RF-EOI-24-001



Title of the project
The clinical & cost-effectiveness of total ankle replacement versus arthrodesis in the treatment of end-stage ankle osteoarthritis.

Layperson summary

Each year, over 29,000 patients with ankle osteoarthritis seek a specialist opinion, of whom 4000 undergo NHS surgical treatment. The main surgical treatments for ankle osteoarthritis are total ankle replacement or arthrodesis (i.e. ankle fusion). Total ankle replacement is a more popular patient choice than ankle fusion but there is limited data to help patients choose the right treatment for them. The TARVA study was the world’s first randomised controlled study to compare these two treatments. The study was funded with more than £2m of public funds by the NIHR HTA and the 1 year results were published in 2022 in the Annals or Internal Medicine. We now have 5 year data including all costs and wish to perform a full health economic analysis of cost effectiveness and look to the ORUK to help fund this study.


Aim of your proposed research

To determine whether ankle replacement is better than ankle fusion in terms of clinical & cost-effectiveness in the treatment of end-stage ankle osteoarthritis.


Your research methodology

The study was funded by an NIHR HTA Grant of over £2m (https://www.journalslibrary.nihr.ac.uk/hta/ptyj1146/#/abstract) to capture a cohort of 303 patients randomised to ankle replacement and ankle fusion. The funding covered recruitment and randomisation in 17 NHS Trusts between the years of 2015 & 2020 and the data capture for longer term outcomes. The study does not fund the analysis of the long term data nor the publication costs at 2, 5 & 10 years. Therefore we already have the data for 5 year outcomes on our database and this study would analyse this data and publish the results.


Impact of your proposed research

This is the worlds first level I evidence randomised controlled trial of two NHS surgical treatments and the eyes of the world orthopaedic patients are on the longer term data. The initial paper (https://www.acpjournals.org/doi/10.7326/M22-2058) achieved an Altmertics score of 413 which is significant and it is likely that the 5 year paper will be even higher imapct and we look to ORUK to help enable this publication by helping us fund the health economist and statistician and publication costs, so in effect, ORUK will leverage over £2m of public funding so that its small contribution will be amplified hugely.


Are you a start-up?
No

Research activity area follow definitions provided in UKCRC Health Research Analysis 2022
Underpinning, Treatment Evaluation, Disease Management, Health Services

Amount requested (£)
£10,000

Duration (months)
12 months

Start date
01-08-2024

Is there an external research partner?
Yes

If yes, please specify
NIHR HTA

Is there an Intellectual Property (IP) linked to this research?
No

Will you be testing on animals?
No

Have you previously received funding from ORUK?
No

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