Highly Cross-Linked Ultrahigh Molecular Weight Polyethylene With Improved Fatigue Resistance for Total Joint Arthroplasty

Oral, Ebru; Malhi, Arnaz S.; Wannomae, Keith K.; Muratoglu, Orhun K.

doi:10.1016/j.arth.2007.09.027

Cited by 67 publications

(58 citation statements)

References 30 publications

(42 reference statements)

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“…The fatigue strength of a vitamin E-blended UHMWPE with an equivalent crosslink density to 100-kGy irradiated and melted virgin UHMWPE is improved approximately 30% [33,58,62]. Tensile mechanical and fatigue testing after accelerated aging of vitamin E-stabilized UHMWPE corroborated the lack of oxidative degradation of these properties [59].…”

Section: Discussionmentioning

confidence: 92%

“…Both are safe for human consumption in prepared food [32], but their intra-articular effects are not known. Simulated manufacturing conditions showed no detectable elution from vitamin E-diffused UHMWPE [20,59], but there was measurable elution in water at 40°C. The concentration profile became uniform at approximately 0.7 wt% at 3 years, suggesting saturation at this concentration at 40°C.…”

Section: Discussionmentioning

confidence: 95%

“…The strength of vitamin E-stabilized UHMWPE remained unchanged when accelerated aged, while that of gammasterilized UHMWPE deteriorated considerably [55,59]. Vitamin E alone had no effect on the mechanical properties of UHMWPE [75].…”

Section: Effects Of Vitamin E On Microstructure Tribologic and Mechmentioning

confidence: 91%

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Vitamin E-stabilized UHMWPE for Total Joint Implants: A Review

Bracco

Oral

2011

Clinical Orthopaedics &Amp; Related Research

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254

162

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Background Osteolysis due to wear of UHMWPE limits the longevity of joint arthroplasty. Oxidative degradation of UHMWPE gamma-sterilized in air increases its wear while decreasing mechanical strength. Vitamin E stabilization of UHMWPE was proposed to improve oxidation resistance while maintaining wear resistance and fatigue strength. Questions/purposes We reviewed the preclinical research on the development and testing of vitamin E-stabilized UHMWPE with the following questions in mind: (1) What is the rationale behind protecting irradiated UHMWPE against oxidation by vitamin E? (2) What are the effects of vitamin E on the microstructure, tribologic, and mechanical properties of irradiated UHMWPE? (3) Is vitamin E expected to affect the periprosthetic tissue negatively? Methods We performed searches in PubMed, Scopus, and Science Citation Index to review the development of vitamin E-stabilized UHMWPEs and their feasibility as clinical implants.Results The rationale for using vitamin E in UHMWPE was twofold: improving oxidation resistance of irradiated UHMWPEs and fatigue strength of irradiated UHMWPEs with an alternative to postirradiation melting. Vitamin E-stabilized UHMWPE showed oxidation resistance superior to that of irradiated UHMWPEs with detectable residual free radicals. It showed equivalent wear and improved mechanical strength compared to irradiated and melted UHMWPE. The biocompatibility was confirmed by simulating elution, if any, of the antioxidant from implants.Conclusions Vitamin E-stabilized UHMWPE offers a joint arthroplasty technology with good mechanical, wear, and oxidation properties. Clinical Relevance Vitamin E-stabilized, irradiated UHMWPEs were recently introduced clinically. The rationale behind using vitamin E and in vitro tests comparing its performance to older materials are of great interest for improving longevity of joint arthroplasties.

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Section: Discussionmentioning

confidence: 92%

Section: Discussionmentioning

confidence: 95%

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Vitamin E-stabilized UHMWPE for Total Joint Implants: A Review

Bracco

Oral

2011

Clinical Orthopaedics &Amp; Related Research

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254

162

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“…The addition of an antioxidant, a-tocopherol (the principal ingredient in vitamin E), to UHMWPE powder before consolidation has been shown to improve its oxidative stability after gamma sterilization [12,29]. The infusion of a-tocopherol into consolidated and gamma-irradiated, highly crosslinked UHMWPE block has been reported to further enhance its mechanical properties and fatigue strength [16]. However, the infused a-tocopherol could be at risk of migrating out of the device in the long term.…”

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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“…Highly cross-linked polyethylene has shown an excellent medium-term performance [35,36]. Nowadays, second generation highly cross-linked polyethylenes have been developed with even more wear resistance (eg X3 [Stryker Orthopedics, Mahwah, New Jersey, USA], ArCom XL and E-Poly [Biomet Orthopedics, Warsaw, New Jersey, USA]), showing promising in vitro results [4,37,38]. Future research should focus on high quality clinical trials prospectively investigating arthroplasties with cemented acetabular components, in combination with second generation highly cross-linked polyethylene.…”

Section: Discussionmentioning

confidence: 99%

Is there evidence for accelerated polyethylene wear in uncemented compared to cemented acetabular components? A systematic review of the literature

Veen

Jonbergen

Poolman

et al. 2012

International Orthopaedics (SICOT)

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Joint arthroplasty registries show an increased rate of aseptic loosening in uncemented acetabular components as compared to cemented acetabular components. Since loosening is associated with particulate wear debris, we postulated that uncemented acetabular components demonstrate a higher polyethylene wear rate than cemented acetabular components in total hip arthroplasty. We performed a systematic review of the peer-reviewed literature, comparing the wear rate in uncemented and cemented acetabular components in total hip arthroplasty. Studies were identified using MEDLINE (PubMed), EMBASE and the Cochrane Central Register of Controlled Trials. Study quality was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. The search resulted in 425 papers. After excluding duplicates and selection based on title and abstracts, nine studies were found eligible for further analysis: two randomised controlled trials, and seven observational studies. One randomised controlled trial found a higher polyethylene wear rate in uncemented acetabular components, while the other found no differences. Three out of seven observational studies showed a higher polyethylene wear in uncemented acetabular component fixation; the other four studies did not show any differences in wear rates. The available evidence suggests that a higher annual wear rate may be encountered in uncemented acetabular components as compared to cemented components.

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Highly Cross-Linked Ultrahigh Molecular Weight Polyethylene With Improved Fatigue Resistance for Total Joint Arthroplasty

Cited by 67 publications

References 30 publications

Vitamin E-stabilized UHMWPE for Total Joint Implants: A Review

Vitamin E-stabilized UHMWPE for Total Joint Implants: A Review

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

Is there evidence for accelerated polyethylene wear in uncemented compared to cemented acetabular components? A systematic review of the literature

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