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Mixing of components from different manufacturers in total hip arthroplasty: prevalence and comparative outcomes: A study of over 90,000 cases of mixed components in the National Joint Registry for England and Wales

Background and purpose — There have recently been highly publicized examples of suboptimal outcomes with some newer implant designs used for total hip replacement. This has led to calls for tighter regulation. However, surgeons do not always adhere to the regulations already in place and often use i...

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Autores principales: Tucker, Keith, Pickford, Martin, Newell, Claire, Howard, Peter, Hunt, Linda P, Blom, Ashley W
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Informa Healthcare 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4750765/
https://www.ncbi.nlm.nih.gov/pubmed/26201845
http://dx.doi.org/10.3109/17453674.2015.1074483
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author Tucker, Keith
Pickford, Martin
Newell, Claire
Howard, Peter
Hunt, Linda P
Blom, Ashley W
author_facet Tucker, Keith
Pickford, Martin
Newell, Claire
Howard, Peter
Hunt, Linda P
Blom, Ashley W
author_sort Tucker, Keith
collection PubMed
description Background and purpose — There have recently been highly publicized examples of suboptimal outcomes with some newer implant designs used for total hip replacement. This has led to calls for tighter regulation. However, surgeons do not always adhere to the regulations already in place and often use implants from different manufacturers together to replace a hip, which is against the recommendations of the Medicines and Healthcare Products Regulatory Agency (MHRA) and the directions of the manufacturers. Patients and methods — We used data from the National Joint Registry of England and Wales (NJR) to investigate this practice. Results — Mixing of components was common, and we identified over 90,000 cases recorded between 2003 and 2013. In the majority of these cases (48,156), stems and heads from one manufacturer were mixed with polyethylene cemented cups from another manufacturer. When using a cemented stem and a polyethylene cup, mixing of stems from one manufacturer with cups from another was associated with a lower revision rate. At 8 years, the cumulative percentage of revisions was 1.9% (95% CI: 1.7–2.1) in the mixed group as compared to 2.4% (2.3–2.5) in the matched group (p = 0.001). Mixing of heads from one manufacturer with stems from another was associated with a higher revision rate (p < 0.001). In hip replacements with ceramic-on-ceramic or metal-on-metal bearings, mixing of stems, heads, and cups from different manufacturers was associated with similar revision rates (p > 0.05). Interpretation — Mixing of components from different manufacturers is a common practice, despite the fact that it goes against regulatory guidance. However, it is not associated with increased revision rates unless heads and stems from different manufacturers are used together.
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spelling pubmed-47507652016-03-02 Mixing of components from different manufacturers in total hip arthroplasty: prevalence and comparative outcomes: A study of over 90,000 cases of mixed components in the National Joint Registry for England and Wales Tucker, Keith Pickford, Martin Newell, Claire Howard, Peter Hunt, Linda P Blom, Ashley W Acta Orthop Articles Background and purpose — There have recently been highly publicized examples of suboptimal outcomes with some newer implant designs used for total hip replacement. This has led to calls for tighter regulation. However, surgeons do not always adhere to the regulations already in place and often use implants from different manufacturers together to replace a hip, which is against the recommendations of the Medicines and Healthcare Products Regulatory Agency (MHRA) and the directions of the manufacturers. Patients and methods — We used data from the National Joint Registry of England and Wales (NJR) to investigate this practice. Results — Mixing of components was common, and we identified over 90,000 cases recorded between 2003 and 2013. In the majority of these cases (48,156), stems and heads from one manufacturer were mixed with polyethylene cemented cups from another manufacturer. When using a cemented stem and a polyethylene cup, mixing of stems from one manufacturer with cups from another was associated with a lower revision rate. At 8 years, the cumulative percentage of revisions was 1.9% (95% CI: 1.7–2.1) in the mixed group as compared to 2.4% (2.3–2.5) in the matched group (p = 0.001). Mixing of heads from one manufacturer with stems from another was associated with a higher revision rate (p < 0.001). In hip replacements with ceramic-on-ceramic or metal-on-metal bearings, mixing of stems, heads, and cups from different manufacturers was associated with similar revision rates (p > 0.05). Interpretation — Mixing of components from different manufacturers is a common practice, despite the fact that it goes against regulatory guidance. However, it is not associated with increased revision rates unless heads and stems from different manufacturers are used together. Informa Healthcare 2015-11 /pmc/articles/PMC4750765/ /pubmed/26201845 http://dx.doi.org/10.3109/17453674.2015.1074483 Text en Copyright: © Nordic Orthopaedic Federation 2015 http://creativecommons.org/licenses/by-nc-nd/3.0/ This is an open-access article distributed under the terms of the CC-BY-NC-ND 3.0 License which permits users to download and share the article for non-commercial purposes, so long as the article is reproduced in the whole without changes, and provided the original source is credited.
spellingShingle Articles
Tucker, Keith
Pickford, Martin
Newell, Claire
Howard, Peter
Hunt, Linda P
Blom, Ashley W
Mixing of components from different manufacturers in total hip arthroplasty: prevalence and comparative outcomes: A study of over 90,000 cases of mixed components in the National Joint Registry for England and Wales
title Mixing of components from different manufacturers in total hip arthroplasty: prevalence and comparative outcomes: A study of over 90,000 cases of mixed components in the National Joint Registry for England and Wales
title_full Mixing of components from different manufacturers in total hip arthroplasty: prevalence and comparative outcomes: A study of over 90,000 cases of mixed components in the National Joint Registry for England and Wales
title_fullStr Mixing of components from different manufacturers in total hip arthroplasty: prevalence and comparative outcomes: A study of over 90,000 cases of mixed components in the National Joint Registry for England and Wales
title_full_unstemmed Mixing of components from different manufacturers in total hip arthroplasty: prevalence and comparative outcomes: A study of over 90,000 cases of mixed components in the National Joint Registry for England and Wales
title_short Mixing of components from different manufacturers in total hip arthroplasty: prevalence and comparative outcomes: A study of over 90,000 cases of mixed components in the National Joint Registry for England and Wales
title_sort mixing of components from different manufacturers in total hip arthroplasty: prevalence and comparative outcomes: a study of over 90,000 cases of mixed components in the national joint registry for england and wales
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4750765/
https://www.ncbi.nlm.nih.gov/pubmed/26201845
http://dx.doi.org/10.3109/17453674.2015.1074483
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