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. 2024 Mar;8(2):235-249.
doi: 10.1007/s41669-023-00449-4. Epub 2024 Jan 8.

Cost-Utility Analysis of Total Ankle Replacement Compared with Ankle Arthrodesis for Patients Aged 50-85 Years with End-Stage Ankle Osteoarthritis: The TARVA Study

Andrew J Goldberg #  1   2   3 , Ekaterina Bordea #  4 , Kashfia Chowdhury  5 , Iva Hauptmannova  2 , James Blackstone  5 , Deirdre Brooking  2 , Elizabeth L Deane  5 , Stephen Bendall  6 , Andrew Bing  7 , Chris Blundell  8 , Sunil Dhar  9 , Andrew Molloy  10 , Steve Milner  11 , Mike Karski  12 , Steve Hepple  13 , Malik Siddique  14 , David T Loveday  15 , Viren Mishra  16 , Paul Cooke  17 , Paul Halliwell  18 , David Townshend  19 , Simon S Skene  20 , Caroline J Doré  5 ; TARVA Study Group
Collaborators, Affiliations

Cost-Utility Analysis of Total Ankle Replacement Compared with Ankle Arthrodesis for Patients Aged 50-85 Years with End-Stage Ankle Osteoarthritis: The TARVA Study

Andrew J Goldberg et al. Pharmacoecon Open. 2024 Mar.

Abstract

Background: Patients with end-stage ankle osteoarthritis suffer from reduced mobility and quality of life and the main surgical treatments are total ankle replacement (TAR) and ankle fusion (AF).

Objectives: Our aim was to calculate the mean incremental cost per quality-adjusted life-year (QALY) of TAR compared with AF in patients with end-stage ankle osteoarthritis, over 52 weeks and over the patients' lifetime.

Method: We conducted a cost-utility analysis of 282 participants from 17 UK centres recruited to a randomised controlled trial (TARVA). QALYs were calculated using index values from EQ-5D-5L. Resource use information was collected from case report forms and self-completed questionnaires. Primary analysis was within-trial analysis from the National Health Service (NHS) and Personal Social Services (PSS) perspective, while secondary analyses were within-trial analysis from wider perspective and long-term economic modelling. Adjustments were made for baseline resource use and index values.

Results: Total cost at 52 weeks was higher in the TAR group compared with the AF group, from the NHS and PSS perspective (mean adjusted difference £2539, 95% confidence interval [CI] £1142, £3897). The difference became very small from the wider perspective (£155, 95% CI - £1947, £2331). There was no significant difference between TAR and AF in terms of QALYs (mean adjusted difference 0.02, 95% CI - 0.015, 0.05) at 52 weeks post-operation. The incremental cost-effectiveness ratio (ICER) was £131,999 per QALY gained 52 weeks post-operation. Long-term economic modelling resulted in an ICER of £4200 per QALY gained, and there is a 69% probability of TAR being cost effective at a cost-effectiveness threshold of £20,000 per QALY gained.

Conclusion: TAR does not appear to be cost effective over AF 52 weeks post-operation. A decision model suggests that TAR can be cost effective over the patients' lifetime but there is a need for longer-term prospectively collected data. Clinical trial registration ISRCTN60672307 and ClinicalTrials.gov NCT02128555.

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Conflict of interest statement

AJG received a grant from NIHR HTA (12/35/27); has been a paid presenter for Stryker Inc. and Paragon 28; has patents issued, but not relevant to this manuscript; is an American Orthopaedic Foot and Ankle Society, British Orthopaedic Foot and Ankle Society, and National Joint Registry for England board or committee member; is a minor shareholder for Standing CT Company and Elstree Waterfront Outpatients; and holds stock options in X Bolt Orthopaedics. DL is a member of the British Foot and Ankle Society scientific committee. MK has received funding from the NIHR TARVA trial to set-up the trial locally and for the Research Department to collect data. SH is a paid consultant for Stryker Medical and a principal investigator in a long-term follow-up study of Infinity TARs, and has received payments for attending meetings relevant to this study. JB was paid by a UK NIHR HTA grant via UCL as Trial Manager for this project, 2015–2018. ED was paid by a UK NIHR HTA grant via UCL. AB was paid by a UK NIHR HTA grant via his institution, and received consulting fees from Wright Medical and MatOrtho. CB is a Director of the British Orthopaedic Foot and Ankle Society. SD received consulting fees from Wright Medical, Stryker, DePuy and MatOrtho, and was a President of the British Orthopaedic Foot and Ankle Society. SM received an institutional per-patient payment from a UK NIHR HTA grant; received personal fees from EIDO Healthcare for authoring patient information documents; and received travel support from DePuy and Arthrex to attend an educational workshop. PC received royalty assignment fees from Orthosolutions for an unrelated implant, and owns a company providing expert testimonials to lawyers on the management of foot and ankle disorders for use in court cases. PH received payment from Stryker and DJO UK for teaching and training, and was President of the British Orthopaedic Foot and Ankle Society from 2022 to 2023. DT received an institutional payment from a UK NIHR HTA grant; received personal consulting fees, payment for guest lectures and payment for travel support from Stryker; is a National Joint Registry Scientific committee member and British Orthopaedic Foot and Ankle Society member; and holds stock in Standing CT company. CD received an institutional payment from a UK NIHR HTA grant. POD, EB, KC, IH, DB, SB, AM, SS, VM, and MS declare that they have no conflicts of interest.

Figures

Fig. 1
Fig. 1
Model structure
Fig. 2
Fig. 2
Cost-effectiveness plane (within-trial analysis). QALYs quality-adjusted life-years
Fig. 3
Fig. 3
Cost-effectiveness acceptability curve (within-trial analysis). QALY quality-adjusted life-year
Fig. 4
Fig. 4
Cost-effectiveness plane (model-based analysis). QALYs quality-adjusted life-years
Fig. 5
Fig. 5
Cost-effectiveness acceptability curve (model-based analysis). QALY quality-adjusted life-year
See this image and copyright information in PMC

References

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    1. The Institute for Health Metrics and Evaluation. Osteoarthritis Level 3 cause. Global Health Metrics 2023. https://www.healthdata.org/results/gbd_summaries/2019/osteoarthritis-lev.... Accessed 08 Jun 2023.
    1. Goldberg AJ, et al. The demand incidence of symptomatic ankle osteoarthritis presenting to foot & ankle surgeons in the United Kingdom. Foot. 2012;22(3):163–166. doi: 10.1016/j.foot.2012.02.005. - DOI - PubMed
    1. Li Y, He J, Hu Y. Comparison of the efficiency and safety of total ankle replacement and ankle arthrodesis in the treatment of osteoarthritis: an updated systematic review and meta-analysis. Orthopaedic Surg. 2020;12(2):372–377. doi: 10.1111/os.12635. - DOI - PMC - PubMed
    1. TARVA. Ankle Replacement. 2023. https://www.anklearthritis.co.uk/ankle-replacement. Accessed 10 Jun 2023.

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