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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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ISSN: 1756-1833
Published: BMJ 2022
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fullrecord <?xml version="1.0"?><rfc1807><datestamp>2022-12-22T13:15:32.9811144</datestamp><bib-version>v2</bib-version><id>61756</id><entry>2022-11-02</entry><title>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</title><swanseaauthors><author><sid>10b1bd08dbad1f2681ff1e527af9f9a3</sid><ORCID>0000-0001-7724-6621</ORCID><firstname>Shaun</firstname><surname>Harris</surname><name>Shaun Harris</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2022-11-02</date><deptcode>PHAC</deptcode><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 &#x2265;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 &#x2212;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 &#xA3;11&#x2009;167 (95% confidence interval &#xA3;638 to &#xA3;21&#x2009;696) at a &#xA3;20&#x2009;000 per quality adjusted life years threshold (&#xA3;1.0; $1.1; &#x20AC;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.</abstract><type>Journal Article</type><journal>BMJ</journal><volume>0</volume><journalNumber/><paginationStart>e071281</paginationStart><paginationEnd/><publisher>BMJ</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint/><issnElectronic>1756-1833</issnElectronic><keywords/><publishedDay>31</publishedDay><publishedMonth>10</publishedMonth><publishedYear>2022</publishedYear><publishedDate>2022-10-31</publishedDate><doi>10.1136/bmj-2022-071281</doi><url/><notes>Randomized Controlled Trial. 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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.</funders><projectreference/><lastEdited>2022-12-22T13:15:32.9811144</lastEdited><Created>2022-11-02T08:52:32.1269182</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">School of Health and Social Care</level></path><authors><author><firstname>Ashley W</firstname><surname>Blom</surname><orcid>0000-0002-9940-1095</orcid><order>1</order></author><author><firstname>Erik</firstname><surname>Lenguerrand</surname><orcid>0000-0002-0371-731x</orcid><order>2</order></author><author><firstname>Simon</firstname><surname>Strange</surname><orcid>0000-0002-4306-4640</orcid><order>3</order></author><author><firstname>Sian M</firstname><surname>Noble</surname><orcid>0000-0002-8011-0722</orcid><order>4</order></author><author><firstname>Andrew D</firstname><surname>Beswick</surname><orcid>0000-0002-7032-7514</orcid><order>5</order></author><author><firstname>Amanda</firstname><surname>Burston</surname><orcid>0000-0003-3480-4210</orcid><order>6</order></author><author><firstname>Kirsty</firstname><surname>Garfield</surname><orcid>0000-0002-8301-3602</orcid><order>7</order></author><author><firstname>Rachael</firstname><surname>Gooberman-Hill</surname><orcid>0000-0003-3353-2882</orcid><order>8</order></author><author><firstname>Shaun</firstname><surname>Harris</surname><orcid>0000-0001-7724-6621</orcid><order>9</order></author><author><firstname>Setor K</firstname><surname>Kunutsor</surname><orcid>0000-0002-2625-0273</orcid><order>10</order></author><author><firstname>J Athene</firstname><surname>Lane</surname><orcid>0000-0002-7578-4925</orcid><order>11</order></author><author><firstname>Alasdair</firstname><surname>MacGowan</surname><orcid>0000-0002-6720-5268</orcid><order>12</order></author><author><firstname>Sanchit</firstname><surname>Mehendale</surname><orcid>0000-0002-4955-1968</orcid><order>13</order></author><author><firstname>Andrew J</firstname><surname>Moore</surname><orcid>0000-0003-3185-1599</orcid><order>14</order></author><author><firstname>Ola</firstname><surname>Rolfson</surname><orcid>0000-0001-6534-1242</orcid><order>15</order></author><author><firstname>Jason C J</firstname><surname>Webb</surname><orcid>0000-0003-0112-3873</orcid><order>16</order></author><author><firstname>Matthew</firstname><surname>Wilson</surname><orcid>0000-0002-8520-9596</orcid><order>17</order></author><author><firstname>Michael R</firstname><surname>Whitehouse</surname><orcid>0000-0003-2436-9024</orcid><order>18</order></author></authors><documents><document><filename>61756__25954__70639647ad9f441181ded7a5d95bce3f.pdf</filename><originalFilename>61756.pdf</originalFilename><uploaded>2022-11-29T15:26:12.2642127</uploaded><type>Output</type><contentLength>620382</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language><licence>http://creativecommons.org/licenses/by-nc/4.0/</licence></document></documents><OutputDurs/></rfc1807>
spelling 2022-12-22T13:15:32.9811144 v2 61756 2022-11-02 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 10b1bd08dbad1f2681ff1e527af9f9a3 0000-0001-7724-6621 Shaun Harris Shaun Harris true false 2022-11-02 PHAC 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. Journal Article BMJ 0 e071281 BMJ 1756-1833 31 10 2022 2022-10-31 10.1136/bmj-2022-071281 Randomized Controlled Trial. Cite as: BMJ 2022;379:o2924 COLLEGE NANME Public Health COLLEGE CODE PHAC Swansea University 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. 2022-12-22T13:15:32.9811144 2022-11-02T08:52:32.1269182 Faculty of Medicine, Health and Life Sciences School of Health and Social Care Ashley W Blom 0000-0002-9940-1095 1 Erik Lenguerrand 0000-0002-0371-731x 2 Simon Strange 0000-0002-4306-4640 3 Sian M Noble 0000-0002-8011-0722 4 Andrew D Beswick 0000-0002-7032-7514 5 Amanda Burston 0000-0003-3480-4210 6 Kirsty Garfield 0000-0002-8301-3602 7 Rachael Gooberman-Hill 0000-0003-3353-2882 8 Shaun Harris 0000-0001-7724-6621 9 Setor K Kunutsor 0000-0002-2625-0273 10 J Athene Lane 0000-0002-7578-4925 11 Alasdair MacGowan 0000-0002-6720-5268 12 Sanchit Mehendale 0000-0002-4955-1968 13 Andrew J Moore 0000-0003-3185-1599 14 Ola Rolfson 0000-0001-6534-1242 15 Jason C J Webb 0000-0003-0112-3873 16 Matthew Wilson 0000-0002-8520-9596 17 Michael R Whitehouse 0000-0003-2436-9024 18 61756__25954__70639647ad9f441181ded7a5d95bce3f.pdf 61756.pdf 2022-11-29T15:26:12.2642127 Output 620382 application/pdf Version of Record true This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license true eng http://creativecommons.org/licenses/by-nc/4.0/
title 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
spellingShingle 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
Shaun Harris
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
author_id_str_mv 10b1bd08dbad1f2681ff1e527af9f9a3
author_id_fullname_str_mv 10b1bd08dbad1f2681ff1e527af9f9a3_***_Shaun Harris
author Shaun Harris
author2 Ashley W Blom
Erik Lenguerrand
Simon Strange
Sian M Noble
Andrew D Beswick
Amanda Burston
Kirsty Garfield
Rachael Gooberman-Hill
Shaun Harris
Setor K Kunutsor
J Athene Lane
Alasdair MacGowan
Sanchit Mehendale
Andrew J Moore
Ola Rolfson
Jason C J Webb
Matthew Wilson
Michael R Whitehouse
format Journal article
container_title BMJ
container_volume 0
container_start_page e071281
publishDate 2022
institution Swansea University
issn 1756-1833
doi_str_mv 10.1136/bmj-2022-071281
publisher BMJ
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str School of Health and Social Care{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}School of Health and Social Care
document_store_str 1
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description 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.
published_date 2022-10-31T04:20:49Z
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