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

Goldberg, AJ; Zaidi, R; Thomson, C; Doré, CJ; Skene, SS; Cro, S; Round, J; Molloy, A; Davies, M; Karski, M; et al. Goldberg, AJ; Zaidi, R; Thomson, C; Doré, CJ; Skene, SS; Cro, S; Round, J; Molloy, A; Davies, M; Karski, M; Kim, L; Cooke, P; TARVA study group (2016) Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial. BMJ Open, 6 (9). e012716. ISSN 2044-6055 https://doi.org/10.1136/bmjopen-2016-012716
SGUL Authors: Kim, Unchung Louise

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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
Additional Information: 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/
Keywords: ankle arthrodesis, ankle replacement, randomised controlled trial
Journal or Publication Title: BMJ Open
ISSN: 2044-6055
Language: eng
Dates:
DateEvent
6 September 2016Published Online
1 September 2016Published
15 August 2016Accepted
Publisher License: Creative Commons: Attribution-Noncommercial 4.0
PubMed ID: 27601503
Web of Science ID: WOS:000391302900059
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/108594
Publisher's version: https://doi.org/10.1136/bmjopen-2016-012716

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