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Clinical and cost effectiveness of single stage compared with two stage revision for hip prosthetic joint infection (INFORM): pragmatic, parallel group, open label, randomised controlled trial

Ashley W Blom Orcid Logo, Erik Lenguerrand Orcid Logo, Simon Strange Orcid Logo, Sian M Noble Orcid Logo, Andrew D Beswick Orcid Logo, Amanda Burston Orcid Logo, Kirsty Garfield Orcid Logo, Rachael Gooberman-Hill Orcid Logo, Shaun Harris Orcid Logo, Setor K Kunutsor Orcid Logo, J Athene Lane Orcid Logo, Alasdair MacGowan Orcid Logo, Sanchit Mehendale Orcid Logo, Andrew J Moore Orcid Logo, Ola Rolfson Orcid Logo, Jason C J Webb Orcid Logo, Matthew Wilson Orcid Logo, Michael R Whitehouse Orcid Logo

BMJ, Start page: e071281

Swansea University Author: Shaun Harris Orcid Logo

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DOI (Published version): 10.1136/bmj-2022-071281

Abstract

Objectives To determine whether patient reported outcomes improve after single stage versus two stage revision surgery for prosthetic joint infection of the hip, and to determine the cost effectiveness of these procedures.Design Pragmatic, parallel group, open label, randomised controlled trial.Sett...

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Published in: BMJ
ISSN: 1756-1833
Published: BMJ 2022
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URI: https://cronfa.swan.ac.uk/Record/cronfa61756
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Abstract: Objectives To determine whether patient reported outcomes improve after single stage versus two stage revision surgery for prosthetic joint infection of the hip, and to determine the cost effectiveness of these procedures.Design Pragmatic, parallel group, open label, randomised controlled trial.Setting High volume tertiary referral centres or orthopaedic units in the UK (n=12) and in Sweden (n=3), recruiting from 1 March 2015 to 19 December 2018.Participants 140 adults (aged ≥18 years) with a prosthetic joint infection of the hip who required revision (65 randomly assigned to single stage and 75 to two stage revision).Interventions A computer generated 1:1 randomisation list stratified by hospital was used to allocate participants with prosthetic joint infection of the hip to a single stage or a two stage revision procedure.Main outcome measures The primary intention-to-treat outcome was pain, stiffness, and functional limitations 18 months after randomisation, measured by the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes included surgical complications and joint infection. The economic evaluation (only assessed in UK participants) compared quality adjusted life years and costs between the randomised groups.Results The mean age of participants was 71 years (standard deviation 9) and 51 (36%) were women. WOMAC scores did not differ between groups at 18 months (mean difference 0.13 (95% confidence interval −8.20 to 8.46), P=0.98); however, the single stage procedure was better at three months (11.53 (3.89 to 19.17), P=0.003), but not from six months onwards. Intraoperative events occurred in five (8%) participants in the single stage group and 20 (27%) in the two stage group (P=0.01). At 18 months, nine (14%) participants in the single stage group and eight (11%) in the two stage group had at least one marker of possible ongoing infection (P=0.62). From the perspective of healthcare providers and personal social services, single stage revision was cost effective with an incremental net monetary benefit of £11 167 (95% confidence interval £638 to £21 696) at a £20 000 per quality adjusted life years threshold (£1.0; $1.1; €1.4).Conclusions At 18 months, single stage revision compared with two stage revision for prosthetic joint infection of the hip showed no superiority by patient reported outcome. Single stage revision had a better outcome at three months, fewer intraoperative complications, and was cost effective. Patients prefer early restoration of function, therefore, when deciding treatment, surgeons should consider patient preferences and the cost effectiveness of single stage surgery.Trial registration ISRCTN registry ISRCTN10956306.
Item Description: Randomized Controlled Trial. Cite as: BMJ 2022;379:o2924
College: Faculty of Medicine, Health and Life Sciences
Funders: This study is funded by the NIHR Programme Grant for Applied Research (reference RP-PG-1210-12005). This study was also supported by the NIHR Biomedical Research Centre at the University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol.
Start Page: e071281

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