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

Skene, Simon, Goldberg, A J, Zaidi, R, Thomson, C, Doré, C J, Cro, S, Round, J, Molloy, A, Davies, M, Karski, M , Kim, L and Cooke, P (2016) Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial BMJ Open, 6 (9), e012716.

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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.

Item Type: Article
Divisions : Faculty of Health and Medical Sciences > Surrey Clinical Research Centre
Faculty of Health and Medical Sciences
Authors :
NameEmailORCID
Skene, Simons.skene@surrey.ac.uk
Goldberg, A J
Zaidi, R
Thomson, C
Doré, C J
Cro, S
Round, J
Molloy, A
Davies, M
Karski, M
Kim, L
Cooke, P
Date : 6 September 2016
DOI : 10.1136/bmjopen-2016-012716
Copyright Disclaimer : Copyright The Author(s) 2016. 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 noncommercially, 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/
Related URLs :
Depositing User : Diane Maxfield
Date Deposited : 23 Apr 2018 11:53
Last Modified : 22 Jun 2018 11:44
URI: http://epubs.surrey.ac.uk/id/eprint/846288

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