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Recommendations for design and conduct of preclinical in vivo studies of orthopedic device-related infection

T Fintan Moriarty, Llinos Harris Orcid Logo, Robert A. Mooney, Joseph C. Wenke, Martijn Riool, Sebastian A. J. Zaat, Annette Moter, Thomas P. Schaer, Nina Khanna, Richard Kuehl, Volker Alt, Andrea Montali, Jianfeng Liu, Stephan Zeiter, Henk J. Busscher, David W. Grainger, R. Geoff Richards

Journal of Orthopaedic Research®, Volume: 37, Issue: 2, Pages: 271 - 287

Swansea University Author: Llinos Harris Orcid Logo

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DOI (Published version): 10.1002/jor.24230

Abstract

Orthopedic device-related infection (ODRI), including both fracture-related infection (FRI) and periprosthetic joint infection (PJI), remain amongst the most challenging complications in orthopedic and musculoskeletal trauma surgery. ODRI has been convincingly shown to delay healing, worsen function...

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Published in: Journal of Orthopaedic Research®
ISSN: 07360266
Published: 2019
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URI: https://cronfa.swan.ac.uk/Record/cronfa49633
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To address this clinical problem, ever more sophisticated technologies targeting the prevention and/or treatment of ODRI are being developed and tested in vitro and in vivo. Amongst the most commonly described innovations are antimicrobial-coated orthopedic devices, antimicrobial-loaded bone cements and void fillers, and dual osteo-inductive/antimicrobial biomaterials. Unfortunately, translation of these technologies to the clinic has been limited, at least partially due to the challenging and still evolving regulatory environment for antimicrobial drug-device combination products, and a lack of clarity in the burden of proof required in preclinical studies. Preclinical in vivo testing (i.e. animal studies) represents a critical phase of the multidisciplinary effort to design, produce and reliably test both safety and efficacy of any new antimicrobial device. Nonetheless, current in vivo testing protocols, procedures, models and assessments are highly disparate, irregularly conducted and reported, and without standardization and validation. The purpose of the present opinion piece is to discuss best practices in preclinical in vivo testing of antimicrobial interventions targeting ODRI. By sharing these experience-driven views, we aim to aid others in conducting such studies both for fundamental biomedical research, but also for regulatory and clinical evaluation.</abstract><type>Journal Article</type><journal>Journal of Orthopaedic Research&#xAE;</journal><volume>37</volume><journalNumber>2</journalNumber><paginationStart>271</paginationStart><paginationEnd>287</paginationEnd><publisher/><issnPrint>07360266</issnPrint><keywords>preclinical study; in vivo; biofilm; orthopedic device-related infection; antimicrobial device.</keywords><publishedDay>11</publishedDay><publishedMonth>3</publishedMonth><publishedYear>2019</publishedYear><publishedDate>2019-03-11</publishedDate><doi>10.1002/jor.24230</doi><url/><notes/><college>COLLEGE NANME</college><department>Biomedical Sciences</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>BMS</DepartmentCode><institution>Swansea University</institution><apcterm/><lastEdited>2019-03-21T10:02:07.3010976</lastEdited><Created>2019-03-19T16:37:09.3405644</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Medicine</level></path><authors><author><firstname>T Fintan</firstname><surname>Moriarty</surname><order>1</order></author><author><firstname>Llinos</firstname><surname>Harris</surname><orcid>0000-0002-0295-3038</orcid><order>2</order></author><author><firstname>Robert A.</firstname><surname>Mooney</surname><order>3</order></author><author><firstname>Joseph C.</firstname><surname>Wenke</surname><order>4</order></author><author><firstname>Martijn</firstname><surname>Riool</surname><order>5</order></author><author><firstname>Sebastian A. J.</firstname><surname>Zaat</surname><order>6</order></author><author><firstname>Annette</firstname><surname>Moter</surname><order>7</order></author><author><firstname>Thomas P.</firstname><surname>Schaer</surname><order>8</order></author><author><firstname>Nina</firstname><surname>Khanna</surname><order>9</order></author><author><firstname>Richard</firstname><surname>Kuehl</surname><order>10</order></author><author><firstname>Volker</firstname><surname>Alt</surname><order>11</order></author><author><firstname>Andrea</firstname><surname>Montali</surname><order>12</order></author><author><firstname>Jianfeng</firstname><surname>Liu</surname><order>13</order></author><author><firstname>Stephan</firstname><surname>Zeiter</surname><order>14</order></author><author><firstname>Henk J.</firstname><surname>Busscher</surname><order>15</order></author><author><firstname>David W.</firstname><surname>Grainger</surname><order>16</order></author><author><firstname>R. Geoff</firstname><surname>Richards</surname><order>17</order></author></authors><documents><document><filename>0049633-21032019100140.pdf</filename><originalFilename>49633.pdf</originalFilename><uploaded>2019-03-21T10:01:40.8870000</uploaded><type>Output</type><contentLength>385683</contentLength><contentType>application/pdf</contentType><version>Accepted Manuscript</version><cronfaStatus>true</cronfaStatus><embargoDate>2020-02-21T00:00:00.0000000</embargoDate><copyrightCorrect>true</copyrightCorrect><language>eng</language></document></documents><OutputDurs/></rfc1807>
spelling 2019-03-21T10:02:07.3010976 v2 49633 2019-03-19 Recommendations for design and conduct of preclinical in vivo studies of orthopedic device-related infection dc70f9d4badbbdb5d467fd321986d173 0000-0002-0295-3038 Llinos Harris Llinos Harris true false 2019-03-19 BMS Orthopedic device-related infection (ODRI), including both fracture-related infection (FRI) and periprosthetic joint infection (PJI), remain amongst the most challenging complications in orthopedic and musculoskeletal trauma surgery. ODRI has been convincingly shown to delay healing, worsen functional outcome and incur significant socio-economic costs. To address this clinical problem, ever more sophisticated technologies targeting the prevention and/or treatment of ODRI are being developed and tested in vitro and in vivo. Amongst the most commonly described innovations are antimicrobial-coated orthopedic devices, antimicrobial-loaded bone cements and void fillers, and dual osteo-inductive/antimicrobial biomaterials. Unfortunately, translation of these technologies to the clinic has been limited, at least partially due to the challenging and still evolving regulatory environment for antimicrobial drug-device combination products, and a lack of clarity in the burden of proof required in preclinical studies. Preclinical in vivo testing (i.e. animal studies) represents a critical phase of the multidisciplinary effort to design, produce and reliably test both safety and efficacy of any new antimicrobial device. Nonetheless, current in vivo testing protocols, procedures, models and assessments are highly disparate, irregularly conducted and reported, and without standardization and validation. The purpose of the present opinion piece is to discuss best practices in preclinical in vivo testing of antimicrobial interventions targeting ODRI. By sharing these experience-driven views, we aim to aid others in conducting such studies both for fundamental biomedical research, but also for regulatory and clinical evaluation. Journal Article Journal of Orthopaedic Research® 37 2 271 287 07360266 preclinical study; in vivo; biofilm; orthopedic device-related infection; antimicrobial device. 11 3 2019 2019-03-11 10.1002/jor.24230 COLLEGE NANME Biomedical Sciences COLLEGE CODE BMS Swansea University 2019-03-21T10:02:07.3010976 2019-03-19T16:37:09.3405644 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine T Fintan Moriarty 1 Llinos Harris 0000-0002-0295-3038 2 Robert A. Mooney 3 Joseph C. Wenke 4 Martijn Riool 5 Sebastian A. J. Zaat 6 Annette Moter 7 Thomas P. Schaer 8 Nina Khanna 9 Richard Kuehl 10 Volker Alt 11 Andrea Montali 12 Jianfeng Liu 13 Stephan Zeiter 14 Henk J. Busscher 15 David W. Grainger 16 R. Geoff Richards 17 0049633-21032019100140.pdf 49633.pdf 2019-03-21T10:01:40.8870000 Output 385683 application/pdf Accepted Manuscript true 2020-02-21T00:00:00.0000000 true eng
title Recommendations for design and conduct of preclinical in vivo studies of orthopedic device-related infection
spellingShingle Recommendations for design and conduct of preclinical in vivo studies of orthopedic device-related infection
Llinos Harris
title_short Recommendations for design and conduct of preclinical in vivo studies of orthopedic device-related infection
title_full Recommendations for design and conduct of preclinical in vivo studies of orthopedic device-related infection
title_fullStr Recommendations for design and conduct of preclinical in vivo studies of orthopedic device-related infection
title_full_unstemmed Recommendations for design and conduct of preclinical in vivo studies of orthopedic device-related infection
title_sort Recommendations for design and conduct of preclinical in vivo studies of orthopedic device-related infection
author_id_str_mv dc70f9d4badbbdb5d467fd321986d173
author_id_fullname_str_mv dc70f9d4badbbdb5d467fd321986d173_***_Llinos Harris
author Llinos Harris
author2 T Fintan Moriarty
Llinos Harris
Robert A. Mooney
Joseph C. Wenke
Martijn Riool
Sebastian A. J. Zaat
Annette Moter
Thomas P. Schaer
Nina Khanna
Richard Kuehl
Volker Alt
Andrea Montali
Jianfeng Liu
Stephan Zeiter
Henk J. Busscher
David W. Grainger
R. Geoff Richards
format Journal article
container_title Journal of Orthopaedic Research®
container_volume 37
container_issue 2
container_start_page 271
publishDate 2019
institution Swansea University
issn 07360266
doi_str_mv 10.1002/jor.24230
college_str Faculty of Medicine, Health and Life Sciences
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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 Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
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description Orthopedic device-related infection (ODRI), including both fracture-related infection (FRI) and periprosthetic joint infection (PJI), remain amongst the most challenging complications in orthopedic and musculoskeletal trauma surgery. ODRI has been convincingly shown to delay healing, worsen functional outcome and incur significant socio-economic costs. To address this clinical problem, ever more sophisticated technologies targeting the prevention and/or treatment of ODRI are being developed and tested in vitro and in vivo. Amongst the most commonly described innovations are antimicrobial-coated orthopedic devices, antimicrobial-loaded bone cements and void fillers, and dual osteo-inductive/antimicrobial biomaterials. Unfortunately, translation of these technologies to the clinic has been limited, at least partially due to the challenging and still evolving regulatory environment for antimicrobial drug-device combination products, and a lack of clarity in the burden of proof required in preclinical studies. Preclinical in vivo testing (i.e. animal studies) represents a critical phase of the multidisciplinary effort to design, produce and reliably test both safety and efficacy of any new antimicrobial device. Nonetheless, current in vivo testing protocols, procedures, models and assessments are highly disparate, irregularly conducted and reported, and without standardization and validation. The purpose of the present opinion piece is to discuss best practices in preclinical in vivo testing of antimicrobial interventions targeting ODRI. By sharing these experience-driven views, we aim to aid others in conducting such studies both for fundamental biomedical research, but also for regulatory and clinical evaluation.
published_date 2019-03-11T04:00:47Z
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