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1.
Osteoporos Int ; 24(2): 451-8, 2013 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-22422305

RESUMO

SUMMARY: The life expectancy of vertebral compression fracture (VCF) patients was evaluated as a function of their treatment. Compared to non-operated patients, the kyphoplasty and vertebroplasty patient cohort had 115% and 44% greater adjusted life expectancy, respectively. Kyphoplasty patients had a 34% greater adjusted life expectancy than vertebroplasty patients. INTRODUCTION: Balloon kyphoplasty and vertebroplasty are minimally invasive procedures for the treatment of painful VCFs. This comparative effectiveness study characterized the life expectancy of VCF patients as a function of their treatment. METHODS: Life expectancy of VCF patients in the 100% U.S. Medicare dataset (2005-2008) was estimated using a parametric Weibull survival model (adjusted for comorbidities), and compared between operated and non-operated patients as well as between kyphoplasty and vertebroplasty patients. A total of 858,978 patients with a newly diagnosed VCF were identified, including 119,253 kyphoplasty patients (13.9%) and 63,693 vertebroplasty patients (7.4%). RESULTS: Adjusted life expectancy was 85% greater for operated than non-operated patients (p < 0.001; 95% confidence interval: 82-89%). Compared to non-operated patients, the kyphoplasty and vertebroplasty patient cohort had 115% (p < 0.001; 95% confidence interval: 111-119%) and 44% (p < 0.001; 95% confidence interval: 42-47%) greater adjusted life expectancy, respectively. Kyphoplasty patients had a 34% greater adjusted life expectancy than vertebroplasty patients (p < 0.001; 95% confidence interval: 31-36%). Across all gender-age groups, the median life expectancy predicted by the parametric Weibull model was 2.2-7.3 years greater for operated than non-operated patients. CONCLUSIONS: Statistically significant and substantial differences in life expectancy were observed between the treated and non-treated cohorts in the Medicare population. Among the treated cohorts, patients in the vertebroplasty group experienced less of a survival benefit than those who received kyphoplasty. The results will be a useful basis for future cost effectiveness studies of VCF treatments for the Medicare population.


Assuntos
Fraturas por Compressão/mortalidade , Expectativa de Vida , Fraturas da Coluna Vertebral/mortalidade , Vertebroplastia/métodos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Pesquisa Comparativa da Efetividade , Feminino , Fraturas por Compressão/cirurgia , Humanos , Cifoplastia/métodos , Masculino , Medicare , Fatores Sexuais , Fraturas da Coluna Vertebral/cirurgia , Análise de Sobrevida , Resultado do Tratamento , Estados Unidos/epidemiologia
2.
J Biomed Mater Res B Appl Biomater ; 75(1): 205-9, 2005 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-16037962

RESUMO

In this study, a novel micro-CT-based technique for evaluating wear in retrieved acetabular liners was introduced and validated. Six UHMWPE acetabular components ranging in implantation time from 2.7 to 14.4 years were collected and evaluated with the use of a high-resolution micro-CT scanner. The components were scanned with a uniform volumetric resolution of 74 microns (16-bit precision) with the use of a 1,024 x 1,024 in-plane image matrix. Manual rigid 3D image registration of the interior hemispherical portion of the acetabular cup with geometric primitives by trained observers allowed for isolation, visualization, and measurement of the wear volume. Results for these six components indicated an average wear rate of 65 mm(3)/year. Overall scanner error was quantified gravimetrically and associated with a maximum uncertainty of 0.6%. Intra-- and interobserver uncertainty analysis showed the method to be both accurate and repeatable.


Assuntos
Acetábulo/patologia , Teste de Materiais/instrumentação , Tomógrafos Computadorizados , Acetábulo/cirurgia , Reprodutibilidade dos Testes
3.
Biomaterials ; 26(17): 3699-712, 2005 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-15621260

RESUMO

The use of bone cement to treat vertebral compression fractures in a percutaneous manner requires placement of the cement under fluoroscopic image guidance. To enhance visualization of the flow during injection and to monitor and prevent leakage beyond the confines of the vertebral body, the orthopedic community has described increasing the amount of radiopacifier in the bone cement. In this study, static tensile and compressive testing, as well as fully reversed fatigue testing, was performed on three PMMA-based bone cements. Cements tested were SimplexP with 10% barium sulfate (Stryker Orthopedics, Mahwah, NJ) which served as a control; SimplexP with 36% barium sulfate prepared according to the clinical recommendation of Theodorou et al.; and KyphX HV-R with 30% barium sulfate (Kyphon Inc., Sunnyvale, CA). Static tensile and compressive testing was performed in accordance with ASTM F451-99a. Fatigue testing was conducted in accordance with ASTM F2118-01a under fully reversed, +/-10-, +/-15-, and +/-20-MPa stress ranges. Survival analysis was performed using three-parameter Weibull modeling techniques. KyphX HV-R was found to have comparable static mechanical properties and significantly greater fatigue life than either of the two control materials evaluated in the present study. The static tensile and compressive strengths for all three PMMA-based bone cements were found to be an order of magnitude greater than the expected stress levels within a treated vertebral body. The static and fatigue testing data collected in this study indicate that bone cement can be designed with barium sulfate levels sufficiently high to permit fluoroscopic visualization while retaining the overall mechanical profile of a conventional bone cement under typical in vivo loading conditions.


Assuntos
Sulfato de Bário/análise , Sulfato de Bário/química , Materiais Biocompatíveis/química , Cimentos Ósseos/análise , Cimentos Ósseos/química , Polimetil Metacrilato/análise , Polimetil Metacrilato/química , Materiais Biocompatíveis/análise , Cimentos Ósseos/uso terapêutico , Força Compressiva , Meios de Contraste , Dureza , Teste de Materiais , Porosidade , Radiografia , Fraturas da Coluna Vertebral/diagnóstico por imagem , Fraturas da Coluna Vertebral/terapia , Estresse Mecânico , Propriedades de Superfície , Resistência à Tração
4.
Orthopade ; 33(1): 48-55, 2004 Jan.
Artigo em Alemão | MEDLINE | ID: mdl-14747910

RESUMO

The study quantified the stress levels in treated and untreated vertebral bodies following kyphoplasty. Three-dimensional FE models of treated and untreated T11, T12, L1, and L2 vertebral bodies were evaluated to examine the stress levels within the bone and bone cement. A validated T12-L1 model was used to investigate the effect of kyphoplasty treatment on adjacent vertebral stresses and strains. Using the single vertebral models, bone cement modulus changes had minimal effect on the stresses in the bone or the cement. The presence of bone cement had a minimal effect on the stress magnitudes or distribution in the adjacent T12 vertebra. This study provides quantification of the stress levels in bone cement and bone in vertebral bodies treated with kyphoplasty under in vivo-like loading conditions. The presence of bone cement immediately following kyphoplasty has only a slight effect on the stress magnitudes or distributions in adjacent vertebrae.


Assuntos
Cimentos Ósseos , Análise de Elementos Finitos , Cifose/cirurgia , Vértebras Lombares , Coluna Vertebral/cirurgia , Vértebras Torácicas , Fenômenos Biomecânicos , Humanos , Cifose/etiologia , Vértebras Lombares/fisiologia , Modelos Anatômicos , Estresse Mecânico , Vértebras Torácicas/fisiologia
5.
J Biomed Mater Res A ; 66(2): 298-309, 2003 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-12889000

RESUMO

Previous observations of reduced uniaxial elongation, fracture resistance, and crack propagation resistance of highly crosslinked ultrahigh molecular weight polyethylene (UHMWPE) have contributed to concern that the technology may not be appropriate for systems undergoing cyclic fatigue loading. Using a "total life" approach, we examined the influence of radiation crosslinking on the fatigue response of UHMWPE under cyclic loading via the small punch test. Our goal in this study was to evaluate the suitability of the small punch test for conducting miniature-specimen, cyclic loading, and fatigue experiments of conventional and highly crosslinked UHMWPE. We subjected four types of conventional and highly crosslinked UHMWPE to cyclic loading at 200 N/s and at body temperature in a small punch test apparatus. After failure, the fracture surfaces were characterized with the use of field emission scanning electron microscopy to evaluate the fatigue mechanisms. Cyclic small punch testing under load control was found to be an effective and repeatable method for relative assessment of the fatigue resistance of conventional and highly crosslinked UHMWPE specimens under multiaxial loading conditions. For each of the four conventional and highly crosslinked UHMWPE materials evaluated in this study, fatigue failures were consistently produced according to a power law relationship in the low cycle regimen, corresponding to failures below 10000 cycles. The fatigue failures were all found to be consistent with a single source of initiation and propagation to failure. Our long-term goal in this research is to develop miniature-specimen fatigue testing techniques for characterization of retrieved UHMWPE inserts.


Assuntos
Teste de Materiais , Polietilenos/química , Microscopia Eletrônica de Varredura , Estresse Mecânico
6.
J Biomed Mater Res ; 63(5): 492-500, 2002.
Artigo em Inglês | MEDLINE | ID: mdl-12209892

RESUMO

Evaluation of the surface morphology of short-term retrieved cross-linked acetabular components requires differentiation between the features generated during machining and the smaller-scale morphologies generated during the in vivo wear process. Previously, the distinction between the waviness of machining and the roughness of wear has been related to the grain size of the UHMWPE. Here a low-frequency cutoff is proposed, based on the maximum spectral frequency of machining marks, rather than on the grain size of the bulk UHMWPE material, as a reliable method for deconvolving machining marks from in vivo wear following short-term implantation. To this end, as-machined articulating surfaces of conventional (GUR 1050) and two groups of highly cross-linked UHMWPE acetabular components were examined to determine whether they exhibited a periodic surface morphology with a well-defined spatial frequency. The surface frequency spectra revealed low-frequency peaks associated with the machining marks, which were unique to each type of implant. Furthermore, the surface frequency spectra appeared uniform within a single group of implants. Statistically significant differences in the surface roughness and waviness were observed between the three groups of new implants. Our research suggests that machining marks can be effectively deconvolved from the articulating surface with the use of a Fourier transform algorithm with a single cutoff frequency of 0.08 1/microm, corresponding to a wavelength of 12.5 microm. The results of this study provide a unified conceptual framework for discriminating between waviness and roughness of the articulating surface for machined orthopedic components. The distinction between waviness and roughness is expected to be crucial for the comprehensive evaluation of wear surfaces after short-term implantation, when machining marks may be partially worn away or plastically deformed in vivo.


Assuntos
Artroplastia de Quadril , Prótese de Quadril , Acetábulo , Algoritmos , Análise de Fourier , Humanos , Teste de Materiais , Tamanho da Partícula , Polietilenos , Estresse Mecânico , Propriedades de Superfície
7.
Biomaterials ; 23(17): 3681-97, 2002 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-12109694

RESUMO

Three series of uniaxial tension and compression tests were conducted on two conventional and two highly crosslinked ultra-high molecular weight polyethylenes (UHMWPEs) all prepared from the same lot of medical grade GUR 1050. The conventional materials were unirradiated (control) and gamma irradiated in nitrogen with a dose of 30 kGy. The highly crosslinked UHMWPEs were gamma irradiated at room temperature with 100 kGy and then thermally processed by either annealing below the melt transition at 100 degrees C or by remelting above the melt transition at 150 degrees C. The true stress-strain behavior of the four UHMWPE materials was characterized as a function of strain rate (between 0.02 and 0.10 s(-1)) and test temperature (20-60 degrees C). Although annealing and remelting of UHMWPE are primarily considered as methods of improving oxidation resistance, thermal processing was found to significantly impact the crystallinity, and hence the mechanical behavior, of the highly crosslinked UHMWPE. The crystallinity and radiation dose were key predictors of the uniaxial yielding, plastic flow, and failure properties of conventional and highly crosslinked UHMWPEs. The thermomechanical behavior of UHMWPE was accurately predicted using an Arrhenius model, and the associated activation energies for thermal softening were related to the crystallinity of the polymers. The conventional and highly crosslinked UHMWPEs exhibited low strain rate dependence in power law relationships, comparable to metals. In light of the unifying trends observed in the true stress-strain curves of the four materials investigated in this study, both crosslinking (governed by the gamma radiation dose) and crystallinity (governed by the thermal processing) were found to be useful predictors of the mechanical behavior of UHMWPE for a wide range of test temperatures and rates. The data collected in this study will be used to develop constitutive models based on the physics of polymer systems for predicting the thermomechanical behavior of conventional and crosslinked UHMWPE used in total joint replacements.


Assuntos
Materiais Biocompatíveis/química , Prótese Articular , Polietilenos/química , Materiais Biocompatíveis/efeitos da radiação , Fenômenos Biomecânicos , Reagentes de Ligações Cruzadas , Raios gama , Humanos , Técnicas In Vitro , Teste de Materiais/instrumentação , Polietilenos/efeitos da radiação , Temperatura , Termodinâmica
8.
Biomaterials ; 23(9): 1907-19, 2002 May.
Artigo em Inglês | MEDLINE | ID: mdl-11996031

RESUMO

Despite the critical role that shear is hypothesized to play in the damage modes that limit the performance of total hip and knee replacements, the shear behavior of ultra-high molecular weight polyethylene (UHMWPE) remains poorly understood, especially after oxidative degradation or radiation crosslinking. In the present study, we developed the miniature specimen (0.5 mm thickness x 6.4mm diameter) shear punch test to evaluate the shear behavior of UHMWPE used in total joint replacement components. We investigated the shear punch behavior of virgin and crosslinked stock materials, as well as of UHMWPE from tibial implants that were gamma-irradiated in air and shelf aged for up to 8.5 years. Finite element analysis, scanning electron microscopy, and interrupted testing were conducted to aid in the interpretation of the shear punch load-displacement curves. The shear punch load-displacement curves exhibited similar distinctive features. Following toe-in, the load-displacement curves were typically bilinear, and characterized by an initial stiffness, a transition load, a hardening stiffness, and a peak load. The finite element analysis established that the initial stiffness was proportional to the elastic modulus of the UHMWPE, and the transition load of the bilinear curve reflected the development of a plastically deforming zone traversing through the thickness of the sample. Based on our observations, we propose two interpretations of the peak load during the shear punch test: one theory is based on the initiation of crystalline plasticity, the other based on the transition from shear to tension during the tests. Due to the miniature specimen size, the shear punch test offers several potential advantages over bulk test methods, including the capability to directly measure shear behavior, and quite possibly infer ultimate uniaxial behavior as well, from shelf aged and retrieved UHMWPE components. Thus, the shear punch test represents an effective and complementary new tool in the armamentarium of miniature specimen mechanical testing methods for UHMWPE used in total joint replacement components.


Assuntos
Artroplastia de Substituição , Polietilenos/química , Materiais Biocompatíveis , Fenômenos Biomecânicos , Raios gama , Teste de Materiais , Microscopia Eletrônica de Varredura , Estresse Mecânico , Resistência à Tração , Tíbia/cirurgia , Fatores de Tempo
9.
Biomaterials ; 23(11): 2329-43, 2002 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-12013180

RESUMO

When subjected to a monotonically increasing deformation state, the mechanical behavior of UHMWPE is characterized by a linear elastic response followed by distributed yielding and strain hardening at large deformations. During the unloading phases of an applied cyclic deformation process, the response is characterized by nonlinear recovery driven by the release of stored internal energy. A number of different constitutive theories can be used to model these experimentally observed events. We compare the ability of the J2-plasticity theory, the "Arruda-Boyce" model, the "Hasan-Boyce" model, and the "Bergström-Boyce" model to reproduce the observed mechanical behavior of ultra-high molecular weight polyethylene (UHMWPE). In addition a new hybrid model is proposed, which incorporates many features of the previous theories. This hybrid model is shown to most effectively predict the experimentally observed mechanical behavior of UHMWPE.


Assuntos
Materiais Biocompatíveis/química , Polietileno/química , Fenômenos Biomecânicos , Elasticidade , Humanos , Técnicas In Vitro , Prótese Articular , Teste de Materiais , Modelos Biológicos , Peso Molecular , Reologia
10.
J Biomed Mater Res ; 61(2): 312-22, 2002 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-12007212

RESUMO

The resin and processing route have been identified as potential variables influencing the mechanical behavior, and hence the clinical performance, of ultra-high molecular weight polyethylene (UHMWPE) orthopedic components. Researchers have reported that components fabricated from 1900 resin may oxidize to a lesser extent than components fabricated from GUR resin during shelf aging after gamma sterilization in air. Conflicting reports on the oxidation resistance for 1900 raise the question of whether resin or manufacturing method, or an interaction between resin and manufacturing method, influences the mechanical behavior of UHMWPE. We conducted a series of accelerated aging studies (no aging, aging in oxygen or in nitrogen) to systematically examine the influence of resin (GUR or 1900), manufacturing method (bulk compression molding or extrusion), and sterilization method (none, in air, or in nitrogen) on the mechanical behavior of UHMWPE. The small punch testing technique was used to evaluate the mechanical behavior of the materials, and Fourier transform infrared spectroscopy was used to characterize the oxidation in selected samples. Our study showed that the sterilization environment, aging condition, and specimen location (surface or subsurface) significantly affected the mechanical behavior of UHMWPE. Each of the three polyethylenes evaluated seem to degrade according to a similar pathway after artificial aging in oxygen and gamma irradiation in air. The initial ability of the materials to exhibit post-yield strain hardening was significantly compromised by degradation. In general, there were only minor differences in the aging behavior of molded and extruded GUR 1050, whereas the molded 1900 material seemed to degrade slightly faster than either of the 1050 materials.


Assuntos
Materiais Biocompatíveis/normas , Teste de Materiais , Polietilenos/normas , Materiais Biocompatíveis/efeitos da radiação , Análise de Falha de Equipamento , Raios gama , Mecânica , Nitrogênio/farmacologia , Oxigênio/farmacologia , Polietilenos/efeitos da radiação , Resinas Sintéticas/farmacologia , Esterilização/métodos , Fatores de Tempo
11.
J Biomed Mater Res ; 61(2): 323-9, 2002 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-12007213

RESUMO

In Part I of this series, we showed that aging at elevated oxygen pressure is more successful at increasing the depth to which degradation occurs although it, too, generally causes greater degradation at the surface than at the subsurface. Therefore we hypothesized that thermal degradation alone, in the absence of free radicals, could be sufficient to artificially age UHMWPE in a manner analogous to natural aging. In the present study, virgin and air-irradiated UHMWPE (extruded GUR 1050 and compression-molded 1900) were aged up to 4 weeks at elevated oxygen pressure, and the mechanical behavior at the surface and subsurface was examined. All the materials were substantially degraded following 4 weeks of aging, but the spatial variations in the nonirradiated materials more closely mimicked the previously observed subsurface peak of degradation seen in naturally aged UHMWPE following irradiation in air. This aged material could provide a more realistic model for subsurface mechanical degradation, making it suitable for further mechanical testing in venues such as wear simulation.


Assuntos
Materiais Biocompatíveis/normas , Teste de Materiais , Polietilenos/normas , Análise de Falha de Equipamento , Raios gama , Temperatura Alta , Mecânica , Oxigênio/farmacologia , Fatores de Tempo
12.
J Biomed Mater Res ; 63(1): 15-23, 2002.
Artigo em Inglês | MEDLINE | ID: mdl-11787024

RESUMO

An international oxidation index standard would greatly benefit the orthopedic community by providing a universal scale for reporting oxidation data of ultra-high molecular weight polyethylene (UHMWPE). We investigated whether severe oxidation associated with long-term shelf aging affects the repeatability and reproducibility of area-based oxidation index measurement techniques based on normalization with the use of 1370- or 2022-cm(-1) infrared (IR) absorption reference peaks. Because an oxidation index is expected to be independent of sample thickness, subsurface oxidation was examined with the use of both 100- and 200-microm-thick sections from tibial components (compression-molded GUR 1120, gamma irradiated in air) that were shelf aged for up to 11.5 years. Eight institutions in the United States and Europe participated in the present study, which was administered in accordance with ASTM E691. On average, the 100-microm-thick samples were associated with significantly greater interlaboratory relative standard uncertainty (40.3%) when compared with the 200-microm samples (21.8%, p = 0.002). In contrast, the intralaboratory relative standard uncertainty was not significantly affected by the sample thickness (p = 0.21). The oxidation index method did not significantly influence either the interlaboratory or intralaboratory relative standard uncertainty (p = 0.32 or 0.75, respectively). Our interlaboratory data suggest that with the suitable choice of specimen thickness (e.g., 200 microm) and either of the two optimal oxidation index methods, interlaboratory reproducibility of the most heavily oxidized regions in long-term shelf-aged components can be quantified with a relative standard uncertainty of 21% or less. Therefore, both the 1370-cm(-1) and the 2022-cm(-1) reference peaks appear equally suitable for use in defining a standard method for calculating an oxidation index for UHMWPE.


Assuntos
Polietilenos/química , Artefatos , Estabilidade de Medicamentos , Teste de Materiais , Peso Molecular , Oxirredução , Padrões de Referência , Reprodutibilidade dos Testes , Espectroscopia de Infravermelho com Transformada de Fourier
13.
Biomaterials ; 22(13): 1875-81, 2001 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-11396893

RESUMO

Polymethylmethacrylate (PMMA) bone cement is used in total joint replacements to anchor implants to the underlying bone. Establishing and maintaining the integrity of bone cement is thus of critical importance to the long-term outcome of joint replacement surgery. The goal of the present study was to evaluate the suitability of a novel testing technique, the small punch or miniaturized disk bend test, to characterize the elastic modulus and fracture behavior of PMMA. We investigated the hypothesis that the crack initiation behavior of PMMA during the small punch test was sensitive to the test temperature. Miniature disk-shaped specimens, 0.5 mm thick and 6.4 mm in diameter, were prepared from PMMA and Simplex-P bone cement according to manufacturers' instructions. Testing was conducted at ambient and body temperatures, and the effect of test temperature on the elastic modulus and fracture behavior was statistically evaluated using analysis of variance. For both PMMA materials, the test temperature had a significant effect on elastic modulus and crack initiation behavior. At body temperature, the specimens exhibited "ductile" crack initiation, whereas at room temperature "brittle" crack initiation was observed. The small punch test was found to be a sensitive and repeatable test method for evaluating the mechanical behavior of PMMA. In light of the results of this study, future small punch testing should be conducted at body temperature.


Assuntos
Artroplastia de Substituição , Cimentos Ósseos , Elasticidade , Teste de Materiais/métodos , Polimetil Metacrilato , Microscopia Eletrônica de Varredura
14.
J Biomed Mater Res ; 52(3): 447-59, 2000 Dec 05.
Artigo em Inglês | MEDLINE | ID: mdl-11007612

RESUMO

The surfaces of worn components hold clues to the underlying wear mechanisms. Previous evidence suggested that the absolute wear rates of acetabular components in a hip simulator were related to mechanical behavior; we hypothesized that the surface morphology of the liners might also be sensitive to mechanical properties. A noncontact, three-dimensional surface topography measurement system based on white light interferometry was used to quantify the surface morphology of ultra-high molecular weight polyethylene, polytetrafluoroethylene, high-density polyethylene, and polyacetal liners, and their corresponding femoral heads, after 3 million cycles in a multi-directional hip simulator. Comparisons were made with the fatigue soaked and control (as machined) components. Statistically significant power law relationships were observed between the arithmetic mean surface roughness (R(a)) of the worn acetabular liners and the volumetric wear rate in the hip simulator (p < 0.01, r(2) = 0.52). Significant relationships were also observed between R(a) and the elastic and large deformation mechanical behavior of the liner materials, measured directly from the wear-tested liners using the small punch test (p < 0.01, r(2) = 0.54-0.81). The results support the hypothesis that wear mechanisms of acetabular liners during hip simulator testing are related to surface morphology in conjunction with the mechanical behavior of the polymeric materials.


Assuntos
Materiais Revestidos Biocompatíveis/análise , Prótese de Quadril , Teste de Materiais/métodos , Acetais/análise , Elasticidade , Humanos , Interferometria , Polietileno/análise , Polímeros/análise , Politetrafluoretileno/análise , Propriedades de Superfície , Suporte de Carga
15.
Biomaterials ; 21(14): 1451-60, 2000 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-10872774

RESUMO

Ultra-high molecular weight polyethylene (UHMWPE) is known to degrade during natural (shelf) aging following gamma irradiation in air, but the mechanical signature of degradation remains poorly understood. Accelerated aging methods have been developed to reproduce the natural aging process as well as to precondition total joint replacement components prior to joint simulator wear testing. In this study, we compared the mechanical behavior of naturally (shelf) aged and accelerated aged tibial inserts using a previously validated miniature specimen testing technique known as the small punch test. Tibial inserts made-of GUR 1120 and sterilized with 25 to 40 kGy of gamma radiation (in air) in 1988, 1993, and 1997 were obtained; a subset of the 1997 implants were subjected to 4 weeks of accelerated aging in air at 80 degrees C. To determine the spatial variation of mechanical properties within each insert, miniature disk shaped specimens were machined from the surface and subsurface regions of the inserts. Analysis of variance of the test data showed that aging significantly affected the small punch test measures of elastic modulus, initial load, ultimate load, ultimate displacement, and work to failure. The accelerated aging protocol was unable to reproduce the spatial mechanical profile seen in shelf aged components, but it did mechanically degrade the surface of GUR 1120 tibial components to an extent comparable to that seen after 10 years of natural aging. Test specimens showed a fracture morphology consistent with the decreased ductility and toughness which was corroborated by the small punch test metrics of this study. Our data support the hypothesis that UHMWPE undergoes a spatially nonuniform change towards a less ductile (more brittle) mechanical behavior after gamma irradiation in air and shelf aging.


Assuntos
Substitutos Ósseos/química , Prótese do Joelho , Polietilenos/química , Substitutos Ósseos/efeitos da radiação , Varredura Diferencial de Calorimetria , Estabilidade de Medicamentos , Raios gama , Humanos , Microscopia Eletrônica de Varredura , Oxirredução , Polietilenos/efeitos da radiação , Reprodutibilidade dos Testes , Propriedades de Superfície , Fatores de Tempo
16.
J Arthroplasty ; 15(3): 321-31, 2000 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-10794228

RESUMO

The elastic and large-deformation mechanical behavior of 4 materials with known clinical performance was examined and correlated with the wear behavior in a hip simulator. Acetabular liners of a commercially available design were machined from ultra-high molecular weight polyethylene (UHMWPE), high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), and polyacetal and wear tested in a multidirectional hip joint simulator. Elastic and large-deformation mechanical behavior was directly measured from the wear-tested liners using the small punch test. The finite element method was used to compute elastic modulus from the measured small punch test initial stiffness, and the contact stress for the liners was calculated using the theory of elasticity solution. Positive, statistically significant correlations were observed between the hip simulator wear rate and the initial peak load, ultimate load, and work to failure from the small punch test. Negative correlations were observed between the wear rate and the elastic modulus and contact stress. The results of this study support the hypothesis that the large-deformation mechanical behavior of a polymer plays a greater role in the wear mechanisms prevalent in total hip replacements than the elastic behavior.


Assuntos
Materiais Biocompatíveis , Prótese de Quadril , Polímeros , Elasticidade , Humanos , Desenho de Prótese , Estresse Mecânico
17.
Biomaterials ; 21(3): 283-91, 2000 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-10646945

RESUMO

Many aspects of the proposed relationship between material properties and clinical performance of UHMWPE components remain unclear. In this study, we explored the hypothesis that the clinical performance of tibial inserts is directly related to its large-deformation mechanical behavior measured near the articulating surface. Retrieval analysis was performed on three conventional UHMWPE and three Hylamer-M tibial components of the same design and manufacturer. Samples of material were then obtained from the worn regions of each implant and subjected to mechanical characterization using the small punch test. Statistically significant relationships were observed between the metrics of the small punch test and the total damage score and the burnishing damage score of the implants. We also examined the near-surface morphology of the retrievals using transmission electron microscopy. TEM analysis revealed lamellar alignment at and below the wear surfaces of the conventional UHMWPE retrievals up to a maximum depth of approximately 8 microm, consistent with large-deformation crystalline plasticity. The depth of the plasticity-induced damage layer varied not only between the retrievals, but also between the conventional UHMWPE and Hylamer-M components. Thus, the results of this study support the hypothesis that the clinical performance of UHMWPE tibial inserts is related to the large-deformation mechanical behavior measured near the articulating surface.


Assuntos
Materiais Biocompatíveis , Implantes Experimentais , Teste de Materiais , Tíbia , Microscopia Eletrônica
18.
Biomaterials ; 20(18): 1659-88, 1999 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-10503968

RESUMO

Despite the recognized success and worldwide acceptance of total joint arthroplasty, wear is a major obstacle limiting the longevity of implanted UHMWPE components. Efforts to solve the wear problem in UHMWPE have spurred numerous detailed studies into the structure, morphology, and mechanical properties of the polymer at every stage of its production from original resin into stock material and final fabricated form. Scientific developments in this field are occurring at an accelerating rate, and periodic review of UHMWPE technology is therefore increasingly necessary. The present article provides a four-part comprehensive review of technological advancements in the processing, manufacture, sterilization, and crosslinking of UHMWPE for total joint replacements. The first part of this article describes the recently updated nomenclature of UHMWPE, including the process of resin production and conversion to stock material. The second part outlines the methods of manufacturing UHMWPE into joint replacement components and provides overviews of alternate forms of UHMWPE, namely carbon-fiber reinforced UHMWPE (Poly II) and UHMWPE recrystallized under high temperature and pressure (Hylamer). The third part summarizes the sterilization and degradation of UHMWPE. Newly developed methods for accelerating the oxidation of UHMWPE after sterilization (for preconditioning of test specimens), as well as methods for quantifying the oxidation of UHMWPE, are also discussed. Finally, the fourth part reviews the development and properties of crosslinked UHMWPE, a promising alternate biomaterial for total joint replacements.


Assuntos
Materiais Biocompatíveis , Prótese Articular , Polietilenos/química , Esterilização/métodos , Tecnologia/tendências , Reagentes de Ligações Cruzadas , Humanos , Manufaturas , Peso Molecular , Terminologia como Assunto
19.
J Arthroplasty ; 14(5): 616-27, 1999 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-10475563

RESUMO

The mechanism for the improved wear resistance of cross-linked ultra-high-molecular-weight polyethylene (UHMWPE) remains unclear. This study investigated the effect of cross-linking achieved by gamma irradiation in nitrogen on the tribologic, mechanical, and morphologic properties of UHMWPE. The goal of this study was to relate UHMWPE properties to the wear mechanism in acetabular-bearing inserts. Wear simulation of acetabular liners was followed by detailed characterization of the mechanical behavior and crystalline morphology at the articulating surface. The wear rate was determined to be directly related to the ductility, toughness, and strain-hardening behavior of the UHMWPE. The concept of a plasticity-induced damage layer is introduced to explain the near-surface orientation of the crystalline lamellae observed in the wear-tested acetabular liners. Cross-linking reduces abrasive wear of acetabular components by substantially reducing--but not eliminating--the plasticity-induced damage layer that precedes abrasive wear.


Assuntos
Artroplastia de Quadril , Polietilenos , Falha de Prótese , Acetábulo , Elasticidade , Humanos , Teste de Materiais , Resistência à Tração
20.
Biomaterials ; 20(16): 1449-62, 1999 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-10458558

RESUMO

The mechanical behavior and evolution of crystalline morphology during large deformation of eight types of virgin and crosslinked ultra high molecular weight polyethylene (UHMWPE) were studied using the small punch test and transmission electron microscopy (TEM). We investigated the hypothesis that both radiation and chemical crosslinking hinder molecular mobility at large deformations, and hence promote strain hardening and molecular alignment during the multiaxial loading of the small punch test. Chemical crosslinking of UHMWPE was performed using 0.25% dicumyl peroxide (GHR 8110, GUR 1020 and 1050), and radiation crosslinking was performed using 150 kGy of electron beam radiation (GUR 1150). Crosslinking increased the ultimate load at failure and decreased the ultimate displacement of the polyethylenes during the small punch test. Crosslinking also increased the near-ultimate hardening behavior of the polyethylenes. Transmission electron microscopy was used to characterize the crystalline morphology of the bulk material, undeformed regions of the small punch test specimens, and deformed regions of the specimens oriented perpendicular and parallel to the punch direction. In contrast with the virgin polyethylenes, which showed only subtle evidence of lamellar alignment, the crosslinked polyethylenes exhibited enhanced crystalline lamellae orientation after the small punch test, predominantly in the direction parallel to the punch direction or deformation axis. Thus, the results of this study support the hypothesis that crosslinking promotes strain hardening during multiaxial loading because of increased resistance to molecular mobility at large deformations effected by molecular alignment. The data also illustrate the sensitivity of large deformation mechanical behavior and crystalline morphology to the method of crosslinking and resin of polyethylene.


Assuntos
Materiais Biocompatíveis/efeitos da radiação , Polietilenos/química , Fenômenos Biomecânicos , Prótese de Quadril , Teste de Materiais , Microscopia Eletrônica , Peso Molecular , Desenho de Prótese , Estresse Mecânico
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