Methods for Sterilizing Clinically Relevant Wear Particles Isolated from Metal-on-Metal Hip Implants
Engineered or incidental particles may contain endotoxin from contaminated environments associated with generation, production, or handling activities. Endotoxins are ubiquitous contaminants that may yield false positive responses in immunological assays if present. The purpose of this study was to...
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| Veröffentlicht in: | Scientific reports 2018-02, Vol.8 (1), p.2384-6, Article 2384 |
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| description | Engineered or incidental particles may contain endotoxin from contaminated environments associated with generation, production, or handling activities. Endotoxins are ubiquitous contaminants that may yield false positive responses in immunological assays if present. The purpose of this study was to develop a sterilization method for removal of endotoxin from clinically relevant wear particles isolated from metal-on-metal (MoM) hip implant lubricant. In this case, the goal of particle sterilization was to sufficiently reduce endotoxin levels to acceptable levels for sensitive biological assays while retaining the physical and chemical characteristics of the original particles. Optimization of treatment with 0.05 NaOH in 50% ethanol successfully achieved a 5-log (>99.999%) reduction of endotoxin content while retaining the size and chemistry of MoM hip implant wear particles. Using the optimized method, the concentration of endotoxin was reduced from 161,000 to 1.19 EU/mL. As particle types can vary, sterilization strategies will also differ to optimize endotoxin removal while retaining key particle characteristics. To our knowledge, this study represents the first published sterilization method for clinically relevant MoM hip implant wear particles isolated from serum-rich lubricant. |
| doi_str_mv | 10.1038/s41598-017-18239-4 |
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Endotoxins are ubiquitous contaminants that may yield false positive responses in immunological assays if present. The purpose of this study was to develop a sterilization method for removal of endotoxin from clinically relevant wear particles isolated from metal-on-metal (MoM) hip implant lubricant. In this case, the goal of particle sterilization was to sufficiently reduce endotoxin levels to acceptable levels for sensitive biological assays while retaining the physical and chemical characteristics of the original particles. Optimization of treatment with 0.05 NaOH in 50% ethanol successfully achieved a 5-log (>99.999%) reduction of endotoxin content while retaining the size and chemistry of MoM hip implant wear particles. Using the optimized method, the concentration of endotoxin was reduced from 161,000 to 1.19 EU/mL. As particle types can vary, sterilization strategies will also differ to optimize endotoxin removal while retaining key particle characteristics. To our knowledge, this study represents the first published sterilization method for clinically relevant MoM hip implant wear particles isolated from serum-rich lubricant.</description><identifier>ISSN: 2045-2322</identifier><identifier>EISSN: 2045-2322</identifier><identifier>DOI: 10.1038/s41598-017-18239-4</identifier><identifier>PMID: 29402892</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>631/250 ; 631/61 ; Bone implants ; Chemical Phenomena - radiation effects ; Contaminants ; Endotoxins ; Endotoxins - analysis ; Ethanol ; Hip ; Hip joint ; Hip Prosthesis ; Humanities and Social Sciences ; Lubricants - chemistry ; Lubricants - radiation effects ; Metals ; multidisciplinary ; Particulate matter ; Science ; Science (multidisciplinary) ; Sterilization ; Sterilization - methods ; Transplants & implants</subject><ispartof>Scientific reports, 2018-02, Vol.8 (1), p.2384-6, Article 2384</ispartof><rights>The Author(s) 2018</rights><rights>2018. 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Endotoxins are ubiquitous contaminants that may yield false positive responses in immunological assays if present. The purpose of this study was to develop a sterilization method for removal of endotoxin from clinically relevant wear particles isolated from metal-on-metal (MoM) hip implant lubricant. In this case, the goal of particle sterilization was to sufficiently reduce endotoxin levels to acceptable levels for sensitive biological assays while retaining the physical and chemical characteristics of the original particles. Optimization of treatment with 0.05 NaOH in 50% ethanol successfully achieved a 5-log (>99.999%) reduction of endotoxin content while retaining the size and chemistry of MoM hip implant wear particles. Using the optimized method, the concentration of endotoxin was reduced from 161,000 to 1.19 EU/mL. As particle types can vary, sterilization strategies will also differ to optimize endotoxin removal while retaining key particle characteristics. 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Unice, Kenneth M. ; Paustenbach, Dennis J. ; Finley, Brent L. ; Kovochich, Michael</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c511t-4c1aa2b500dacc5d6d48eb7b314a9f4acc0feff19d48cafa4d99f4ef944a9e963</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>631/250</topic><topic>631/61</topic><topic>Bone implants</topic><topic>Chemical Phenomena - radiation effects</topic><topic>Contaminants</topic><topic>Endotoxins</topic><topic>Endotoxins - analysis</topic><topic>Ethanol</topic><topic>Hip</topic><topic>Hip joint</topic><topic>Hip Prosthesis</topic><topic>Humanities and Social Sciences</topic><topic>Lubricants - chemistry</topic><topic>Lubricants - radiation effects</topic><topic>Metals</topic><topic>multidisciplinary</topic><topic>Particulate matter</topic><topic>Science</topic><topic>Science (multidisciplinary)</topic><topic>Sterilization</topic><topic>Sterilization - methods</topic><topic>Transplants & implants</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fung, Ernest S.</creatorcontrib><creatorcontrib>Unice, Kenneth M.</creatorcontrib><creatorcontrib>Paustenbach, Dennis J.</creatorcontrib><creatorcontrib>Finley, Brent L.</creatorcontrib><creatorcontrib>Kovochich, Michael</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Biology Database (Alumni Edition)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</collection><collection>Biological Science Database</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Scientific reports</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fung, Ernest S.</au><au>Unice, Kenneth M.</au><au>Paustenbach, Dennis J.</au><au>Finley, Brent L.</au><au>Kovochich, Michael</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Methods for Sterilizing Clinically Relevant Wear Particles Isolated from Metal-on-Metal Hip Implants</atitle><jtitle>Scientific reports</jtitle><stitle>Sci Rep</stitle><addtitle>Sci Rep</addtitle><date>2018-02-05</date><risdate>2018</risdate><volume>8</volume><issue>1</issue><spage>2384</spage><epage>6</epage><pages>2384-6</pages><artnum>2384</artnum><issn>2045-2322</issn><eissn>2045-2322</eissn><abstract>Engineered or incidental particles may contain endotoxin from contaminated environments associated with generation, production, or handling activities. Endotoxins are ubiquitous contaminants that may yield false positive responses in immunological assays if present. The purpose of this study was to develop a sterilization method for removal of endotoxin from clinically relevant wear particles isolated from metal-on-metal (MoM) hip implant lubricant. In this case, the goal of particle sterilization was to sufficiently reduce endotoxin levels to acceptable levels for sensitive biological assays while retaining the physical and chemical characteristics of the original particles. Optimization of treatment with 0.05 NaOH in 50% ethanol successfully achieved a 5-log (>99.999%) reduction of endotoxin content while retaining the size and chemistry of MoM hip implant wear particles. Using the optimized method, the concentration of endotoxin was reduced from 161,000 to 1.19 EU/mL. As particle types can vary, sterilization strategies will also differ to optimize endotoxin removal while retaining key particle characteristics. To our knowledge, this study represents the first published sterilization method for clinically relevant MoM hip implant wear particles isolated from serum-rich lubricant.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>29402892</pmid><doi>10.1038/s41598-017-18239-4</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0002-3840-3628</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | 631/250 631/61 Bone implants Chemical Phenomena - radiation effects Contaminants Endotoxins Endotoxins - analysis Ethanol Hip Hip joint Hip Prosthesis Humanities and Social Sciences Lubricants - chemistry Lubricants - radiation effects Metals multidisciplinary Particulate matter Science Science (multidisciplinary) Sterilization Sterilization - methods Transplants & implants |
| title | Methods for Sterilizing Clinically Relevant Wear Particles Isolated from Metal-on-Metal Hip Implants |
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