In Vivo Oxidation of γ-Barrier–Sterilized Ultra–High-Molecular-Weight Polyethylene Bearings

Currier, Barbara H.; Currier, John H.; Mayor, Michael B.; Lyford, Kimberly A.; Citters, Douglas W. Van; Collier, John

doi:10.1016/j.arth.2006.07.006

Cited by 105 publications

(118 citation statements)

References 13 publications

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“…Moderate oxidation (average OI [ 1) was evident at the rim in annealed and gamma inert liners, but over half of the retrieved annealed liners exhibited severe rim oxidation (average OI [ 3). Previous studies have suggested an ASTM OI exceeding 3 is the critical level at which the mechanical properties are reduced severely enough that the material's ability to withstand repeated loading is diminished [8,17,19]. The rims of acetabular components do not necessarily undergo repetitive mechanical loading throughout the duration of implantation.…”

Section: Discussionmentioning

confidence: 96%

“…The maximum oxidation index (OI) was calculated from the infrared spectra as the area ratio between the carbonyl peak centered at 1715 cm À1 and the reference band at 1370 cm À1 . Previous studies have suggested an ASTM OI exceeding 3 is the critical level, above which the mechanical properties are reduced and severely compromised [8,17,19]. An OI of less than 1 on the ASTM scale is associated with low oxidation and negligible impact on mechanical behavior.…”

Section: Methodsmentioning

confidence: 99%

“…Many clinical studies of firstgeneration highly crosslinked polyethylenes have reported superior wear performance of both annealed and remelted materials in the first decade of use [4, 9-14, 16, 24, 28] when compared with controls. Comparatively few studies have explored their long-term oxidative stability in vivo [8,18,20,30].…”

Section: Introductionmentioning

confidence: 99%

“…First-generation annealed and highly crosslinked polyethylene, which contain a higher concentration of macroradicals as compared with gammasterilized conventional polyethylene liners [5], would be expected to exhibit greater in vivo oxidation than uncrosslinked gas-sterilized liners and remelted highly crosslinked liners. At elevated levels, oxidation may compromise the ultimate strength and ductility of the polyethylene, leading to the complete loss of mechanical integrity [8,17,19].…”

Section: Introductionmentioning

confidence: 99%

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Do First-generation Highly Crosslinked Polyethylenes Oxidize In Vivo?

MacDonald

Sakona

Ianuzzi

et al. 2011

Clinical Orthopaedics &Amp; Related Research

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Background Highly crosslinked and thermally treated polyethylenes were clinically introduced to reduce wear and osteolysis. Although the crosslinking process improves the wear performance, it also introduces free radicals into the polymer that can subsequently oxidize. Thermal treatments have been implemented to reduce oxidation; however, the efficacy of these methods with regard to reducing in vivo oxidative degradation remains to be seen. Polyethylene oxidation is a concern because it can compromise the ultimate strength and ductility of the material. Questions/purposes We analyzed the oxidation, oxidation potential, and mechanical behavior of thermally treated highly crosslinked polyethylene retrieved acetabular liners. Methods Three hundred seven acetabular liners were collected from consecutive revision surgeries at six institutions over a 10-year period. Twenty-four were sterilized using nonionizing methods, 43 were sterilized in an inert environment, 80 were highly crosslinked and annealed, and 160 were highly crosslinked and remelted. Oxidation and oxidation potential were assessed by Fourier transmission infrared spectroscopy. Mechanical behavior was assessed by the small punch test. Results Oxidation and hydroperoxide (oxidation potential) indices were elevated in the annealed and gamma inert sterilized groups compared with those of the remelted liners and uncrosslinked gas sterilized controls, particularly at the rim. We also detected an increase in oxidation over time at the bearing surface of the remelted group. Ultimate strength of the polyethylene at the bearing surface was negatively correlated with implantation time for the annealed liners. Conclusions Within the first decade of implantation, the clinical outlook for first-generation highly crosslinked polyethylene remains promising. However, ongoing research continues to be warranted for first-generation highly crosslinked polyethylene bearings to monitor the implications of elevated oxidation at the rim of annealed liners as well as to better understand the subtle changes in oxidation at the bearing surface of remelted liners that occur in vivo.

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Section: Discussionmentioning

confidence: 96%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Do First-generation Highly Crosslinked Polyethylenes Oxidize In Vivo?

MacDonald

Sakona

Ianuzzi

et al. 2011

Clinical Orthopaedics &Amp; Related Research

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“…Ultrahigh-molecular-weight polyethylene (UHMWPE) materials that have been exposed to high-energy ionizing radiation such as gamma or e-beam have been reported to be susceptible to oxidative degradation both in vivo as well as on the shelf [5,10,21,23]. To address this vulnerability, UHMWPE materials have been stabilized by thermal means with varying success [6,11,13,27].…”

Section: Introductionmentioning

confidence: 99%

Spectroscopic and Chromatographic Quantification of an Antioxidant-stabilized Ultrahigh-molecular-weight Polyethylene

Narayan

2015

Clinical Orthopaedics &Amp; Related Research

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Background The oxidative stability of various antioxidant-containing ultrahigh-molecular-weight polyethylene (UHMWPE) formulations has been widely reported. Depending on which specific antioxidant is used, the process by which it is incorporated into UHMWPE, and the amount of the antioxidant incorporated, there could be substantial differences in the material and toxicological properties of the UHMWPE formulation. Pentaerythritol tetrakis (3-[3,5-di tertiary butyl-4-hydroxyphenyl] propionate) (PBHP) has been extensively used as an efficient antioxidant in various applications. However, it has not thus far been used to stabilize UHMWPE in orthopaedic implants. It is therefore important to characterize and verify the concentration and homogeneity of distribution of PBHP in the composition, the chemical consequence of exposure of the antioxidant to gamma irradiation, and to assess the toxicological risk of use by the identification and quantification of leachables before the use of PBHP-containing UHMWPE in implantable devices. Questions/purposes (1) Can the concentration and uniformity of distribution of the antioxidant PBHP in UHMWPE powder and in the consolidated, preirradiated formulation be verified? (2) Can the leachable compounds in the gamma radiation crosslinked PBHP/UHMWPE formulation be identified and quantified? Methods PBHP in GUR 1020 UHMWPE was quantified by Fourier transform infrared (FTIR) and ultraviolet-visible (UV-Vis) spectroscopy. The chemical byproducts generated by gamma irradiation of PBHP were identified using gas chromatography in conjunction with mass spectrometry followed by a second-stage mass spectrometry (GC-MS/ MS). When GC-MS/MS was coupled with Stir Bar Sorptive extraction, leachable components in the UHMWPE formulation were identified and quantified. Results The percent concentration of PBHP in UHMWPE powder was confirmed by UV-Vis spectroscopy and the concentration and uniform distribution of PBHP in UHMWPE after consolidation and before radiation crosslinking was verified through FTIR spectroscopy. GC-MS/ MS analysis enabled the identification and quantification of 16 gamma irradiation byproducts of PBHP. These 16 compounds were verified as potentially leachable compounds in PBHP-stabilized UHMWPE and were found to be well below the safety threshold concern of 150 ng/ device in orthopaedic knee inserts made from PBHP-stabilized UHMWPE. Conclusions Spectroscopic analysis has been successfully used to demonstrate the ability to reliably quantify the amount as well as the distribution of PBHP in UHMWPE in orthopaedic bearings. State-of-the-art chemical extraction and analytical techniques have enabled the identification of the gamma radiation-induced byproducts of PBHP and the quantification of these components as leachables from the PBHP-stabilized UHMWPE formulation. Clinical Relevance Antioxidant-stabilized UHMWPE materials being considered for orthopaedic bearings must

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Vitamin E can be used to hinder scissioning in radiation cross‐linked UHMWPE during high‐temperature melting

Doshi

Oral

Muratoglu

2015

J of Applied Polymer Sci

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High-temperature melting (HTM) of ultrahigh molecular weight polyethylene (UHMWPE) was shown to improve its elongation and toughness. This was believed to be due to increased scissioning and increased diffusion of polymer chains. It was hypothesized here that the toughness of previously radiation cross-linked UHMWPEs could also be improved by HTM. To test this hypothesis, the wear resistance, tensile mechanical properties, and Izod impact strength of radiation cross-linked virgin (no additive) and antioxidant-blended (with vitamin E) UHMWPEs were tested. The results suggested that although the impact strength of crosslinked UHMWPEs could be improved significantly by HTM, the wear resistance was decreased. Thus, this procedure can be optimized to be especially suited in high-stress applications, such as total knee replacements with lessened wear concerns. V C 2015 Wiley Periodicals, Inc. J. Appl. Polym. Sci. 2015, 132, 42735.

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In Vivo Oxidation of γ-Barrier–Sterilized Ultra–High-Molecular-Weight Polyethylene Bearings

Cited by 105 publications

References 13 publications

Do First-generation Highly Crosslinked Polyethylenes Oxidize In Vivo?

Do First-generation Highly Crosslinked Polyethylenes Oxidize In Vivo?

Spectroscopic and Chromatographic Quantification of an Antioxidant-stabilized Ultrahigh-molecular-weight Polyethylene

Vitamin E can be used to hinder scissioning in radiation cross‐linked UHMWPE during high‐temperature melting

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