals Birmingham NHS Trust (Selly Oak Hospital)
  J Cooper, K Porter
• Wrexham Maelor Hospital
  P Laing, N Makwana
• Cardiff & Vale NHS Trust (University Hospital)
  D O'Doherty, S Hemmadi, R Thomas
• University of Leicester NHS Trust (Royal Infirmary)
  G Taylor, A Best
• Norfolk & Norwich NHS Trust
  AD Patel, J Albert, R Hutchinson
• Leeds Teaching Hospital NHS Trust (University Hospital)
  P Giannoudis, N Harris, R Monkhouse
• Sheffield Teaching Hospitals NHS Trust (Northern General Hospital)
  C Blundell, M Davies, R Gibson
• South Tees Hospitals NHS Trust (James Cook University Hospital)
  A Hui, A Rangan, A Adedapo, I McMurtry, I Wallace, P MacKenney, R Liow
• The Royal Liverpool & Broadgreen University Hospitals NHS Trust (Royal Hospital)
  C Walker, S Sirikonda
• Wirral Hospital NHS Trust (Arrowe Park Hospital)
  M Hennessy, S Platt
• Bolton Hospitals NHS Trust
  A Henderson
• Aintree University Hospitals NHS FoundationTrust
  C Butcher, A Molloy, D Simmons
• Taunton & Somerset NHS Trust (Musgrove Park Hospital)
  A Kelly, J Williams
• Royal Devon & Exeter NHS FoundationTrust
  I Sharpe
• Gloucestershire Hospitals NHS FoundationTrust
  R Brown, M Henderson, I McFadyen, C Curwen
• St George's Healthcare NHS Trust
  M Rickman
• Belfast Health & Social Care Trust
  J Barr, A Adair
  
  
  

Status: Recruitment is now running in 17 centres across the UK.

Funded by: The Arthritis Research Campaign (arc) 0870 850 5000 www.arc.org.uk

Central Office for Research Ethics Committees (COREC) approval reference number 06/Q1604/58

International Standard Randomised Controlled Trial Number: ISRCTN37188541