In vivo oxidation in retrieved highly crosslinked tibial inserts.

The current study determined (I) the environment where oxidation in a series of retrieved, HXL UHMWPE tibial inserts occurred (in vivo or postexplant); and (II) the effect of fabrication variables (irradiation source, irradiation dose) and thermal processing after irradiation (annealing or remelting) on oxidation resistance. Hypotheses examined are (1) HXL UHMWPE tibial inserts have potential to oxidize in vivo, and (2) annealed HXL UHMWPE oxidizes at a higher rate in vivo than remelted HXL UHMWPE. Highly crosslinked UHMWPE tibial inserts (87), received by an IRB-approved retrieval laboratory from 20 surgeons at 10 institutions across the U.S., were analyzed from 2005 to 2011. Fourier transform infrared spectroscopy was used to determine oxidation and trans-vinylene index for each retrieved insert. Measured oxidation that was maximum subsurface was found in 56% of all HXL tibial inserts. This maximum oxidation correlated significantly with in vivo time, trans-vinylene index, and thermal processing after irradiation. Articular oxidation rate correlated with crosslinking irradiation dose and thermal processing after irradiation. Retrieved below-melt annealed tibial inserts had significantly higher articular oxidation rates than remelted tibial inserts (p < 0.001). Articular oxidation rates correlated positively with cross-linking irradiation dose and postirradiation thermal processing. Edge oxidation correlated with postirradiation thermal processing. Oxidation of HXL UHMWPE may have clinical implications for tibial inserts, since loss of UHMWPE toughness resulting from oxidation has led to fatigue damage in gamma-sterilized tibial inserts.

In vivo oxidation in remelted highly cross-linked retrievals.

BACKGROUND: Elimination of free radicals to prevent oxidation has played a major role in the development and product differentiation of the latest generation of highly cross-linked ultra-high molecular weight polyethylene bearing materials. In the current study, we (1) examined oxidation in a series of retrieved remelted highly cross-linked ultra-high molecular weight polyethylene bearings from a number of device manufacturers and (2) compared the retrieval results with findings for shelf-stored control specimens. The hypothesis was that radiation-cross-linked remelted ultra-high molecular weight polyethylene would maintain oxidative stability in vivo comparable with the stability during shelf storage and in published laboratory aging tests. METHODS: Fifty remelted highly cross-linked ultra-high molecular weight polyethylene acetabular liners and nineteen remelted highly cross-linked ultra-high molecular weight polyethylene tibial inserts were received after retrieval from twenty-one surgeons from across the U.S. Thirty-two of the retrievals had been in vivo for two years or more. Each was measured for oxidation with use of Fourier transform infrared spectroscopy. A control series of remelted highly cross-linked ultra-high molecular weight polyethylene acetabular liners from three manufacturers was analyzed with electron paramagnetic resonance spectroscopy to measure free radical content and with Fourier transform infrared spectroscopy to measure oxidation initially and after eight to nine years of shelf storage in air. RESULTS: The never-implanted, shelf-aged controls had no measurable free-radical content initially or after eight to nine years of shelf storage. The never-implanted controls showed no increase in oxidation during shelf storage. Oxidation measurements showed measurable oxidation in 22% of the retrieved remelted highly cross-linked liners and inserts after an average of two years in vivo. CONCLUSIONS: Because never-implanted remelted highly cross-linked ultra-high molecular weight polyethylene materials had no measurable free-radical concentration and no increase in oxidation during shelf storage, these materials were expected to be oxidation-resistant in vivo. However, some remelted highly cross-linked ultra-high molecular weight polyethylene retrievals showed measurable oxidation after an average of more than two years in vivo. This apparent departure from widely expected behavior requires continued study of the process of in vivo oxidation of ultra-high molecular weight polyethylene materials.

Effect of fabrication method and resin type on performance of tibial bearings.

Polyethylene has been used successfully for more than 30 years as an orthopedic bearing material. During this time, several polyethylene resins and fabrication methods have been used to produce bearings. Some bearings fail prematurely due to fatigue, which has been linked to oxidation and degradation of mechanical properties resulting from gamma sterilization in air. Fabrication method and/or resin have been hypothesized to govern whether oxidative degradation occurs in gamma-sterilized bearings. This study evaluates the effect of fabrication (machining/direct compression molding) and resin type on oxidation and the resulting mechanical properties for a large series of never-implanted bearings. While many molded bearings studied exhibit lower oxidation than machined bearings, fabrication method is not a significant predictor of oxidation. Resin type and shelf-age are found to be significant predictors of oxidation. Bearings fabricated from Himont 1900 exhibit lower oxidation than those from GUR 415/412 at comparable times after gamma in air. However, Himont 1900 bearings lose strength and elongation at lower oxidation levels than GUR 415/412 bearings. But since Himont 1900 oxidizes more slowly, Himont 1900 bearings retain mechanical properties for longer shelf times than comparable GUR 415/412 bearings. These effects are seen in retrievals as well.

Current sterilization and packaging methods for polyethylene.

Gamma sterilization in an air environment can induce oxidation in polyethylene. Oxidation can lead to polyethylene embrittlement, compromising mechanical integrity and clinical performance of polyethylene bearings. For these reasons, orthopaedic manufacturers have modified their methods of sterilizing and packaging polyethylene. Two alternative approaches have emerged: sterilization by non-radiation methods and sterilization by gamma irradiation in inert environments. The current study presents a prognosis for clinical performance of polyethylene sterilized with new methods, based on material property analyses (oxidation levels, mechanical properties, crosslink density) of never implanted and retrieved bearings. Data from bearings that were never implanted which were sterilized with the new methods and shelf aged as many as 3 years, show negligible oxidation, ductility above 400%, and ultimate tensile strength near 50 MPa, all exceeding specifications of the American Society for Testing and Materials. There are significant differences in crosslink density (swell ratio) depending on the sterilization method. Retrievals indicate that bearings sterilized with these new methods are performing well clinically and that the majority are not changing with time. The current study suggests that the shelf oxidation problem has been addressed by these new sterilization techniques and that clinical performance at short followup is acceptable. However, long-term clinical performance must be evaluated in the future.

In vitro simulation of contact fatigue damage found in ultra-high molecular weight polyethylene components of knee prostheses.

An in vitro simulation of fatigue loading of ultra-high molecular weight polyethylene (UHMWPE) knee components was carried out on a knee simulator and on a rolling and sliding wear tester. Tibial components for the knee simulator were gamma-sterilized, implantable components taken from manufacturing inventory. The rolling/sliding UHMWPE discs were machined from bar stock and either gamma sterilized in air and accelerated aged, or left as non-sterilized (controls). Cracking and delamination of samples that had been gamma sterilized in air and aged were observed in both types of tests. Contact fatigue damage was visible in as few as 150,000 cycles using the knee simulator at loads of 122 N (275 1b). The rolling/sliding samples showed signs of damage in as few as 130,000 cycles with an estimated stress of 15 MPa and 25 per cent sliding. However, cracking and delamination were not generated in the never-sterilized or recently sterilized controls. UHMWPE that has been gamma sterilized in air and aged is shown to be susceptible to contact fatigue damage. These results are important to the interpretation of in vitro total knee replacement simulations used to assess the performance of tibial bearings.

An analysis of hylamer and polyethylene bearings from retrieved acetabular components.

Hylamer and conventional polyethylene acetabular liners of the same design, revised for a variety of reasons, were examined and compared to assess the performance of Hylamer as a bearing material. Clinical damage modes, linear wear rates, oxidation levels, and mechanical properties were measured. In both series, many liners were retrieved for dislocation. Wear/osteolysis was the most common reason for retrieval in the Hylamer series, while none of the conventional polyethylene liners were retrieved for this reason. Nearly all liners exhibited abrasion, burnishing, scratching, and creep. The Hylamer liners had more cracking, delamination, and pitting. The Hylamer liners had an average linear wear rate of 0.32 mm/year, while the conventional polyethylene liners had an average wear rate of 0.20 mm/year. Due to sample size, no statistical difference in wear rate was noted between the two groups. In general, both the Hylamer and conventional polyethylene showed oxidation peaks subsurface, resulting from their exposure to gamma radiation in air. Liners with elevated oxidation had decreased ultimate tensile strength, elongation, and toughness. For given oxidation levels, the corresponding mechanical properties of Hylamer appeared lower than those of conventional polyethylene. The ultimate tensile strength values ranged from 14 to 33 MPa for Hylamer and 19 to 32 MPa for conventional polyethylene. Elongation ranges were 19% to 350% (Hylamer) and 80% to 375% (conventional). The Hylamer retrievals in this study gave initial indications of performance; Hylamer appeared to behave similarly, but not superiorly, to conventional polyethylene, in the early functional period with respect to clinical wear and clinical performance. Both Hylamer and conventional polyethylene liners were degraded by gamma sterilization in air, with Hylamer liners demonstrating greater property changes.

The impact of sterilization method on wear in knee arthroplasty.

Sterilization by gamma irradiation in air has been shown to have the potential to accelerate the oxidation of polyethylene components resulting in reduced mechanical properties. In the hip, it has been reported that the occurrence of delamination and cracking in retrieved bearings is significantly different when comparing components sterilized with gamma irradiation in air with components sterilized with ethylene oxide. Using a collection of 1635 retrieved polyethylene knee bearings, this study pursues a similar comparison of sterilization method with clinical wear in the knee. It confirms that retrieved polyethylene knee components that were gamma irradiated in air have a high incidence of delamination and cracking, leading at times to complete wear through of the bearing. Knee components sterilized with ethylene oxide showed no evidence of fatigue damage even after in vivo durations in excess of 15 years.

Shelf life and in vivo duration. Impacts on performance of tibial bearings.

Polyethylene has been used for more than 30 years as an orthopaedic bearing material; however, recently concern has been focused on the early failure of some polyethylene bearings. The damage seen in some bearings has been linked to gamma radiation sterilization performed in an air environment. Gamma sterilization in air has been documented to cause an increase in oxidation and degradation of mechanical properties that continue with time. However, not all retrieved bearings that are gamma sterilized in air exhibit the elevated oxidation and mechanical property degradation that lead to early component failure. Bearings that are gamma sterilized in air oxidize while sitting in inventory before implantation. Shelf oxidation rate was estimated based on analysis of a series of never implanted tibial bearings. This shelf oxidation rate allowed estimation of in vivo oxidation for retrieved tibial bearings of known sterilization date. Bearings with less than 1 year of shelf life after gamma sterilization in air had lower in vivo oxidation and better in vivo performance than did those with longer shelf life before implantation. Shelf time before implantation appears to be a significant factor in the success or failure of bearings that are gamma sterilized in air.

Tibial insert undersurface as a contributing source of polyethylene wear debris.

Sixty-seven ultrahigh molecular weight polyethylene tibial inserts from cementless total knee arthroplasties were retrieved at autopsy and revision surgery and analyzed for evidence of articular and nonarticular surface wear after a mean implantation time of 62.8 months (range, 4-131 months). Polyethylene cold flow and abrasive wear on the nonarticular insert surface (undersurface) were assigned a wear severity score (Grade 0-4). The severity of articular wear was assessed quantitatively and graded. Corresponding prerevision radiographs were evaluated for evidence of tibial metaphyseal osteolysis and osteolysis around tibial fixation screws. Exact nonparametric conditional inference methods were used to establish correlations between different variables and the occurrence of tibial metaphyseal osteolysis. Severe Grade 4 wear of the tibial insert undersurface was associated with tibial metaphyseal osteolysis or osteolysis around fixation screws. Time in situ statistically was related to Grade 4 undersurface wear and tibial metaphyseal osteolysis. The occurrence of tibial osteolysis was not related statistically to articular wear severity, insert thickness, or implant type. The main articulation between the femoral implant and ultrahigh molecular weight polyethylene insert has been assumed to be the primary source of polyethylene debris contributing to osteolysis and total knee arthroplasty implant failure. The undersurface of the insert is an additional source of polyethylene debris contributing to tibial metaphyseal osteolysis. To lessen polyethylene debris produced at this modular interface, the tibial implant locking mechanism should fix the insert firmly to the metal backing to decrease relative micromotion. Because motion between the insert and metal backing may be inevitable, the wear characteristics of the inner tray surface should be optimized to minimize wear debris production at this other articulation.

Overview of polyethylene as a bearing material: comparison of sterilization methods.

Polyethylene has been used for more than 30 years as an orthopaedic bearing material; however, there has been recent concern regarding the early failure of a small percentage of the polyethylene bearings. The damage seen in some retrieved polyethylene components has been linked to gamma radiation sterilization in air, which was widely used by the industry for years. Gamma radiation in air has been documented to cause an increase in oxidation and degradation of mechanical properties with time. The degradation of polyethylene initiated by gamma sterilization in air has led the orthopaedic industry toward alternative sterilization methods, including gamma radiation in an inert gas or vacuum environment, ethylene oxide gas sterilization, and gas plasma sterilization. For many of these alternative techniques, little clinical performance data exist. This study is a comparative evaluation of sterilization methods using the same analytic techniques that have been used to document the effects of gamma sterilization in air on polyethylene. Fourier transform infrared spectroscopy, electron spin resonance, and uniaxial tensile testing are used to compare, respectively, the oxidation levels, free radical concentration, and mechanical properties of material sterilized by each method. The polyethylene is evaluated before sterilization, poststerilization, and postartificial aging. All examined alternative sterilization methods, when compared with gamma sterilization in air, caused less material degradation during a component's preimplantation shelf life.

Impact of gamma sterilization on clinical performance of polyethylene in the knee.

Damage and rapid wear of the ultrahigh-molecular-weight polyethylene bearings of knee components continue to be major sources of failure of knee prostheses. Despite considerable research into the roles of design, polyethylene thickness and quality, and component alignment, the source of the rapid wear failures has remained a mystery. This study documents elevated oxidation resulting from the use of gamma sterilization in air, the most common sterilization technique used by the orthopaedic implant industry. This oxidation reduces static strength and elongation properties and significantly decreases the resistance of polyethylene bearings to fatigue, a frequent source of early damage of many of these devices.

The Otto Aufranc Award. Impact of gamma sterilization on clinical performance of polyethylene in the hip.

Despite studies to determine their causes, significant variations in polyethylene acetabular component wear rates, radial cracking of component rims, and occasional delamination cannot be explained. A subsurface white band frequently occurs in such damaged components. These damaged components often are gamma sterilized. To date, the origin of the band and its effect on polyethylene chemical and mechanical properties, and hence, clinical performance, have not been confirmed, and correlations between radiation sterilization and clinical wear have not been made. By developing techniques for polyethylene retrieval testing and rating, chemical analysis, and mechanical analysis, this research has determined that gamma sterilization in air alters the chemical and mechanical properties of polyethylene over time, resulting in high subsurface oxidation, reduced ductility, and reduced strength. Gamma sterilization-induced oxidation is found to be most severe in the subsurface region of components, and coincides with zones of significantly reduced strength and ductility. This chemical and mechanical property degradation is time dependent and is not typically visible until after 3 years' postirradiation. The presence of the subsurface white band significantly correlates with clinical cracking and delamination observed in retrieved components. Wear of the retrieved components often is observed to have progressed into this heavily oxidized, weakened, and embrittled zone. A method for accelerated aging shows that irradiating in air causes oxidation damage in polyethylene components that is not seen with other sterilization methods. Modifications of gamma sterilization techniques to minimize this damage are discussed.

The tradeoffs associated with modular hip prostheses.

In an effort to gain greater insight into the tradeoffs associated with modular hip prostheses, 2 approaches were taken. A questionnaire was sent to each of the orthopaedic implant manufacturing companies asking specific questions regarding modular components, and a series of retrieved prostheses, both modular and nonmodular, were examined to determine the potential sources of problems associated with modular connections. The respondents to the questionnaire generally agreed that it was more expensive to produce modular prostheses due to the required tolerances at the modular connections, and that the increased flexibility provided by the modularity was important to surgical outcome. There was less consensus on whether inventories were reduced and little data to support any improvement in surgical outcome caused by modularity. The most frequent problems associated with modular connections were fretting and corrosion. Easily observable significant fretting occurred in 4% of 701 head/neck tapers. Corrosion was observed in > 30% of the mixed-alloy head/stem combinations, in < 10% of all-titanium-alloy modular components, and in < 6% of all-cobalt-alloy devices. In 1 series of retrieved modular femoral components (15 titanium alloy and 15 cobalt alloy) with both sets having approximately the same duration of implantation, 7% of the all-cobalt-alloy components had corrosion, whereas 33% of the mixed-alloy components had corrosion.

A comparison of contact pressures in tibial and patellar total knee components before and after service in vivo.

Laboratory testing of total knee components indicates that many designs produce contact stresses that exceed the yield strength of ultra-high molecular weight polyethylenes (UHMWPEs). It is often assumed that the polyethylene component will creep and wear to become more conforming over time, thus reducing these stresses. To test this theory, retrieved polyethylene tibial and patellar components, which showed signs of increased contact area through in vivo deformation, were tested for contact stress against matching components using Fuji Prescale pressure-sensitive film. The results showed an inverse relationship between initial conformity and in vivo changes in contact stress. More conforming devices showed little or no change in contact stress, and less conforming components showed small decreases in contact stress as a result of creep and wear. Even with these changes, however, the contact stresses for nonconforming designs remained well above those for the more conforming devices as well as the uniaxial yield strength of UHMWPE.

The correlation between fusion defects and damage in tibial polyethylene bearings.

Recent reports of fatigue failures of polyethylene tibial and patellar components have led to investigation of the role of design and material properties in these failures. Earlier investigations, concluding that high contact stress designs suffered greater damage in service, could not account for some of the fatigue failures. The current study hypothesizes that this failure is related to variations in the material properties of the polyethylene due to incomplete consolidation of the powder during manufacture, resulting in fusion defects. Retrieved polyethylene components and samples of polyethylene stock were examined to gain insight into the relationship between fusion defects, component failure, material forming processes, and powder grade. Statistically significant correlations (p < 0.05) were observed between the extent of defects and cracking, delamination, total wear damage, and duration in vivo. These correlations indicate that components manufactured from material with fusion defects may be less resistant to fatigue than components formed of fully consolidated material.

Loss of hydroxyapatite coating on retrieved, total hip components.

The goal of this study was to examine the early retrievals of hydroxyapatite-(HA) coated hip prostheses to assess evidence of osteoconductivity, resorption of HA, and the integrity of the HA/implant bond. Six retrieved HA-coated hip prostheses (3 femoral hip stems, 3 acetabular cups) were analyzed for the amount of bone ongrowth or ingrowth of the HA-coated surface and the extent to which the coating was still present after in vivo service. The examination of these six HA-coated prostheses indicates that HA appeared to be osteoconductive. There was evidence of debonding of HA from the smooth-surfaced femoral prosthesis, although that may have been a result of the extraction process. The five plasma-spray surfaced, HA-coated prostheses showed evidence of considerable loss of the HA coating at the time of receipt in the authors' laboratory, although it is was not possible to determine the cause of the loss of coating.

Failure of a well-fixed bone-ingrown titanium hip prosthesis.

A cementless titanium femoral stem was revised 5 years after implantation because of acute pain and progressive osteolysis. Substantial amounts of titanium and polyethylene wear debris were found in the surrounding tissues. Multiple sources of this debris were found as well as detachment of titanium fiber-mesh pads from the body of the femoral stem.