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.
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.
| Original language | English |
|---|---|
| Article number | e071281 |
| Number of pages | 11 |
| Journal | The BMJ |
| Volume | 379 |
| DOIs | |
| Publication status | Published - 31 Oct 2022 |
Bibliographical note
Funding Information:Funding: 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. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The funder had no role in considering the study design or in the collection, analysis, interpretation of data, writing of the report, or decision to submit the article for publication. The Bristol Trials Centre receives NIHR CTU Support Funding to underpin the development and conduct of NIHR funded trials.
Funding Information:
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from NIHR for the submitted work. RGH reports individual payments as co-chair, UK Committee on Research Integrity. SM reports payments for organising the Palacademy Basic Sciences Course for Fellowship of the Royal College of Surgeons trainees by Heraeus. OR reports research funding paid to employer by Pfizer, educational/lecturer payments from Link Sweden, payments for Novartis advisory board, and unpaid roles as past president, International Society of Arthroplasty Registries, and deputy editor, Clinical Orthopaedics and Related Research. MW reports an institutional payment for an institutional contract between Exeter Hip Unit and Stryker Orthopaedics, personal payments in relation to intellectual property for Exeter Hip System, patents in relation to Exeter Hip Systems, honorary treasurer (British Hip Society), and associate editor (Annals of the Royal College of Surgeons of England). MRW is principal investigator of the Lot 2 contract for statistical analysis and support for the National Joint Registry from Healthcare Quality Improvement Partnership, principal investigator on an independently conducted research grant, funded by CeramTec investigating the association of total hip replacement bearing materials with outcomes, editor of two general orthopaedic textbooks for which he receives royalties from Taylor and Francis, undertakes teaching on basic sciences for Orthopaedic trainees preparing for the for Fellowship of the Royal College of Surgeons and on courses on the principles and performance of total hip replacements for trainees with market rate institutional payment for this teaching from Heraeus, editorial board member of Bone Joint Journal and Hip International, and research committee member of British Orthopaedic Association and British Hip Society.
Publisher Copyright:
© Author(s) (or their employer(s)) 2019.
Research Groups and Themes
- INFORM
- Prosthetic joint infection
- Hip replacement
- Randomised controlled trial
- Cost-effectiveness
- Patient reported outcome
Keywords
- Prosthetic joint infection; Hip replacement; Randomised controlled trial; Cost-effectiveness; Patient reported outcome
- Hip replacement
- randomised controlled trial
- Cost-effectiveness
- Patient reported outcome
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INFORM Trial WP4 Qualitative
Blom, A. (Creator) & Moore, A. (Creator), University of Bristol, 22 Feb 2023
DOI: 10.5523/bris.2vkcyerlpu3224zhtituieyqu, http://data.bris.ac.uk/data/dataset/2vkcyerlpu3224zhtituieyqu
Dataset