Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial

Andrew J Goldberg, Razi Zaidi, Claire Thomson, Caroline J Doré, Simon S Skene, Suzie Cro, Jeff Round, Andrew Molloy, Mark Davies, Michael Karski, Louise Kim, Paul Cooke, TARVA study group, Stephen Bendall, Andrew Bing, Chris Blundell, Clifford Butcher, Caroline Chadwick, Tim Clough, Nick Cullen, James Davenport, Howard Davies, Paul Halliwell, Simon Hill, Rajesh Kakwani, Mike Karski, David Loveday, Nilesh Makwana, Chris Marquis, Steve Milner, Viren Mishra, An Murty, Mark Rogers, Javed Salim, Hemant Sharma, Malik Siddique, Dishan Singh, George Smith, Robert Smith, Rhys Thomas, Paulo Torres, David Townshend, Andrew J Goldberg, Razi Zaidi, Claire Thomson, Caroline J Doré, Simon S Skene, Suzie Cro, Jeff Round, Andrew Molloy, Mark Davies, Michael Karski, Louise Kim, Paul Cooke, TARVA study group, Stephen Bendall, Andrew Bing, Chris Blundell, Clifford Butcher, Caroline Chadwick, Tim Clough, Nick Cullen, James Davenport, Howard Davies, Paul Halliwell, Simon Hill, Rajesh Kakwani, Mike Karski, David Loveday, Nilesh Makwana, Chris Marquis, Steve Milner, Viren Mishra, An Murty, Mark Rogers, Javed Salim, Hemant Sharma, Malik Siddique, Dishan Singh, George Smith, Robert Smith, Rhys Thomas, Paulo Torres, David Townshend

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.

Keywords: ankle arthrodesis; ankle replacement; randomised controlled trial.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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Source: PubMed

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