The Comprehensive Clinical Trials Unit at UCL



1 November 2018

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



    ClinicalTrials.gov: NCT02128555