Introduction. Highly cross-linked ultrahigh molecular weight polyethylene (UHMWPE) is the most common bearing surface used in total joint arthroplasty due to its excellent wear resistance. While radiation cross-linking is currently used, cross-linking using a cross-linking agent such as a peroxide can also be effective with improved oxidative stability, which can be achived by an antioxidant such as vitamin E. The peroxide cross-linking behavior of UHMWPE in the presence of vitamin E was unknown. We investigated the cross-linking behavior and the clinically relevant mechanical and wear properties of peroxide cross-linked, vitamin E-blended UHMWPE. Materials and Methods. Medical grade UHMWPE (GUR1050) was blended with vitamin E and the peroxide (2,5-Dimethyl-2,5-di(t-butylperoxy)hexyne-3 or P130) before compression molding. Various vitamin E (0.1, 0.2, 0.3, 0.5, 0.6, 0.8 and 1.0 wt%) and peroxide concentrations (0.5, 1 and 1.5 wt%) were studied. The cross-link density was calculated as previously described (Oral 2010). The wear rate was determined using a custom-designed pin-on-disc wear tester against CoCr polished discs at 2 Hz and a rectangular path of 5 × 10 mm in undiluted bovine serum (Bragdon 2001). Tensile mechanical properties were determined using Type V dogbones according to ASTM D638. Oxidative stability was determined using oxidation induction testing (Braithwaite 2010). Double-notching and IZOD impact testing was performed according to ASTM D256. Samples prepared with vitamin E concentrations of 0.3 wt% and above and P130 concentrations of 0.5 and 1 wt% were also terminally gamma sterilized. Controls were 150-kGy irradiated vitamin E blends of UHMWPE. Results and Discussion. The cross-link density of peroxide cross-linked UHMWPEs were higher than the irradiated controls at a given vitamin E concentration (For example 250, 301 and 355 mol/dm3 for 0.5, 1 and 1.5 wt% peroxide cross-linked UHMWPE compared to 217 mol/dm3 for 150 kGy irradiated UHMWPE; Figure 1). The cross-link density dependence of wear was similar to radiation cross-linked UHMWPE, resulting in clinically relevant wear rates of 0.5 to 1.5 mg/MC. While the cross-link density of radiation cross-linked UHMWPE became saturated at vitamin E concentrations above 0.3 wt% (Oral 2008), this was not observed in peroxide cross-linked UHMWPE (Figure 2), suggesting more efficient cross-linking in the presence of the antioxidant. The impact strength was 30% higher for the peroxide cross-linked UHMWPEs at the comparable wear rate compared to irradiated controls (72 vs. 56 kJ/m2). The oxidation induction time of all peroxide cross-linked UHMWPEs (up to 57 min) was higher than that of the 0.1 wt% vitamin E-blended, 150-kGy irradiated UHMWPE (6 min). Gamma sterilization of peroxide cross-linked vitamin E blends decreased wear (0.5 wt% peroxide in Figure 3). Thus, peroxide concentration for cross-linking can be reduced if terminal sterilization is used. The mechanical properties and the oxidative stability of the material were not significantly affected by gamma sterilization. Significance. Peroxide cross-linking enabled good wear resistance for high vitamin E concentration blends of UHMWPE (>0.3 wt%), previously not possible by irradiation. Peroxide cross-linking of vitamin E-blended UHMWPE can provide a one-step, cost-effective method to manufacture wear resistant total joint implants with improved oxidative stability

INTRODUCTION. Electron-beam-irradiated dl-α-Tocopherol (Vitamin E)-blended UHMWPE is now being considered as a potential new bearing surface material for hip prosthesis [1]. However, Vitamin E stabilizes some of the primary free-radicals required for crosslinking, thereby reducing the material's crosslink density [2]. Additionally, some biological-stabilization effects of Vitamin E may also be reduced by oxidation. In this study, Vitamin E radicals in electron-beam-irradiated UHMWPE were measured and identified using Electron Spin Resonance (ESR), and the effects of annealing on radical stabilization and crosslink density were examined. MATERIALS & METHODS. Both pure UHMWPE and Vitamin E added (0.3% w/w) resin was used to produce bulk specimens via vacuum direct compression molding at 220°C under 25 MPa for 30 min. Cylindrical pins (3.5 mm diameter, 40 mm length) for ESR measurement were then machined and placed in vacuum packaging. The pins were irradiated at 300 kGy, with half of each test group annealed at 80°C for 24 hours. Free radical measurements were made using a high-sensitive X-band ESR operating at 9.44 GHz. Detection of Vitamin E radicals was performed by comparing the characteristic symmetrical spectrum of oxidized Vitamin E to the spectra observed for the pins using both g-value and linewidth as references. Crosslink density was measured via gel fraction analysis and was performed in accordance with ASTM D2765. Thin sections (20 × 40 mm. 2. , 200 μm) were machined from the bulk specimens, which were then placed in vacuum packaging, irradiated and annealed at the same conditions as those for the ESR measurements. Two of these thin sections were then placed in a stainless-steel cage (200 µm pore diameter) and were immersed in decahydronaphtalene at 200°C for 24 hours. These specimens were then extracted using soxhlet extractor at 100°C for 24 hours and dried in vacuum at 150°C for 12 hours. RESULTS. The characteristic symmetrical spectrum of oxidized Vitamin E was measured and identified in the electron-beam-irradiated Vitamin E-blended specimens [Fig. 1]. For the annealed samples, this spectrum was reduced [Fig. 2]. The annealing treatments increased gel fraction [Fig. 3] and decreased the total amount of primary free-radicals [Fig. 4] in the electron-beam-irradiated Vitamin E-blended specimens at the same rate as that for the Virgin specimens. DISCUSSION & CONCLUSIONS. Electron-beam-irradiated Vitamin E-blended specimens showed the same characteristic symmetrical spectrum as that of oxidized Vitamin E. Thus, measurement and identification of Vitamin E radicals in electron-beam-irradiated UHMWPE was confirmed. Also, annealing treatment at 80°C for 24 hours was effective in stabilizing Vitamin E radicals. The results showed in [Fig. 3] and [Fig. 4] suggest that the treatments increased gel fraction by accelerating the reaction between primary free-radicals. The results also suggest that Vitamin E radical stabilization was achieved through the interaction of Vitamin E radicals amongst themselves, and not through the interchange between Vitamin E radicals and primary free-radicals

The addition of vitamin E has been shown to improve wear performance in highly crosslinked (HXL) ultra high molecular weight polyethylene (UHMWPE) total knee replacements (TKR) [1]. We set-out to verify if a new type of vitamin E stabilized HXL UHMWPE would substantially improve wear performance, and we present our new results together with our previous ones to tell a fuller story. This paper therefore reports in vitro wear of tibial bearings of both conventional and HXL UHMWPE (with vitamin E) for a total of 16 specimens covering both ends of the TKR size spectrum, very large and very small. Different designs, sizes and four material types/processes of UHMWPE were tested. In material type 1, tested previously, the polyethylene was machined from isostatic molded GUR1020 bar stock, crosslinked with 10 Mrad, and then doped with vitamin E. From this material, 4 samples of large posterior stabilized (LPS1) TKRs were tested. Material type 2 was HXL where vitamin E was blended into the polyethylene (GUR1020) at the powder stage and the final irradiation was to 9 Mrad. From this material, 2 large cruciate retaining (LCR2) samples and 2 small cruciate retaining (SCR2) samples were tested. The above sample groups from both material types 1 and 2 were compared in the same simulator testing to corresponding identical design, size and sample numbers of conventional UHMWPE not highly crosslinked and with no vitamin E (material types 3 & 4 respectively). Each test was run on a significantly upgraded (in house) 4-station Instron-Stanmore force-controlled knee simulator. The machine simulated flexion with anatomically realistic joint reaction forces and torques between tibia and femur, and included a spring-based system to simulate soft-tissue restraining forces and torques. The force-control waveforms of the walking cycle specified in ISO-14243-1 were applied for 5 million cycles (Mc) at 1Hz, with bovine serum lubrication with 20g/l protein concentration at 37°C). The tibial bearing inserts were weighed at various intervals standardized between all tests. No gross delamination or fracture of the tibial inserts was observed in any tests, but all inserts showed measurable wear. The vitamin E stabilized material exhibited an 85% reduction in wear for the LPS1 designs (p < 0.05, ANOVA) compared to its corresponding conventional poly control material. The LCR2 and SCR2 designs with the new vitamin E material exhibited wear reductions of 61% and 77%, respectively when compared to their corresponding conventional bearings (p < 0.05, ANOVA). The vitamin E highly crosslinked UHMWPE tibial bearings significantly reduced overall wear when compared to conventional tibial bearings of the same design. Such level of wear reduction should translate to worthy clinical significance in preventing osteolysis. Highly crosslinked UHMWPE stabilized with vitamin E appears to be promising for use as a bearing surface in TKR, from at least two different technologies/processes

INTRODUCTION. Highly cross-linked polyethylene (XLPE) inserts have shown significant improvements in decreasing wear and osteolysis in total hip arthroplasty [1]. In contrast to that, XLPE has not shown to reduce wear or aseptic loosening in total knee arthroplasty [2,3,4]. One major limitation is that current wear testing in vitro is mainly focused on abrasive-adhesive wear due to level walking test conditions and does not reflect “delamination” as an essential clinical failure mode [5,6]. The objective of our study was to use a highly demanding daily activities wear simulation to evaluate the delamination risk of polyethylene materials with and without vitamin E stabilisation. MATERIALS & METHODS. A cruciate retaining fixed bearing TKA design (Columbus® CR) with artificially aged polyethylene knee bearings (irradiation 30 & 50 kGy) blended with and without 0.1% vitamin E was used under medio-lateral load distribution and soft tissue restrain simulation. Daily patient activities measured by Bergmann et al. [7] in vivo, were applied for 5 million knee wear cycles in a combination of 40% stairs up, 40 % stairs down, 10% level walking, 8% chair raising and 2% deep squatting with up to 100° flexion [8] (Fig. 1). The specimens were evaluated for gravimetric wear and analysed for abrasive-adhesive and delamination wear modes. RESULTS. The total amount of gliding surface wear was 28.7±1.9 mg for the vitamin E stabilised polyethylene irradiated with 30 kGy and 26.5±5.7 mg with 50 kGy irradiation, compared to 355.9±119.8 mg for the standard material. The combination of artificial ageing and high demanding knee wear simulation leads to visible signs of delamination in the articulating standard polyethylene bearing areas in vitro. Delamination began after 2 million test cycles for the standard polyethylene, indicated by the transition between linear and exponential slope in Fig. 2. Delamination was not found in the Vitamin E blended gliding surfaces. CONCLUSION. To evaluate moderately or highly cross-linked polyethylenes in regard to ageing and wear behaviour in vitro, conditions are simulated to create clinical relevant failure modes given in total knee arthroplasty. With the applied test protocol it is possible to discriminate between the polyethylene bearing materials with and without Vitamin E stabilisation. To view tables/figures, please contact authors directly

Introduction. In vitro studies showed that the anti-oxidative properties of vitamin E stabilize free radicals while retaining the mechanical strength of UHMWPE. The purpose was to evaluate vitamin E diffused polyethylene (VEPE) wear and stability of femoral components using RSA. Patient reported outcome measures (PROMs) were evaluated to determine the clinical outcome at 5 years. Methods. 48 patients (52 hips), with osteoarthritis, participated in a 5 year RSA study. Each patient received a VEPE liner, a porous titanium coated shell, and an uncemented stem with a 32mm head. Tantalum beads were inserted into the VEPE and the femur to measure head wear and stem stability using RSA. RSA and PROM follow-up was obtained postoperatively, 6 months, 1, 2, 3, and 5 years after surgery. The Wilcoxon signed-ranks test determined if changes in penetration or migration were significant (p≤0.05). Results. 47 hips were followed at 3 years, and 35 at 5 years. The median± standard error (SE) superior head penetration into the polyethylene was 0.05±0.01mm at 3 years and 0.06±0.01 mm at 5 years. There was no difference after 2 years. The median± SE distal stem migration was 0.06±0.21mm at 3 years, and 0.06±0.29mm at 5 years with no significant differences over time. All PROMs improved significantly from the preoperative to all other intervals (p<0.001 for all). Discussion. The VEPE liners show low head penetration at 5 years. The early head penetration, probably due to creep, is lower relative to that reported for non-VEPE measured by RSA. While most stems were stable, the high standard error results from one stem that migrated substantially by 6 months (9.4mm), which has since stabilized. This study documents the longest-term evaluation of in vivo wear performance of vitamin E stabilized UHMWPE. The low wear and the stability of the femoral stem shows promise for long-term survivorship

Ultra-high molecular weight polyethylene (UHMWPE) has been the gold standard material of choice for the load-bearing articulating surface in knee joint prostheses. However, the application of joint replacements to younger (aged < 64 years) and more active people plus the general increase in life expectancy results in an urgent need for a longer lasting material with better in-use performance. There are three major material related causes that can lead to joint failure in UHMWPE knee joint replacements: free radical induced chemical degradation; mechanical degradation through wear and delamination; and UHMWPE micron and submicron wear debris induced osteolysis. As a potential solution to these problems, highly crosslinked UHMWPE stabilised with infused antioxidant vitamin E (α-Tocopherol), which is abbreviated as E-Poly, has been of great interest. In the current work, the wear performance and mechanical properties of Vanguard cruciate retaining (CR) E-Poly tibial inserts were assessed and compared with Vanguard CR Arcom tibial inserts. Also E-Poly plates were compared with direct compression moulded UHMWPE wear plates. Both a multi-directional pin-on-plate tester and a six-station Prosim (Manchester, UK) knee wear simulator were used to assess wear properties of E-Poly plates and E-Poly tibial inserts respectively. All E-Poly plates and tibial inserts were sterilised and vacuum packed in the same way as Vanguard implants before wear testing. The wear knee simulator test was conducted in accordance with ISO 14243-3:2004 with the exception that a more aggressive Tibial Rotation and Anterior/Posterior displacement profiles, based on the kinematics of the natural knee were incorporated. Under the same aggressive pre-clinical wear testing condition, compared with Vanguard Arcom CR tibial inserts, Vanguard E-Poly CR tibial inserts experienced an 85% reduction in the mean wear rate. The former had a mean wear rate of 6.51±1.75 mm. 3. per million cycles (MC) and the latter had a mean wear rate of 0.96±0.11 mm. 3. /MC over the 7 million cycle testing period. A similar reduction (80%±8.5) in the mean wear factor was also observed on E-Poly plates compared with a series of direct compression moulded GUR1050 UHMWPE plates processed under a range of manufacturing processing conditions. Wear testing was conducted with a configuration of flat-ended stainless steel indenters multi-directionally sliding against the UHMWPE plates. Mechanical properties on Vanguard Arcom UHMWPE and E-Polys were evaluated using the small punch test. All tests were carried out using an Instron 5565 Universal Testing System at a constant crosshead speed of 0.5mm/min. With regard to work-to-failure, no statistical difference was observed, with the former being 254.2±4.1 mJ and the latter 255.6±28.2 mJ. However, all E-Polys exhibited strain stiffening due to the stretch of crosslinks. This resulted in a ca 12% reduction in elongation to break observed for E-Polys compared with that of Arcom UHMWPE. The former had an elongation to break of 4.1±0.2 mm and the latter of 4.7±0.3 mm. In conclusion, we have found that Vitamin E Stabilised UHMWPE tibial inserts are promising for knee joint prostheses. However, further investigations are needed to address potential issues such as the particle size and size distribution of E-Poly wear debris and the associated reactivity

Introduction. Ultra high molecular weight polyethylene (UHMWPE) has been used successfully as a bearing material in hip, knee, and shoulder joint replacements. However, there are problems to cause a failure in UHMWPE component, which are wear behavior and creep deformation. Continuous bearing motion and dynamic load have occurred to UHMWPE wear debris caused osteolysis in periprosthetic tissue and to plastic deformation of joint component, and subsequent aseptic loosening of components. Therefore, many studies have being carried out in order to reduce wear debris and to improve mechanical strength from UHMWPE, and there is tremendous improvement of mechanical property in UHMWPE from gamma irradiated conventional UHMWPE (GIPE), highly crosslinked PE (XLPE), and XLPE with vitamin E1, 2. Friction has a significant one of the factors effect on the wear and creep deformation. In this study, the short-term frictional behaviors of three typical types of GIPE, remelted XLPE (R-XLPE), and s annealed XLPE (A-XLPE), and XLPE with Vitamin E against Co-Cr alloy were compared under three levels of contact pressures which occured in hip, knee, and shoulder joints. Methods. Friction tests were conducted with UHMWPE against Co-Cr alloy by using pin-on-disk type triboteter. For test, tribotester performed in a repeat pass rotational slidintg motion with a velocity of 60rpm. Applied contact pressure selected three kinds of levels, 5, 10, and 20MPa which were within the range of maximum contact pressures for total hip, knee, and shoulder joint replacements. To analyze the frictional effect of UHMWPE type, it conducted t-test and p-values less than 0.05 were used to determine the statistically significant difference. Results. In this study, it was observed that coefficients of friction (COF) were affected by various conditions, kinds of materials and applied load. We can reveal the frictional behavior of UHMWPE in various contact pressures. The average of the COF measured that GIPE was 0.029∼0.0423, R-XLPE was 0.018∼0.031, A-XLPE was 0.023∼0.038, and XLPE with Vitamin E was 0.013∼0.027 under 5, 10, and 20MPa. Discussion. COF of R-XLPE, A-XLPE, and XPLE with Vitamin E were lower than GIPE for all levels of contact pressures. This study showed the trend that COF decreased as contact pressure increased. Also, XPLE with Vitamin E has lowest frictional values among UHMWPEs. In the viewpoint of applied load, it was decreased as a contact pressure increased for COF of GIPE, RXLPE, and AXLPE against Co-Cr alloy. COF of GIPE, XLPEs, and XLPE with Vitamin E against Co-Cr alloy were as low as using bio materials compared with the COF of cartilage to cartilage, which was about 0.024. Conclusions. In conclusion, average COF of XLPE with Vitamin E was significantly lower than those of R-XLPE and A-XLPE. XLPEs showed much lower COF than GIPE

Introduction. Increased oxidative stability of orthopedic implants can be achieved by adding an antioxidant, such as Vitamin E (VE) to UHMWPE[1]. The effect of shelf live and accelaterated aging in combination with shelf live on antioxidative effectiveness of VE needs to be investigated to better understand the long-time behavior of VE-blended UHMWPE in an oxidative environment. Currently, IR techniques provide detection limits as low as 0.05 %w/w[2], also it is known that thermo analytical techniques can push the limit of detection down to 10 ppm[3]. The goal of this study was to quantify VE in UHMWPE powder and compression molded UHMWPE with 11 different VE concentrations using FTIR and DSC techniques and to establish respective regression curves. Methods & Materials. GUR 1050 UHMWPE resin (Ticona, Germany) was blended with VE (DSM, Netherlands) to the following target concentrations (%w/w): 0.01, 0.02, 0.05, 0.1, 0.25, 0.35. Concentrations of 0.001, 0.002, 0.003, 0.004, 0.005 were obtained by mixing of the 0.1 powder with virgin GUR 1050 powder. VE-free GUR 1050 was used as reference. Samples of blended resin were compression molded in a low oxygen environment atmosphere at Zimmer Inc. (Warsaw, IN). Subsequently the blocks were microtomed, creating films with a thickness of 200µm for each concentration. The VE concentration was measured using infrared (IR) spectroscopy (BioRad FT6000). The ratios were calculated by normalizing the integrated ether C-O(R) signal (1232cm. −1. to 1275cm. −1. ) and the integrated hydroxyl C-O(H) signal (1190cm. −1. to 1228cm. −1. ) using the twisting CH bond (1980cm. ∗∗∗∗∗. to 2100cm. −1. ) as reference peak area. Oxidative induction time (OIT) at 200°C was measured according to ASTM D 3895–98 using blended and mixed powder samples. Results. Infrared spectroscopy. A strong positive linear correlation between the normalized peak areas and the effectively blended VE content was detected for both ether (Figure 1) and hydroxyl ratios. Figure 1: Normalized ether signal plotted over blended VE sample (928 IR spectra / 7 VE concentrations). Samples below 0.01 %w/w were not FTIR tested as they fell below the detection limits of 0.0074 and 0.0092 %w/w[4] based on ether and hydroxyl ratios. Oxidative-induction time. A logarithmic correlation between oxidation time and the effectively blended VE content was detected (Figure 2). Figure 2: OIT over effectively blended VE concentration (36 data points / 12 VE concentrations). Using OIT, VE concentrations down to 0.001 and 0.002 %w/w VE were quantified with D. absolute. of below 0.0002 %w/w and D. relative. of below 20% to the regression (Figure 3). Figure 3: Relative differences of quantification of VE over blended VE to regression via OIT and IR. Discussion. This study proves detectability of VE concentrations of 0.01 %w/w via calibrated IR absorbance and 0.001 %w/w using a calibrated OIT method at 200°C. Thus, mapping of VE chemical moities within UHMWPE samples below 0.05 %w/w VE by IR and detection of antioxidative stabilization in UHMWPE samples containing less than 0.002 %w/w VE can be achieved. Based on these findings, highly accurate VE measurements for aged, unaged, retrieved and differently processed materials shall be enabled

Background. dl-α-Tocopherol (vitamin E) blended ultra-high molecular weight Polyethylene (UHMWPE) was originally developed as a bearing material for use in knee prostheses . (1). The reduced biological response observed for vitamin E (VE) blended UHMWPE wear particles in in vitro experimentation . (2). has also demonstrated the materials potential for use in other orthopedic applications, especially total hip arthroplasty (THR). However, due to the excellent results achieved by highly crosslinked UHMWPE in hip simulator testing . (3). , the use of VE blended UHMWPE in THR would similarly require crosslinking. It was previously reported that VE radicals are formed during radiation crosslinking of VE blended UHMWPE . (4). , and it is hypothesized that these VE radicals may negatively impact the materials biological activity. In this study, ascorbic acid 6-palmitate (lipophilic vitamin C) was applied to electron-beam-irradiated VE blended UHMWPE in an attempt to oxidatively reduce the VE radicals. Electron Spin Resonance (ESR) was used to measure the number of VE radicals within the material and evaluate the regenerating effect of ascorbic acid 6-palmitate. Materials & Methods. UHMWPE resin powder (GUR 1050, Ticona, USA) was mixed with dl-a-Tocopherol (vitamin E) at 0.3 wt% and molded under direct compression at 25 MPa and 220°C. Virgin samples were produced by the same process, but without the addition of vitamin E (VE). Cylindrical pins (length: 40 mm, diameter: 3.5 mm) were then machined from these samples, packaged in a vacuum, and irradiated by electron-beam at 300 kGy. Samples were subsequently doped with either ascorbic acid 6-palmitate (Sigma, Japan) or ethanol (Ethanol 99.5%, Kishida, Japan) and subjected to a hydrostatic pressure of 100 MPa for 7, 14, and 21 days at room temperature. Radical measurements were made using ESR at 9.44 GHz and room temperature. All ESR spectra were recorded at 0.1 mW microwave power and 0.1 mT modulation amplitude. Results & Discussion. The observed characteristic ESR peak for VE radicals was shown to decrease with time in the electron-beam-irradiated VE blended UHMWPE samples that were doped with ascorbic acid 6-palmitate (Figure 1 & 2). This particular spectrum was confirmed as that for VE radicals through g-value and line width analysis (Figure 3). These results showed that the number of VE radicals in electron-beam-irradiated VE blended UHMWPE was reduced by doping with ascorbic acid 6-palmitate at 100 MPa. The reduced VE radical may transform into a quinine, or react with other VE radicals to form dimmers/trimers. Due to the fact that VE radicals in UHMWPE have been shown to be stable at room temperature, it is thought that the observed reduction in number of VE radicals is a result of the direct action ascorbic acid 6-palmitate

Introduction. We have previously demonstrated that peroxide crosslinked vitamin E-blended UHMWPE maintains its clinically-required wear and mechanical properties [1]. This material can potentially be used as an irradiation-free bearing surface for TJA. However, using organic peroxides in medical devices requires a thorough examination of tissues in contact with the implant. For this study we crosslinked polyethylene using five times the needed concentration of peroxide (2,5-Dimethyl-2,5-di(t-butylperoxy)-hexyne-3 or P130), followed by implantation to determine implant biocompatibility, and pre and post implant peroxide residual contents. Methods. The study was performed after institutional approval following ISO standard 10993–6. Study groups: not crosslinked (0.2 (1050) VE), crosslinked (0.2 VE (1050)/5% P130) and crosslinked-high temperature melted (HTM) (0.2 VE (1050)/5% P130). Materials were blended and consolidated, machined (2.5 diameter × 2.5 cm height), sterilized and implanted in the dorsum New Zealand white rabbits. Pre and post implantation FTIR was performed. Two samples were implanted in each rabbit; n=6 samples were included for each group. After 4 weeks, samples were explanted, analyzed using FTIR, and subcutaneous tissues processed for histological analysis. Results. FTIR absorbances at 914cm. −1. , 1169cm. −1. , and the OH absorbance at 3450cm. −1. showed differences between materials (Fig 1A). There was a significant increase in the absorbance at 914 for the non-crosslinked and crosslinked samples after explantation (p = 2.77E–17, p = 4.22E–23, Fig 1B). There was a significant decrease in all peroxide related absorbances after explantation for the crosslinked and HTM samples (p < 0.05, Fig 1B). Before implantation, these absorbances were significantly higher in the crosslinked and crosslinked/HTM samples than those in the non crosslinked sample (p<0.05, Fig 2A). Peroxide related absorbances of the crosslinked sample were also significantly higher than those of the crosslinked/HTM sample (p<0.05, Fig 2A). After explantation, the crosslinked samples had significantly higher absorbances than both the non crosslinked and crosslinked/HTM samples (p < 0.05, Fig 2A). All peroxide related absorbances of the crosslinked/HTM samples were significantly higher than those of the non crosslinked sample (p < 0.05, Fig 2A). The non crosslinked sample showed no significant differential between these absorbances at implantation and after retrieval. The crosslinked sample had the largest differential between the total peak absorbances before implantation and retrieval at 914cm. −1. The crosslinked/HTM samples had the largest differential between the total peak absorbances before and after implantation for both 1169cm. −1. and the OH absorbances (Fig 2B). All explants were recovered after four weeks in vivo (Fig 3A). No difference was found in the histological analysis of the tissue characterized by a synovial-like lining with signs of fibrosis around the implants (Fig 3B). Discussion. The main challenge of this study was identifying pre and postoperative implant peroxide residual peaks via FTIR. We wanted to ensure that peroxide was present in implants before implantation, to ensure their elution into tissues. Conclusions. Peroxide crosslinked polyethylene stabilized with vitamin E can potentially be used as an alternate bearing surface. Irradiation-free processing could result in cost-effectiveness and more accurate cross-linking of polyethylene implants

Introduction. Osteolysis caused by wear of the ultrahigh molecular weight polyethylene (UHMWPE) often leads to failure. Cross-linking improves wear, but also produces residual free radicals that decrease oxidative stability. In vitro studies have shown that the anti-oxidative properties of vitamin E UHMWPE stabilize free radicals while retaining the physical and chemical properties of UHMWPE. The porous surface of the Regenerex™ shell was developed for improved bone in-growth fixation. The increased porosity of the Regenerex™ shell promotes early bony in-growth with the goal of greater long-term stability. The purpose of this study was to evaluate vitamin E infused polyethylene (VEPE) wear and stability of acetabular and femoral components using RSA. Methods. 58 patients (64 observed hips), all with osteoarthritis, gave informed consent to participate in a 5 year RSA study. Each patient received a VEPE liner, a Regenerex™ acetabular shell, and an uncemented stem with either a 32mm or 36 mm cobalt chrome femoral head. Tantalum beads were inserted into the VEPE, the pelvic and the femoral bone to measure head penetration into the polyethylene, and shell and stem stability over time, using RSA. RSA radiographs were scheduled immediately postoperatively (up to 6 weeks) and 6 months, 1, 2, 3, and 5 years after surgery. The Wilcoxon signed-ranks nonparametric test was used to determine if changes in penetration or migration were significant over time at p≤0.05. Results. 58 hips have been followed for 6 months, 55 at 1 year, 52 at 2 years, 47 at 3 years and 18 at 5 years. The 36mm cohort data is not reported at this time due to insufficient follow-up. The median± standard error (SE) superior head penetration into the polyethylene was 0.05±0.01mm at 2 years, 0.05±0.01mm at 3 years, and 0.05±0.02 mm at 5 years. The acetabular components had a median± SE cup translation in the proximal direction of 0.09±0.03mm at 2 years, 0.04±0.04mm at 3 years, and 0.06±0.06mm at 5 years. The median± SE cup rotation was −0.09±0.16 degrees at 2 years, −0.02±0.15 degrees at 3 years, and 0.30±0.20 degrees at 5 years. There was a statistically significant difference in cup rotation between the 6 month and 1 year intervals (p=0.007), but no significant differences in translation or head penetration. The median± SE stem distal migration was 0.08±0.07mm at 2 years, 0.05±0.23mm at 3 years, and 0.02±0.17mm at 5 years, with a significant difference between the 6 month and 3 year intervals (p=0.029). Discussion. The VEPE liners show low head penetration at 5 years. The early head penetration, probably due to creep, is substantially lower relative to that reported for non-vitamin E stabilized UHMWPE measured by similar techniques. At 5 years, all acetabular components were stable, with the early significant difference in rotation at 1 year likely due to early settling of the cup. This study documents the longest-term evaluation of in vivo wear performance of vitamin E stabilized UHMWPE. The stability of the Regenerex™ shell and femoral stem shows promise for long-term survivorship

Introduction. Over 40-years the dominant form of implant fixation has been bone cement (PMMA). However the presence of circulating PMMA debris represents a 3rd-body wear mechanism for metal-on-polyethylene (MPE). Wear studies using PMMA slurries represent tests of clinical relevance (Table 1). Cup designs now use many varieties of highly-crosslinked polyethylene (HXPE) of improved wear resistance. However there appears to be no adverse wear studies of vitamin-E blended cups.1–4 The addition of vitamin E as an anti-oxidant is the currently preferred method to preserve mechanical properties and ageing resistance of HXPE. Therefore the present study examined the response of vitamin-E blended liners to PMMA abrasion combined with CoCr and ceramic heads. The hip simulator wear study was run in two phases to compare wear with, (i) clean lubricants and (ii) PMMA slurries. Methods. The vitamin-e blended polyethylene liners (HXe+) were provided by DJO Surgical (Austin, TX) with 40mm CoCr and ceramic femoral heads (Biolox-delta). Polyethylene liners were run in standard “Inverted” test. (Table 1) All cups were run in ‘clean’ serum lubricant for 6-million load cycles (6Mc)5 and in a debris slurry (PMMA: 5mg/ml concentration) for 2Mc.4 A commercial bone cement powder was used as “abrasive” (Biomet, Warsaw, IN). PMMA slurries were added at test intervals 6, 6.5, 7 and 7.5Mc.4 Wear was assessed gravimetrically and characterized by linear regression. Bearing roughness was analyzed by interferometry and SEM. Results. The acetabular cups showed low wear-rates to 6Mc duration with both ceramic and CoCr heads (Fig. 1). The debris slurries created much higher wear-rates, whereas control liners continued as before (Table 2). Discussion. This is the 1st study of vitamin-E blended polyethylene under 3rd-body wear conditions. With clean lubricant conditions, CPE combination wore approximately 50% less than MPE combination. Under abrasive lubricant conditions, CPE and MPE combinations wore at approximately same rate but more than an order of magnitude greater than the clean test phase. This was typical of such PMMA abrasion tests (Table 1). However there are no guidelines as to optimal choice of particulate type, morphology, dosage, frequency of injection or duration of test intervals (Table 1). The production of particulates in vivo is an unpredictable phenomenon and consequently laboratory simulation is fraught with uncertainties.6 On completion of the abrasive challenge (6–8Mc duration), our study will continue under clean conditions to 10Mc to define the important recovery phase of the vitamin-E blended polyethylene.3

Introduction. Periprosthetic joint infection (PJI) and particle-induced osteolysis are closely related to peri-implant local immunity and macrophage function. We previously demonstrated that titanium particles attenuate the immune response of macrophages caused by chronic inflammation [1]. In a separate study, we have determined that UHMWPE wear particles containing vitamin E (VE) induce less osteolysis compared to HXL UHMWPE wear particles in a murine calvarium model [2]. For this study we hypothesized that macrophages exposed to HXL UHMWPE particles containing VE would better maintain their ability to respond to S. aureus compared to HXL UHMWPE without VE. Methods. A gamma-sterilized, HXL UHMWPE tibial bearing containing VE (E1, Biomet, “VE-PE”) and 100kGy irradiated and melted UHMWPE (“CISM 100”) were cryomilled to particles by Bioengineering Solutions (Oak Park, IL). In the first in vitro study, RAW 264.7 mouse macrophages were exposed (inverted co-culture) to either VE-PE particles or CISM100 particles and lipopolysaccharide (LPS) for 1–7 days. Macrophage viability was measured using a cell counting kit (CCK-8). Control group with no particles and a LPS group were also included. Terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) staining was performed to determine macrophage apoptosis rate in response to particle exposure over time. In the second study, macrophages were exposed to VE-PE or CISM100 particles for 48h, then exposed to LPS for 30 min. Subsequently, reactive oxygen species (ROS) generation and extracellular regulated protein kinase (ERK) phosphorylation were measured. In a third study, after exposure to particles for 48h, fatigued macrophages were co-cultured with bioluminescent S. aureus strain Xen29 for 3h and 6h. Bioluminescence signal was determined to measure the total amount of bacteria. Bacterial live/dead staining and optical density at 600 nm (OD 600) were also performed to determine S. aureus viability. Statistical analysis was performed using one-way or two-way ANOVA with a post hoc examination. *indicates p<0.05. Results. CISM100 particles significantly decreased macrophage viability at day 5 and day 7 (p<0.05, Fig. 1A), while the viability of macrophages exposed to VE-PE particles was similar to controls (macrophages not exposed to particles). After 48h, macrophages exposed to VE-PE particles showed a lower TUNEL-positive rate (less apoptosis) compared to CISM100 particles (Fig. 1B, C). 48h-exposure to VE-PE particles increased ROS generation and ERK phosphorylation in 30 min-LPS-activated macrophages when compared to CISM100 particles (Fig. 2). This immune response caused by VE-PE particles resembles that of macrophages without particles. Furthermore, 48h exposure to E1 particles showed less S. aureus at 6h (Fig. 3). Conclusions. These results suggest that VE-PE particles cause reduced macrophage apoptosis and protect the macrophages' immune response. VE-PE particles also preserved the innate immunity of macrophages, unlike CISM100, as evidenced by the S. aureus co-culture study. Thus, patients with vitamin-E containing implants may be less likely to develop PJI

Aim

Biofilm-related infections represent a recurrent problem in the orthopaedic setting. In recent years, great interest was directed towards the identification of novel molecules capable to interfere with pathogens adhesion and biofilm formation on implant surfaces. In this study, two stable forms of α-tocopherol, the hydrophobic acetate ester and the water-soluble phosphate ester, were tested in vitro as coating for titanium prostheses.

INTRODUCTION. Since the early 2000s, highly cross-linked (HXL) UHMWPE's have become a popular option with multiple experimental and clinical studies showing that gamma or electron radiation doses between 50–100kGY reduce wear and potentially extend the bearing life of UHMWPE. However, the increased wear resistance came at a compromise to mechanical properties due to the cross-linking process. Vitamin E has been added to some HXL UHMWPE materials to offer a solution to the compromise by increasing oxidation resistance and maintaining sufficient fatigue strength. However, limited data is available on the effect of the fabrication process, especially the method of irradiation, on the properties of the Vitamin E blended HXL UHMWPE. The purpose of this study was to evaluate the effects of adding the antioxidant vitamin E to highly crosslinked UHMWPE on wear rates. METHODS. Wear testing was performed on six highly crosslinked UHMWPE acetabular liners containing vitamin E (0.1% wt. alpha tocopherol) fabricated using the Cold Irradiation Mechanically Annealed (CIMA) process, initially cross-linked with approximately 100 kGy gamma irradiation, and terminally gamma sterilized. The liners were paired with three 40mm CoCr femoral heads and 40mm three ceramic femoral heads. Testing was completed per ASTM F1714 and ISO 14242 on an orbital hip joint wear simulator (Shore Western, California) and lubricated with 90% bovine calf serum, 20mM EDTA, 0.2% wt. NaN. 3. and DI water. A 1.1Hz Paul-type loading waveform with a peak of 2kN was used for a total of 5E6 wear cycles. Three loaded soak controls were used in parallel to adjust for fluid absorption. Samples were weighed every 5E5 wear cycles. RESULTS. The wear rates for the HXL blended vitamin-E liners were calculated using the slope of the linear regression over the steady state and resulted in a wear rate of 0.49mg/Mc. This is a decrease of approximately 95% compared to the 9.54 mg/Mc 28mm ID conventional UHMWPE wear rates as well as a notable difference for the other HXL UHMWPE liner wear rates discussed in the review. DISCUSSION. HXL blended vitamin-E 40mm liners demonstrated an approximate 95% reduction in wear rates compared to a 28mm ID conventional UHMWPE. The reduced wear rate confirmed the design expectation that a higher irradiation dose in the fabrication process resulted in an increased amount of polymer crosslinking. Additionally, the wear rate of the HXL blended vitamin-E liners studied was well below 20mg/Mc, which was shown by Dowd et al. to be the threshold of osteolysis in THA. SIGNIFICANCE. The HXL vitamin E blended UHMWPE liner tested in this study demonstrated reduced wear rates by approximately 95% compared to conventional polyethylene. Osteolysis-causing wear debris is reduced while maintaining other mechanical properties. This liner material and manufacturing process is a promising alternative to conventional polyethylene, but long-term clinical results are warranted

Introduction. Radiation cross-linked UHMWPE is preferred in total hip replacements due to its wear resistance [1]. In total knees, where stresses are higher, there is concern of fatigue damage [2]. Antioxidant stabilization of radiation cross-linked UHMWPE by blending vitamin E into the polymer powder was recently introduced [3]. Vitamin E greatly hinders radiation cross-linking in UHMWPE [4]. In contrast peroxide cross-linking of UHMWPE is less sensitive to vitamin E concentration [5]. In addition, exposing UHMWPE to around 300°C, increases its toughness by inducing controlled chain scission and enhanced intergranular diffusion of chains, simultaneously [6]. We present a chemically cross-linked UHMWPE with high vitamin E content and improved toughness by high temperature melting. Methods and Materials. Medical grade GUR1050 UHMWPE was blended with vitamin E and with 2,5-Di(tert-butylperoxy)-2,5-dimethyl-3-hexyne or P130 (0.5% Vitamin-E and 0.9% P130). The mixed powder was consolidated into pucks. The pucks were melted for 5 hours in nitrogen at 300, 310 and 320°C. One set of pucks melted at 310°C was accelerated aged at 70°C at 5 atm. oxygen for 2 weeks. Tensile mechanical properties were determined using ASTM D638. Izod impact toughness was determined using ASTM D256 and F648. Wear rate was determined using a bidirectional pin-on-disc (POD) tester with cylindrical pins of UHMWPE against polished CoCr discs in undiluted, preserved bovine serum. Results. The vinyl index increased as a function of temperature (Fig 1a). Cross-link density steadily decreased and impact strength increased with increasing vinyl index (Fig 1b). The ultimate tensile strength (UTS) was not affected by HTM (Table 2). Impact strength was significantly improved for all treatment temperatures (P<0.05) and wear was significantly increased only for the sample melted at 320°C (Table 2). Discussion. High temperature melting (HTM) was shown to increase toughness of UHMWPEs presumably due to controlled chain scissioning and increased intergranular diffusion of chains [6]. For radiation cross-linked UHMWPE, it was shown that an increase in elongation-at-break and impact strength could be obtained without sacrificing wear resistance up to an elongation of about 500% [7]. This vitamin E-blended, peroxide cross-linked, high temperature melted UHMWPE has very high oxidation resistance due to its high antioxidant content, high wear resistance due to cross-linking and much improved toughness, representing an optimum joint replacement surface. For figures/tables, please contact authors directly.

Introduction:. Irradiated ultra-high molecular weight polyethylene (UHMWPE), used in the fabrication of joint implants, has increased wear resistance [1]. But, increased crosslinking decreases the mechanical strength of the polymer [2], thus limiting the crosslinking to the surface is desirable. Here, we usedelectron beam irradiation with low energy electrons to limit the penetration of the radiation exposure and achieve surface cross-linking. Methods:. Medical grade 0.1 wt% vitamin E blended UHMWPE (GUR1050) was consolidated and irradiated using an electron beam at 0.8 and 3 MeV to 150 kGy. Fourier Transform Infrared Spectroscopy (FTIR) was used from the surface along the depth at an average of 32 scans and a resolution of 4 cm. −1. A transvinylene index (TVI) was calculated by normalizing the absorbance at 965 cm. −1. (950–980 cm. −1. ) against 1895 cm. −1. (1850–1985 cm. −1. ). TVI in irradiated UHMWPE is linearly correlated with the radiation received [3]. Vitamin E indices were calculated as the ratio of the area under 1265 cm. −1. (1245–1275 cm. −1. ) normalized by the same. Pin-on-disc (POD) wear testing was conducted on cylindrical pins (9 mm dia., 13 mm length, n = 3) as previously described at 2 Hz [4] for 1.2 million cycles (MC). Wear rate was measured as the linear regression of gravimetric weight change vs. number of cycles from 0.5 to 1.2 MC. Double notched IZOD impact testing was performed (63.5 × 12.7 × 6.35 mm) in accordance with ASTM F648. Cubes (1 cm) from 0.1 wt% blended and 150 kGy irradiated pucks (0.8 MeV) were soaked in vitamin E at 110°C for 1 hour followed by homogenization at 130°C for 48 hours. Results:. The penetration of the electron beam for cross-linking was limited at low beam energy and cross-linking of the surface 2 mm was achieved (Fig 1). The wear rate of samples irradiated at 0.8 and 3 MeV was 1.12 ± 0.15, and 0.98 ± 0.11, respectively (p > 0.5). In addition, the wear rate of the surface (0.8 MeV) irradiated UHMWPE was 0.33 ± 0.02 mg/MC 1 mm below the surface. The impact strength of UHMWPE irradiated at 0.8 MeV was 73 kJ/m. 2. and 54.2 kJ/m. 2. for that irradiated at 3 MeV (p = 0.001). Doping with vitamin E and homogenization increased the surface vitamin E concentration from undetectable levels to 0.11 ± 0.01. Discussion:. The wear rate of this surface cross-linked UHMWPE was comparable to uniformly cross-linked UHMWPEs irradiated at higher electron beam energies. Even lower wear rate subsurface suggested the feasibility of machining 1 mm from the surface in implant fabrication. Limiting cross-linking to the surface resulted in higher impact strength compared to a uniformly cross-linked UHMWPE. Vitamin E was optionally replenished by additional doping after cross-linking; an advantage of this method may be increased oxidation resistance. Significance: Low energy irradiation of vitamin E blended UHMWPE is feasible to fabricate total joint implants with high wear resistance and impact strength

Introduction:. Periprosthetic infections that accompany the use of total joint replacement devices cause unwanted and catastrophic outcomes for patients and clinicians. These infections become particularly problematic in the event that bacterial biofilms form on an implant surface. Previous reports have suggested that the addition of Vitamin E to ultra-high-molecular-weight polyethylene (UHMWPE) may prevent the adhesion of bacteria to its surface and thus reduce the risk of biofilm formation and subsequent infection. 1–3. In this study, Vitamin E was blended with two types of UHMWPE material. It was hypothesized that the Vitamin E blended UHMWPE would resist the adhesion and formation of clinically relevant methicillin-resistant Staphylococcus aureus (MRSA) biofilms. Methods and Materials:. Five sample types were manufactured, machined and sterilized (Table 1). To determine if MRSA biofilms would be reduced or prevented on the surface of the Vitamin E (VE) loaded samples (HXL VE 150 kGy and HXL VE 75 kGy) in comparison to the other three clinically relevant material types, each was tested for biofilm formation using a flow cell system. 4. Direct Bacterial Quantification – An n = 7 samples of each material type were placed individually into a chamber of the flow cell. A solution of 10% modified brain heart infusion (BHI) broth containing 10. 5. MRSA cells/mL was flowed through each chamber. Using previously established protocols,. 4–7. after 48 hours of growth, each sample was removed, and the number of colony forming units (CFU) determined using a 10-fold dilution series. SEM Imaging – Using the same protocol as above, after the 48-hour incubation period, an n = 7 of each material type were fixed in 2.5% glutaraldehyde, dehydrated in ascending concentrations of ethanol, coated with carbon and imaged using scanning electron microscopy (SEM). Results:. Results indicated that the Vitamin E blended materials did not resist the attachment/formation of MRSA biofilms to any greater degree than the other three material types. All materials had greater than 10. 7. CFU/cm. 2. (Figure 1). SEM images corroborated with the quantification data (Figure 2). Discussion:. In contrast to previously published results,. 1–3. these data indicated that Vitamin E blended UHMWPE may not have the ability to prevent biofilm formation of a clinical MRSA isolate from occurring

Malpositioning still occurs in total hip arthroplasty (THA). As a result of mal-orientation, THA bearing can be subjected to edge loading. The main objective of the study was to assess if the wear rate of ceramic-on-ceramic and metal-on-polyethylene increases under edge loading conditions and to determine which of the most commonly used hip bearings is the most forgiving to implant mal-orientation. Materials and methods. Two different polyethylenes (UHMWPE and vitamin E blended HXLPE) and ceramics (pure aluminum PAL and alumina-toughened zirconia ATZ) were tested with a hip simulator and compared to metal-on-metal results. The inclination angle was selected at 45°, 65° and 80°. In addition, the ceramic-on-ceramic barings were tested at conditions that produced microseparation. Results. Contrary to metal-on-metal that is highly susceptible to edge loading, the wear rate of ceramic-on-ceramic and metal-on-polyethylene articulations does not increase with increasing cup inclination. In fact, the polyethylenes showed a contra-intuitive behaviour as its wear rate decreased slightly but significantly with increasing inclination angle. This behaviour can be explained when looking closely at the contact stresses and areas. (Figure 1 shows the wear area of the vitamin E blended HXLPE at 45° and figure 2 at 80° cup inclination). The newest biomaterials, vitamin E blended HXLPE and ATZ, showed markedly lower wear rates compared to their conventional counterparts, UHMWPE and PAL. The ATZ ceramic-on-ceramic articulation showed the lowest wear rate (even when microseparation is included) of all tested pairings, but the new vitamin-doped HXLPE seems to be the most forgiving materials when it comes to implant mal-orientation. It shows low wear rate even at an extremely high cup inclination angle. Therefore, a surgeon that discovers a mal-positioned polyethylene cup at the first post-op X-ray will not need to worry unduly about increased wear (but “only” about a potential dislocation)

Introduction:. First generation highly crosslinked polyethylenes (HXPLEs) have proven successful in lowering both penetration and osteolysis rates. However, 1. st. generation annealing and remelting thermal stabilization have been associated with in vivo oxidation or reduced mechanical properties. Thus, 2. nd. generation HXLPEs were developed to improve oxidative stability while still maintaining material properties. Little is known about the in vivo clinical failure modes of these 2. nd. generation HLXPEs. The purpose of this study was to assess the revision reasons, wear, oxidative stability, and mechanical behavior of retrieved sequentially annealed Vitamin E diffused HXLPE in THA and TKA. Methods:. 251 2. nd. Generation HXLPE hip and knee components were consecutively retrieved during revision surgeries and continuously analyzed in a prospective, IRB approved, multicenter study. 123 acetabular liners (Implanted 1.2y; Range 0–5.0y) and 117 tibial inserts (Implanted 1.6y; Range 0–5.8y) were highly crosslinked and annealed in 3 sequential steps (X3). Five acetabular liners (Implanted 0.6y; Range 0–2.0y) and six tibial inserts (Implanted 1.3y; Range 0.5–1.8y) were diffused with Vitamin E (E1). Patient information was collected from medical records (Table 1). Linear penetration of liners was measured using a calibrated digital micrometer (accuracy: 0.001 mm). Surface damage of tibial components was assessed using the Hood method. Thin sections were taken from the acetabular liners (along the superior/inferior axis) and the tibial components (along the medial condyle and central spine) for oxidation analysis and analyzed according to ASTM 2102. Mechanical behavior was assessed via the small punch test (ASTM 2183). Results:. The liners and tibial components fabricated from both HXLPEs were revised predominantly for loosening, instability, and infection (Figure 1). The average penetration rate for the Sequentially Annealed group was low (PR = 0.045 mm/yr). Pitting, scratching and burnishing were the predominant damage mechanisms of the tibial inserts within both material groups, with no evidence of delamination. Oxidation indices were low (Mean OI≤0.3) and similar between liners and inserts of the Sequentially Annealed components at the bearing and backside surface (Figure 2, p ≥ 0.15). Oxidation was positively correlated with implantation time at the bearing surface of the Sequentially Annealed groups (Rho > 0.29, p < 0.005). The Ultimate Load of the Sequentially Annealed acetabular liners was statistically higher than the tibial components (p < 0.001), however the mean difference was minimal (∼6N). Discussion:. This study evaluated the properties of 2. nd. generation HXLPEs used in THA and TKA. Sequentially Annealed liners had penetration rates comparable with 1. st. generation HXLPEs. While oxidation was low for both sequentially annealed and Vitamin E HXLPEs, we were able to detect regional variations in the oxidative in the sequentially annealed cohort. Longer-term retrievals are necessary to fully assess the oxidative stability of Vitamin E diffused HXLPE used in TKA and THA