Introduction. Vitamin-E has been introduced into highly-crosslinked polyethylene liners to reduce the oxidation potential of the material while maintaining low wear rates. However, little has been reported on adverse testing of the material with one test on diffused vitamin-E polyethylene [1] and no adverse tests of vitamin-E blended polyethylene reported. Adverse testing of crosslinked polyethylene has focused on the use of large diameters, the incorporation of third body particles, roughening of the counterface or severe activity [2–4]. This investigation considers the wear of vitamin-E blended highly-crosslinked polyethylene under standard and adverse conditions articulating against uncoated and chromium nitride (CrN) coated metal heads. Methods. Seven metal heads were tested against prototype ϕ52 mm 0.1 wt% vitamin-E blended highly-crosslinked polyethylene liners (Corin, UK). Three heads remained as cast double heat treated metal (MoP) while four, of similar metallurgy, were coated with CrN via electron beam physical vapour deposition (CrNoP) (Tecvac, UK) and polished to a similar surface finish. Tests were conducted for 5 million cycles (mc) under conditions described in ISO 14242–3: 2009. Alumina particles (mean size 2.4 μm) at concentrations of 0.15 mg/mL were added to the lubricant for 1 mc to consider the effect of severe head damage. Testing continued for a further 1 mc without the presence of the particles and then 3 jogging intervals (14,400 cycles each) were conducted at slow, medium and fast speeds [3]. Wear volume was determined gravimetrically for the heads and liners and fluid collected throughout the testing was analysed for cobalt concentration using graphite furnace atomic absorption spectroscopy. Results. Wear rates of the liners were similar under standard conditions for both combinations (Figure 1). The introduction of alumina particles created a 17 fold increase in the wear of the MoP liners and increased head wear and cobalt release rates (Figure 2). Damage to the uncoated metal heads was observed as the average surface roughness Ra, of the uncoated heads was rougher (0.018 μm) than the coated heads (0.007 μm). The CrNoP bearings showed a small increase in liner and head wear but not cobalt release. The removal of the alumina particles saw the CrNoP bearings recover in liner and head wear while wear of the liners and cobalt release remained elevated in MoP bearings. Jogging did not significantly increase the wear of the MoP and CrNoP liners. Discussion. Under standard testing the use of large diameter MoP appears low wearing, but adverse conditions can increase the polyethylene wear and cobalt release. During 3. rd. body testing higher cobalt levels than those reported in adverse metal-on-metal tests [5] were observed, although this test was extreme and not clinically relevant. CrN coating the heads showed improved wear resistance and reduced cobalt release during all forms of adverse testing

The benefits of HXLPE in total knee arthroplasty (TKA) have not been as evident as total hip arthroplasty (THA). A systematic review and meta-analysis to assess the impact of highly-crosslinked polyethylene (HXLPE) on TKA outcomes compared to conventional polyethylene (CPE) is described. All studies comparing HXLPE with CPE for primary TKA were included for analysis. The minimum dataset included revision rates, indication for revision, aseptic component loosening and follow-up time. The primary outcome variables were all-cause revision, aseptic revision, revision for loosening, radiographic component loosening, osteolysis and incidence of radiolucent lines. Secondary outcome measures included postoperative functional knee scores. A random-effects meta-analysis allowing for all missing data was performed for all primary outcome variables. Six studies met the inclusion criteria. In total, there were 2,234 knees (1,105 HXLPE and 1,129 CPE). The combined mean follow-up for all studies was 6 years. The aseptic revision rate in the HXLPE group was 1.02% compared to 1.97% in the CPE group. There was no difference in the rate of all-cause revision (p = 0.131), aseptic revision (p = 0.298) or revision for component loosening (p = 0.206) between the two groups. Radiographic loosening (p = 0.200), radiolucent lines (p = 0.123) and osteolysis (p = 0.604) was similar between both groups. Functional outcomes were similar between groups. The use of HXLPE in TKA yields similar results for clinical and radiographic outcomes when compared to CPE at midterm follow-up. HXLPE does not confer the same advantages to TKA as seen in THA

The purpose of this investigation is to assess the rate of wear the effect once the “bedding in period”/ poly creep had been eliminated. Creep is the visco-elastic deformation that polyethylene exhibits in the first 6–12 weeks. We also assessed the wear pattern of four different bearing couples in total hip arthroplasty (THA): cobalt-chrome (CoCr) versus oxidized zirconium (OxZir) femoral heads with ultra-high molecular weight polyethylene (UHMWPE) versus highly-crosslinked polyethylene (XLPE) acetabular liners. This was a randomized control study involving 92 patients undergoing THA. They were randomized to one of four bearing couples: (1) CoCr/UHMWPE (n= 23), (2) OxZir/UHMWPE (n=21), (3) CoCr/XLPE (n=24), (4) OxZir/XLPE (n=24). Patients underwent a posterior approach from one of three surgeons involved in the study. All patients received a porous-coated cementless acetabular shell and a cylindrical proximally coated stem with 28 mm femoral heads. Each patient was reviewed clinically and radiographically at six weeks, three and 12 months, two, five and 10 years after surgery. Standardized anteroposterior and lateral radiographs were taken. All polyethylene wear was measured by an independent blinded reviewer. Linear and volumetric wear rates were measured on radiographs using a validated computer software (Polyware Rev. 5). Creep was defined as the wear at 6 or 12 weeks, depending on if there was a more than 10% difference between both measurements. If a greater than 10% difference occurred than the later period's wear would be defined as creep. 72 hips were included in analysis after exclusion of seven revisions, three deaths and 10 losses to follow-up. The annual linear wear rates (in mm/y) at 10 years were (1) 0.249, (2) 0.250, (3) 0.074 and (4) 0.050. After adjusting for creep these rates become were (1) 0.181, (2) 0.142, (3) 0.040 and (4) 0.023. There is statistical differences between raw and adjusted linear wear rates for all bearing couples. The percentage of the radiographically measured wear at 10 years due to creep is (1) 30% (2) 44%, (3) 58.5% and (4) 51.5% with significant differences in couples with XLPE versus those with UHMWPE. There was no significant correlation between age, gender, cup size, tilt, planar anteversion and the linear or volumetric wear rates. The linear wear rate of both UHMWPE and XLPE are even lower thxdsxzan previously described when creep is factored out. XLPE has again demonstrated far superior linear wear rates at 10 years than UHMWPE. There were no significant differences in wear rate at 10 years between CoCr and OxZir, this may be due to an underpowered study. XLPE exhibits proportionally more creep than UHMWPE within the first 6–12 weeks and accounts for more of the total wear at 10 years as measured radiographically at the end period

Total hip arthroplasty (THA) is one of the most successful and commonly performed surgical interventions worldwide. Based on registry data, at one-year post THA, implant survivorship is nearly 100% and patient satisfaction is 90%. A novel, porous coated acetabular implant was introduced in Europe and Australia in 2007. Several years after its introduction, warnings were issued for the system when used with metal-on-metal bearings due to adverse local tissue reaction, with one study reporting a 24% failure rate (Dramis et al. 2014). A subsequent 2018 study by Teoh et al. showed that the acetabular system had a survival rate of 98.9% at five years when used with conventional polyethylene or ceramic bearing surfaces. The current study was conducted to determine the safety and effectiveness of the acetabular system using standard highly-crosslinked polyethylene (XLPE) and ceramic liners at five-year follow-up. Our hypothesis was that the acetabular system would exhibit survivorship comparable to other acetabular components on the market at five-year follow-up. A prospective, non-randomized study was conducted from February 2009 to June 2017 at eight sites in Canada and the USA. One hundred fifty-five hips were enrolled and 148 hips analyzed after THA indicated for degenerative arthritis. At five-year follow-up, 103 subjects remained for final analysis. All patients received a zero, three, or multi-hole R3 acetabular shell with Stiktite porous coating (Smith & Nephew, Inc., Memphis, TN, USA). Standard THA surgical techniques were employed, with surgical approach and either of a XLPE or ceramic bearing surface chosen at the discretion of the surgeon. The primary outcome was revision at five-years post-op with secondary outcomes including the Harris Hip Score (HHS), Hip Disability and Osteoarthritis Outcome Score (HOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), radiographic analysis, and post-operative adverse events. Data and outcomes were analyzed using summary statistics with 95% confidence intervals, t-tests, and Wilcoxon Rank tests. At five-year follow-up the overall success rate was 97.14% (95% CI: 91.88–100). When analyzed by liner type, the success rate was 96.81% (95% CI: 90.96–99.34) for polyethylene (n=94) and 100% (95% CI: 71.51–100) for ceramic (n=11), with no significant difference between either liner type (p=1). There were three revisions during the study (1.9%), two for femoral stem revision post fracture, and one for deep infection. The HHS (51.36 pre-op, 94.50 five-year), all 5 HOOS sub-scales, and WOMAC (40.9 pre-op, 89.13 five-year) scores all significantly improved (p < 0 .001) over baseline scores at all follow-up points. One (0.7%) subject met the criteria for radiographic failure at one-year post-op but did not require revision. Six (1.8%) of the reported adverse events were considered related to the study device, including four cases of squeaking, one bursitis, and one femur fracture. Results from this five-year, multicenter, prospective study indicate good survivorship for this novel, porous coated acetabular system. The overall survivorship of 97.14% at five-year follow-up is comparable to that reported for similar acetabular components and aligns with previous analyses (Teoh et al. 2018)

Recent issues related to trunionosis have created a new paradigm in choosing femoral head material in total hip arthroplasty. While many consider highly-crosslinked polyethylene (XLPE) to be the gold standard currently in acetabular liner bearing surface, the debate remains whether metal or ceramic heads are best paired with XLPE. Wear characteristics are similar within an order of magnitude when comparing cobalt chrome femoral heads with ceramic when used in combination with XLPE. Therefore, discernable differences between the two femoral head materials with respect to outcomes would be the result of other biomechanical factors. Notably the fretting and corrosion of metal heads at the modular taper of femoral components is a serious concern and represents a significant deterrent when considering this material. The fretting corrosion that occurs with metal femoral heads has recently been well documented in multiple reports, and can be associated with adverse local tissue reactions necessitating revision hip arthroplasty. Frictional torque has recently been implicated in taper corrosion at modular junctions. In a recent simulated in vivo study, large diameter CoCr femoral heads were associated with increased frictional torque compared to smaller metal heads, supporting recent taper corrosion retrieval studies. In one recent series, a 1.1% incidence of head-neck taper corrosion with a metal head was reported and the authors recommended use of ceramic femoral heads. The notable downside of ceramic femoral heads is the implant cost and potential for fracture. However, the incidence of femoral head fracture with the newer mixed delta ceramic heads is exceptionally low and infrequent (rate 1.7 per 100,000). Furthermore, the incidence of taper corrosion is negligible with ceramic heads, making it the bearing couple of choice among many surgeons in combination with XLPE

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:. Although commonly used, the clinical performance of highly crosslinked polyethylene in total knee arthroplasty (TKA) remains unknown and concerns exist regarding fatigue resistance and oxidation, particularly in posterior-stabilized (PS) designs. The purpose of this study is to compare highly crosslinked and conventional polyethylene in a PS TKA design at a minimum of 5-years. Methods:. A prospective cohort study of 114 consecutive TKAs in 83 patients was performed as a subset of a multi-center prospective study. All TKAs utilized an identical PS design. Conventional polyethylene inserts were used in 50 knees and second-generation highly cross-linked polythethylene inserts were implanted in 64 TKAs. All patients were followed with clinical outcome measures (Short-Form 36, Knee Society Scores, WOMAC and LEAS) and radiographically for a minimum of 5 years. Results:. The mean age of the highly cross-linked polyethylene group was 4 years less than the conventional group (p = 0.03). There was no difference in BMI (p = 0.3) or preoperative outcome measures between groups with numbers available. Seven patients died or were lost to follow up and one underwent revision for infection at 3 months postoperatively. 103 TKAs obtained minimum 5-year follow up. Mean Knee Society Scores were 12 points higher (p = 0.01) and 14 points higher (p = 0.005) in the physical function subset of the SF-36 in the highly cross-liked polyethylene group. There was no difference in the other outcome measures with the numbers available. There was no radiographic osteolysis or mechanical failures related to the tibial polyethylene in either group. Conclusion:. Mechanical failure or radiographic osteolysis was not observed with either conventional or highly cross-linked polyethylene in this PS TKA design at mid-term follow up. To our knowledge, this is the first minimum 5-year follow-up of highly cross-linked polyethylene in a posterior-stabilized design. While the results support comparative safety, longer-term follow-up is warranted to determine if wear resistance and mechanical properties of highly crosslinked polyethylene are maintained. Significance: Concerns regarding early fatigue failure and mechanical complications related to the PS post-cam articulation of highly-crosslinked polyethylene in TKR were not substantiated at a minimum of 5 years clinical followup in this prospective cohort study. Highly cross-linked polyethylene demonstrated clinical equivalency compared to conventional polyethylene, even when used in a younger and presumably more active patient group

Introduction. Modular femoral necks have shown promising clinical results in total hip arthroplasty (THA) to optimize offset, rotation, and leg length. Given the wide variety of proximal femoral morphology, fine-tuning these kinematic parameters can help decrease femoroacetabular impingement, decrease wear rates and help prevent dislocations. Yet, additional implant junctions introduce additional mechanisms of failure. We present two patients who developed an abnormal soft tissue reaction consistent with a metal hypersensitivity reaction at a modular femoral neck/stem junction requiring revision arthroplasty. Methods. Two patients underwent THA for primary osteoarthritis with the same series of components: 50 mm shell, a 36 mm highly-crosslinked polyethylene liner, uncemented titanium alloy modular stem with a 130 degree Cobalt Chromium (CoCr) modular femoral neck, and 36 mm CoCr head with a +5-mm offset. Patient 1 was a 63 year-old female who had an uneventful post-operative course but presented seven months later with progressive pain in the left hip. Patient 2 was an 80 year-old female who did well post-operatively, but presented with limp and persistent pain at 10 months post-op. An initial evaluation of a painful THA to rule out aseptic loosening, infection, mal-positioning, loosening and osteolysis included radiographs, lab work (CBC, ESR, CRP, Cobalt & Chromium levels) and Metal Artifact Reduction Sequence (MARS) MRI. Results. Elevated ion levels (Table 1) and Metal Artifact Reduction Sequence (MARS) MRI were consistent with an abnormal soft tissue reaction. A histological analysis of operative specimens displayed extensive necrosis and lymphocytosis, consistent with the diagnosis of metal hypersensitivity reactions (MHSR). Both patients underwent debridement and revision femoral arthroplasty with non-modular counterparts of the original femoral implant and have been asymptomatic post-operatively at greater than 1 year follow-up. Discussion. MHSR reactions are primarily described in the setting of metal on metal articulations of the head and acetabulum in THA and hip resurfacing. These reactions have not been reported at the modular neck/stem junction. Although modular necks show promise in THA, the advantages of increased component modularity must be carefully weighed against the risks of mechanical wear and subsequent MHSR and/or component failure