Aims. The first aim of this study was to evaluate whether preoperative renal function is associated with postoperative changes in whole blood levels of metal ions in patients who have undergone a Birmingham Hip Resurfacing (BHR) arthroplasty with a metal-on-metal bearing. The second aim was to evaluate whether exposure to increased cobalt (Co) and chromium (Cr) levels for ten years adversely affected renal function. Methods. As part of a multicentre, prospective post-approval study, whole blood samples were sent to a single specialized laboratory to determine Co and Cr levels, and the estimated glomerular filtration rate (eGFR). The study included patients with 117 unrevised unilateral BHRs. There were 36 females (31%). The mean age of the patients at the time of surgery of 51.3 years (SD 6.5), and they all had preoperative one-, four-, five-, and ten-year laboratory data. The mean follow-up was 10.1 years (SD 0.2). Results. Median Co levels at one year postoperatively increased significantly compared with the preoperative values, by a factor of 9.7, from 0.13 to 1.26 ppb (p < 0.001), and the median Cr levels increased significantly by a factor of 2.5, from 0.60 to 1.50 ppb (p < 0.001). Lower preoperative eGFRs were associated with significantly larger increases in Co at one year compared with the preoperative levels (ρ = -0.26; p = 0.005), but there was no relationship between preoperative eGFRs and changes in Cr at one year (ρ = -0.13; p = 0.153). Metal levels remained relatively constant with the passage of time, with a median ten-year value of 1.12 ppb for Co and 1.29 ppb for Cr. There was no significant relationship between the Co and Cr levels at ten-year follow-up and the change in eGFR from the preoperative level to that at ten years (ρ = -0.02; p = 0.827 for Co; ρ = -0.008; p = 0.933 for Cr). Conclusion. Although patients with lower preoperative eGFRs tended to have larger increases in Co levels at one year, increased metal levels for patients who underwent unilateral BHR did not adversely affect renal function during the first ten postoperative years. Cite this article: Bone Joint J 2024;106-B(3 Supple A):44–50

Aims. This study compared the cobalt and chromium serum ion concentration of patients treated with two different metal-on-metal (MoM) hinged total knee arthroplasty (TKA) systems, as well as a titanium nitride (TiN)-coated variant. Methods. A total of 63 patients (65 implants) were treated using either a MoM-coated (n = 29) or TiN-coated (n = 7) hinged TKA (GenuX mobile bearing, MUTARS; Implantcast, Germany) versus the BPKS (Brehm, Germany) hinged TKA (n = 27), in which the weight placed on the MoM hinge is diffused through a polyethylene (PE) inlay, reducing the direct load on the MoM hinge. Serum cobalt and chromium ion concentrations were assessed after minimum follow-up of 12 months, as well as functional outcome and quality of life. Results. No differences in mean age (69 years, 40 to 86), mean age adapted Charlson Comorbidity Index (3.1 (SD 1.4)), mean BMI (29.2 kg/m. 2. (SD 5.8)), or number of other implants were observed between groups. Significant improvements in outcome scores and pain levels were achieved for all groups, and there was no difference in quality of life (12-Item Short-Form Health Survey questionnaire (SF-12)). Mean cobalt and chromium ion levels were significantly higher for the GenuX versus the BPKS hinged TKA (GenuX vs BPKS: cobalt: 16.3 vs 9.4 µg/l; chromium: 9.5 vs 5.2 µg/l). The TiN-coated implants did not appear to confer improvement in the metal ion levels. Metal ion concentrations above 7 µg/l were detected in 81%(29/36) of GenuX patients versus 41% (11/27) in the BPKS group. No GenuX patients had normal levels under 2 µg/l, versus 22% of BPKS patients. No significant reduction in outcome scores was observed regardless of the metal ion levels, whereas higher work-related activity was correlated with higher chromium concentrations. Conclusion. Hinged TKA, using MoM hinges, resulted in critically high cobalt and chromium ion concentrations. The BPKS hinged TKA showed significantly lower metal ion concentrations compared with the GenuX TKA. No benefits were observed using TiN coating. The different weightbearing mechanics might influence the wear of the component materials. Higher workloads and physical activity could influence chromium levels. Cite this article: Bone Joint J 2022;104-B(3):376–385

The advent of modular porous metal augments has ushered in a new form of treatment for acetabular bone loss. The function of an augment can be seen as reducing the size of a defect or reconstituting the anterosuperior/posteroinferior columns and/or allowing supplementary fixation. Depending on the function of the augment, the surgeon can decide on the sequence of introduction of the hemispherical shell, before or after the augment. Augments should always, however, be used with cement to form a unit with the acetabular component. Given their versatility, augments also allow the use of a hemispherical shell in a position that restores the centre of rotation and biomechanics of the hip. Progressive shedding or the appearance of metal debris is a particular finding with augments and, with other radiological signs of failure, should be recognized on serial radiographs. Mid- to long-term outcomes in studies reporting the use of augments with hemispherical shells in revision total hip arthroplasty have shown rates of survival of > 90%. However, a higher risk of failure has been reported when augments have been used for patients with chronic pelvic discontinuity. Cite this article: Bone Joint J 2024;106-B(4):312–318

Aims. Metal particles detached from metal-on-metal hip prostheses (MoM-THA) have been shown to cause inflammation and destruction of tissues. To further explore this, we investigated the histopathology (aseptic lymphocyte-dominated vasculitis-associated lesions (ALVAL) score) and metal concentrations of the periprosthetic tissues obtained from patients who underwent revision knee arthroplasty. We also aimed to investigate whether accumulated metal debris was associated with ALVAL-type reactions in the synovium. Methods. Periprosthetic metal concentrations in the synovia and histopathological samples were analyzed from 230 patients from our institution from October 2016 to December 2019. An ordinal regression model was calculated to investigate the effect of the accumulated metals on the histopathological reaction of the synovia. Results. Median metal concentrations were as follows: cobalt: 0.69 μg/g (interquartile range (IQR) 0.10 to 6.10); chromium: 1.1 μg/g (IQR 0.27 to 4.10); and titanium: 1.6 μg/g (IQR 0.90 to 4.07). Moderate ALVAL scores were found in 30% (n = 39) of the revised knees. There were ten patients with an ALVAL score of 6 or more who were revised for suspected periprosthetic joint infection (PJI), aseptic loosening, or osteolysis. R2 varied between 0.269 and 0.369 for the ordinal regression models. The most important variables were model type, indication for revision, and cobalt and chromium in the ordinal regression models. Conclusion. We found that metal particles released from the knee prosthesis can accumulate in the periprosthetic tissues. Several patients revised for suspected culture-negative PJI had features of an ALVAL reaction, which is a novel finding. Therefore, ALVAL-type reactions can also be found around knee prostheses, but they are mostly mild and less common than those found around metal-on-metal prostheses. Cite this article: Bone Joint Res 2024;13(4):149–156

Aims. The survival of humeral hemiarthroplasties in patients with relatively intact glenoid cartilage could theoretically be extended by minimizing the associated postoperative glenoid erosion. Ceramic has gained attention as an alternative to metal as a material for hemiarthroplasties because of its superior tribological properties. The aim of this study was to assess the in vitro wear performance of ceramic and metal humeral hemiarthroplasties on natural glenoids. Methods. Intact right cadaveric shoulders from donors aged between 50 and 65 years were assigned to a ceramic group (n = 8, four male cadavers) and a metal group (n = 9, four male cadavers). A dedicated shoulder wear simulator was used to simulate daily activity by replicating the relevant joint motion and loading profiles. During testing, the joint was kept lubricated with diluted calf serum at room temperature. Each test of wear was performed for 500,000 cycles at 1.2 Hz. At intervals of 125,000 cycles, micro-CT scans of each glenoid were taken to characterize and quantify glenoid wear by calculating the change in the thickness of its articular cartilage. Results. At the completion of the wear test, the total thickness of the cartilage had significantly decreased in both the ceramic and metal groups, by 27% (p = 0.019) and 29% (p = 0.008), respectively. However, the differences between the two were not significant (p = 0.606) and the patterns of wear in the specimens were unpredictable. No significant correlation was found between cartilage wear and various factors, including age, sex, the size of the humeral head, joint mismatch, the thickness of the native cartilage, and the surface roughness (all p > 0.05). Conclusion. Although ceramic has better tribological properties than metal, we did not find evidence that its use in hemiarthroplasty of the shoulder in patients with healthy cartilage is a better alternative than conventional metal humeral heads. Cite this article: Bone Joint J 2024;106-B(11):1273–1283

Aims. Head-taper corrosion is a cause of failure in total hip arthroplasty (THA). Recent reports have described an increasing number of V40 taper failures with adverse local tissue reaction (ALTR). However, the real incidence of V40 taper damage and its cause remain unknown. The aim of this study was to evaluate the long-term incidence of ALTR in a consecutive series of THAs using a V40 taper and identify potentially related factors. Methods. Between January 2006 and June 2007, a total of 121 patients underwent THA using either an uncemented (Accolade I, made of Ti. 12. Mo. 6. Zr. 2. Fe; Stryker, USA) or a cemented (ABG II, made of cobalt-chrome-molybdenum (CoCrMo); Stryker) femoral component, both with a V40 taper (Stryker). Uncemented acetabular components (Trident; Stryker) with crosslinked polyethylene liners and CoCr femoral heads of 36 mm diameter were used in all patients. At a mean folllow-up of 10.8 years (SD 1.1), 94 patients (79%) were eligible for follow-up (six patients had already undergone a revision, 15 had died, and six were lost to follow-up). A total of 85 THAs in 80 patients (mean age 61 years (24 to 75); 47 (56%) were female) underwent clinical and radiological evaluation, including the measurement of whole blood levels of cobalt and chrome. Metal artifact reduction sequence MRI scans of the hip were performed in 71 patients. Results. A total of 20 ALTRs were identified on MRI, with an incidence of 26%. Patients with ALTR had significantly higher median Co levels compared with those without ALTR (2.96 μg/l (interquartile range (IQR) 1.35 to 4.98) vs 1.44 μg/l (IQR 0.79 to 2.5); p = 0.019). Radiological evidence of osteolysis was also significantly associated with ALTR (p = 0.014). Median Cr levels were not significantly higher in those with ALTR compared with those without one (0.97 μg/l (IQR 0.72 to 1.9) v 0.67 μg/l (IQR 0.5 to 1.19; p = 0.080). BMI, sex, age, type of femoral component, head length, the inclination of the acetabular component, and heterotopic ossification formation showed no significant relationship with ALTR. Conclusion. Due to the high incidence of local ALTR in our cohort after more than ten years postoperatively, we recommend regular follow-up investigation even in asymptomatic patients with V40 taper and metal heads. As cobalt levels correlate with ALTR occurrence, routine metal ion screening and consecutive MRI investigation upon elevation could be discussed. Cite this article: Bone Joint J 2022;104-B(7):852–858

Purpose of Study:. To look at the difference in metal ion levels using Ceramic on Metal (COM) and Metal on Metal (MOM) bearings in Total Hip Replacements, comparing the results between well placed and poorly placed cups. Methods:. Metal ion levels using the ICP-MS method of assay have been studied as part of a prospective randomised trial between 4 different bearing combinations. The ion levels have been raised in the COM and MOM bearings. Metal ions are not raised in the Ceramic on Ceramic (COC) and Ceramic on X linked Poly(COP) bearings, showing that no other material in the study prosthesis aside from the bearing surfaces contribute to raised ion levels. Cup inclination and cup anteversion has been measured in all patients. Results:. At 3 year follow-up the Cobalt and Chrome levels are significantly lower with the COM bearing than the MOM bearing when both well and poorly placed cups are included, and seem to be returning to normal pre-operative levels. Taking cups put in in Lewinnik's safe zones, then the Chrome levels are similar between the two bearings, but the Cobalt levels remain raised in the MOM bearing. Conclusion:. Cobalt and Chrome levels are significantly lower in COM bearings than MOM bearings when cups are not placed in the ideal position. This represents an added advantage in the use of COM bearings as compared to MOM bearings

Metal on Metal coupling in total hip replacement has been widely used since many years. After the rebirth of resurfacing a new trend to use very large diameter metal-metal coupling with standard stem prostheses has been started. New prostheses, old and new problems. We analyze first failures with new large diameter metal on metal coupling. The analysis focused on seven early failures of large diameter metal-metal prostheses (two resurfacing and five cementless prosthesis with XL head) over the first series of 350 cases (100 resurfacing and 250 cementless) in the first year. Synovial fluid aspiration have been performed in all failed patients searching for metal ions and bacterial proliferation. Moreover, prosthetic component positioning was also studied as a possible primum movens of these failures. Some failed patients underwent epicutaneous patch test for skin reaction to metal. One resurface prosthesis failed as a result of an vascular necrosis and conseguent fracture of the femoral neck and revealed a moderate increment in metal ion concentration in blood and synovial fluid obtained at time of revision. One resurface prosthesis failed as a result of an infected metallosis with a huge intraabdominal mass and revealed a huge increment in metal ion concentration in blood, addominal and synovial fluid. This patient underwent a lumbotomy to evacuate the abdominal retroperitoenal mass before prosthesis removal for a two step procedure. Out of the five failures of metal on metal cementless prosthesis with XL head four were the result of aseptic loosening and one was the result of a low grade infection discovered at coltures after revision surgery. Three showed clear metallosis caused by wrong positioning (more than 50° of cup inclination). All of these three presented an articular noise and elevated blood and sinovial fluid metal ion concentration. The fourth patient with aseptic loosening had a good component positioning but demonstrated an epicutanous allergic reaction to Cobalt. Also one of the three patients with metallosis resulted allergic to Cobalt. The blood and sinovial metal ion values were always elevated but particularly high in patients with cup inclination over 50°. Large head metal on metal prostheses demonstrated a higher percentage of early failure in our experience. They are very sensible to positioning. Blood and sinovial metal ion determination helps to promptly diagnose a bad metal on metal prosthetic functioning. A more accurate analysis about the different metals available on the market and their resistance to edge wear should not be delayed any further

Cemented total hip arthroplasty yields reliable results in short to medium term studies, but aseptic loosening remains a problem in long-term follow up, especially in young and active patients. Aseptic loosening has been related to wear, and in order to minimize wear various alternatives to the traditional metal on polyethylene have been proposed. Both ceramic on polyethylene (COP) and metal on metal (MOM) have been shown to produce less wear than metal on polyethylene (MOP). In order to study the effect of the bearing, we have utilized identical stems and cups while comparing the different bearings. Methods and material. 396 hips were randomized to MOP, COP or MOM using a cemented triple tapered polished stem (MS-30; Sulzer Orthopedics) with a cemented polyethylene cup (Weber; Sulzer, Orthopedics) and a 28 millimeter head. For the MOP and COP articulations, a all-polyethylene cup was used with a Protasul™ metal head or a Sulox™ alumina head, whereas a polyethylene cup with metal insert was used for the MOM articulations (Weber Polyethylene Cup with Metasul™ Insert) with a Metasul™ metal head. Harris Hip Score (HHS) and radiological evaluation was performed after two, five and seven years. Ethical approval was obtained. Results. HHS was available for 338 hips after seven years. The HHS in the MOP group (116 hips) was 93.7 (SD 9.0), 93.5 in the COP group (112 hips) (SD 8.8), and 91.0 (SD 13.4) in the MOM group (110 hips). Radiographic evaluation was available for 335 hips. Radiolucencies around the stem larger than one millimeter were found in five of 115 MOP hips, seven of 111 COP hips and in seven of 110 MOM hips. Periacetabular radiolucencies identified as larger than one millimeter were found in none of the 116 MOP hips, five of the 112 COP hips and in 19 of the 110 MOM hips. Ten revisions were performed. In the MOP group there were three revisions (infection, dislocation, pain); one in the COM group (infection), and six in the MOM group (three infections, two aseptic loosening and one septic loosening). Discussion. Clinically, the three bearing types perform equally well at seven years, and there are few signs of impending failure for the stem. However, there are an alarmingly high proportion of cups showing signs of loosening. Two hips have been revised in the MOM group for aseptic loosening as opposed to none in the two other groups, which adds to the concern. The MOM articulation used in this study should be monitored closely for signs of aseptic loosening

Introduction. It is well-known that wear debris generated by metal-on-metal hip replacements leads to aseptic loosening. This process starts in the local tissue where an inflammatory reaction is induced, followed by an periprosthetic osteolysis. MOM bearings generate particles as well as ions. The influence of both in human bodies is still the subject of debate. For instance hypersensitivity and high blood metal ion levels are under discussion for systemic reactions or pseudotumors around the hip replacement as a local reaction. The exact biopathologic mechanism is still unknown. The aim of this study was to investigate the impact of local injected metal ions and metal particles. Material and Methods. We used an established murine inflammation model with Balb/c mice and generated three groups. Group PBS (control group, n=10) got an injection of 50µl 0.1 vol% PBS-suspension, Group MI (Metal-ion, n=10) got an injection of 50µl metal ion suspension at a concentration of 200µg/l and Group MP (Metal-particles, n=10) got an injection of 50µl 0.1 vol% metal particle suspension each in the left knee. After incubation for 7 days the mice were euthanized and the extraction of the left knee ensued. Followed by immunhistochemical treatment with markers of inflammation that implied TNFα, IL-6, IL-1β, CD 45, CD 68, CD 3, we counted the positive cells in the synovial layer in the left knees by light microscopy, subdivided into visual fields 200× magnified. The statistical analysis was done with Kruskal-Wallis test and a post hoc Bonferroni correction. Results. The Group with metal particles showed significantly elevated inflammatory markers (TNFα, IL-6, IL-1β, CD 68, CD 45) compared to all other groups. Interestingly, CD 3 as a marker for T-lymphocytes showed no increased levels in all groups. The metal ion group showed significant elevated CD 45 expressions compared to the control group. Conclusion. The results clearly demonstrate that especially metal wear particles lead to an intensive inflammatory reaction. The tissue formations in the metal particle group show an osseous destructive behavior in previously demonstrated results, comparable to pseudotumors. But, in this study, the expression of the immunohistological markers CD 3, CD 45 and CD 68 indicate that the tissue consists of leucocytes and macrophages, whereas lymphocytes could not be detected. This might be due to an acute inflammatory reaction, whereas the adaptive immune response by T-lymphocytes seems not (yet) to be activated. Overall it must be stated that solid metal wear particles are responsible for local inflammatory reactions, whereas it is still unknown whether wear particles corrode in vivo and release a potentially high level of locally toxic metal ions

Introduction and Aims: Polyethylene wear continues to be the most significant issue following total hip arthroplasty (THA), leading to the current increase in use of alternative bearing surfaces. We performed a prospective, randomised, blinded clinical trial comparing metal versus polyethylene bearing surfaces in patients receiving THA. Method: Forty-one patients were randomised to receive a metal (23) or a polyethylene (18) insert with identical femoral and acetabular components. Patients were evaluated pre-operatively at three, six, 12 months and annually thereafter, including an evaluation of erythrocyte and 24-hour urine cobalt, chromium and titanium metal ion levels, validated outcome measures (WOMAC, SF-12, Harris Hip Score) and radiographs. Results: No patients were lost to follow-up. One patient died of unrelated causes. At an average 4.4 (range 3.3–5.1) years follow-up there were no differences in any outcome measures or radiographic findings. Patients receiving metal liners had significantly elevated metal ion measurements. At the latest follow-up erythrocyte cobalt levels were seven times elevated (median 1.2μg/l (metal) Vs 0.18μg/l (poly), p< .001). Urine cobalt levels were 41 times elevated (median 11.9μg/day (metal) Vs 0.29μg/day (poly), p< .001) and urine chromium levels were 14 times elevated (median 4.9μg/day (metal) Vs 0.36μg/day (poly), p< .001). Erthrocyte chromium, titanium and urine titanium were not significantly different between groups. As well, contrary to previous reports, there was not a significant trend towards decreasing ion levels over time. Conclusion: In this prospective randomised blinded clinical trail comparing metal to polyethyle bearing surfaces, both cobalt and chromium ion levels were significantly elevated in the blood and urine of the patients randomised to receive the metal on metal THA

Introduction: Local problems of metal on metal (MOM) hip arthroplasty such as pseudotumours, neck thinning and osteolysis maybe related to concentrations of cobalt and chromium ions in the synovial fluid. There is little reported on these values. Our aim was to determine the range of metal ion levels in synovial fluid, and to investigate the relationship between these samples and simultaneous blood samples. Methods: Synovial fluid and whole blood samples were taken from 30 consecutive patients at the time of revision surgery for a painful MOM hip. Aspirated fluid was not visibly contaminated with blood. Impants were in situ for a mean period of 31 months. All had normal renal function. Samples were analysed using ICP mass spectrometry and compared with 10 samples from patients without implants. Results: The mean (and range) of synovial fluid metal ion levels were 1965 ug/l (30 to 13618) and 6265 ug/l (11 to 81630) for Cobalt and Chromium respectively. There was a good correlation between synovial and blood levels for both cobalt (R=0.65, p = 0.0001) and chromium (R = 0.59, p = 0.006). Discussion and Conclusion: Metal ions in synovial fluid from MOM hips are generated from wear of the bearing surfaces, the correlation with blood metal ion levels, shown in this study, suggest that blood levels may be used as surrogate marker for hip wear rate. Our range of synovial fluid metal ion levels may be useful for those conducting in vitro studies on the biocompatibility of MOM hips

Aims. Metal and ceramic humeral head bearing surfaces are available choices in anatomical shoulder arthroplasties. Wear studies have shown superior performance of ceramic heads, however comparison of clinical outcomes according to bearing surface in total shoulder arthroplasty (TSA) and hemiarthroplasty (HA) is limited. This study aimed to compare the rates of revision and reoperation following metal and ceramic humeral head TSA and HA using data from the National Joint Registry (NJR), which collects data from England, Wales, Northern Ireland, Isle of Man and the States of Guernsey. Methods. NJR shoulder arthroplasty records were linked to Hospital Episode Statistics and the National Mortality Register. TSA and HA performed for osteoarthritis (OA) in patients with an intact rotator cuff were included. Metal and ceramic humeral head prostheses were matched within separate TSA and HA groups using propensity scores based on 12 and 11 characteristics, respectively. The primary outcome was time to first revision and the secondary outcome was non-revision reoperation. Results. A total of 4,799 TSAs (3,578 metal, 1,221 ceramic) and 1,363 HAs (1,020 metal, 343 ceramic) were included. The rate of revision was higher for metal compared with ceramic TSA, hazard ratio (HR) 3.31 (95% confidence interval (CI) 1.67 to 6.58). At eight years, prosthesis survival for ceramic TSA was 98.7% (95% CI 97.3 to 99.4) compared with 96.4% (95% CI 95.2 to 97.3) for metal TSA. The majority of revision TSAs were for cuff insufficiency or instability/dislocation. There was no significant difference in the revision rate for ceramic compared with metal head HA (HR 1.33 (95% CI 0.76 to 2.34)). For ceramic HA, eight-year prosthetic survival was 92.8% (95% CI 86.9 to 96.1), compared with 91.6% (95% CI 89.3 to 93.5) for metal HA. The majority of revision HAs were for cuff failure. Conclusion. The rate of all-cause revision was higher following metal compared with ceramic humeral head TSA in patients with OA and an intact rotator cuff. There was no difference in the revision rate for HA according to bearing surface. Cite this article: Bone Joint J 2024;106-B(5):482–491

Objectives. Alarm over the reported high failure rates for metal-on-metal (MoM) hip implants as well as their potential for locally aggressive Adverse Reactions to Metal Debris (ARMDs) has prompted government agencies, internationally, to recommend the monitoring of patients with MoM hip implants. Some have advised that a blood ion level >7 µg/L indicates potential for ARMDs. We report a systematic review and meta-analysis of the performance of metal ion testing for ARMDs. Methods. We searched MEDLINE and EMBASE to identify articles from which it was possible to reconstruct a 2 × 2 table. Two readers independently reviewed all articles and extracted data using explicit criteria. We computed a summary receiver operating curve using a Bayesian random-effects hierarchical model. Results. Our literature search returned 575 unique articles; only six met inclusion criteria defined a priori. The discriminative capacity of ion tests was homogeneous across studies but that there was substantial cut-point heterogeneity. Our best estimate of the “true” area under curve (AUC) for metal ion testing is 0.615, with a 95% credible interval of 0.480 to 0.735, thus we can state that the probability that metal ion testing is actually clinically useful with an AUC ≥ 0.75 is 1.7%. Conclusion. Metal ion levels are not useful as a screening test for identifying high risk patients because ion testing will either lead to a large burden of false positive patients, or otherwise marginally modify the pre-test probability. With the availability of more accurate non-invasive tests, we did not find any evidence for using blood ion levels to diagnose symptomatic patients. Cite this article: M. Pahuta, J. M. Smolders, J. L. van Susante, J. Peck, P. R. Kim, P. E. Beaule. Blood metal ion levels are not a useful test for adverse reactions to metal debris: a systematic review and meta-analysis. Bone Joint Res 2016;5:379–386. DOI: 10.1302/2046-3758.59.BJR-2016-0027.R1

Aims. Metal allergy in knee arthroplasty patients is a controversial topic. We aimed to conduct a scoping review to clarify the management of metal allergy in primary and revision total knee arthroplasty (TKA). Methods. Studies were identified by searching electronic databases: Cochrane Central Register of Controlled Trials, Ovid MEDLINE, and Embase, from their inception to November 2020, for studies evaluating TKA patients with metal hypersensitivity/allergy. All studies reporting on diagnosing or managing metal hypersensitivity in TKA were included. Data were extracted and summarized based on study design, study population, interventions and outcomes. A practical guide is then formulated based on the available evidence. Results. We included 38 heterogeneous studies (two randomized controlled trials, six comparative studies, 19 case series, and 11 case reports). The evidence indicates that metal hypersensitivity is a rare complication with some histopathological features leading to pain and dissatisfaction with no reliable screening tests preoperatively. Hypoallergenic implants are viable alternatives for patients with self-reported/confirmed metal hypersensitivity if declared preoperatively; however, concerns remain over their long-term outcomes with ceramic implants outperforming titanium nitride-coated implants and informed consent is paramount. For patients presenting with painful TKA, metal hypersensitivity is a diagnosis of exclusion where patch skin testing, lymphocyte transformation test, and synovial biopsies are useful adjuncts before revision surgery is undertaken to hypoallergenic implants with shared decision-making and informed consent. Conclusion. Using the limited available evidence in the literature, we provide a practical approach to metal hypersensitivity in TKA patients. Future national/registry-based studies are needed to identify the scale of metal hypersensitivity, agreed diagnostic criteria, and management strategies. Cite this article: Bone Jt Open 2021;2(10):785–795

During the past fifty years metal hip implants have been used in orthopaedics. While these implants are considered biologically inert, several studies indicated that prosthetic implants could release metal ions following wear. The aim of this study was to evaluate serum and urine concentrations of metal ions in patients treated with hybrid surface replacement of the hip. Co, Cr, Mn, Mo, and Ni in the serum and urine of 14 patients and 19 controls were quantified by Sector Field Inductively Coupled Plasma Mass Spectrometry (SF-ICP-MS). A Spectrometer ELEMENT (Finnigan MAT, Bremen, Germany) was used at the following resolution: 98Mo, 100Mo, (m/D;m = 300); 52Cr, 53Cr, 55Mn, 59Co, 60Ni, (m/D;m = 3000). The internal standard method (In) was applied to correct the random fluctuations of the signal. Indium was added to the sample solutions so as to reach a final concentration of 1 ng mL-1. Limits of Detection were calculated on the basis of the 3=555; criterion for 10 replicate measurements of solutions containing dilute pooled blood serum and dilute pooled urine, and recovery was obtained by quantifying the analytes of interest in spiked serum and urine. Recoveries of the elements ranged between 94.6% (serum Cr) and 118% (urine Ni). Data support the assumption that the concentrations of Co and Cr (the major components of the alloy) are substantially higher in serum and urine of patients than in those of controls while for the other elements no specific trend could be observed. Actually there isn’t any explanation on the possible biological consequences related to the increase of the metal ions levels although many hypothesis have been made. Further studies are thus mandatory to clarify this pattern

Introduction: Several studies have shown the presence of cobalt (Co) and chromium (Cr) ions in blood, urine, and organs of patients after THA using Co-Cr alloy-based implants. Even though it is well known that exposure to heavy metals may lead to significant alterations in human sperm morphology and motility, less is known on the effect of Co and Cr on semen parameters after metal on metal (MOM) hip replacement. Methods: Semen was collected form 10 patients between 41 and 49 years old (mean=45.9±3.0 years) by masturbation after 2–3 days of abstinence. The time of implantation varied from 1 to 9 years (mean=5.1±3.9 years). Samples were collected in a sterile container and examined within 1h after ejaculation for morphology, motility, and number of sperm cells following standard criteria. All patients were doing well at their follow-up visits (Harris Hip Score=94±4; UCLA activity a score=7±1) and no sign of osteolysis was observed on X-rays. Co and Cr concentrations were measured in both the seminal plasma and in the blood of patients by inductively coupled plasma-mass spectroscopy (ICP-MS). Results: results showed that the levels of Co in the seminal plasma and the blood of the patients were not statistically different. However, the level of Cr was significantly lower in the seminal plasma than in the blood of the patients. The ejaculate volume (2.1 ±0.6 ml), the sperm density (66±53 x 106), the total sperm count (151±75 x 106/ml), the pH (8), and the percentage of normal morphology (46±18%) were in the range of the WHO criteria for fertile population and also in the range of reference patients in the city of measurements. However, the viability was lower than that observed in a fertile population without prosthesis (41±19%). Conclusions: results of the present study strongly suggest that both Co and Cr ions crossover to the semen but that their concentrations were too low to significantly affect sperm parameters of young patients with MM prosthesis. Further longitudinal studies are however necessary to conclusively determine the effect of metal ions from MM prosthesis on sperm parameters

Aims: Measure serum chromium (SrCr) and cobalt (SrCo) and urine chromium (UCr) levels in patients with metal on metal surface arthroplasty of the hip. Methods: Ion levels were measured prospectively in 22 patients implanted with the Conserve Plusª (Wright Medical, TN) CoCr hip resurfacing. There were 15 males and 7 females with an average age of 49 years (range 28 Ð 62 yr). Serum and urine samples were collected using strict anti-contamination techniques pre-operatively and at 3, 6 and 12 months using graphite furnace atomic absorption spectrophotometry. Results: All postoperative metal levels were increased compared to their pre-operative levels. SrCr and SrCo values are at their highest at 3 months post operative and then begin to decrease. UrCr although elevated at 3 and 6 months postoperatively compared to the preop values, the levels continued to increase after the 6-month interval. These values are approximately 4-fold, 7-fold and 3-fold higher in SrCr, UrCr and SrCo, respectively, compared to the values seen in a group of patients with well functioning conventional metal (CoCr) on polyethylene total hips at 84 months postoperative measured by our group. Conclusions: The present levels are 2-fold lower in both SrCr and UrCr and 3-fold lower in SrCo than a group of patients with older generation surface arthroplasties reported previously by our group, suggesting improved manufacturing techniques and material properties have resulted in reduced component wear and generation of wear particles. 12 and 24 month data are currently being collected and analyzed

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

Introduction. Cemented stems have shown 90–100% survivorship when coupled with polyethylene acetabular component. This study aims to compare cemented stem behaviour in combination with large metal on metal (MOM) vs. metal on poly (MOP) bearings. Patients and Methods. 100 patients were recruited into a single centre RCT (we required 40 in each group for power .90 to confirm stem subsidence of >0.5mm at 2 years; p< 0.05). Recruits were randomized to MOP (28mm) or MOM femoral heads with CPCS cemented femoral stem. Assessments included X-rays (AP pelvis), Harris Hip Scores, blood metal ion levels and patient questionnaires (WOMAC, SF-36, satisfaction questionnaire). Evaluations were done pre-operatively and 3, 12 and 24 months post operatively; blood metal ion measures at 1 year. Results. There were 50 patients in each arm of study matched for age (64 ± 8.5) and BMI (29.04 ±5.5). There was no difference in femoral stem subsidence at 2 years 1.34 (±1.3) and 1.4 (±1.2) mm for MOM and MOP respectively (p=0.88). There was significant improvement in HHS from pre-op to 3 months: 41 to 87 for MOM and 44 to 86 for MOP (p=0.00). This was maintained with no difference between groups at 2 years (p=0.74). Similar pattern was seen for WOMAC and SF-36 scores for both groups at 2 years (p>0.05). Increased blood Cobalt and Chromium levels were observed in 17% and 0% for MOM and MOP group. MOM group reported better patient satisfaction for overall (91% vs. 79%), pain relief (82% vs 66%) and improvement in ADL activities (94% vs.70%) at 2 years. Conclusions. There were no significant differences between groups for stem behavior, clinical and patient reported outcomes. Despite higher patient satisfaction reported by MOM patients, increased metal ion levels had raised concerns regarding the use of MOM bearings with cemented stems for primary THR