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Recommendations for design and conduct of preclinical in vivo studies of orthopedic device-related infection / 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
Journal of Orthopaedic Research®, Volume: 37, Issue: 2, Pages: 271 - 287
Swansea University Author: Llinos, Harris
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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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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.
preclinical study; in vivo; biofilm; orthopedic device-related infection; antimicrobial device.
Swansea University Medical School