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Identification of implant outliers in joint replacement registries

Recent concerns surrounding joint replacements that have a higher than expected rate of revision have led to stricter controls by regulatory authorities with regards to the introduction of new devices into the marketplace. Implant post-market surveillance remains important, and joint replacement reg...

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Autores principales: de Steiger, Richard N, Hallstrom, Brian R, Lübbeke, Anne, Paxton, Elizabeth W, van Steenbergen, Liza N, Wilkinson, Mark
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Bioscientifica Ltd 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9969008/
https://www.ncbi.nlm.nih.gov/pubmed/36705620
http://dx.doi.org/10.1530/EOR-22-0058
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author de Steiger, Richard N
Hallstrom, Brian R
Lübbeke, Anne
Paxton, Elizabeth W
van Steenbergen, Liza N
Wilkinson, Mark
author_facet de Steiger, Richard N
Hallstrom, Brian R
Lübbeke, Anne
Paxton, Elizabeth W
van Steenbergen, Liza N
Wilkinson, Mark
author_sort de Steiger, Richard N
collection PubMed
description Recent concerns surrounding joint replacements that have a higher than expected rate of revision have led to stricter controls by regulatory authorities with regards to the introduction of new devices into the marketplace. Implant post-market surveillance remains important, and joint replacement registries are ideally placed to perform this role. This review examined if and how joint replacement registries identified outlier prostheses, outlined problems and suggested solutions to improve post-market surveillance. A search was performed of all joint replacement registries that had electronic or published reports detailing the outcomes of joint replacement. These reports were examined for registry identification of outlier prostheses. Five registries publicly identified outlier prostheses in their reports and the methods by which this was performed, and three others had internal reports. Identification of outlier prostheses is one area that may improve overall joint replacement outcomes; however, further research is needed to determine the optimum methods for identification, including the threshold, the comparator and the numbers required for notification of devices. Co-operation of registries at a global level may lead to earlier identification of devices and thereby further improve the results of joint replacement.
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spelling pubmed-99690082023-02-28 Identification of implant outliers in joint replacement registries de Steiger, Richard N Hallstrom, Brian R Lübbeke, Anne Paxton, Elizabeth W van Steenbergen, Liza N Wilkinson, Mark EFORT Open Rev General Orthopaedics Recent concerns surrounding joint replacements that have a higher than expected rate of revision have led to stricter controls by regulatory authorities with regards to the introduction of new devices into the marketplace. Implant post-market surveillance remains important, and joint replacement registries are ideally placed to perform this role. This review examined if and how joint replacement registries identified outlier prostheses, outlined problems and suggested solutions to improve post-market surveillance. A search was performed of all joint replacement registries that had electronic or published reports detailing the outcomes of joint replacement. These reports were examined for registry identification of outlier prostheses. Five registries publicly identified outlier prostheses in their reports and the methods by which this was performed, and three others had internal reports. Identification of outlier prostheses is one area that may improve overall joint replacement outcomes; however, further research is needed to determine the optimum methods for identification, including the threshold, the comparator and the numbers required for notification of devices. Co-operation of registries at a global level may lead to earlier identification of devices and thereby further improve the results of joint replacement. Bioscientifica Ltd 2023-01-27 /pmc/articles/PMC9969008/ /pubmed/36705620 http://dx.doi.org/10.1530/EOR-22-0058 Text en © The authors https://creativecommons.org/licenses/by-nc/4.0/This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. (https://creativecommons.org/licenses/by-nc/4.0/)
spellingShingle General Orthopaedics
de Steiger, Richard N
Hallstrom, Brian R
Lübbeke, Anne
Paxton, Elizabeth W
van Steenbergen, Liza N
Wilkinson, Mark
Identification of implant outliers in joint replacement registries
title Identification of implant outliers in joint replacement registries
title_full Identification of implant outliers in joint replacement registries
title_fullStr Identification of implant outliers in joint replacement registries
title_full_unstemmed Identification of implant outliers in joint replacement registries
title_short Identification of implant outliers in joint replacement registries
title_sort identification of implant outliers in joint replacement registries
topic General Orthopaedics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9969008/
https://www.ncbi.nlm.nih.gov/pubmed/36705620
http://dx.doi.org/10.1530/EOR-22-0058
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