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Surgery
Protocol
Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial
  1. Andrew J Goldberg1,
  2. Razi Zaidi1,
  3. Claire Thomson2,
  4. Caroline J Doré3,
  5. Simon S Skene3,
  6. Suzie Cro4,
  7. Jeff Round5,
  8. Andrew Molloy6,
  9. Mark Davies7,
  10. Michael Karski8,
  11. Louise Kim9,
  12. Paul Cooke10
  13. on behalf of the TARVA study group
    1. 1UCL Institute of Orthopaedics and Musculoskeletal Science (IOMS), Royal National Orthopaedic Hospital (RNOH), London, UK
    2. 2Surgical Intervention Trials Unit, University of Oxford, Botnar Research Centre, Oxford, UK
    3. 3Comprehensive Clinical Trials Unit, University College London, London, UK
    4. 4MRC Clinical Trials Unit, University College London, London, UK
    5. 5School of Social and Community Medicine, University of Bristol, Bristol, UK
    6. 6Aintree University Hospitals NHS Foundation Trust, Liverpool, UK
    7. 7Northern General Hospital, Sheffield, UK
    8. 8Wrightington Hospital, Wigan, UK
    9. 9Joint Research and Enterprise Office, St George's University of London and St George's University Hospitals NHS Foundation Trust, London, UK
    10. 10Oxford University Hospitals NHS Trust, Nuffield Orthopaedic Centre, Oxford, UK
    1. Correspondence to Razi Zaidi; razizaidi{at}doctors.net.uk

    Abstract

    Introduction Total ankle replacement (TAR) or ankle arthrodesis (fusion) is the main surgical treatments for end-stage ankle osteoarthritis (OA). The popularity of ankle replacement is increasing while ankle fusion rates remain static. Both treatments have efficacy but to date all studies comparing the 2 have been observational without randomisation, and there are no published guidelines as to the most appropriate management. The TAR versus arthrodesis (TARVA) trial aims to compare the clinical and cost-effectiveness of TAR against ankle arthrodesis in the treatment of end-stage ankle OA in patients aged 50–85 years.

    Methods and analysis TARVA is a multicentre randomised controlled trial that will randomise 328 patients aged 50–85 years with end-stage ankle arthritis. The 2 arms of the study will be TAR or ankle arthrodesis with 164 patients in each group. Up to 16 UK centres will participate. Patients will have clinical assessments and complete questionnaires before their operation and at 6, 12, 26 and 52 weeks after surgery. The primary clinical outcome of the study is a validated patient-reported outcome measure, the Manchester Oxford foot questionnaire, captured preoperatively and 12 months after surgery. Secondary outcomes include quality-of-life scores, complications, revision, reoperation and a health economic analysis.

    Ethics and dissemination The protocol has been approved by the National Research Ethics Service Committee (London, Bloomsbury 14/LO/0807). This manuscript is based on V.5.0 of the protocol. The trial findings will be disseminated through peer-reviewed publications and conference presentations.

    Trial registration number NCT02128555.

    • randomised controlled trial
    • ankle replacement
    • ankle arthrodesis

    This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

    https://doi.org/10.1136/bmjopen-2016-012716

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