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



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.



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.



NCT02128555.
UCL Institute of Orthopaedics and Musculoskeletal Science (IOMS), Royal National Orthopaedic Hospital (RNOH), London, UK.
Andrew J
AJ
Goldberg
UCL Institute of Orthopaedics and Musculoskeletal Science (IOMS), Royal National Orthopaedic Hospital (RNOH), London, UK.
Razi
R
Zaidi
Surgical Intervention Trials Unit, University of Oxford, Botnar Research Centre, Oxford, UK.
Claire
C
Thomson
Comprehensive Clinical Trials Unit, University College London, London, UK.
Caroline J
CJ
Doré
Comprehensive Clinical Trials Unit, University College London, London, UK.
Simon S
0000-0002-7828-3122
SS
Skene
MRC Clinical Trials Unit, University College London, London, UK.
Suzie
S
Cro
School of Social and Community Medicine, University of Bristol, Bristol, UK.
Jeff
J
Round
Aintree University Hospitals NHS Foundation Trust, Liverpool, UK.
Andrew
A
Molloy
Northern General Hospital, Sheffield, UK.
Mark
M
Davies
Wrightington Hospital, Wigan, UK.
Michael
M
Karski
Joint Research and Enterprise Office, St George's University of London and St George's University Hospitals NHS Foundation Trust, London, UK.
Louise
L
Kim
Oxford University Hospitals NHS Trust, Nuffield Orthopaedic Centre, Oxford, UK.
Paul
P
Cooke
D000368:Aged; D000369:Aged, 80 and over; D001174:Arthrodesis; D058737:Arthroplasty, Replacement, Ankle; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000601:surgery*; D000071066:Patient Reported Outcome Measures; D011183:Postoperative Complications / Q000453:epidemiology*; D011788:Quality of Life; D012086:Reoperation / Q000706:statistics & numerical data; D012107:Research Design; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D006113:United Kingdom
ankle arthrodesis; ankle replacement; randomised controlled trial