TARVA

Total Ankle Replacement vs Arthrodesis

The main surgical treatments for end-stage ankle arthritis are ankle arthrodesis or total ankle replacement (TAR). Approximately 3,000 patients with ankle arthritis undergo ankle arthrodesis or TAR in the NHS each year. Both treatments are available on the NHS, and both have been reported to have good results. Some studies suggest that TAR restores a more natural walking pattern than ankle fusion but other studies have suggested that the need for further surgery is higher with TAR than with fusion. There has never been a published randomised trial directly comparing the two procedures.

Patients who are eligible and wish to consent to join the study will be randomised based on a number of factors, including presence of arthritis in adjacent joints.  Once randomised, patients will undergo either a TAR or arthrodesis operation on their affected ankle, and be followed up at five visits over a 12-month period.  Both pre- and post-operatively, patients will answer a range of questionnaires used to assess function and health economic impacts.  The primary outcome of the study will compare improvements in the walking-standing domain score from the Manchester-Oxford Foot Questionnaire (MOXFQ) between treatment groups.

Recruitment and followups for TARVA, a Phase III study, have now concluded and the trial has officially closed.

Official TARVA study website: www.anklearthritis.co.uk

Publications

• Andrew J. Goldberg, Kashfia Chowdhury, Ekaterina Bordea, Iva Hauptmannova, James Blackstone, Deirdre Brooking, Elizabeth L. Deane, Stephen Bendall, Andrew Bing, Chris Blundell, Sunil Dhar, Andrew Molloy, Steve Milner, Mike Karski, Steve Hepple, Malik Siddique, David T. Loveday, Viren Mishra, Paul Cooke, Paul Halliwell, David Townshend, Simon S. Skene, and Caroline J. Doré, on behalf of the TARVA Study Group. Total Ankle Replacement Versus Arthrodesis for End-Stage Ankle Osteoarthritis: A Randomized Controlled Trial. Ann Intern Med. [Epub 15 November 2022]. doi:10.7326/M22-2058
• Sarveen Gajebasia, Toby Jennison, James Blackstone, Razi Zaidi, Patrick Muller, Andrew Goldberg | Patient Reported Outcome Measures in Ankle Replacement Versus Ankle Arthrodesis – A Systematic Review | The Foot, available online 29 October 2021, 101874, https://doi.org/10.1016/j.foot.2021.101874
• Alba X. Realpe, James Blackstone, Damian R. Griffin, Andrew J. F. Bing, Michael Karski, Stephen A. Milner, Malik Siddique, Andrew Goldberg | Barriers to recruitment to an orthopaedic randomized controlled trial comparing two surgical procedures for ankle arthritis, a qualitative study | Bone Jt Open 2021;2(8):631–637

• Muller P, Skene SS, Chowdhury K, Cro S, Goldberg AJ, Doré CJ, on behalf of the TARVA Study Group. A randomised, multi-centre trial of total ankle replacement versus ankle arthrodesis in the treatment of patients with end stage ankle osteoarthritis (TARVA): statistical analysis plan. Trials 2020;21, 197.

• Goldberg AJ, Zaidi R, Thomson C, Doré CJ, Skene SS, Cro S, Round J, Molloy A, Davies M, Karski M, Kim L, Cooke P, on behalf of the TARVA study group. Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial. BMJ Open 2016;6:e012716

ISRCTN60672307

ClinicalTrials.gov: NCT02128555