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ABSTRACT: Gas sterilization (eg, ethylene oxide [EtO] and gas plasma) was introduced for polyethylene to reduce oxidation due to free radicals occurring during radiation sterilization. Recently, oxidation has been observed in polyethylenes with undetectable levels of free radicals, which were expected to be oxidatively stable. It is unclear whether in vivo oxidation will occur in unirradiated inserts sterilized with EtO.
We analyzed the oxidation, mechanical behavior, and surface damage mechanisms of tibial inserts of a single design sterilized using EtO.
We collected 20 EtO-sterilized tibial inserts at revision surgeries. We assessed oxidative using Fourier transform infrared spectroscopy and mechanical properties using the small punch test. Surface damage was assessed using damage scoring techniques and micro-CT.
Oxidation indexes were low and uniform between the regions. The subtle changes did not affect the mechanical properties of the polymer. The dominant surface damage modes included burnishing, abrasion, and third-body wear. There was no evidence of delamination in the retrievals.
The retrieved EtO-sterilized UHMWPE retrievals remained stable with respect to both oxidative and mechanical properties for up to 10 years in vivo. We did observe slight measurable amounts of oxidation in the inserts; however, it was far below levels that would be expected to compromise the strength of the polymer.
Due to the stable oxidative and mechanical properties, EtO-sterilized tibial components appear to be an effective alternative to gamma-sterilized inserts, at least in short-term implantations.
Clinical Orthopaedics and Related Research 11/2011; 470(7):1826-33. · 2.53 Impact Factor
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ABSTRACT: 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.
We analyzed the oxidation, oxidation potential, and mechanical behavior of thermally treated highly crosslinked polyethylene retrieved acetabular liners.
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.
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.
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.
Clinical Orthopaedics and Related Research 12/2010; 469(8):2278-85. · 2.53 Impact Factor
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ABSTRACT: Because of their unique geometry, characterization of wear damage in total disc replacement (TDR) is difficult. In the article, we developed and validated an automated damage calculation technique for explanted TDR components. Eight polyethylene cores implanted from 4.6 to 16.0 years were using cone-beam microCT imaging (SCANCO Medical, Switzerland). The nominal uniform voxel size for the implant under investigation was 18 mum, however with a smaller sample size increased resolutions (10-microm nominal voxel size) could be achieved using the same microCT imaging hardware. Nominal surface data for both sizes of TDR components we examined were obtained from manufacturer's drawings (Link, Germany) and converted to highly discretized triangular meshes. The damage calculation technique utilized an initial alignment phase, followed by a pointwise calculation of the linear damage at each 3D surface point. During the alignment phase, a three-dimensional surface of the undamaged component was automatically aligned with volumetric image data from the damaged component. The alignment algorithm maximized the contact area between undamaged portions of the implant and its nominal surface using an iterative optimization technique. Linear damage at each triangle on the nominal surface was computed by moving along the local normal of the surface both inward and outward direction for a distance much less than the size of the implant. For the retrieved components, the maximum damage occurred away from the central axis of the dome close to the rim. Penetrations of up to 0.8 mm were observed in this region. Lower magnitude penetrations were observed near the pole of the dome. In conclusion, we have developed an analytical method to automatically align and measure three-dimensional surface damage with both high resolution and accuracy on implants with complicated, nonparametric, surface geometry and used this technique to analyze eight implants.
Journal of Biomedical Materials Research Part B Applied Biomaterials 08/2010; 94(2):312-7. · 2.15 Impact Factor
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ABSTRACT: This study is an evaluation of wear and oxidation in retrieved total disc replacements (TDRs). Forty-eight CHARITE TDRs were retrieved from 41 patients after 7.8 years of average implantation. All implants were removed because of intractable back pain and/or facet degeneration. Three unimplanted implants served as controls.
Our aim was to determine whether gamma-sterilized polyethylene components implanted in the spine oxidize in vivo, and if so, whether polyethylene oxidation has clinical relevance for the long-term performance of TDRs.
The natural history of polyethylene oxidation following gamma sterilization and long-term implantation in the spine has not yet been investigated.
Oxidation and oxidation potential were measured at the rim and dome of 47 components using Fourier transform infrared spectroscopy. The wear patterns of each retrieved polyethylene core were analyzed at the rim and dome.
Oxidation was significantly higher at the rim, as compared with the dome of the cores. Hydroperoxide index was also significantly higher at the rim, as compared with the dome. Dome penetration rate was negatively correlated to implantation time (P < 0.0001) but not correlated to oxidation or hydroperoxide index (P > 0.05). Implants with evidence of chronic rim loading had higher rim oxidation.
The data support our hypothesis that, for the historical packaging methods employed by the manufacturer, polyethylene oxidation and oxidation potential were significantly higher at the rim as opposed to the dome. The mechanism is governed by access to oxygen in vivo and may be accelerated under certain combined modes of repeated rim loading. Our findings have clinical significance in cases of chronic impingement, when the rim has to support repeated loading for the lifetime of the implant.
Spine 09/2009; 34(22):2369-77. · 2.08 Impact Factor
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ABSTRACT: In the 1990s, oxidation was found to occur in ultra-high molecular weight polyethylene total joint replacement components following gamma irradiation and prolonged shelf aging in air. Orthopaedic manufacturers developed barrier packaging to reduce oxidation during and after radiation sterilization. The present study explores the hypothesis that polyethylene components sterilized in a low-oxygen environment undergo similar in vivo oxidative mechanisms as inserts sterilized in air. In addition, the potential influence of the different sterilization processes on the wear performance of the polyethylene components was examined.
An analysis of oxidation, wear, and surface damage was performed for forty-eight acetabular liners and 123 tibial inserts. The mean implantation time was 12.3+/-3.7 years for thirty-one acetabular liners that had been gamma sterilized in air and 4.0+/-2.5 years for the seventeen acetabular liners that had been gamma sterilized in inert gas. The mean implantation time was 11.0+/-3.2 years for the twenty-six tibial inserts that had been sterilized in air and 2.8+/-2.2 years for the ninety-seven tibial inserts that had been gamma sterilized in inert gas. Oxidation and hydroperoxide levels were characterized in loaded and unloaded regions of the inserts.
Measurable oxidation and oxidation potential were observed in all cohorts. The oxidation and hydroperoxide levels were regional. Surfaces with access to body fluids were more heavily oxidized than protected bearing surfaces were. This variation appeared to be greater in historical (gamma-in-air-sterilized) components. Regarding wear performance, historical and conventional acetabular liners showed similar wear penetration rates, whereas a low incidence of delamination was confirmed for the conventional tibial inserts in the first decade of implantation.
The present study explores the impact of industry-wide changes in sterilization practices for polyethylene. We found lower oxidation and oxidation potential in the conventional acetabular liners and tibial inserts that had been gamma sterilized in inert gas as compared with the historical components that had been gamma sterilized in air. However, we also found strong evidence that conventional components undergo mechanisms of in vivo oxidation similar to those observed following gamma irradiation in air. In addition, gamma sterilization in inert gas did not provide polyethylene with a significant improvement in terms of wear resistance as compared with gamma sterilization in air, except for a lower incidence of delamination in the first decade of implantation for tibial inserts.
The Journal of Bone and Joint Surgery 05/2009; 91(4):839-49. · 3.27 Impact Factor
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ABSTRACT: This study combined the evaluation of retrieved total disc replacements (TDRs) with a biomechanical study using human lumbar spines. Thirty-eight CHARITE TDRs were retrieved from 32 patients after 7.3 years average implantation. All implants were removed because of intractable back pain and/or facet degeneration. In parallel, 20 new implants were evaluated at L4-L5 and L5-S1 in an in vitro lumbar spine model.
The purpose of this study was to correlate wear and damage patterns in retrieved TDRs with motion patterns observed in an in vitro lumbar spine model. We also sought to determine whether one-sided wear and motion patterns were associated with greater in vivo wear.
The comparison of polyethylene wear in TDRs after long-term implantation to those tested using an in vitro model had not yet been investigated.
The wear patterns of each retrieved PE core was analyzed at the rim and dome. Thirty-five cores were further analyzed using MicroCT to determine the penetration symmetry. For the in vitro study the implants were tested under physiologic loads using a validated cadaveric model. Motion patterns of the in vitro-tested implants were tracked using sequential video-fluoroscopy.
Fifteen of 35 retrieved cores (43%) displayed one-sided wear patterns. Significant correlations were observed between implantation time and penetration and penetration rate. In the in vitro study, there was evidence of motion at both articulations, motion at both articulation but predominantly at the top articulation, and solelyat the top articulation. Core entrapment and pinching was observed and associated with visual evidence of core bending or deformation.
This is the first study to directly compare the long-term PE wear and damage mechanisms in TDR retrievals with the motion patterns generated by a validated in vitro cadaveric testing model. The retrievals exhibited wear patterns consistent with the in vitro testing.
Spine 04/2008; 33(5):481-9. · 2.08 Impact Factor
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ABSTRACT: This study reports on detailed analyses of retrieved, annealed cross-linked liners. Twelve cross-linked liners (Crossfire, Stryker Orthopaedics, Mahwah, NJ) of the same Omnifit design were retrieved at revision surgery by one institution after an average 1.9 years (0.02-4.8 years) in vivo. In each case, the revision surgery was performed for reasons unrelated to wear. The mechanical properties and extent of oxidation of all inserts were characterized using a standard small punch test and measurement of the oxidation index. Results indicated that there was no association between implantation time and either mechanical properties or extent of oxidation for the inserts near the worn bearing surface. Slight variation in properties was observed as a function of sampling location, with the properties near the unworn surface displaying the greatest relative variability. We conclude that the variability in polyethylene properties observed in this small study was not clinically significant for these short-term-implanted, annealed cross-linked liners.
The Journal of Arthroplasty 11/2005; 20(7):840-9. · 2.38 Impact Factor
