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

The 2021 Australian Orthopaedic Association National Joint Replacement Registry report indicated that total shoulder replacement using both mid head (TMH) length humeral components and reverse arthroplasty (RTSA) had a lower revision rate than stemmed humeral components in anatomical total shoulder arthroplasty (aTSA) - for all prosthesis types and diagnoses. The aim of this study was to assess the impact of component variables in the various primary total arthroplasty alternatives for osteoarthritis in the shoulder. Data from a large national arthroplasty registry were analysed for the period April 2004 to December 2020. The study population included all primary aTSA, RTSA, and TMH shoulder arthroplasty procedures undertaken for osteoarthritis (OA) using either cross-linked polyethylene (XLPE) or non-cross-linked polyethylene (non XLPE). Due to the previously documented and reported higher revision rate compared to other anatomical total shoulder replacement options, those using a cementless metal backed glenoid components were excluded. The rate of revision was determined by Kaplan-Meir estimates, with comparisons by Cox proportional hazard models. Reasons for revision were also assessed. For a primary diagnosis of OA, aTSA with a cemented XLPE glenoid component had the lowest revision rate with a 12-year cumulative revision rate of 4.7%, compared to aTSA with cemented non-XLPE glenoid component of 8.7%, and RTSA of 6.8%. The revision rate for TMH was lower than aTSA with cemented non-XLPE, but was similar to the other implants at the same length of follow-up. The reason for revision for cemented aTSR was most commonly component loosening, not rotator cuff deficiency. Long stem humeral components matched with XLPE in aTSA achieve a lower revision rate compared to shorter stems, long stems with conventional polyethylene, and RTSA when used to treat shoulder OA. In all these cohorts, loosening, not rotator cuff failure was the most common diagnosis for revision

Purpose:. Although short term outcomes of reverse total shoulder arthroplasty (rTSA) have been promising, long-term success may be limited due to complications, including scapular notching. Scapular notching has been explained primarily as a mechanical erosion, however, generation of wear debris may lead to further biologic changes contributing to the severity of scapular notching. Highly cross-linked ultra-high molecular weight polyethylene (UHMWPE) has been used routinely in constrained joint applications such as total hip arthroplasty for reduction of wear debris particles. Although rTSA shares similarity in design conformity, conventional UHMWPE remains the gold standard. Methods:. A commercially available hip simulator was converted to a 12-station rTSA wear simulator. Conventional and highly cross-linked UHMWPE humeral liners were subjected to 5,000,000 cycles of alternating abduction-adduction and flexion-extension loading profiles. Every 250,000 cycles, liners were evaluated with gravimetric wear measurements and test serum was collected for morphological characterization of wear particles. Results:. Highly cross-linked UHMWPE liners (36.5 ± 10.0 mm. 3. /million cycle) exhibited significantly lower volumetric wear rates compared to conventional UHMWPE liners (83.6 ± 20.6 mm3/million cycle) (p < 0.001) (Figure 1). The flexion-extension loading profile exhibited significantly higher wear rates for both conventional (p < 0.001) and highly cross-linked UHMWPE (p < 0.001) compared to the abduction-adduction loading profile. Highly cross-linked wear particles had an equivalent circle diameter significantly smaller than wear particles from conventional UHMWPE (p < 0.001) (Figure 2). Highly cross-linked wear particles were also significantly less fibrillar than conventional UHMWPE particles with respect to particle aspect ratio (p < 0.001) and particle roundness (p < 0.001). Conclusion:. This is the first study to examine the effect of cross-linked PE in a rTSA wear simulation. Highly cross-linked UHMWPE liners significantly reduced UHWMPE wear and subsequent particle generation. More favorable wear properties with the use of highly cross-linked UHMWPE may lead to increased rTSA device longevity and fewer complications but must be weighed against the impact of reduced mechanical properties

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. Highly cross-linked polyethylene has been introduced to decrease osteolysis secondary to polyethylene wear debris generation, but there are few long-term data on revision total hip arthroplasty using highly cross-linked polyethylene liners. The purpose of this study was to report the long-term radiographic and clinical outcomes of a highly cross-linked polyethylene liner in revision total hip arthroplasty. Materials & Methods. We analyzed 63 revision total hip arthoplasties that were performed in 63 patients using a highly cross-linked polyethylene liner between April 2000 and February 2005. Of these, nine died and four were lost to follow-up before the end of the 10-year evaluation. Thus, the final study cohort consisted of 50 patients (50 hips). There were 26 males and 24 females with a mean age at time of revision total hip arthoplasty of 53 years (range, 27–75 years). Mean duration of follow-up was 11 years (range, 10–14 years). Results. Mean Harris hip score improved from 44 points preoperatively to 85 points at final follow-up. No radiographic evidence of osteolysis was found in any hip. One hip required re-revision surgery for acetabular cup loosening at 6.5 years postoperatively. One required re-revision with a constrained liner because of recurrent dislocation. Three sustained deep infections requiring additional surgical procedures. Kaplan-Meier survivorship with an end point of re-revision for any reason was 91.0% and for aseptic cup loosening was 97.9% at 11 years (Figs. 1 and 2). Conclusions. At a minimum of 10 years, the highly cross-linked polyethylene liners showed excellent clinical performance and implant survivorship, and were not associated with osteolysis in our group of patients with revision total hip arthoplasties

Introduction. Technological advances in the processing of polyethylene have led to improved survivorship of total hip arthroplasty. The purpose of this study was to determine if a second generation highly cross-linked polyethylene could improve upon wear rates compared to conventional and first generation cross-linked polyethylene in patients undergoing primary total hip arthroplasty. Methods. Linear and volumetric wear rates of a second generation highly cross-linked polyethylene were evaluated following primary total hip arthroplasty. There were 44 patients with an average age of 68.6 years and mean follow-up of 5.3 years. Patients were evaluated at six weeks, one, two and five years. Wear rates were determined from digitized AP Pelvis radiograph by an independent observer using Martell's software. Acetabular inclination and femoral head size were also evaluated to determine variability in wear rates. Results. The mean linear wear rate for the entire group was 0.015mm/year (±0.055). There was a 64% decrease in linear wear rate when compared to a first generation highly cross-linked polyethylene from the same institution. There was a 90% decrease in wear rate compared to conventional polyethylene. There were no differences in the linear wear rate between the 32mm vs. larger head sizes (36mm and 40mm). However, there was a 30% increase in volumetric wear rate with larger head sizes. The mean wear rate in patients with cup inclination less than 45 degrees was 0.006mm/year compared with 0.024mm/year for those with an inclination greater than 45 degrees. The amount of linear wear was increased by 4 times in patients with a cup inclination of greater than 45 degrees. There was no evidence of any osteolysis in this group of patients. Conclusion. Our data with a mean follow-up of 5.3 years, using a second generation highly cross-linked polyethylene, demonstrates a dramatic decrease in incidents of linear wear compared to conventional polyethylene and first generation highly cross-linked polyethylene (Figure 1). Of concern is the higher volumetric wear rate noted with larger head sizes and increased linear wear rates with cup inclination angles of greater than 45 degrees. Despite improvements in wear rates using a second generation highly cross-linked polyethylene, cup orientation and choice of head size play significant roles in implant survivorship

Purpose. Cross-linking of polyethylene greatly reduces its wear rate in hip simulator studies. We conducted a systematic review and meta-analysis of randomized controlled trials comparing cross-linked to conventional polyethylene liners for total hip arthroplasty to determine if there is a clinical reduction of: 1) wear rates, 2) radiographic osteolysis, and 3) need for total hip revision. Method. A systematic search of MEDLINE, EMBASE, and COCHRANE databases was conducted from inception to May 2010 for all trials involving the use of cross-linked polyethylene for total hip arthroplasty. Eligibility for inclusion in the review was: use of a random allocation of treatments; a treatment arm receiving cross-linked polyethylene and a treatment arm receiving conventional polyethylene for total hip arthroplasty; and use of radiographic wear as an outcome measure. Eligible studies were obtained and read in full by two co-authors who then independently applied the Checklist to Evaluate a Report of a Nonpharmacological Trial to each study. Pooled mean differences were calculated for the following continuous outcomes: bedding-in, linear wear rate, three dimensional linear wear rate, volumetric wear rate, and total linear wear. Pooled risk ratios were calculated for radiographic osteolysis and revision hip arthroplasty. Results. The literature search strategy identified 194 potential studies of which 12 met inclusion criteria. All studies reported a significant reduction in radiographic wear with cross-linked polyethylene. Pooled mean differences for linear wear rate, three dimensional linear wear rate, volumetric wear rate, and total linear wear were all significantly reduced for cross-linked polyethylene. The risk ratio for radiographic osteolysis was 0.40 (95% C.I. of 0.27 to 0.58; p<0.01; I2=0%), favoring cross-linked polyethylene. There were no significant differences in need for revision total hip arthroplasty or amount of bedding-in. Conclusion. Cross-linked polyethylene liners demonstrate reduced radiographic wear and osteolysis up to 8 years after implantation. Follow up is not long enough to show a difference in need for revision total hip arthroplasty. Cross-linked polyethylene should be considered for young patients undergoing total hip arthroplasty

Introduction. The wear performances of polyethylene in THA are influenced at a great extent by the manufacturing process. During the past decade, highly cross-linked materials have been developed with encouraging results in terms of wear, whereas another body of the literature has indicated potential catastrophic failures related to reduced fatigue properties and oxidation due to lipids adsorption and fatigue mechanism. Also, each of the materials available on the market has its own processing characteristics. Therefore, a specific evaluation is necessary for each of them. The aim of this retrospective study was to evaluate the wear properties of metal-back sockets using a first generation highly cross-linked PE in a consecutive series of primary THAs. Materials. Between August 2005 and December 2007, 80 patients (80 hips) with a mean age of 62.7 ± 8.9 years were included. All patients had a 28mm CoCr femoral head articulating with a highly cross-linked insert (Highcross®, Medacta SA) that was 100 Mrads gamma radiated, remelted at 150°C, and ethylene oxide sterilized. The primary criterion for evaluation was linear head penetration measurement using the Martell system, performed by an investigator trained to this technique. Also, steady state wear was calculated. Functional results were evaluated according to WOMAC score. Results. At the minimum of 5-year follow-up, complete data were available for analysis in 67 patients at a mean follow-up of 5.5 years (5.0 to 6.8). At the latest follow-up, the mean femoral head penetration measured 0.07 ± 0.23 mm/year (median of 0.09). The steady state penetration from one year onward representing wear was −0.03 ± 0.25 mm/year (median of 0.01). The WOMAC score significantly increased from 16.5 ± 5.93 preoperatively to 4.12 ± 5.5 at the latest follow-up (Mann-Whitney, p < 0.001). No case of polyethylene insert fracture was recorded, and no hip had signs of periprosthetic osteolysis on the acetabular or femoral side. Discussion and conclusion. The minimal 5-year results of this retrospective study indicate that this highly cross-linked and remelted polyethylene had a low wear rate. The use of highly cross-linked inserts seem to be safe option provided that a minimal thickness of polyethylene is preserved. Longer-term results are needed to warrant that these mid-term data will generate less occurrence of osteolysis and aseptic loosening

Background. Cross-linked polyethylene has much less wear than conventional polyethylene and can used in a more bone conserving thickness of 4 mm. We have used it for hip resurfacing since 2001. Questions/Purposes. This study evaluated the effectiveness of a highly cross-linked polyethylene acetabular component for hip resurfacing in patients under age 50. I posed 5 questions: (1) What are the functional results, (2) What are the complications, (3) What is the 10-year implant survivorship, (4) What is the femoral head penetration into the polyethylene, and (5) What is the bone conservation?. Participants and Methods. There were 160 resurfacing procedures (144 participants) using a 2 piece acetabular shell and a cobalt chromium femoral component (fig. 1). Participants averaged 43 years of age at the time of surgery (range, 23 – 49.5 years) and 70% were women. Inclusion criteria were patients with adequate acetabular bone and a high enough head-neck ratio so that the reconstruction would not violate the femoral neck cortices or medial acetabular wall. The largest cross-linked polyethylene available was 49 mm so only patients with smaller femoral geometries were included. The Harris, WOMAC, and UCLA hip scores were used to assess pain, activity, and function and participants were asked about their satisfaction with the procedure. Digital radiography and computed tomographic scans were used to evaluate femoral head penetration and osteolysis. Removed polyethylene liners were analyzed. Results. The median follow-up was 11.5 years (range, 10 – 14 years). One participant was lost to follow-up and 1 died. The mean Harris Hip Score was 95 and 95% of the participants rated the results of their procedure as excellent. The average UCLA activity score was 8. One patient underwent successful revision surgery for acetabular loosening. Four participants underwent successful revision to a total hip replacement because of femoral neck fracture (2), femoral loosening, or infection. The Kaplan-Meier survivorship was 96%. There were no revisions for polyethylene wear and there were no instances of osteolysis. The medial acetabular wall thickness averaged 7.3 mm (range, 1.5 mm – 14.9 mm). The mean inclination angle was 39°. The mean femoral head penetration was 0.05 mm/year (range, .028 – .09 mm/year). Conclusions. Hip resurfacing with a highly cross-linked polyethylene acetabular component is a reliable procedure at mid-term follow-up. The rate of polyethylene wear is below the osteolytic threshold of .1 mm/yr. The preservation of both acetabular and femoral bone is reasonable even in comparison to thin metal shells available for metal-on-metal resurfacing and total hip replacement. The functional results are comparable to those of metal-on-metal resurfacing without the concerns of a metal bearing couple. The procedures are demanding and patient selection is critical to the success of the procedure. Although long-term follow-up is needed to determine if implant survivorship with highly cross-linked polyethylene acetabular components will equal that of metal-on-metal prostheses, the low rate of femoral head penetration suggests that many years of use in young highly active participants are possible

Introduction. Vitamin-E (VE, dl-α-tocopherol) is a powerful antioxidant for highly cross-linked polyethylene (XLPE). It was previously reported that VE-stabilized XLPE succeeded in retaining no measurable oxidation even after accelerated aging tests combined with cyclic loading or lipid absorption. Thus, VE-stabilized XLPE is nowadays recognized worldwide as one of the new standard materials in total hip arthroplasty (THA). However, the effects of such VE addition on physical behavior of polyethylene remain to be fully elucidated by contrast to the clear statement of its chemical role (i.e., the enhanced oxidation resistance) in the published literature. In this presentation, we shall attempt to provide those missing notations and to explore the microstructural and biomechanical role of VE in XLPE acetabular liner on the molecular scale. Methods. The two different types of XLPE acetabular liners, VE-blended and VE-free (no VE-blended) component (n=3 for each sample), were investigated by means of laser-scanning confocal polarized micro-Raman spectroscopy. In both components, the cross-linking was achieved by electron-beam irradiation with a total dose of 300kGy in vacuum. Raman spectroscopy offers non-destructive, contactless, and high-resolution analyses of polymer morphologies. In this study, we performed an in-depth profiling of crystalline and non-crystalline phase (i.e., amorphous and intermediate phase between crystalline and amorphous regions) percentages and degree of molecular orientation in the above two liners before and after introducing the 10% plastic deformation via uniaxial compression loading at room temperature. These results were also compared to the morphological analyses under the same compression conditions performed on the virgin conventional polyethylene (Virgin liner) without radiation crosslinking as well as VE blending. Results. In the deformed state, Virgin and VE-blended liner showed a pronounced development of the surface crystalline texture. On the other hand, deformation-induced texturing occurred at much less extent in VE-free liner. According to the results of phase percentages, there was no crystallinity change in VE-blended liner by contrast to the marked increase of crystallinity in Virgin and VE-free liner after compression deformation. Alternatively, amorphous-to-intermediate phase transition was confirmed in VE-blended liner. Discussion/Conclusion. We found molecular rearrangement and phase transitions in crystalline and non-crystalline phase as a reconstruction process after plastic deformation in the investigated samples, which can be deeply related to their wear and mechanical properties. The morphological comparisons between Virgin and VE-free liner suggested that the intermolecular cross-linked networks in polyethylene highly restricted the molecular chain mobility as evidenced by few texture evolutions in VE-free liner. On the other hand, the comparisons between VE-free/-blended liner indicated that the presence of VE might promote molecular chain mobility even in the cross-linked structure, resulting in the significant surface texturing. These physical and structural aspects of VE blending would imply the possibility of the increased micromechanical wear through the strain-softening and weakening phenomena due to the molecular reorientation during in-vivo service. However, in other words, wear resistance of VE-blended liner might be further maximized by the more rigid control of molecular movements

Introduction. In order to reduce polyethylene wear and incidence of osteolysis, and improve the long-term durability of total hip arthroplasty (THA), highly cross-linked polyethylene was introduced for clinical use in substitution for conventional polyethylene. We performed 35 cementless THAs between December 2000 and February 2002, and cross-linked polyethylene was used in these surgeries. The purpose of this study is to research linear wear rate of these hips, and to find the risk factor for high wear rate. Patients and Methods. 32 hips (26 patients) among the 35 could be evaluated at more than 10 years postoperatively. One hip required reoperations due to infection at 8 years postoperatively, and two were lost to followup in less than 10 years. There were 2 males and 24 females, and the observation period was 11.4 years in average (range 10?13 years). The age at the time of operation was 49.4 years in average (range 24?67 years), and body mass index was 22.4 in average (15?34). We used AHFIX total hip prostheses (KYOCERA Medical Corporation) for both acetabular and femoral replacement, and 22 mm Zirconia head was used in all cases. The median cup diameter was 46 mm (range 42?50). Osteolysis and loosening of the implant was evaluated on the anteroposterior radiograph of the hip. Using software for wear measurement (Hip Analysis Suite), linear wear rate and cup inclination angle were measured. Correlation between linear wear rate and age, BMI, cup inclination angle, and cup diameter was investigated using correlation coefficient. Results. Osteolysis and loosening were not found in any cases on the final radiograph. Cup inclination angle was 44.7±4.6 degree, and linear wear rate was 0.034±0.019 mm/y in average. No statistical correlation was found between linear wear rate and age, BMI, cup inclination angle, and cup diameter. Discussion. Long-term clinical performance of cross-linked polyethylene is rarely reported, although it is considered to have excellent wear resistance, and reduces the risk of osteolysis and loosening. Linear wear rate in this series was relatively low, and osteolysis and loosening were not observed. It was demonstrated that cross-linked polyethylene had excellent wear resistance when used in combination with 22 mm zirconia head, and observed for more than 10 years

Polyethylene wear is the main factor leading to periprosthetic osteolysis, aseptic loosening and long-term failure of the implant in total hip arthroplasty (THA). The present study compares the clinical and radiographic outcomes of 88 patients who underwent primary THA with either conventional polyethylene or cross-linked polyethylene (XLPE) from the same manufacturer (Zimmer®, Warsaw, IN, USA). There were no significant differences between the two sub-populations in average age, gender, side affected and prosthetic stem and cup size. The average follow-up was 104 months, ranging from 55 to 131 months: to our knowledge this is the longest follow-up for this particular insert. Clinical and x-ray evaluation was obtained at 1, 3, 6 and 12 months and yearly thereafter. Our results showed that cross-linked polyethylene has a significantly greater wear reduction than that of standard polyethylene

Background. The advent of highly cross-linked polyethylene has resulted in improved wear rates and reduced osteolysis with at least intermediate follow-up when compared to conventional polyethylene. However, the role of alternative femoral head bearing materials in decreasing wear is less clear. The purpose of this study was to determine in-vivo polyethylene wear rates across ceramic, Oxinium, and cobalt chrome femoral head articulations. Methods. A review of our institutional database was performed to identify patients who underwent a total hip arthroplasty using either ceramic or oxidized zirconium (Oxinium) femoral head components on highly cross-linked polyethylene between 2008 and 2011. These patients were then matched on implant type, age, sex and BMI with patients who had a cobalt chrome bearing implant during the same time period. RSA analysis was performed using the center index method to measure femoral head penetration (polyethylene wear). Secondary quality of life outcomes were collected using WOMAC and HHS Scores. Paired analyses were performed to detect differences in wear rate (mm/year) between the cobalt chrome cohorts and their matched ceramic and Oxinium cohorts. Additional independent group comparisons were performed by analysis of variance with the control groups collapsed to determine wear rate differences between all three cohorts. Results. A total of 75 patients underwent RSA analysis. 20 patients with a ceramic femoral head component and 16 patients with an Oxinium femoral head component along with the same number of matched patients with cobalt chrome femoral head component were included in the analysis. The time in vivo for the Oxinium (5.17 +/− 0.96 years), Oxinium matched cohort (5.13 +/− 0.72 years), ceramic (5.15 +/− 0.76 years) and ceramic matched cohort (5.36 +/− 0.63 years) were comparable. The demographics of all bearing surface cohorts were similar. The paired comparison between the Oxinium and cobalt chrome cohorts (0.32 vs. 0.28 mm/year, p=0.427) and ceramic vs cobalt chrome cohorts (0.28 vs. 0.22 mm/year, p=0.202) did not demonstrate a significant difference in wear rate. The independent groups analysis revealed a significantly higher wear rate of Oxinium (0.33 mm/year) compared to cobalt chrome (0.24 mm/year) (p = 0. 038). There were no differences in HHS and WOMAC scores between the Oxinium and cobalt chrome cohorts (HHS: p = 0.71, WOMAC: p=0.08) or the ceramic and cobalt chrome cohorts (HHS: p=0.15, WOMAC: p =023). Conclusion. This study presents evidence of a greater wear rate (mm/year) of the Oxinium femoral head component compared to a cobalt chrome femoral head component. This difference was not demonstrated in the ceramic femoral head component. Despite this difference, there were no clinical differences as measured by the HHS and WOMAC. Future research should focus on factors that may contribute to the higher wear rate seen in the Oxinium cohort. Level of Evidence – Level II. Disclosures - Institutional support provided by Depuy, Stryker, and Smith and Nephew

Introduction. Inradiation cross-linked and melted ultrahigh molecular weight polyethylene (UHMWPE) total joint implants, the oxidation potential is afforded to the material by by post-irradiation melting. The resulting cross-linked UHMWPE does not contain detectable free radicals at the time of implantation and was expected to be resistant against oxidation for the lifetime of the implants. Recently, analysis of long-term retrievals revealed detectable oxidation in irradiated and melted UHMWPEs, suggesting the presence of oxidation mechanisms initiated by mechanisms other than those involving the free radicals at the time of implantation. However, the effect of oxidation on these materials was not well studied. We determined the effects of in vitro oxidation on the wear and mechanical properties of irradiated and melted UHMWPEs. Materials and Methods. Medical grade slab compression molded UHMWPE (GUR1050) was irradiated using 10, 50, 75, 100, 120 or 150 kGy. The irradiated and melted UHMWPEs were accelerated aged at 70°C for 2, 3, 4, 6 and 8 weeks at 5 atm of oxygen. Oxidation profiles were determined by first microtoming 150 μm cross sections; these were then extracted by boiling hexane for 16 hours and vacuum dried for 24 hours. They were then analyzed on an infrared microscope as a function of depth away from the surface. An oxidation index was calculated per ASTM 2102 as the ratio of the area under the carbonyl peak at 1740 cm-1 to the area under the crystalline polyethylene 1895 cm-1 peak. 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. Results and Discussion. Oxidation increased as a function of aging duration for all UHMWPE samples. The cross-link density decreased non-linearly with increasing oxidation and the wear rate increased non-linearly. The dependence of wear on cross-link density was different for freshly irradiated, unoxidized samples in contrast to aged and oxidized samples (Figure 1). The elongation at break and the ultimate tensile strength decreased with increasing oxidation (Figure 2) and the modulus increased with increasing oxidation. There was an increase in the oxidation rates and oxidation levels of irradiated and melted UHMWPEs with increasing radiation dose (Figure 1), which suggested that regardless of the presence of residual free radicals, increased cross-linking made the material more prone to oxidation and oxidative degradation. The wear rate was not very sensitive to oxidation with an increase only observed at an oxidation index of 1 (Figure 3), suggesting a significant level of degradation and oxidative damage only at this level of oxidation. In contrast, the tensile strength and elongation-at-break were very sensitive to oxidation, showing severe degradation at low oxidation levels. Significance. This is the first study exploring the effects of simulated oxidation in irradiated and melted UHMWPEs without detectable free radicals known to cause oxidation. We have shown that when oxidation occurs, severe degradation may occur in irradiated and melted UHMWPEs

Introduction:. The management strategy regarding optimally addressing polyethylene wear with a well-fixed acetabular shell remains controversial. The purpose of the present study was to document outcomes of cementation of a highly cross-linked polyethylene (PE) liner into a well-fixed acetabular metal shell in 36 hips. Materials & Methods:. We identified 37 patients (39 hips) who had undergone revision THA by cementation of a highly cross-linked PE liner into a well-fixed metal shell between June 2004 and April 2009. Of these patients, one (1 hip) died before the end of the 3-year evaluation and another was lost to follow-up. Thus, the study cohort consisted of 35 patients (36 hips). There were 23 males (24 hips) and 12 female (12 hips) patients with a mean age at time of revision surgery of 57.6 years (range, 38–79 years). All operations were performed by a single surgeon using only one type of liner. Clinical and radiographic evaluation was performed at a mean of 6.1 years (range, 3–8 years) postoperatively. Results:. Mean Harris hip score improved from 58.1 (range, 39–81 points) preoperatively to 91.3 (range, 45–100 points) postoperatively (p < 0.001). Of the 36 hips, 29 (80.1%) had an excellent result, 6 (16.7%) a good result, and 1 (2.8%) a poor result. The patient with a poor clinical result had aseptic cup loosening with a greater trochanteric fracture at 2 years postoperatively and was treated by acetabular cup revision and internal fixation of the fracture. However, no case of PE liner dislodgement from the cement or of dissociation of the PE-cement construct from the metal shell was encountered. At last follow-up, no new osteolytic lesion was identified and previous osteolytic lesions filled with bone graft were completely or partially incorporated. Other complications included 1 incomplete peroneal nerve palsy and 1 dislocation. Conclusions:. The results of this study and previous reports demonstrated that cementation of highly cross-linked PE liner into well-fixed metal shell could provide good midterm durability

The advent of highly cross-linked polyethylene has resulted in improved wear rates and reduced osteolysis with at least intermediate follow-up when compared to conventional polyethylene. However, the role of alternative femoral head bearing materials in decreasing wear is less clear. The purpose of this study was to determine in-vivo polyethylene wear rates across ceramic, Oxinium, and cobalt chrome femoral head articulations. A review of our institutional database was performed to identify patients who underwent a total hip arthroplasty using either ceramic or oxidised zirconium (Oxinium) femoral head components on highly cross-linked polyethylene between 2008 and 2011. These patients were then matched on implant type, age, sex and BMI with patients who had a cobalt chrome bearing implant during the same time period. RSA analysis was performed using the centre index method to measure femoral head penetration (polyethylene wear). Secondary quality of life outcomes were collected using WOMAC and HHS Scores. Paired analyses were performed to detect differences in wear rate (mm/year) between the cobalt chrome cohorts and their matched ceramic and Oxinium cohorts. Additional independent group comparisons were performed by analysis of variance with the control groups collapsed to determine wear rate differences between all three cohorts. A total of 68 patients underwent RSA analysis. Fifteen patients with a ceramic femoral head component and 14 patients with an Oxinium femoral head component along with the same number of matched patients with cobalt chrome femoral head component were included in the analysis. The time in vivo for the Oxinium (5.17 +/− 0.96 years), Oxinium matched cohort (5.13 +/− 0.72 years), ceramic (5.15 +/− 0.76 years) and ceramic matched cohort (5.36 +/− 0.63 years) were comparable. The demographics of all bearing surface cohorts were similar. The paired comparison between the Oxinium and cobalt chrome cohorts (0.33 vs. 0.29 mm/year, p=0.284) and ceramic vs cobalt chrome cohorts (0.26 vs. 0.20 mm/year, p=0.137) did not demonstrate a significant difference in wear rate. The independent groups analysis revealed a significantly higher wear rate of Oxinium (0.33 mm/year) compared to cobalt chrome (0.24 mm/year) (p = 0. 038). There were no differences in HHS and WOMAC scores between the Oxinium and cobalt chrome cohorts (HHS: p = 0.71, WOMAC: p=0.08) or the ceramic and cobalt chrome cohorts (HHS: p=0.15, WOMAC: p=023). This study presents evidence of a greater wear rate (mm/year) of the Oxinium femoral head component compared to a cobalt chrome femoral head component. This difference was not demonstrated in the ceramic femoral head component. Despite this difference, there were no clinical differences as measured by the HHS and WOMAC. Future research should focus on factors that may contribute to the higher wear rate seen in the Oxinium cohort

Introduction. In vitro findings (Bladed CL et al. ORS 2011 and J Biomed Mater Res B Appl Biomater, 2012) have suggested that UHMWPE wear particles containing vitamin-E (VE) may have reduced functional biologic activity and decreased osteolytic potential. Currently, there is no in vivo data determining the effects of wear debris from this new generation of implants. In this study we hypothesized that particles from VE-stabilized, radiation cross-linked UHMWPE (VE-UHMWPE) would cause reduced levels of osteolysis in a murine calvarial bone model when compared to virgin gamma irradiated cross-linked UHMWPE. Methods. Study groups: 1). Radiation cross-linked VE-UHMWPE, 0.8% by weight, diffused after 100 kGy; 2). Radiation cross-linked virgin UHMWPE (virgin UHMWPE); 3). Shams. Particle generation and implantation: UHMWPE was sent to Bioengineering Solutions for particle generation. After IACUC approval, C57BL/6 mice (n = 12 for each group) received 3 mg of particulate debris overlying the calvarium and euthanized after 10 days. Micro-CT scans: Performed using an X-Tek-HMX-ST-225 with 70 kV voltage and 70 μA current. Topographical Grading Scale: Each calvarial bone was blindly scored with the following scale: 0 = No osteolysis, defined as intact bone; 1 = Minimal osteolysis, affecting 1/3 or less of the bone area; 2 = Moderate osteolysis, affecting at least 2/3 of the bone area; 3 = Severe osteolysis, defined as completely osteolytic bone. Histology H&E and TRAP staining was performed. Statistical Analysis: Inter-rater analysis was performed using Cohen's kappa analysis. Inter-rater coefficient >0.65 was considered as high inter-rater agreement. Comparison between groups was made using one-way ANOVA with post hoc Bonferroni correction for multiple comparisons. Correlations are reported as Spearman's rho. A p-value<0.05 was considered statistically significant. Results. More than 83% of the VE-UHMWPE and more than 85% of the virgin UHMWPE particles measured less than 1 μm in mean particle size. There was a statistically significant greater level of osteolysis visualized on the topographical grading scale in calvaria implanted with virgin UHMWPE wear particles. The micro-CT findings were confirmed histologically (Fig. 1). A greater amount of inflammatory tissue overlaying the calvaria was observed in the virgin UHMWPE group when compared to both shams and VE-UHMWPE groups. Post hoc analysis revealed significant difference between VE-UHMWPE and virgin UHMWPE for the topographical osteolysis grading score (p = 0.002) but no difference in osteoclast count (p = 0.293). Discussion/Conclusion. This is the first in vivo study reporting the effects of clinically-relevant UHMWPE particles generated from a VE-UHMWPE implant that is in current clinical use. These results suggest that VE-UHMWPE particles have reduced osteolysis potential in vivo when compared to virgin, highly cross-linked UHMWPE in a murine calvarial bone model

Introduction. Radiation cross-linked UHMWPEs were developed to address osteolysis-induced joint arthroplasty failure by improving wear resistance and reducing associated particulate debris. Introduced clinically fifteen years ago, they are the primary bearing surface in use with excellent clinical outcomes and wear resistance. First generation materials sought to maintain oxidative stability by reducing or eliminating free radicals through thermal treatments, while second generation aimed to further balance oxidation resistance and improve mechanical properties through sequential irradiation and annealing or the incorporation of an antioxidant. Recent reports have identified lipid absorption and cyclic loading as potential in vivo oxidation-inducing mechanisms. In this on-going retrieval study, we report on the current status of oxidative stability in these two generations of UHMWPE bearings. Materials & Methods. Six types of highly cross-linked UHMWPE hip and knee bearings (Table 1) were surgically-retrieved and collected under IRB approval. Standard material analysis was performed on cross-sections of loaded and unloaded bearing surfaces of the components. Thin sections (150 µm thickness) were extracted in boiling hexanes under reflux for 16 hours followed by vacuum drying for 24 hours. FTIR was used to evaluate oxidation and calculated from post-hexane absorbance spectra by normalizing the area under 1740 cm. −1. (1680–1780 cm. −1. ) to the area under 1370 cm. −1. (1330–1390 cm. −1. ), per ASTM F2102-13. Gravimetric swelling of regional cross-sectional blocks (1–2 mm. 3. ) for 2 hours in 130°C boiling xylenes was used to assess cross-link density, per ASTM 2214. Results. Irradiated and melted retrievals all showed detectable (OI>0.1) subsurface oxidation in the articular surface of retrievals (Fig 1). Behavior between materials types differed: 47% of Longevity acetabular liners (MOI=0.14±0.19; Table 2) showed detectable oxidation as opposed to 19% in Marathon retrievals (MOI=0.07±0.08), both with comparable sample sizes and in vivo durations. We saw no concomitant change in the cross-link density, except in one case where OI>1.0. Sequentially irradiated and annealed (X3) retrievals showed the highest incidence of detectable oxidation (76%), highest average maximum oxidation (0.35±0.39), signs of oxidative embrittlement and a loss of cross-link density which correlated with decreasing oxidation (R. 2. =0.30; p-value=0.000016). Oxidation was in both loading regions of X3 knees, while Prolong knees were observed to have oxidation solely at the articular surface. Antioxidant-stabilized E1 retrievals showed low detectable oxidation values (MOI=0.11±0.03) in both regions without change in cross-link density. Discussion. Throughout the first decade of service, irradiated and melted UHMWPE retrievals showed subsurface oxidation, but with little to no impact on material properties. Detectable oxidation and embrittlement were identified in sequentially irradiated and annealed retrievals at shorter time points. Residual free radicals and pre-implantation shelf oxidation, as a result of air permeable packaging, are potential factors behind the higher oxidation at earlier time points. Antioxidant-stabilized retrievals showed no change in their oxidative behavior with the lowest oxidation and variability in this very short 0–3 year follow-up. Continued analysis is needed to understand the second decade of behavior along with longer-term follow-up with patients to understand if these changes could affect clinical outcomes through oxidation-induced changes in material or mechanical properties

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

Irradiated, thermally stabilized, highly cross-linked UHMWPE bearings have demonstrated superior wear performance and improved in vitro oxidation resistance compared with terminally gamma-sterilized bearings, yet retrieval analysis reveals unanticipated in vivo oxidation in these materials. There has been little evidence to date that oxidation in these materials is leading to degradation of mechanical properties, but since oxidation has previously been shown to cause chain scission in other materials, there is the potential for oxidation to cause decreased molecular weight and crosslink density. The aim of this study was to determine whether measured in vivo oxidation in highly cross-linked tibial bearings corresponds with a decreasing crosslink density. Retrieval analysis for three tibial bearing materials reveals that crosslink density is decreasing following in vivo duration, and that the change in crosslink density is strongly correlated with oxidation. The results suggest that oxidation in highly cross-linked materials is causing chain scissions that may impact the material properties. If the correlation between oxidation and duration continues, then as longer duration, more oxidized devices are retrieved there is a potential for measurable mechanical property changes