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Living with a recalled implant: a qualitative study of patients’ experiences with ASR hip resurfacing arthroplasty

BACKGROUND: Total hip arthroplasty is the traditional treatment for osteoarthritis in the hip joint. Hip resurfacing arthroplasty, with metal on metal bearing, is a modern concept initially developed mainly for young active people. The metal-on-metal hip arthroplasty implant, Articular Surface Repla...

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Autores principales: Bitar, Christian, Krupic, Ferid, Felländer-Tsai, Li, Crnalic, Sead, Wretenberg, Per
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7788783/
https://www.ncbi.nlm.nih.gov/pubmed/33407687
http://dx.doi.org/10.1186/s13037-020-00278-y
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author Bitar, Christian
Krupic, Ferid
Felländer-Tsai, Li
Crnalic, Sead
Wretenberg, Per
author_facet Bitar, Christian
Krupic, Ferid
Felländer-Tsai, Li
Crnalic, Sead
Wretenberg, Per
author_sort Bitar, Christian
collection PubMed
description BACKGROUND: Total hip arthroplasty is the traditional treatment for osteoarthritis in the hip joint. Hip resurfacing arthroplasty, with metal on metal bearing, is a modern concept initially developed mainly for young active people. The metal-on-metal hip arthroplasty implant, Articular Surface Replacement (ASR), was implanted in approximately 93,000 patients before it was recalled in 2010 due to a high complication rate. This study aimed to evaluate patients’ own experiences living with an implant that they knew had a high complication rate and had been recalled from the market. METHODS: A total of 14 patients, still living with the implant, of a cohort of 34 patients were available for follow-up. Qualitative semi-structured interviews were conducted with 14 patients where a majority actively sought for metal-on-metal hip resurfacing arthroplasty (HRA), and subsequently underwent HRA with an ASR prosthesis between 11/21/2006 and 09/28/2009. The responses were analyzed using content analysis described by Graneheim and Lundman to compress text and identify categories and subcategories. RESULTS: The results showed that most patients had already decided that they wanted a metal-on-metal HRA implant before meeting the surgeon. They expressed that the implant made it possible to live an active life. A majority did not think about the fact that they had a hip implant, because they lacked subjective pain. Most of the patients were positive about the annual exams at the hospital and wanted them to continue. None of them felt that their trust towards the healthcare system had changed after the implant recall. They expressed a belief that they would need new surgery sooner than they first thought. CONCLUSIONS: Despite all the attention when the ASR prosthesis was recalled, patients with ASR-HRA did not report themselves negatively affected by the recall in this group of patients where a majority had actively sought for an HRA procedure. The healthcare system has an obligation to continue the annual exams, even if the implant provider does not continue reimbursement. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13037-020-00278-y.
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spelling pubmed-77887832021-01-07 Living with a recalled implant: a qualitative study of patients’ experiences with ASR hip resurfacing arthroplasty Bitar, Christian Krupic, Ferid Felländer-Tsai, Li Crnalic, Sead Wretenberg, Per Patient Saf Surg Research BACKGROUND: Total hip arthroplasty is the traditional treatment for osteoarthritis in the hip joint. Hip resurfacing arthroplasty, with metal on metal bearing, is a modern concept initially developed mainly for young active people. The metal-on-metal hip arthroplasty implant, Articular Surface Replacement (ASR), was implanted in approximately 93,000 patients before it was recalled in 2010 due to a high complication rate. This study aimed to evaluate patients’ own experiences living with an implant that they knew had a high complication rate and had been recalled from the market. METHODS: A total of 14 patients, still living with the implant, of a cohort of 34 patients were available for follow-up. Qualitative semi-structured interviews were conducted with 14 patients where a majority actively sought for metal-on-metal hip resurfacing arthroplasty (HRA), and subsequently underwent HRA with an ASR prosthesis between 11/21/2006 and 09/28/2009. The responses were analyzed using content analysis described by Graneheim and Lundman to compress text and identify categories and subcategories. RESULTS: The results showed that most patients had already decided that they wanted a metal-on-metal HRA implant before meeting the surgeon. They expressed that the implant made it possible to live an active life. A majority did not think about the fact that they had a hip implant, because they lacked subjective pain. Most of the patients were positive about the annual exams at the hospital and wanted them to continue. None of them felt that their trust towards the healthcare system had changed after the implant recall. They expressed a belief that they would need new surgery sooner than they first thought. CONCLUSIONS: Despite all the attention when the ASR prosthesis was recalled, patients with ASR-HRA did not report themselves negatively affected by the recall in this group of patients where a majority had actively sought for an HRA procedure. The healthcare system has an obligation to continue the annual exams, even if the implant provider does not continue reimbursement. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13037-020-00278-y. BioMed Central 2021-01-06 /pmc/articles/PMC7788783/ /pubmed/33407687 http://dx.doi.org/10.1186/s13037-020-00278-y Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Bitar, Christian
Krupic, Ferid
Felländer-Tsai, Li
Crnalic, Sead
Wretenberg, Per
Living with a recalled implant: a qualitative study of patients’ experiences with ASR hip resurfacing arthroplasty
title Living with a recalled implant: a qualitative study of patients’ experiences with ASR hip resurfacing arthroplasty
title_full Living with a recalled implant: a qualitative study of patients’ experiences with ASR hip resurfacing arthroplasty
title_fullStr Living with a recalled implant: a qualitative study of patients’ experiences with ASR hip resurfacing arthroplasty
title_full_unstemmed Living with a recalled implant: a qualitative study of patients’ experiences with ASR hip resurfacing arthroplasty
title_short Living with a recalled implant: a qualitative study of patients’ experiences with ASR hip resurfacing arthroplasty
title_sort living with a recalled implant: a qualitative study of patients’ experiences with asr hip resurfacing arthroplasty
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7788783/
https://www.ncbi.nlm.nih.gov/pubmed/33407687
http://dx.doi.org/10.1186/s13037-020-00278-y
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