Fu-Wen Shen

Effect of sterilization method and other modifications on the wear resistance of acetabular cups made of ultra-high molecular weight polyethylene. A hip-simulator study.

Background: Wear of ultra-high molecular weight polyethylene acetabular cups in hip prostheses produces billions of submicrometer wear particles annually that can cause osteolysis and loosening of the components. Thus, substantial improvement of the wear resistance of ultra-high molecular weight polyethylene could extend the clinical life span of total hip prostheses. It has become apparent that the conditions under which ultra-high molecular weight polyethylene cups have been sterilized can markedly affect their long-term wear properties, and new sterilization methods and other modifications have been developed to minimize the negative effects. Methods: In the present study, a hip-joint simulator was used to assess whether it is preferable to sterilize ultra-high molecular weight polyethylene cups without gamma irraSdiation, to avoid radiation-induced oxidative degradation, or to sterilize with gamma irradiation while the cups are packaged in a suitable low-oxygen atmosphere to minimize oxidation while retaining the increased wear resistance conferred by the radiation-induced cross-linking. Ion-implanted cups and cups made of a highly crystalline polyethylene (Hylamer) also were investigated. Cups made of each material were subjected to wear-testing prior to and after artificial thermal aging to accelerate oxidative degradation. Results: The results of the present study demonstrated that the cross-linking induced by gamma irradiation improves the wear resistance of ultra-high molecular weight polyethylene, while oxidation reduces it. Without thermal aging, the two types of cups that were sterilized with gamma irradiation while in low-oxygen packaging exhibited about a 50 percent lower rate of wear than did either the nonsterilized cups or the nonirradiated cups sterilized with gas plasma. There was a comparable advantage in the rate of wear after fourteen days of thermal aging. However, after thirty days of aging, the cups sterilized with gamma irradiation in low-oxygen packaging wore several times faster than did the nonirradiated cups. Ion-implanting improved the wear resistance without thermal aging, but after extensive thermal aging the oxidation and wear were greater than those of the controls. Hylamer cups (that is, those that were sterilized with gas plasma) exhibited wear properties very close to those of the nonsterilized ultra-high molecular weight polyethylene cups (the controls) with or without aging. Conclusions: Sterilizing an ultra-high molecular weight polyethylene acetabular cup without radiation (for example, with ethylene oxide or gas plasma) avoids immediate and long-term oxidative degradation of the implant but does not improve the inherent wear resistance of the polyethylene. Sterilizing with use of gamma irradiation with the implant packaged in a low-oxygen atmosphere avoids immediate oxidation and cross-links the polyethylene, thereby increasing its wear resistance, but long-term oxidation of the residual free radicals may markedly reduce the wear resistance. Ideally, cross-linking with gamma irradiation to reduce wear should be done in a manner that avoids both immediate and long-term oxidation. Clinical Relevance: The present study demonstrated how the fabrication and sterilization processes influence the resistance to oxidation and wear of the various types of ultra-high molecular weight polyethylene that are currently available. As an exact quantitative relationship between days of thermal aging and years of real-time aging (on the shelf and/or in vivo) has not yet been established, it is not possible to predict precisely when, if ever, the in vivo wear rate of cups sterilized with gamma irradiation while in low-oxygen packaging would exceed that of nonirradiated cups. Nevertheless, the results of these wear tests with use of a hip simulator suggest that, for at least ten years of clinical use, the in vivo wear rate of cups sterilized with gamma irradiation while in low-oxygen packaging will be substantially lower than that of cups sterilized without irradiation. The fundamental interactions among radiation, cross-linking, and oxidation exhibited by the specific materials included in the present study may also apply to acetabular cups of other types of polyethylene. Understanding these fundamental interactions will assist the surgeon in making an informed choice among the materials examined in the present study and among other types of modified polyethylene already in clinical use, including those sterilized with ethylene oxide, those sterilized with gamma irradiation in other forms of low-oxygen packaging, and the various new cross-linked and thermally stabilized polyethylenes.

Wear of gamma-crosslinked polyethylene acetabular cups against roughened femoral balls

Crosslinking of ultrahigh molecular weight polyethylene has been shown to markedly improve its wear resistance in clinical studies and laboratory tests using hip joint simulators. However, because most of the laboratory studies have been done under clean conditions using prosthesis-quality, highly polished counterfaces, there is concern regarding how well an intentionally crosslinked polyethylene acetabular cup will resist abrasion by a femoral ball that has been damaged by third-body abrasion in vivo. To investigate this, conventional and radiation crosslinked-remelted acetabular cups of ultra-high molecular weight polyethylene were tested in a hip joint simulator bearing against smooth femoral balls and against balls with moderate and severe roughening. Cups were tested with and without aging to accelerate any oxidative degradation. The crosslinked cups were produced by exposing extruded GUR 4150 bar stock of ultrahigh molecular weight polyethylene to 5 Mrad gamma radiation under a partial vacuum and then the bars were remelted to extinguish residual free radicals. Artificial aging at 70 degrees C under 5 atm oxygen for 14 days induced negligible oxidation in the crosslinked and remelted material. Against smooth balls, the wear of the crosslinked cups, with or without aging, averaged approximately 15% of that of the conventional cups. Against the moderately rough balls, the wear rate of the conventional cups was unchanged, whereas the wear rate increased slightly for the nonaged and aged crosslinked cups, but was still only 26% and 20% of that of the conventional cups, respectively. Against extremely rough balls, the mean wear rates increased markedly for each material such that during the final 1 million cycle interval, the average wear rates of the nonaged and the aged crosslinked cups were 72% and 47% of that of the conventional cups, respectively. That is, the crosslinked polyethylene showed substantially better wear resistance than conventional polyethylene across the range of ball roughnesses, with or without accelerated aging.

Biologic and tribologic considerations of alternative bearing surfaces.

Patients who are young or active or both who require total joint replacement pose a unique challenge; their high activity demands wear-resistant bearings that will perform for decades, without suffering from the adverse effects of accumulated wear products. We discuss the tribologic and biologic properties of newly introduced bearing materials for hip prostheses. The new PEs are intended to address the aseptic loosening problem by reducing the volume of submicron PE particles to a level well below that historically associated with osteolysis. However, choosing among the several variations of the cross-linked thermally-stabilized PEs is confounded by conflicting opinions regarding the optimum balance between long-term wear resistance and mechanical strength, and regarding potential effects of differences in morphologic features of the submicron-sized wear particles on their relative osteolytic potential. Metal-on-metal bearings have clinically proven wear resistance and the advantage of self-polishing, but the long-term biologic effects of metallic ions remain unknown. Ceramic-on-ceramic bearings have the advantage of high biocompatibility and usually very low wear, but fracture remains a rare but catastrophic complication. The choice of an appropriate bearing couple should be made after a thorough consideration of the relative risks and potential benefits of each of these materials.

Potential errors in FTIR measurement of oxidation in ultrahigh molecular weight polyethylene implants

Potential sources of error in the use of FTIR to measure the level of oxidation in ultrahigh molecular weight polyethylene acetabular cups were evaluated using cups from a hip simulator wear study with and without artificial aging, as well as cups retrieved from clinically failed hip prostheses. Oxidation was measured as a function of depth below the bearing surface using transmission FTIR on microtomed sections of the cups. To account for the variation of the thickness of the microtomed sections, oxidation was plotted as the ratio of the absorbance of the carbonyl groups to the absorbance of a reference band at 2022 cm-1. Overnight soaking in hexane reduced the apparent levels of oxidation, presumably due to the extraction of absorbed contaminants. In cups with low to moderate levels of oxidation, the reference absorption was relatively independent of the level of oxidation and was linearly proportional to the thickness of the specimens, providing reproducible oxidation ratios. However, the scatter in the reference absorption and in the apparent oxidation ratio increased with increasing levels of oxidation and was greatest for the thickest (400 microm) microtomed sections. The profiles of the oxidation ratios for a given specimen that were plotted by the present study method could be numerically adjusted to coincide with the ratios plotted using the methods of two previous investigators, providing conversion factors that are useful for comparing results among the studies.

Surface-gradient cross-linked polyethylene acetabular cups: oxidation resistance and wear against smooth and rough femoral balls.

Two methods were developed and evaluated for cross-linking the bearing surface of a polyethylene acetabular cup to a limited depth, in order to improve its resistance to wear without degrading the mechanical properties of the bulk of the component. In the first method, low-energy electron beams were used to cross-link only the bearing surface of the cups to a maximum depth of about 2 mm. The cups then were annealed at 100°C in vacuum for 3 or 6 days to reduce the residual free radicals, and the resultant resistance to oxidation was compared by artificially aging the cups at 80°C in air. Chemically cross-linked surface layers were produced by coating the bearing surfaces of the cups with a thin layer of polyethylene powder mixed with 1% weight peroxide, and compressing them at 6.9 MPa (1000 psi) and 170°C. This resulted in a cross-linked surface layer that extended about 3 mm deep, with a gradual transition to conventional (noncross-linked) polyethylene in the bulk of the implant. In hip simulator wear tests with highly polished (implant quality) femoral balls, both types of surface cross-linking were found to improve markedly the wear resistance of the acetabular cups. In tests with roughened femoral balls, the wear rates were much higher and were comparable to those obtained with similarly roughened balls against noncross-linked polyethylene cups in a previous study, indicating that the full benefit of cross-linking may not be realized under conditions of severe third-body abrasion. Nevertheless, these results show a promising approach for optimizing the wear resistance and the bulk mechanical properties of polyethylene components in total joint arthroplasty.