ZrN-multilayer coating is clinically well established in total knee arthroplasty [1-3] and has demonstrated significant reduction in polyethylene wear and metal ion release [4,5]. The goal of our study was to analyze the biotribological behaviour of the ZrN-multilayer coating on a polished cobalt-chromium cemented hip stem. CoCr28Mo6 alloy hip stems with ZrN-multilayer coating (CoreHip®AS) were tested versus an un-coated version. In a worst-case-scenario the stems with ceramic heads have been tested in bovine serum in a severe cement interface debonding condition under a cyclic load of 3,875 N for 15 million cycles. After 1, 3, 5, 10 & 15 million cycles the surface texture was analysed by scanning-electron-microscopy (SEM) and energy-dispersive x-ray (EDX). Metal ion concentration of Co,Cr,Mo was measured by inductively coupled plasma mass spectroscopy (ICP-MS) after each test interval. Based on SEM/EDX analysis, it has been demonstrated that the ZrN-multilayer coating keeps his integrity over 15 million cycles of severe stem cemented interface debonding without any exposure of the CoCr28Mo6 substrate. The ZrN-multilayer coated polished cobalt-chromium cemented hip stem has shown a reduction of Co & Cr metal ion release by two orders of a magnitude, even under severe stem debonding and high interface micro-motion conditions. ZrN-multilayer coating on polished cobalt-chromium cemented hip stems might be a suitable option for further minimisation of Co & Cr metal ion release in total hip arthroplasty. Clinical evidence has to be proven during the next years

A concern of metal on metal hip resurfacing arthroplasty is long term exposure to Cobalt (Co) and Chromium (CR) wear debris from the bearing. This study compares whole blood metal ion levels from patients drawn at one-year following Birmingham Hip Resurfacing (BHR) to levels taken at a minimum 10-year follow-up. A retrospective chart review was conducted to identify all patients who underwent a BHR for osteoarthritis with a minimum 10-year follow-up. Whole blood metal ion levels were drawn at final follow-up in June 2019. These results were compared to values from patients with one-year metal ion levels. Of the 211 patients who received a BHR, 71 patients (54 males and 17 females) had long term metal ion levels assessed (mean follow-up 12.7 +/− 1.4 years). The mean Co and Cr levels for patients with unilateral BHRs (43 males and 13 females) were 3.12 ± 6.31 ug/L and 2.62 ± 2.69 ug/L, respectively, and 2.78 ± 1.02 ug/L and 1.83 ± 0.65 ug/L for patients with bilateral BHRs (11 males and 4 females). Thirty-five patients (27 male and 8 female) had metal-ion levels tested at one-year postoperatively. The mean changes in Co and Cr levels were 2.29 ug/l (p = 0.0919) and 0.57 (p = 0.1612), respectively, at one year compared to long-term. These changes were not statistically significant. This study reveals that whole blood metal ion levels do not change significantly when comparing one-year and ten-year Co and Cr levels. These ion levels appear to reach a steady state at one year. Our results also suggest that regular metal-ion testing as per current Medicines and Healthcare products Regulatory Agency (MHRA) guidelines may be impractical for asymptomatic patients. Metal-ion levels, in and of themselves, may in fact possess little utility in determining the risk of failure and should be paired with radiographic and clinical findings to determine the need for revision

Introduction. Systemic metal ion monitoring (Co;Cr) has proven to be a useful screening tool for implant performance to detect failure at an early stage in metal-on-metal hip arthroplasty. Several clinical studies have reported elevated metal ion levels after total knee arthroplasty (TKA), with fairly high levels associated with rotating hinge knees (RHK) and megaprostheses. 1. In a knee simulator study, Kretzer. 2. , demonstrated volumetric wear and corrosion of metallic surfaces. However, prospective in vivo data are scarce, resulting in a lack of knowledge of how levels evolve over time. The goal of this study was to measure serum Co and Cr levels in several types TKA patients prospectively, evaluate the evolution in time and investigate whether elevated levels could be used as an indicator for implant failure. Patients and Methods. The study was conducted at Ghent University hospital. 130 patients undergoing knee arthroplasty were included in the study, 35 patients were lost due to logistic problems. 95 patients with 124 knee prostheses had received either a TKA (primary or revision) (69 in 55 patients), a unicompartimental knee arthroplasty (7 UKA), a RHK (revision −7 in 6 patients) or a megaprosthesis (malignant bone tumours − 28 in 27 patients) (Fig 1). The TKA, UKA and RHK groups were followed prospectively, with serum Co and Cr ions measured preoperatively, at 3,6 and 12 months postoperatively. In patients with a megaprosthesis, metal ions were measured at follow-up (cross-sectional study design). Results (Fig 2 and 3). In primary knees, we did not observe an increase in serum metal ion levels at 3, 6 or 12 months. Two patients with a hip arthroplasty had elevated preTKA Co and Cr levels. There was no difference between unilateral and bilateral knee prostheses. In the revision group, elevated pre-revision levels were found in 2 failures for implant loosening. In both cases, ion levels decreased postoperatively. In revisions with a standard TKA, there was no significant increase in metal ions compared to primary knee arthroplasty. RHK were associated with a significant increase in Co levels even at short-term (3–12 months). The megaprosthesis group had the highest metal ion levels and showed a significant increase in Co and Cr with time in patients followed prospectively. With the current data, we could not demonstrate a correlation between metal ion levels, size of the implant or length of time in situ. Discussion. In primary knee arthroplasty with a standard TKA or UKA, metal ion levels were not elevated till one year postoperatively. This suggests a different mechanism of metal ion release in comparison to metal-on-metal hip arthroplasties. In two cases of revision for implant loosening, pre-revision levels were elevated, possibly associated with component wear, and decreased after revision. With RHK, slightly elevated ion levels were found prospectively. Megaprostheses had significantly elevated Co and Cr levels, due to corrosion of large metallic surfaces and/or wear of components which were not perfectly aligned during difficult reconstruction after tumour resection. Further research is needed to assess the clinical relevance of metal ion levels in knee arthroplasty. For any figures or tables, please contact authors directly (see Info & Metrics tab above).

Purpose. Total shoulder arthroplasty (TSA) has become a successful treatment option for degenerative shoulder disease. With the increasing incidence in primary TSA procedures during the last decades, strategies to improve implant longevity become more relevant. Implant failure is mainly associated with mechanical or biological causes. Chronic inflammation as a response to wear particle exposure is regarded as a main biological mechanism leading to implant failure. Metal ions released by fretting and corrosion at modular taper connections of orthopedic implants can cause cell-mediated hypersensitivity reactions and might lead to aseptic loosening. Modularity is also commonly used in total shoulder replacement. However, little is known about metal ion exposure in patients following TSA. The objective of this study was to determine in-vivo blood metal ion levels in patients after TSA and to compare blood metal ion levels to control subjects without metal implants. Methods. A total of 19 patients with anatomical total shoulder prosthesis (TSA group) and 20 patients with reverse total shoulder prosthesis (RSA group) who underwent unilateral total shoulder replacement at our hospital between March 2011 and December 2014 with no other metal implant or history of environmental metal ion exposure were recruited for analysis of blood metal ion concentrations of cobalt (Co), chromium (Cr) and titanium (Ti) at a mean follow-up period of 2.3 years (0.7–4.3). For comparison of metal ion concentrations blood samples were obtained in a healthy control group of 23 subjects without metal implants. Ethical approval and informed consent of each patient were obtained for this study. Results. Median cobalt ion levels were 0.14µg/l (range 0.03–0.48) in the TSA group, 0.18 µg/l (0.10–0.66) in the RSA group and 0.11µg/l (0.03–0.19) in the control goup. Median chromium ion levels were 0.34µg/l (0.09–1.26) in the TSA group, 0.48µg/l (0.17–2.41) in the RSA group and 0.14µg/l (0.04–0.99) in the control goup. Median titanium ion levels were 0.86µg/l (0.10–1.64) in the TSA group, 1.31µg/l (0.75–4.52) in the RSA group and 0.62µg/l (0.32–2.14) in the control goup. There was a statistically significant difference in chromium and titanium ion concentrations between both study groups and the control group (see figure 1–3). Conclusion. Patients with unilateral total shoulder replacement demonstrated elevated blood metal ion concentrations. Median blood metal ion levels were higher in the RSA group compared to the TSA group, which could be attributable to the modularity of the reverse total shoulder system. However, overall metal ion levels were relatively low compared to those seen in patients with metal-on-metal total hip replacements. The role of local metal ion exposure in the development of aseptic loosening or hypersensitivity reactions associated with total shoulder arthroplasty should be further investigated. For figures/tables, please contact authors directly.

Introduction. Dual modular hip prostheses were introduced to optimize the individual and intra-surgical adaptation of the implant design to the native anatomics und biomechanics of the hip. The downside of a modular implant design with an additional modular interface is the potential susceptibility to fretting, crevice corrosion and wear [1–2]. The purpose of this study was to characterize the metal ion release of a modular hip implant system with different modular junctions and material combinations in consideration of the corrosive physiological environment. Methods. One design of a dual modular hip prosthesis (Ti6Al4V, Metha®, Aesculap AG, Germany) with a high offset neck adapter (CoCrMo, CCD-angle of 130°, neutral antetorsion) and a monobloc prosthesis (stem size 4) of the same implant type were used to characterize the metal ion release of modular and non-modular hip implants. Stems were embedded in PMMA with 10° adduction and 9° flexion according to ISO 7206-6 and assembled with ceramic (Biolox® delta) or CoCrMo femoral heads (XL-offset) by three light impacts with a hammer. All implant options were tested in four different test fluids: Ringer's solution, bovine calf serum and iron chloride solution (FeCl3-concentration: 10 g/L and 114 g/L). Cyclic axial sinusoidal compressive load (Fmax = 3800 N, peak load level of walking based on in vivo force measurements [3]) was applied for 10 million cycles using a servohydraulic testing machine (MTS MiniBionix 370). The test frequency was continuously varied between 15 Hz (9900 cycles) followed by 1 Hz (100 cycles). The metal ion concentration (cobalt, chromium and titanium) of the test fluids were analysed using ICP-OES and ICP-MS at intervals of 0, 5·105, 2·106 and 10·106 cycles (measuring sensitivity < 1 µg/L). Results. Due to the additional modular interface between stem and neck adapter the total metal ion release of the modular hip endoprosthesis system increased significantly and is comparable to the coupling of a monobloc stem and a CoCrMo femoral head (Fig. 1). The application of ceramic femoral heads reduced the total cobalt and chromium release in the stem-head taper interface of non-modular and modular stems. In comparison between the four test fluids could be observed that lower pH-values and higher FeCl3-concentrations increased the metal ion release (Fig 2). In contrast, the use of bovine calf serum decreased the metal ion release of modular junctions due to the presence of proteins and other organic components. Discussion. For testing hip implants with proximal femoral modularity according to ISO and ASTM standards, sodium chloride solutions are frequently used to determine the fatigue strength and durability of the stem-neck connection. The present study illustrate that the expansion of standard requirements of biomechanical testing and the use of alternative test fluids is necessary to simulate metal ion release by electro-chemical processes. A promising approach is the use of adapted iron-chloride solutions (10 g/L FeCl3, pH 2) to evaluate the susceptibility of modular hip junctions to fretting, crevice and contact corrosion

Introduction. The MHRA guidelines for metal on metal (MOM) suggest cobalt and chromium levels of more than 7ppb as potential for soft tissue reaction. However, in some patients soft tissue reaction is seen even in the presence of normal serum metal ions levels. Methods. A prospective review of all patients who had metal-on-metal hip arthroplasty was done. Patients who had both serum metal ion levels and MARS MRI scan were included in this study. Results. There were 574 patients with 319 females and 255 males. 240 patients had both MARS MRI scan and serum metal ions. Fifty nine (24.5%) patients with normal metal ions had metallosis/pseudo tumour on MRI scans, and 17 (7%) patients with increased metal ions had normal MRI scans. Conclusion. This study confirms that there is poor correlation between serum metal ions and soft tissue reaction. Nearly a quarter of patients with normal serum metal ions had evidence of metallosis on MRI scan. Clinicians should be aware of the potential for soft tissue reaction even in the presence of normal metal ions. Hence, consideration should be given to further imaging where appropriate, to ensure early metallosis is picked up and further complications of pseudo tumour prevented

Introduction. Metal-metal surface replacement (MoMSRA) continues to be used in young women. Systemic metal ion release and its effects cause concern. Do metal ions crossing the placenta in pregnant women have potential mutagenic effects? The hypothesis is that metal ions pass freely through the placenta and there is no difference in maternal and cord metal levels. Methods. This is a controlled cross-sectional study of women with MoMSRA. (n = 25, 3 bilateral, mean age 32 years, time from implantation to delivery 60 months). The control group consisted of 24 subjects, mean age 31 years, with no metallic implant and not receiving cobalt/chromium supplements. No patient was known to have renal failure. Whole blood specimens were obtained before delivery and before any infusion or transfusion, and cord blood specimens immediately after delivery. Results. Cobalt and chromium were detectable in all specimens in both cohorts. In the control group, the difference between maternal and cord levels was only 5 to 7% indicating free passage. Study group cord cobalt (0.88 mg/L) and chromium levels (0.34 mg/L) were significantly lower than maternal cobalt (1.57 mg/L, p < 0.05) and chromium Levels (1.43 mg/L, p 0.05). However there is a significant difference between the cord cobalt levels in the study (0.88 mg/L) and control (0.41 mg/L, p < 0.05) groups. Discussion and Conclusion. The limitation of this study is that none of the patients in the study had the excessive metal ion levels recorded in recent times in some of the withdrawn resurfacing arthroplasties. The differences between maternal and cord metal ions in the controls indicate that normally the placenta allows an almost free passage of metal ions. Within the range of levels studied, the relative levels of metal ions in the maternal and cord blood in the study group reveal that the placenta exerts a regulatory influence on metal ion transfer

High short-term failure rates have been observed with a number of metal-on-metal (MoM) hip designs. Most patients require follow-up with blood metal ions, whichprovide a surrogate marker of in-vivo bearing wear. Given these results are used in clinical decision making it is important values obtained within and between laboratories are reproducible. To assess the intra-laboratory and inter-laboratory variability of blood metal ion concentrations analysed by four accredited laboratories. Whole blood was taken from two participants in this prospective study. The study specimen was obtained from a 42 year-old female with ceramic-on-ceramic hip arthroplasty failure resulting in unintended metal-on-ceramic wear and excessively high systemic metal ion levels. The control specimen was from a 52 year-old healthy male with no metal exposure. The two specimens were serially diluted to produce a total of 25 samples with different metal ion concentrations in two different anticoagulants each. Thus 50 samples were sent blinded in duplicate (total 100) to four accredited laboratories (A, B, C, D) to independently analyse blood metal ion concentrations. Ten commercially available reference specimens spiked with different amounts of metal ions were also obtained with known blood metal ion concentrations (range for cobalt 0.15µg/l-11.30µg/l and chromium 0.80µg/l to 37.00µg/l) and analysed by the four laboratories. The intra-laboratory coefficients of variation for repeat analysis of identical patient specimens were 7.32% (laboratory A), 4.64% (B), 7.50% (C), and 20.0% (D). The inter-laboratory variability for the analysis of all 25 samples was substantial. For the unmixed study specimen the laboratory results ranged from a cobalt of 263.7µg/l (D) to 525.1µg/l (D) and a chromium of 13.3µg/l (D) to 36.9µg/l (A). For the unmixed control specimen the laboratory results ranged from a cobalt of 0.13µg/l (B) to 0.77µg/l (D) and a chromium of 0.13µg/l (D) to 7.1µg/l (A). For one of the mixed specimens the laboratory results ranged from a cobalt of 12.50µg/l (A) to 20.47µg/l (D) and a chromium of 0.73µg/l (D) to 5.60µg/l (A). Similar inter-laboratory variation was observed for the other mixed samples. The true mean (standard deviation) of the 10 commercial samples was 4.48µg/l (4.20) for cobalt and 8.97µg/l (10.98) for chromium. This was similar to the values obtained by all four laboratories: mean (standard deviation) cobalt ranged from 3.54µg/l (3.17) in laboratory A to 4.35µg/l (4.13) in laboratory D, and chromium ranged from 7.76µg/l (9.50) in laboratory B to 9.55µg/l (9.16) in laboratory A. When testing patient samples, large variations existed both between and within four laboratories accredited to perform analysis of blood metal ion concentrations. However, this was not the case when assessing commercially spiked samples which are regularly used to validate laboratory testing. This is of great clinical concern and could lead clinicians to either recommend unnecessary revision or delay surgery, with both having the potential to adversely affect patient outcomes. It is recommended that laboratories use patient samples to assess the accuracy and reproducibility of the analyses performed. This may also assist in explaining the variations observed in this study

Introduction. Metal on metal (MoM) bearings have been dealt a severe blow in the past few years. The release of metal ions may have arisen from corrosion, wear, or a combination of the two. Edge loading due to implant malposition is thought to cause a failure of lubrication and to contribute to excessive wear and increased metal ion release [1]. Literature reports aseptic lymphocytic vasculitis-associated lesions (ALVAL) are associated with a variety of failures which occur to some degree in all implanted metal femoral components [2, 3]. Moreover, Willert et al [4] has described ALVAL in non-MoM bearing designs too. This paper has investigated the metal ion release due to total hip replacement (THR), Hip Resurfacing (HR) and total knee replacement (TKR). Methods. Following human ethics approval 200 patients were enrolled in this single surgeon randomised controlled study. The treatment groups were total knee replacement (TKR) (n=100), HR (n=50) and THR (n=50). Serum cobalt (Co) and chromium (Cr) ion levels were taken preoperatively for baseline measurement then at 6 month, 1 year and 2 years postoperatively. Results. A preliminary observation of the data was performed to investigate the release trend of the Metal Ions (Figs 1 & 2). Initially there is a significant difference (p<0.05) between TKR and THR for the 6 month ion levels. At the 1 year time-point there is no difference between the TKR and THR for Cr levels. However, there is a significant difference (p<0.05) between TKR and HR for Cr levels at the 1 year time-point and a highly significant difference (p<0.001) between TKR, THR and HR for Co levels at 1 year. At the 2 year time-point there is no difference (p>0.05) between the TKR and THR for Cr levels. However, there is still a highly significant difference (p<0.001) between TKR, THR and HR for Co levels at 2 years. There was no significant difference detected between THR and HR (p>0.05) for both Co and Cr levels at all time-points. Discussion and Conclusion. All patient metal ion levels were in the safe range. Whilst there are other reported studies comparing the effect of head diameter of MoM bearings on systemic release of metal ions, this is the first paper to compare MoM hip bearings with TKR bearings. There was no difference between the release of Cr levels for the TKR and THR at the 2 year time-point. The trend of metal ion release is similar for all implants. However, THA deviates from HR at the 12 month time-point for Co levels. This paper demonstrates that surgical technique plays an important role in metal ion release and the long term integrity of a MoM bearing

Purpose. There is a postulated association between increased serum metal ions and pseudotumour formation in patients with metal-on-metal hip replacements. The primary aim of this study was to assess the prevalence of pseudotumour in 31 asymptomatic patients with a large femoral head (LFH) metal-on-metal hip implant. This was compared to the prevalence of pseudotumour in 20 matched asymptomatic patients with a hip resurfacing (HRA) and 24 matched asymptomatic patients with a standard metal-on-polyethylene (MOP) total hip. A secondary objective was to assess possible correlation between increased serum metal ions and pseudotumour formation. Method. Ultrasound examination of the three groups was performed at a minimum follow up of two years. Serum metal ions were measured in the metal-on-metal LFH and HRA groups at a minimum of two years. Results. There were 10 (32%) solid or cystic masses in the LFH group with a mean size of 89.3 (8 to 437) cm3. In the HRA group there were five (25%) masses with a mean size of 41.6 (6 to 119) cm3. In the MOP group there was one cystic mass measuring 9.8 cm3. Median serum cobalt and chromium ion levels in the LFH group were 4.50 gL (interquartile range, 2.38 to 7.47) and 2.82 gL (interquartile range, 1.48 to 3.18) compared to 0.83 gL (interquartile range, 0.65 to 1.12) and 1.08 gL (interquartile range, 0.78 to 1.31) in the HRA group. Conclusion. This study demonstrates a significantly higher prevalence of pseudotumours in patients with large head metal-on-metal total hips. The higher levels of metal ions in this group suggest that elevated metal ions may lead to pseudotumour formation

There has been much discussion and controversy in the media recently regarding metal toxicity following large head metal on metal (MoM) total hip replacement (THR). Patients have been reported as having hugely elevated levels of metal ions with, at times, devastating systemic, neurolgical and/or orthopaedic sequelae. However, no direct correlation between metal ion level and severity of metallosis has yet been defined. Normative levels of metal ions in well functioning, non Cobalt-Chrome hips have also not been defined to date. The Exeter total hip replacement contains no Cobalt-Chrome (Co-Cr) as it is made entirely from stainless steel. However, small levels of these metals may be present in the modular head of the prosthesis, and their effect on metal ion levels in the well functioning patient has not been investigated. We proposed to define the “normal” levels of metal ions detected by blood test in 20 well functioning patients at a minimum 1 year post primary Exeter total hip replacement, where the patient had had only one joint replaced. Presently, accepted normal levels of blood Chromium are 10–100 nmol/L and plasma Cobalt are 0–20 nmol/L. The UK Modern Humanities Research Association (MHRA) has suggested that levels of either Cobalt or Chromium above 7 ppb (equivalent to 135 nmol/L for Chromium and 120 nmol/L for Cobalt) may be significant. Below this level it is indicated that significant soft tissue reaction and tissue damage is less likely and the risk of implant failure is reduced. Hips were a mixture of cemented and hybrid procedures performed by two experienced orthopaedic consultants. Seventy percent were female, with a mixture of head sizes used. In our cohort, there were no cases where the blood Chromium levels were above the normal range, and in more than 70% of cases, levels were below recordable levels. There were also no cases of elevated plasma Cobalt levels, and in 35% of cases, levels were negligible. We conclude that the implantation with an Exeter total hip replacement does not lead to elevation of blood metal ion levels

Introduction. Higher concentrations of metal ion levels after Metal-on-metal (MoM) THA are a cause for concern. Elevated cobalt (Co) and chromium (Cr) ion levels in the blood indicate metal wear, and may predict secondary soft-tissue damage (adverse reaction to metal debris; ARMD). Although, it is well known that concentrations of metal ion levels are elevated in the short term after MoM, the long-term consequences in ion concentration and risk factors for increased ion levels are not clarified. We sequentially investigated the postoperative Co and Cr ion levels after MoM THA and the relationship between the metal ion levels and several risk factors. Materials and Methods. We reviewed the data on one hundred and eighty six patients of two hundred ninety one MoM THA cases. The one hundred eighty six patients were measured at least three times after a MoM THA surgery over a five year (2005–2010) period in our institution. Serum cobalt and chromium levels were measured by inductor coupled plasma – mass spectrometry at several times in follow-up period, (measured at the preoperative period, the third month, the sixth month, the first year, the second year, and the fourth year after MoM THA). Furthermore, we investigated the correlation between the metal ion levels and various factors which might influence the release of metal ions, such as Body mass index (BMI), renal function, femoral head size, unilateral or bilateral THA, the cup position, and postoperative activity. The renal function was evaluated by measuring estimated glomerular filtration ratio (GFR) at preoperative examination. A postoperative activity was assessed with a pedometer measurement counting number of steps a day. A cup position was evaluated by lateral inclination measured by X-ray or computed tomography. Results. Average serum Co and Cr concentrations in preoperative period were 0.69 and 0.05 mg/ ml, respectively. Postoperative serum Co and Cr ion levels were significantly increased compared with preoperative value throughout the postoperative period. There was no significant correlation with regards to BMI, renal function, femoral head size tothe metal ion level measurement. In bilateral THA cases, Co and Cr ion concentrations were significantly increased compared with unilateral THA cases. In addition, in cases that its cup inclination was more than 50 degrees, Co and Cr ion concentration were significantly increased compared with cases less than 50 degrees in the first year after surgery. There was a trend for higher metal ion levels in the group of patients who walked more than 7000 steps a day, but this did not reach statistical significance. Conclusion. Metal ion concentrations of almost patients were increased after MoM THA surgery. Side effects related to elevation of serum Co or Cr concentration were currently not identified and overall clinical results were good. However, Longer follow-up would be necessary if the patients have overlapping risk factors, because those patients may experience elevation of the level in postoperative late stage

Introduction. Modern metal-on-metal bearing resurfacings have been in use for nearly two decades. Local and systemic metal ion exposure continues to cause concern. We could not find a prospective metal ion study in such patients with a 10-year follow-up. This is the first ten year prospective study of metal ion levels in blood and their release in urine following hybrid fixed metal-on-metal surface arthroplasty. Methods. Twenty six patients were included in an ongoing longitudinal metal ion study of patients with unilateral metal-on-metal hip resurfacings. Three of them were excluded due to subsequent contralateral resurfacing and one has relocated abroad. Cobalt and chromium levels were assessed in 12 hour urine collections before and periodically after operation (5 days to 10 years) using high resolution plasma mass spectrometry. Mean age at operation was 53 years and mean BMI 27.9. Results. Hip function questionnaires at the 10-year review showed that the patients have well-functioning pain-free resurfacings (mean Oxford hip score 14.3). Metal ion results show median cobalt and chromium release at 10 years were 8.3 μg/24 hr and 4.35 μg/24 hr respectively. A statistically significant early peak 6 months to 1 year after operation is followed by a steady decrease over the following seven years although the reductions are not statistically significant. Discussion and Conclusion. Elevated systemic metal ion exposure continues to cause concern in patients treated with metal-metal arthroplasties. Our results show that metal release in these bearings shows a reducing trend after an initial peak. The unknown significance of persistent metal ion elevation underlines the need for continued long-term monitoring

It has been suggested that metal ion levels are indicative of in vivo bearing performance of metal-on-metal hip replacements. A cobalt or Chromium level of 7μg/L or higher is proposed to be indicative of a bearing malfunction and the need for clinical intervention. Component design, size, acetabular orientation, patient gender and activity level have been suggested as factors leading to accelerated wear and elevated metal ions. The contact patch to rim (CPR) distance is a calculation that describes the distance from the point where a theoretical joint reaction force intersects the cup to the acetabular rim for a patient in standing position, dependent on the coverage, size, and orientation of the acetabular component. It has been suggested that CPR distance determines the hip joint susceptibility to edge loading, and the risk for increased wear and high ion levels (Langton et al JBJS Br 91: 2009). This study examined the effects of patient activity, gender, and CPR distance on serum metal ion concentrations in a series of patients treated with one type of metal on metal hip resurfacing arthroplasty (MMHRA) performed by one surgeon. 182 patients (73 females and 109 males)with a unilateral Conserve Plus (WMT, TN USA) MMHRA and had who had provided blood for metal ion analysis data from December 2000 to June 2011 were retrospectively studied. Only measurements made more than 12 months after surgery were included in order to exclude hips that had yet to reach steady-state wear. For patients with multiple draws, the most recent qualifying draw was used. Activity level was assessed by the UCLA activity score. The mean age was 51.5 years (20.0 to 77.5 years). The mean follow-up time for the last blood draw was 70 months (range, 12 to 165). Serum cobalt (CoS) and chromium (CrS) levels were analyzed using inductively coupled plasma mass spectrometry in a specialized trace element lab. Using acetabular abduction and anteversion measured by EBRA, component size, and reported coverage angle of the acetabular component, the CPR distance was calculated as previously described. Multiple logistic regression was performed to identify significant relationships between high metal ion levels (7 μg/L or greater) and gender, activity and CPR distance. The median CoS level for the entire cohort was 1.13 μg/L (range, 0.15 to 175.30), and the median CrS level was 1.49 μg/L (range, 0.06 to 88.70). The average CPR distance was 13.8 mm (range, 3.2 to 22.1). There was a significant association between low CPR values and CoS and CrS. There was a 37-fold increase in the risk of CoS >7μg/L (p=0.005) and 11-fold increase in the risk of CrS > 7μg/L (p=0.003) when CPR distance was 10 mm or less. No associations were shown for gender and UCLA activity scores. CPR distance was found to be a reliable predictor of ion levels > 7μg/L and appears to be a useful indicator to evaluate the multi-factorial process of edge-loading and wear. Patients with a low CPR distance should be monitored for increased metal ion levels

Blood metal ion sampling can help detect poorly functioning metal-on-metal hip arthroplasties (MoMHA's) requiring revision. Little is known about the variation in these levels following bearing exchange. This study aimed to determine the changes that occur in blood and urine metal ion concentrations following MoMHA revision. A single-centre prospective cohort study was undertaken between 2005 and 2012 of patients with failing large-diameter MoMHA's and high blood metal ions requiring revision to non-metal-on-metal articulations. All patients had normal renal function. Whole blood and urine were collected for metal ion analysis preoperatively and regularly following revision. Twenty-three MoMHAs (21 hip resurfacings and 2 total hip arthroplasties; mean age 56.0 years and 65% female) were revised at a mean time of 7.9 years (range 2.0–14.5 years) from primary surgery. All revisions were performed by the senior author using primary total hip implants (12 ceramic-on-polyethylene bearings, 10 oxinium-on-polyethylene bearings, and 1 metal-on-polyethylene bearing implanted). Mean (range) metal ion concentrations pre-revision were: blood cobalt 13.9µg/l (1.32–74.7µg/l), blood chromium 8.9µg/l (1.29–57.3µg/l), urine cobalt 104.6µg/24 hours (4.35–747.3µg/24 hours), urine chromium 33.2µg/24 hours (4.39–235.4µg/24 hours). After revision the mean metal ion concentrations (percentage of pre-revision values) were: blood cobalt at 2 days=10.7µg/l (77%), 6 days=7.7µg/l (55%), 2 months=3.4µg/l (24%), 1 year=1.0µg/l (7%), 2 years=0.42µg/l (3%); blood chromium at 2 days=8.7µg/l (98%), 6 days=5.5µg/l (62%), 2 months=2.2µg/l (25%), 1 year=1.5µg/l (16%), 2 years=0.97µg/l (11%); urine cobalt at 2 days=31.9µg/24 hours (30%), 6 days=21.5µg/24 hours (21%), 2 months=6.1µg/24 hours (6%), 1 year=0.99µg/24 hours (1%), 2 years=0.61µg/24 hours (1%); urine chromium at 2 days=34.4µg/24 hours (103%), 6 days=15.8µg/24 hours (48%), 2 months=9.3µg/24 hours (28%), 1 year=2.8µg/24 hours (8%), 2 years=1.9µg/24 hours (6%). Following MoM revision cobalt levels decline rapidly in an exponential pattern with a single rate of decay through the 2 year period, reaching reference levels within the first year. Chromium follows a similar pattern but starts lower and takes longer. Renal response to cobalt returns to reference level within days of revision

Introduction. The aim of this study was to analyze the results of our series of female patients treated with <48 mm MOMHR devices at a minimum follow-up of 5 years, to understand which is the most important aspects affecting the results and to define if the metal ions dosage has to be indicated as a routinely follow-up. Methods. This is a retrospective clinical study; the cohort included 198 consecutive MOMHR implanted in 181 female patients (17 bilateral procedures). All operations were performed between 2002 and 2011. All operations were performed by the senior surgeon. Indications to MOMHR included primary or secondary osteoarthritis (OA), rheumatoid arthritis and avascular necrosis. Contraindications included poor proximal femoral bone stock (T-score<−2.5sd in BMD of the femoral neck) or severely distorted hip anatomy. All patients were advised to underwent clinical and radiological review with the operating surgeon at 5 weeks, 3, 6 and 12 months postoperatively and then every subsequent 2 years.182 patients answered to our phone calls; 4 patients died (one of them was operated bilaterally) for causes not related to the study, and in 11 cases the phone number was expired. The minimum follow-up was 5.0 years (mean 7.5, maximum 13.2, sd 0.11). Results. Fourteen devices were revised (7%) in 14 patients: 2 of them were operated bilaterally and the controlateral implant is still fine; thus, the Kaplan-Meier survival rate with revision for any reason as the end point was 92.7% at 13 years (95% confidence interval (CI) 0.9 to 1.0). Revisions data are resumed in table 2. Main OHS was 44 points (4–48, sd 7); no statistical relations were found about any aspect about relation between OHS and metal ions dosage (eg Chi Square Analysis p-value = 0.147>0,05 for Score and CR). Metal ions dosage was performed in only 2 cases before and after the revision (14%); in one case, the Cr dosage was 20 µg/L before and 8 µg/L after surgery; in the other case, the Cr dosage was 100 µg/L before and 10 µg/L after surgery, and the Co dosage was 70 µg/L before and 0.2 µg/L after surgery. Metal ions dosage was performed in 64 cases of the survived implants (35%). Main Cr dosage was 1.50 µg/L (0.09–7.00, sd 1.70) and main Co dosage was 1.30 µg/L (0.09–9.00, sd 1.60), at a main follow-up from surgery of 5.7 years (0.2–11.0, sd 3.1), in 14 different laboratories. No statistical relation were found between clinical outcomes and metal ions increase. Conclusions. MOMHR is a good choice for treating severe hip arthritis also in female patients with <48 mm devices. The results are affected especially by surgical technique and indications. The metal ions dosage has to be performed every year for the first two years and then at a larger follow-up. We believe that additional imaging, such as CT scanning to measure anteversion may better identify the ideal candidate, and specific training with largely experienced surgeons would be mandatory; the metal ions dosage would be used as a monitor of failures

Metal ion levels are used to track the performance of metal containing bearings in hip replacement patients. Changes in whole blood metal ion levels are indicators of wear rates in these bearings. Normal metal ion levels are variable, and range widely. Changes in these “non-bearing” levels over a period of time may influence the monitoring of these bearings. Methods. As part of a prospective randomised trial of different bearing surfaces, whole blood metal ion levels were monitored. This included four cohorts of patients, namely ceramic-on-ceramic (CoC), ceramic-on-polyethylene (CoP), ceramic-on-ceramic (CoC) and ceramic-on-metal (CoM). Serial whole blood metal ion levels in the non-metal bearings, namely CoC and CoP, were analyzed. Results. There was no consistency in these whole blood metal ion levels. Intra-patient variations in these levels over a period of time could not be due to bearing-produced metal ions as these were all metal free, and thus not the source of any endogenous ions. These intra-patient variations may reflect changes in exogenous exposure to these metal ions, fluctuations in these patient's metabolic functions or production of metal ions from non-bearing prosthetic sources. Conclusion. This finding of variations of “normal” intra-patient whole blood metal ions highlights the importance of determining a patient's average baseline levels, particularly when these are used to determine changes in these levels when part of a protocol to monitor the performance of metal containing hip replacement bearings

Introduction. A metal ion study was undertaken in patients who had received an articular surface replacement. The design of these components is optimised in line with lubrication theory and produces low levels of wear in hip joint simulators. Methods. Patients were recruited in four centres. Whole blood samples were analysed for metal ion levels using high resolution ICP-MS (inductively coupled plasma mass spectrophotometry). A total of 75 patients was enrolled into the study and 65 and 47 patients were assessed after 12 and 24 months implantation respectively. Results are included irrespective of clinical outcome. Results. The 12 and 24 month median ion levels were 1.4 μg/l and 1.6 μg/l respectively for chromium and 1.5(μg/l and 1.6 μg/l respectively for cobalt. The pre-operative levels were 0.38(μg/l and 0.34(μg/l for chromium and cobalt respectively. Twenty-seven percent of patients had a pre-operative chromium level that was higher than the 24 month median level. Similarly the value for cobalt was seven percent. However close examination of the data shows that it is skewed by 6 outliers with cobalt or chromium levels greater than 10(μg/l after 24 months implantation. This appears to be related to acetabular component placement. Patients with acetabular components implanted at a high inclination angle (>55deg) are more likely to have elevated metal ion levels compared with a standard angle (<55deg). In the 24 month group two patients (both outliers) have been revised. Furthermore, the high metal ion levels at 24 months could be predicted by intermediate levels after 12 months. Conversely those levels below 10ug/l had already stabilised after 12 months in vivo. Conclusion. Large diameter metal-on-metal bearing with optimised tolerances can produce very low blood metal ion levels. However, in line with other studies, mal-positioning of components may lead to significantly elevated levels of wear and hence blood metal ions

Comparisons of blood metal ion levels of cobalt and chromium (CoCr) between metal-on-metal total and resurfacing hip arthroplasties are limited. High levels of CoCr may result in long-term adverse biological effects. We compare metal ions levels between total and resurfacing implants. 70 patients (28 males and 42 females) had a total hip arthroplasty using the Birmingham (Smith & Nephew) modular femoral component and a variety of stems, articulating with the Birmingham resurfacing component. The average age was 65.5 (±6.8) years and an average follow-up of 6.0 (±2.2) years. 170 patients (145 male and 25 female had a Birmingham resurfacing arthroplasty with an average age of 54.7 (±9.9) years and an average follow-up of 5.9 (±3.0) years. CoCr levels were measured. Bivariate correlations and independent samples t-tests were applied to determine similarities and differences within and between groups. Average ion levels in total arthroplasty patients were: Co 114.17 (±94.01) nmol/L (range 2–414); and Cr 75.12 (±68.45) nmol/L (range 10–312). Average levels in hip resurfacing arthroplasty were: Co 55.98 (±79.5) nmol/L (range 7–505); and Cr 70.77 (±87.41) nmol/L (range 5–751). Both total and resurfacing groups showed significant correlations (p<0.01) between Co and Cr levels. A significant difference was observed between the total and resurfacing group Co levels (p<0.0001). No significant difference was shown between group Cr levels (p>0.672). The average total hip replacement CoCr levels were higher than the hip resurfacing levels. While the overall activity level may be higher in the resurfacing group, possibly the incidence of stop/start frequency may be higher in the total hip replacement group. Hip resurfacing arthroplasty average CoCr levels are lower than those of total hip replacement patients. Associations between Co and Cr metal ion levels are shown within each group. Co levels differ significantly between groups where Cr does not. Long-term follow-up of CoCr levels are required

Wear debris associated with CoCr bearings has been implicated in the development of adverse soft tissue reactions and pseudotumors following THA with large metal heads and following hip resurfacing. Additional concerns have been raised regarding trunion fretting and corrosion. Most recently, the neck-stem junction of some modular femoral stem designs have come under additional scrutiny. We undertook a review of patients who had undergone THA with a proximal modular junction stem design in order to ascertain the state of the junction in early follow up. We examined the records of all patients in our practice who had undergone uncomplicated, unilateral THA with the ARC stem (OmniLife Science, East Taunton, MA, USA) between April 2010 and April 2012. Office records, radiographs and laboratory data were included. Serum or blood cobalt and chromium ion levels were obtained at the one-year post-op visit or later or if the patient had unexpected pain. The test obtained (serum or blood) was dependent on the lab performing the study. In the study period 100 patients met the inclusion criteria and had metal ion levels available for review. No patient required revision for adverse soft tissue reaction or elevated metal ion levels. Cobalt levels fell with the normal lab ranges in the majority of patients with a very small percentage demonstrating levels slightly above the normal range. Chromium levels all fell within the expected normal range. One patient had a neck exchange for mechanical reasons at 8 weeks following primary THA. This patient went on to develop elevated serum cobalt levels and a large hip effusion. The hip was revised at one year to a non-modular stem. A modular proximal stem offers the advantages of addressing variable anatomy and allowing less soft tissue dissection. Some designs have enjoyed success while others have been withdrawn from the market due to fatigue failure, dissociation or metal-associated adverse reactions. Modular junction designs vary greatly which can impact their inherent stability and their ability to resist micro-motion. In this patient group the junction has shown good stability in early follow up as judged by clinical and laboratory data. Cobalt levels were all normal or well below the range considered suspicious for adverse reaction. Chromium levels all fell within the normal range. A case of an exchanged neck with retention of the stem was associated with high cobalt levels. We discuss several junction designs and their characteristics