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).

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. The use of metal-on-metal (MOM) and modular total hip arthroplasty (THA) is associated with potentially serious complications including elevated serum metal ion levels, pseudotumor, cardiomyopathy and neurologic abnormalities. The primary aim of this analysis was to identify any associations between the presence of pseudotumor, serum metal ion levels, and specific dual modular implant components. Methods. We evaluated prospectively collected data from 49 patients, mean age 58.4 years, who underwent implantation of modular THA from 01/2004-01/2010. The collected data spanned a 5–11 year period from the time of index procedure. Serum metal ion levels, including titanium, cobalt and chromium, were collected in 2012 and 2015. Hip ultrasounds were performed on each patient by a trained musculoskeletal radiologist for evaluation of the presence of soft-tissue pseudotumor. Univariate nonparametric tests were used to compare the two groups: Fisher's exact tests for categorical variables, and Wilcoxon two-group tests for continuous variables. For the purposes of analysis, values that were below the level of detection (LOD) were set to half the LOD. All analyses were performed using SAS 9.4 (SAS Institute Inc, Cary, NC, USA). Statistical significance is set at p<0.05. Results. Eight of 49 patients (16.3%) had pseudotumors on ultrasound examination. The average size measured 35.05 cm3 (7.35 cm3 – 130.81 cm3). In patients without pseudotumor, the serum levels (ng/mL) of titanium, cobalt and chromium were 3.2 ± 2.7, 4.4 ± 5.7 and 3.4 ± 4.9 in 2012 and 3.6 ± 4.9, 11.3 ± 33.7 and 5.3 ± 10.8 in 2015, respectively. Patients with pseudotumor had titanium, cobalt and chromium levels of 3.5 ± 2.3, 8.4 ± 8.7 and 6.2 ± 9.4 in 2012 and 4.1 ± 3.4, 6.0 ± 4.5 and 5.1 ± 6.4 in 2015. The ratio of cobalt to chromium was 1.6 ± 1.3 in 2012 and 1.8 ± 1.2 in 2015 in patients without pseudotumor and 2.1 ± 1.2 and 1.9 ± 1.3 with patients with pseudotumor, respectively. There was no statistical correlation between the presence of pseudotumor and age, component pairings (stem, neck and cup) and any of the serum metal ion levels. Discussion/Conclusion. In this prospective cohort study the incidence of pseudotumor was 16.3% in asymptomatic patients with modular THA. The presence of pseudotumor did not correlate with component pairings, serum metal ion levels or cobalt to chromium ratios

Background. Modularity in total hip replacement(THR) enables precise recreation of native hip biomechanics. However, there have been concerns about raised metal ion levels with increased number of interfaces. We present the 3 year results of ML taper with Kinectiv technology(MLKT), a modular neck uncemented stem. This system has modular neck options, but has only one [0] head in various diameters. Methods. 97 hips in 97 patients with a MLKT stem and Continuum socket were included in this prospective study. Harris hip score, Oxford hip scores (HHS and OHS) and yearly blood Cobalt(Co), Chromium(Cr) and Titanium(Ti) were recorded. The primary end point was revision for any reason. Paired t- test was used to assess improvement in functional scores. Results. The mean age was 62.1±8.7 years. The mean follow-up was 3.75±0.67years. The mean HHS improved from 45.8±5.1 to 92.6±3.1(p<0.001) and the mean OHS improved form 17.59±4.71 to 43.1±2.2(p<0.001). One hip was revised for deep infection at 2.6 years. The mean Co, Cr and Ti levels at 3 years were 18.45,19.62 and 36.47 nmol/l respectively. The survivorship of the cohort at a minimum follow-up of 3 years was 98.7%. Conclusion. Our study suggests that despite the presence of an additional interface between the neck and the stem, the MLKT stem does not result in increased metal ion levels or higher failure rate. This is a prospective and consecutive series of patients with complete radiological and functional follow-up. The MLKT stem has good functional results with no concerns about raised metal ion levels in the short term

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

Background. Recent clinical studies have suggested that systemic metal ion levels are significantly elevated at midterm follow-up after ceramic-on-metal (COM) bearing. However, it is not clear whether there is a correlation between patient- and surgical-related factors including the lifestyle and elevated levels of serum metal ions following COM total hip arthroplsty (THA). Material and Methods. Two hundred and one patients (234 hips) including 121 COM patients (140 hips) and 80 non-COM patients (94 hips) were enrolled in accordance with the inclusion criteria. The patients were divided into three groups based on the type of surgical bearings used. The Harris Hip Score (HHS), University of California, Los Angeles (UCLA) activity scale score, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score were measured, and radiographs were obtained for the analysis. Serum metal ion levels of cobalt and chromium were measured using a high-resolution inductively coupled plasma mass spectrometry. Patient- and surgical-related factors were analyzed to determine which group of patients is at a high risk of metal ion-related problems. Results. Significantly higher serum levels of Co and Cr were detected in the serum of the COM THA group (Co: 1.86±4.0 µg/L, range: 0.30 to 34.20 µg/L; Cr: 1.81±2.87 µg/L, range: 0.10 to 27.80 µg/L) than in the serum of the non-COM THA group (Co: 0.27±0.14 µg/L, range: 0.15 to 0.90 µg/L; Cr: 0.19±0.25 µg/L, range; 0.10 to 2.30 µg/L) (p<0.001). The HHS in the COM group was significantly better than that in the non-COM group (p=0.013). The total ROM of the THAs was significantly greater in the 36-mm COM THA group (272.7°, range: 200°–345°) than in the non-COM group (248.5°, range: 135°–300°) (p<0.001). No radiolucency, osteolysis, or loosening was found during the follow-up radiographic examination. The serum Co levels of patients who achieved the squatting position were significantly higher than those of patients who could not squat (Co: p=0.033; Cr: p=0.074). The serum Co and Cr levels of patients who achieved the kneeling position were significantly higher than those of patients who could not kneel (Co: p=0.049; Cr: p=0.031). There was no significant difference between the two groups in the cross-legged sitting position. The metal ion levels of the COM THA group correlated with the total ROM (Co: p=0.0293; Cr: p=0.0399), and those of the patients who were capable of squatting and kneeling were significantly higher than those of the patients who were unable (p<0.05). However, age, BMI, acetabular cup position and patient activity did not show significant correlations with the serum metal ion levels. Conclusions. Patients who underwent a 36-mm COM THA had good clinical outcomes with an excellent hip function at the short and midterm follow-up intervals. However, high levels of metal ions were detected in the serum of COM THA patients. We found that COM THA patients who were capable of greater ROMs, squatting, and kneeling are at risk of metal ion-related problems

Background:. The Rejuvenate modular neck stem (Stryker, Mahwah, NJ) was recently recalled due to corrosion at the neck-stem junction. The purpose of this study was to investigate the rate of corrosion related failures and survivorship of this implant, and analyze the correlation between the implant and patient factors with serum metal ion levels. Material and Methods:. Between June 2009 and July 2012, 123 Rejuvenate stems (97 modular and 26 non-modular) THAs were implanted in 104 patients by a single surgeon via a modified anterolateral approach. Serum Cobalt (Co) and Chromium (Cr) levels (microgram per liter [μg/L]) were obtained in all patients. In cases of elevated serum metal ion levels or symptomatic hip, patients underwent magnetic resonance imaging (MRI) for assessment of osteolysis or adverse local tissue reactions (ALTR). Correlation between implant factors (implant size, head size, head length, offset), patient factors (age, gender, BMI) with serum metal ion levels and revisions were analyzed using logistic regression models. Results:. The mean follow-up was 2.7 ± 0.6 years. The mean Co and Cr levels were 5.4 ± 5.7 μg/L (0.2–31) and 2.1 ± 1.5 μg/L (0.1–4.3), respectively. The differences between the Co and Cr levels in the two groups were statistically significant. 49% of THAs in the modular group had elevated metal ion levels (> 4.0 μg/L). There was a significant correlation between higher metal ion levels, younger age, and higher offset (p < 0.05). Presence of pain and high cobalt levels were significant predictors for revision surgery. The rate of revision at the time of this study was 26%, the majority were in the 2. nd. year after surgery. The Kaplan-Meier survivorship was 75% at the time of this study. Discussion and Conclusions:. The short-term high rate of corrosion related revision with Rejuvenate modular neck stems is extremely alarming. We anticipate more revisions in the near future. Level of Evidence: Level III, Therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence

The search for the ideal bearing surface in Total Hip Replacements continues. The current ‘best’ materials are felt to be combinations of metal, ceramics and cross-linked polyethylene. Laboratory studies suggest that ceramic-on-metal articulations may provide distinct advantages. This study aims to identify the best bearing surface combination with the lowest adverse side effect profile. Between February 2004 and September 2007, 164 hips were replaced in 142 patients. 39% were male and 69% were female. The average age at surgery was 53 years (17-72 years). Follow-up assessment included radiographs, the Harris Hip Score and whole blood samples for metal ion levels. Complications to date included 3 hips which needed femoral revision because of surgery related factors, and 3 cases of sepsis of which 1 settled and 2 needed revision. One hip needed revision of head and liner to a larger bearing size for recurrent dislocations, and is no longer being followed up for blood metal ions. Post-operative whole blood metal ion levels were compared to pre-operative levels to determine the increase or decrease in metal ion levels. There were no changes in those patients with ceramic-on-ceramic and ceramic-on-polyethylene articulations. Moderately raised whole blood metal ion levels were noted at 3 months in the ceramic-on-metal group, while the metal-on-metal group show the greatest increase. This study agrees with laboratory bearing surface wear studies demonstrating lower wear rates in the ceramic-on-metal group compared to the metal-on-metal group. With concerns related to high blood metal ion levels in metal-on-metal articulations, ceramic-on-metal bearing surfaces may well become a bearing surface of choice in the future, but progress needs to be monitored in the longer term

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. Complication and revision rates have shown to be high for all metal-on-metal (MoM) bearings, especially for the ASR Hip System (ASR hip resurfacing arthroplasty (HRA) and ASR XL total hip arthroplasty (THA)). This prompted the global recall of the ASR Hip System in 2010. Many studies have previously explored the association between female gender and revision surgery MoM HRA implants; yet less research has been dedicated to exploring this relationship in MoM THA. The first purpose of this study was to assess the associations between gender and implant survival, as well as adverse local tissue reaction (ALTR), in patients with MoM THA. Secondly, we sought to report the differences between genders in metal ion levels and patient reported outcome measures (PROMs) in patients with MoM THA. Methods. The study population consisted of 729 ASR XL THA patients (820 hips) enrolled from September 2012 to June 2015 in a multicenter follow-up study at a mean of 6.4 (3–11) years from index surgery. The mean age at the time of index surgery was 60 (22–95) years and 338 were women (46%). All patients enrolled had complete patient and surgical demographic information, blood metal ion levels and PROMs obtained within 6 months, and a valid AP pelvis radiograph dating a maximum of 2 years prior to consent. Blood metal ion levels and PROMs were then obtained annually after enrollment. A sub-set of patients from a single center had annual metal artifact reduction sequence (MARS) MRI performed and were analyzed for the presence of moderate-to-severe ALTR. Results. Eighty-nine hips (11%) were revised during the study period. Forty-five of the 338 men underwent revision (13%), and 44 of the 391 women underwent revision (11%). The mean time from index surgery to revision was 7 years for both males and females. After controlling for confounding variables, the only variables found to be associated with revision surgery in patients with unilateral THA were VAS pain (hazard ratio [HR], 1.28; p < 0.001) and elevated cobalt metal ion levels (HR, 1.02; p < 0.001). Patients with bilateral arthroplasties with low HHS (HR, 0.96; p < 0.001) and high cobalt levels (HR, 1.02; p < 0.001) were at increased risk for revision. Moderate-to-severe ALTRs were identified in 48 of the 133 hips with MARS MRI (36%), 17 of which were in females (30% of females) and 31 in males (40% of males). The only variables found to be associated with the presence of moderate-to-severe ALTR were abduction angle (HR, 0.92; p = 0.004) and Corail AMT stem type (HR, 2.31; p = 0.012). Female gender did not influence the risk of revision or ALTR. Chromium concentrations were greater in female patients than males, while cobalt levels were similar between genders. Males reported higher HHS, EQ-5D and UCLA scores than females. Discussion and Conclusion. Both males and females with MoM THA implants should be followed with equal vigilance as gender does not appear to be associated with poor outcomes, such as revision surgery and presence of ALTR

Introduction. Metal-on-metal hip resurfacings (MoMHRAs) have a characteristic wear pattern initially characterised by a run-in period, followed by a lower-wear steady-state. The use of metal ions as surrogate markers of in-vivo wear is now recommended as a screening tool for the in-vivo performance of MoMHRAs. The aims of this retrospective study were to measure ion levels in MoMHRAs at different stages during the steady-state in order to study the evolution of wear at minimum 10 years postoperatively and describe factors that affect it. Materials and methods. A retrospective study was conducted to investigate the minimum 10-year survivorship of a single-surgeon Birmingham Hip Resurfacing (BHR) series, and the evolution of metal ion levels. Implant survival, Harris Hip Scores (HHS), radiographs and serum metal ion levels were assessed. The evolution of metal ion levels was evaluated in 80 patients for whom at least two ion measurements were available at more than 12 months postoperatively, i.e. past the run-in phase. Ion level change (Delta Cr; Delta Co) was defined as Cr or Co level at last assessment minus Cr or Co level at initial assessment. Sub-analysis was performed by gender, diagnosis, age, femoral component size and cup inclination angle. Results. Overall Cr and Co levels were low (Cr: 1.3 μg/L; Co: 1.0 μg/L for unilateral and Cr: 3.2 μg/L; Co: 2.3 μg/L for bilateral resurfacings) and decreased significantly (p < 0.001) from the initial assessment at 4 to 8 years postoperatively (median 6 years) to the last assessment at 10 to 13 years (median 11 years) with a mean reduction of 1.24 μg/L for Cr (Median: −0.80; SD: 1.948; Range: −11.8 to +2.0 μg/L) (p < 0.001) and 0.88 μg/L for Co (Median: −0.75; SD: 1.645; Range: −7.5 to +5.3 μg/L) (p < 0.001). Three patients (4%) had an increase of Co ions >2.5 μg/L, associated with head sizes £50 mm and with clinical symptoms and high cup inclination angles. There was no significant difference in the change of ion levels between genders (Cr: p = 0.845; Co: p = 0.310) although Cr levels at initial and last assessments were higher in females (p = 0.008). Component size did not correlate with change in ion levels (Cr: p = 0.505; Co: p = 0.370). Patients with increased ion levels at follow-up had lower Harris Hip Scores (p = 0.038). Discussion. Low serum Cr and Co ion levels were found in patients with well-functioning unilateral and bilateral MoMHRA. In well-functioning MoMHRA ion levels continue to be low even after . 3. 10 years in situ. In this series, there were no symptomatic patients with low metal ion levels. Increasing metal ion levels >10 μg/l were invariably associated with poorly functioning MoMHRA. The analysis of consecutive ion levels demonstrated a statistically significant overall decrease of Cr and Co levels with time in well-functioning BHR. In 25% of patients ion levels were undetectable at . 3. 10 years postoperatively. Our data are in accordance with tribocorrosion studies indicating a lower-wear bedding-in phase after the initial running-in phase of higher wear. An increase in ion levels after the run-in phase is an indication of continued surface wear which may eventually lead to implant failure potentially associated with soft tissue and bone destruction

Metal-on-metal (MOM) hip arthroplasty has been associated with a variety of new failure modes that may be unfamiliar to surgeons who traditionally perform metal-on-polyethylene THR. These failure modes include adverse local tissue reaction to metal debris, hypersensitivity to metal debris, accelerated wear/metallosis, pseudotumours, and corrosion. A significant number of patients with metal-on-metal hip arthroplasty may present to surgeons for routine followup, concern over their implant, or frank clinical problems. A common issue with MOM hip arthroplasty that can lead to accelerated wear and failure is implant malposition. Malposition of a hard-on-hard bearing can lead to edge loading and accelerated wear at the articular surfaces, which will lead to elevation in blood metal ion levels and metallosis. Distinct from this failure mode is the possibility of metal hypersensitivity, which is believed to be an immunologically mediated reaction to normal amounts of metal debris. Because a modular MOM THR has multiple junctions and tapers that come into contact with one another, there also is the possibility of non-articular metal debris production and corrosion. This type of corrosion reaction can lead to soft tissue destruction not commonly seen with hip resurfacing. Therefore, it is important for orthopaedic surgeons to be aware of the intricacies of following a metal-on-metal hip arthroplasty and to be able to interpret test results such as metal ion levels and cross-sectional imaging. Furthermore, there is a difference in the incidence of problems depending upon the type of implant: hip resurfacing, small-diameter head metal-on-metal total hip replacement, and large diameter head MOM THR. This presentation will discuss the importance of routine monitoring and followup for patients with MOM THR, as well as the utility of measuring blood metal ion levels. The published risk stratification algorithm from the Hip Society will be reviewed

Background. Previous studies have indicated poor outcomes and high complication rate in patients having revision of metal-on-metal (MoM) hip implants resulting from adverse local tissue reactions. Metal ions released by MoM bearings may potentially increase infection occurrence in patients with failed implants. Questions/purposes. We reviewed all patients at our institution who sustained revision of a failed large-head metal-on-metal hip implant to determine if infection-related complications are associated with the elevation of serum metal ions concentration. Methods. From December 2005 to April 2013, we performed 44 revisions of large-head MoM total hip arthroplasty (THA) and resurfacing in 44 patients. In all revision procedures MoM couplings (ASR XL Acetabular System and DePuy ASR Hip Resurfacing System) were explanted. Preoperative diagnosis were: aseptic loosening in 21 hips, hip pain with high serum metal ions levels in 7 hips, high serum metal ions levels without hip pain in 9 hips, deep infections in 4 hips, unexplained hip pain in 2 hips and periprosthetic fracture in 1 hip. Serum cobalt and chromium analysis were preoperatively conducted in 25 patients. Intraoperative fluid aspiration was performed in all cases to determine the presence or absence of periprosthetic joint infection. Results. Fluid analysis for bacteria reported that 35 of 45 cases were culture negative and 10 of 45 cases (22%) were culture positive to Staphylococcus (St) Aureus (4), St Capitis (2), St Epidermidis (2), St Hominis (1), Streptococcus Mitis (1). All preoperative diagnoses of deep infection were confirmed. Within patients evaluated with serum metal ions analysis (mean Co and Cr, 78 μg/l and 39 μg/l, respectively), five cultures resulted positive (20%). The infection rate within patients with higher (> 20 μg/l) metal ions levels (4 positive cultures of 18, 22%) was not significantly higher than infection rate within patients with lower (≤ 20 μg/l) metal ions levels (1 positive culture of 7, 14%). Conclusions. We observed a high rate of periprosthetic joint infection among our revision cases. High metal ions concentrations released by MoM bearings might promote bacterial infections in patients with MoM THA and resurfacing. When evaluating patients with failed MoM hip devices, there may be an increased incidence of co-infection in these patients

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

Introduction. There have been increased concerns with trunnion fretting and corrosion and adverse local tissue reactions (ALTR) in total hip arthroplasty. We report on 11 catastrophic trunnion failures associated with severe ALTR requiring urgent revision arthroplasty. Methods. We retrospectively reviewed 10 patients with gross trunnion failure (n=11) and an additional 3 patients with impending trunnion failure. Results. All patients presented to the emergency department with severe pain, an inability to bear weight, and dramatic radiographs demonstrating implant failure. Patients were an average of 7.8 years from the initial index procedure. Implants were a cementless component with metal on polyethylene bearing from a single manufacturer with a 36mm femoral head size and a range of extended offset of 2.5 to 5.5 and neck length of +0 (n=1), +5 (n=5), and +10 (n=5). The implant was used during a limited time (2.5 years) by single surgeon in our practice using a posterior approach, with the last implant placed 7 years ago. Prior to revision, serum cobalt levels were elevated, typically more than chromium levels. Radiographs demonstrated failure of the implant with a dissociation of the head from the taper and large radiolucent fluid collections from the metal debris (Fig 1). Intraoperative findings and magnetic resonance imaging confirmed a diagnosis of ALTR with loss of abductors, and severe material loss from the taper (Fig 2). We estimate a conservative incidence of catastrophic trunnion failure in our series to be 2.2% (n = 636 total implanted). A femoral revision with a modular Wagner stem was performed, and when necessary the acetabulum was revised secondary to destruction of the locking mechanism from mechanical wear. Discussion and Conclusion. ALTR can occur in patients with catastrophic failure of their trunnion. Radiographs are dramatic. Serum metal ion levels and magnetic resonance imaging is comparable to adverse local tissue reaction in metal on metal bearing surfaces, corrosion at the head neck taper, and corrosion of dual modular taper stems. The initiating events leading to this mechanism of trunnion failure is unknown. We observed trunnion failure at large head sizes and at increased femoral head offsets. Other groups have reported an association of trunnion failure at increased neck length and head size with a variety of manufacturers. Based on our experience, we have been able to identify impending failure based on subtle radiographic criteria and elevated metal ion levels. A failure rate of 2% at 7.8 years is non-trivial. Impending trunnion failure should be considered as a possible diagnosis in a painful total hip arthroplasty with unknown etiology. Serum metal ion levels and magnetic resonance imaging should be obtained as part of the initial evaluation

Introduction:. The ASR™ Articular Surface Replacement and ASR™ XL Metal-on-Metal systems were recalled due to high revision rates at five years. A worldwide clinical follow-up of patients was initiated. This paper summarizes current findings in South Africa (SA) in comparison with those outside SA (OSA). Methods:. Patients were followed annually, or until revision, from 10 clinical centers worldwide. Data collected includes demographic, surgical, radiographic, blood metal ion levels, and patient reported outcome measures (PROM). Results:. There were 715 (353 ASR/336 ASR-XL) hips enrolled in the study; 187 ASR and 32 ASR-XL from South Africa. The average time from index surgery was 6 years (2–10) for both SA and OSA. Since enrollment, 2.7% (19) hips were revised (none from SA) and of these 58% (11) had adverse local tissue reaction. Blood metal Co/Cr ion levels decreased by about 50% post-revision. There was no difference in average blood metal ion levels between patients in SA and OSA. Globally, the average blood cobalt ion level was higher for patients with ASR-XL than patients with ASR. The average cup abduction was 43.2° (20°–65°) with little difference between SA and OSA. The average EQ-5D index for SA patients was 0.93 vs. 0.82 for OSA. Discussion:. Currently, South Africa represented the majority of ASR surface replacement implants in the study, which were predominantly in males. This may have contributed to the higher PROM scores in SA compared to the OSA. While no revisions were reported from SA in this study so far, metal ion levels were lower after revision surgery

Hip simulator studies have shown reduced hip offset can cause microseparation and increased wear in hard-on-hard hip bearings. However this has not been analysed yet in vivo. We studied the effect of reduced hip offset on serum metal ion levels in patients with metal-on-metal (MoM) hip arthroplasty. From all patients who underwent unilateral MoM bearing hip arthroplasty between 2005 and 2009, 63 patients had complete clinical evaluation, measurement of serum chromium and cobalt ion levels as well as biomechanical measurements on pre- and post operative radiographs (cup inclination, head inclination, change in hip offset and change in hip length.). Ten arthroplasties were revised due to adverse metal reaction and six patients awaiting revision. 55% of ASR hips showed higher metal ions (>7 ppb) whereas only 15% of non-ASR hips had higher ion levels. Patients with reduced postoperative hip offset by more than 5 mm had significantly higher mean metal ion levels compared to the the rest of the hips (31.8 ppb vs. 7.4 ppb, p=0.002). On subgroup analysis this effect was present in non-ASR hips (18.7 ppb vs. 4.7 ppb, p=0.025) but was not significant in ASR hips (29.6 ppb vs. 16.3 ppb, p=0.347). Our study demonstrated significantly higher serum metal ion levels in patients who lost more than 5 mm hip offset after arthroplasty. Reduced soft tissue tension leading to microseparation of the articulation and edge loading is a theoretical explanation for this effect. This may be relevant in other hard bearings such as ceramic-on-ceramic as well

Introduction:. The clinical significance of serum metal ion levels alone in patients with stemmed MoM hip arthroplasty remains uncertain. This study aims to measure the metal ion levels in patients with unilateral and bilateral hip arthroplasty to see whether or not the patients with bilateral hips have higher metal ions. Patients and Methods. All the patients with bilateral MoM hip arthroplasty were identified from the research database. These patients were then matched with those in a similar age group who had a unilateral hip arthroplasty, but same University of California Los Angeles (UCLA) activity score. The UCLA activity scores along with other hip scores have been previously gathered for all the patients. Both sets of patients then had measurement of serum cobalt and chromium levels. The results were analyzed and compared. Results:. There were a total of 53 patients with bilateral hips and 53 matched patients with unilateral hips. The average serum Cobalt and Chromium levels were 34 nmol/L (range <10–76) and 23 nmol/L (range <10–104) respectively in the bilateral group; and 14 nmol/L (range <10–45) and 21 nmol/L (range <10–57) in the unilateral group. Given that the MHRA (UK) threshold levels deemed clinically significant are 120 nmol/L and 135 nmol/L for Cobalt and Chromium respectively; the results obtained here are not clinically significant. Conclusions:. One would normally expect, with mathematical reasoning, a patient with bilateral hip arthroplasty to have higher serum metal ion levels than a patient with unilateral arthroplasty. However, this study goes to show that it is not the case

761 cases in 613 patients with minimal two years follow-up had both metal ion levels and quality pelvis X-ray identified in our database and are included in this study. The UCLA activity score, femoral shaft angle, body mass index, weight, American Society of Anesthesiologists (ASA) score, combined range of motion (CROM), diagnosis, age, implant brand, gender, AIA, bearing size, and duration of implantation were analyzed to determine the potential risk factors for elevated metal ion levels with use of uni- and multi-variable logistic regression models. A safe zone for hip resurfacing (RAIL: Relative Acetabular Inclination Limit) was calculated based on implant size and AIA on AP pelvis X-ray. For AIA below the RAIL, there were no adverse wear failures or dislocations, and only 1% of cases with ion levels above 10 μg/L. We have not found a lower limit of AIA where failures occurred. Other than high inclination angle and small bearing size, female gender was the only other factor that correlated with high ion levels in the multivariate analysis. We have described the robust “safe zone” for acetabular component position based on metal ion levels in a large patient cohort for metal-on-metal hip resurfacing arthroplasty. Our study suggests that adverse wear failures with hip resurfacing may be highly predictable and avoidable. If the AIA is below the RAIL, rare dislocations are also prevented