Introduction. The observation of elevated heavy metal ions in arthroplasty patients in association with complications has led to concern on the part of patients and surgeons. The aim of this study was to determine the levels of cobalt chromium ions in three compartments, the joint fluid, plasma, and CSF. Method. Patients were divided into 3 groups:. 239 without any implant(M132F108). 50 having a supplementary implant, with a well performing contralateral THR. – 16 large head MoM arthroplasty (Birmingham modular M7F9). – 44 a Birmingham resurfacing(M39F5). 6 revisions of MoM bearings(M3F3). Blood and CSF specimens were harvested at the time of induction of anaesthesia. Joint fluid was aspirated before the surgical incision was made under sterile conditions. Cobalt was assayed using an Agilent7500ce inductively coupled plasma mass spectrometer. Chromium was assayed with a graphite furnace atomic absorption spectrometer (Varian240zlGFAAS). Bivariate correlations were used to determine similarities between group. Results. All results are in nanomoles/litre. Primary group. Blood: Co4.62±3.86; Cr6.10+I-4.17. CSF: Co2.43±3.44; Cr4.82±3.24. Supplementary group:. THR. Blood: Co37.3±62.96; Cr29.2±45.2. CSF: Co3.7±2.6;Cr7.4±4.9. BHR. Blood: Co35.2+I-48.8; Cr66.5+I-1 01.03. CSF: Co4.7±11.6;Cr6.6-'-I-4.1. Revision Group. Joint Fluid: Co5184.5±4662.9; Cr4452.7 ±3302.9. Blood: Col 07.5+1–77.6, Cr127.5±90.2. CSF: Co6.3±3.0, Cr8.3+I-6.2. Comparing with total hip with resurfacing patients, cobalt levels were not significantly different, but chromium levels were higher in resurfacing patients. The CSF levels, however, were not significantly different in the two groups. The CSF chromium level in all circumstances was higher than the cobalt. In patients with well functioning prostheses the blood ion levels were some 50% to 100% higher than patients without prostheses. While cobalt was higher in the joint fluid and the blood measurements, chromium was higher in the CSF. CSF measurements in the three groups of patients with pre-existing implant either well functioning or not, were not significantly different. The blood levels obtained are consistent with that described as reference values” for cobalt and chromium provided in pathology reports. On that basis, we believe that the CSF levels in the samples tested are an accurate representation of the levels. Conslusion. Blood sample chromium levels were higher than cobalt levels with the exception of total hip replacements. In spite of high levels and joint fluid, and less than 5% of the ion level was found in the blood. Of the blood level, less than 15% of was reflected in the CSF

Aim. Adverse tissue reactions have been a concern in relation to metal components, particularly in hip replacements. We look at a possible correlation between hip joint effusion and metal ion levels. Materials and methods. 56 patients,(42M, 14F) agreed to the study. All had metal-on-mental arthroplasties. Average age was 64.2 (SD 9.8). All patients were asymptomatic. Ultrasound examination performed by one ultrasonographer, using a Sonosite M-Turbo machine with a C60X/5-2 MHz transducer. Cobalt levels were assessed using an inductively coupled plasma mass spectrometer. Chromium levels were assessed using a graphite furnace atomic absorption spectrometer. Results. Average blood ion levels were:. Cobalt 39.02 nmol/L. (SD41.18) range 3 to 215. Chromium 52.51 nmol/L (SD47.48) range 5 to 284. Average Volume: 10.38ml (SD21.3) Range 0 to 219. Conclusion. There was no statistically significant correlation between joint effusion and metal ion levels

Aims. The aim of this study was to present the first retrieval analysis findings of PRECICE STRYDE intermedullary nails removed from patients, providing useful information in the post-market surveillance of these recently introduced devices. Methods. We collected ten nails removed from six patients, together with patient clinical data and plain radiograph imaging. We performed macro- and microscopic analysis of all surfaces and graded the presence of corrosion using validated semiquantitative scoring methods. We determined the elemental composition of surface debris using energy dispersive x-ray spectroscopy (EDS) and used metrology analysis to characterize the surface adjacent to the extendable junctions. Results. All nails were removed at the end of treatment, having achieved their intended lengthening (20 mm to 65 mm) and after regenerate consolidation. All nails had evidence of corrosion localized to the screw holes and the extendable junctions; corrosion was graded as moderate at the junction of one nail and severe at the junctions of five nails. EDS analysis showed surface deposits to be chromium rich. Plain radiographs showed cortical thickening and osteolysis around the junction of six nails, corresponding to the same nails with moderate – severe junction corrosion. Conclusion. We found, in fully united bones, evidence of cortical thickening and osteolysis that appeared to be associated with corrosion at the extendable junction; when corrosion was present, cortical thickening was adjacent to this junction. Further work, with greater numbers of retrievals, is required to fully understand this association between corrosion and bony changes, and the influencing surgeon, implant, and patient factors involved. Cite this article: Bone Jt Open 2021;2(8):599–610

Introduction. Total hip replacement with metal-on-polymer (MoP) hip prostheses is a successful treatment for late-stage osteoarthritis. However, the wear debris generated from the polymer acetabular liners remains a problem as it can be associated with osteolysis and aseptic loosening of the implant. This has led to the investigation of more wear resistant polymers in orthopaedics. Cross-linked polyethylene (XLPE) is now the gold-standard acetabular liner material. However, we asked if carbon fibre reinforced polyether ether ketone (CFR-PEEK) might be a lower wear material. In addition, we sought to understand the influence of contact stress on the wear of both XLPE and CFR-PEEK as this has not previously been reported. Materials and Methods. A 50-station circularly translating pin-on-disc (SuperCTPOD) machine was used to wear test both XLPE and CFR-PEEK pins against cobalt chromium (CoCr) discs to investigate the influence of contact stress on their wear rates. Fifty XLPE and 50 CFR-PEEK pins were articulated against CoCr discs. The pins, 9 mm in outer diameter and 12 mm in height, were drilled with different diameter holes to generate different sized annuli and thus, different contact areas. The pins were tested at 1.10, 1.38, 1.61, 2.00 and 5.30 MPa, which are typical contact stresses observed in the natural hip joint. An additional pin for every test group was used as a control to track the lubricant uptake. The discs were polished to 0.015 μm Sa prior to testing. The test stations contained 16 ml of diluted newborn calf serum (protein concentration: 22 g/L). Wear was measured gravimetrically with a balance (resolution: 10 μm) every 500,000 cycles. A standardised cleaning and weighing protocol was followed. Results and Discussion. The wear rates for the XLPE pins were calculated as 1.05, 0.90, 0.77, 0.48 and 0.28 mg/million cycles for the different pin stress groups respectively. The wear rates decreased with increasing contact stress, which was similar to what was observed for ultra-high molecular weight polyethylene (UHMWPE). The change in weight of the discs was insignificant (p-value:0.85). For the CFR-PEEK pin groups, the wear rates were calculated as 0.56, 0.65, 0.61, 0.58 and 0.65 mg/million cycles respectively. The difference between the wear rates was insignificant (p-value: 0.92). However, the weight of the discs decreased significantly (p-value: 0.00). At 1.11 MPa and taking data for UHMWPE tested in the same way, comparison of the three polymers showed that CFR-PEEK produced the lowest wear against CoCr. Although the wear rates for CFR-PEEK were found to be the lowest, the decrease in weight of the CoCr discs articulated against CFR-PEEK was indicative of metallic wear. Conclusion. CFR-PEEK should not be used against orthopaedic metals. XLPE articulating against CoCr was found to be the optimum combination, producing low wear without causing weight change from the counterface, under varying contact stresses

Metal on metal total hip arthroplasty provides the potential improvement in articular wear and the use of large-diameter femoral heads following the prospect for reduction in the risk of dislocation. The purpose of this study was to compare the clinical and radiographic outcomes as well as serum metal ion level between the two different component designs with small and large femoral heads in metal on metal total hip arthroplasty. We studied 39 patients with large head (Magnum®, Biomet; cup size minus 6 mm) and 37 patients with small head (M2a taper®, Biomet; 28 or 32 mm head) of metal on metal total hip arthroplasty between December 2009 to October 2011 with follow-up of 2.1 years (1.0–3.3 years) after surgery. Harris Hip Score, UCLA activity score, EQ-5D, radiographic assessment, and serum cobalt and chromium ion levels were evaluated. Harris Hip Score, UCLA activity score, and EQ-5D were improved after surgery in small and large head groups, however, no significant differences were observed between both groups. Cup inclination was below 50 degree in all prosthesis. No loosening and no osteolysis were observed. Cobalt and chromium ion was not detected before surgery; however, metal ion levels of both groups were increased after surgery in time dependent manner. There was no significant difference between two groups at one year after surgery. One patient in each group showed the increase of cobalt ion level over 7 ppb (15.4 ppb, 12.9 ppb) without any clinical symptom including pain. Cup inclination was 29 degree in both patients and cup anteversion was 38 and 41 degree, respectively. There was no significant difference of ion levels between both groups. No dislocation was observed in large head group while one dislocation occurred in small head group. No patients required the revision surgery. This metal on metal component, especially with large femoral heads, showed the good clinical results at the maximum follow up of 3.3 year after surgery. However, the ion level of two patients increased over 7 ppb and longer follow-up will be needed

Introduction. Revision of total hip replacements (THRS) is predominantly due to aseptic loosening, pain and infection [1]. The current method used to address the risk of infection is to administer antibiotics and to include antibacterial agents into bone cement (if used) and on implant coatings [2–4]. Currently, silver (Ag) coatings have only been applied to titanium hip stems [3]. Cobalt chromium alloy (CoCr) is a widely used orthopaedic alloy which is commonly used as a bearing surface; revisions of joints using this material often describe adverse reactions to the particulate wear debris [1]. This study considers an Ag containing CrN based coating on a CoCr substrate with the aim to reduce cobalt (Co) release and promote antibacterial silver release. Methods. Silver Chromium Nitride (CrNAg) coatings were developed and applied onto the bearing surfaces of 48 mm diameter metal-on-metal THRs. Three coatings were evaluated: high Ag at the surface (CrNAg+), low Ag at surface (CrNAg-) and uniform Ag (CrNAg=). All bearings were tested under ISO 14242-3 conditions for 0.17 million cycles (mc) representing approximately 2 months use in vivo. Wear was determined gravimetrically; Ag and Co levels in the lubricant were measured using graphite furnace atomic absorption spectroscopy. Testing of the CrNAg= bearings were continued to 2mc under standard conditions; CrNAg- bearings to 5mc incorporating lateralisation, which created separation at swing phase and rim contact at heel strike. Wear volume and Ag/Co release were monitored at 0.33, 0.67, 1mc and every mc thereafter. Results. All bearings produced low levels of wear and released silver into the lubricating fluid. An increase in silver concentration at the surface of the bearings was found to increase both the silver released and wear, Figure 1. Negligible cobalt was released. Testing of the CrNAg= coating to 2mc showed the wear rate to decrease after 0.17mc, Figure 2. Ag release continued up to 2mc but at a decreased rate. The CrNAg- coating tested under lateralisation conditions to 5mc showed no coating failure and negligible cobalt release. Wear and silver release showed similar patterns and reached a steady state after 1mc, Figure 3. Discussion. The AgCrN coatings on bearing surfaces of a hip joint are capable of releasing Ag at concentrations within the ‘No Observable Adverse Effect Limit’ [5]. These coatings also prevented Co release while maintaining a low wear rate. All coatings remained intact and did not delaminate, even under adverse conditions. These coatings have been tested in a metal-on-metal hip bearing surface, the most controversial and challenging condition for a coating, wearing against itself. CoCr is used as a bearing surface against polyethylene in hips and knees, in stems and tapers, as tibial trays in knee replacement and as shells for acetabular cups. This coating may be applied to a wide range of applications, removing some of the challenges over the use of CoCr while reducing infections

Introduction. The metal-on-metal (MoM) total hip prosthesis is widely used. However, the adverse reactions such as pseudotumor around the total hip prosthesis are observed. This is considered the effect of the corrosion of alloy which includes metal ion release and the wear particle generation. As materials for total hip prostheses, cobalt chromium (Co-Cr) alloy is used because of the wear resistance and corrosion resistance. The passive film on the surface of alloy contributes to corrosion resistance. The passive film is removed easily with friction. Therefore, metal ion is released from bare metal. However, this removal of passive film can be restored because of oxidation reaction with neighboring environment. The modular MoM total hip prosthesis such as acetabular component-femoral head or taper junction which connect femoral head and stem have friction interfaces. The friction amplitudes must be different among these interfaces. However, how sliding amplitude affects on removal of a passive film is unclear. The main purpose of this study was to investigate the effect of the sliding amplitude of the reciplocating micromotion on removal and reformation of the passive film of Co-Cr alloy. Methods. The behavior of the passive film was observed by measuring the electric potential of the alloy. Co-Cr alloy (ASTM F75) pin specimen and common tablet specimen were immersed in simulated body fluid PBS(−) and abraded with friction testing machine. The electronic potential between the pin and the Ag/AgCl reference electrode (RE-1C, ALS, Tokyo, Japan) were measured using a high impedance electrometer (HE-104E, HOKUTO DENKO, Tokyo, Japan). The friction amplitude was chosen from 0.2–2 mm. The reciprocating cycle was 1 Hz. The load of 10 N applied on the pin by a weight. Results and discussion. The electric potential neared equilibrium before the friction, and the passive film was stable. Electric potential dropped with the onset of friction and gradually increased with the cessation of friction. The potential difference ΔV and a time constant τ of the rise in electric potential after the friction were estimated. Those ΔV and τ were used as the indicator of the passive film destruction and restoration, respectively. At the friction amplitude of 0.2 mm, ΔV was lowest among at the other amplitudes. On the other hand, τ tended to be longer (Fig. 2). It showed that the reformation of passive film was delayed. When the removal of the passive film was repeated on local area of the friction interfaces, it was presumed similar to a phenomenon of the crevice corrosion. To view tables/figures, please contact authors directly

PURPOSE:. Wright Medical has a long history of modular neck hip implants but had fracture issues with the original titanium necks. They subsequently changed to chrome cobalt modular necks. Direct contact between these dissimilar metal parts in the modular femoral component brings into consideration the possibility of similar adverse reactions of metal-on-metal articulations that have been previously described in other designs. METHODS:. A retrospective review of 10 patients with Wright Medical chrome cobalt modular necks who were evaluated with chromium and cobalt metal ion levels as well as Metal Artifact Reduction Sequence (MARS) MRI's was performed. Pseudotumors were classified by MRI based on wall thickness, T1/T2 signal, shape, and location and given a corresponding type of I, II, or III. For each patient, symptoms or lack thereof were recorded, and time since surgery noted. RESULTS:. Of 10 patients tested, 9 were symptomatic, and 1 was asymptomatic. The patient that was asymptomatic at last clinical visit at 14 months post-op while symptomatic patients averaged 18 months since initial surgery before symptoms began. Those with metal-poly articulation had an average cobalt level of 1.6, ceramic-ceramic articulation had level of <1, and metal-on-metal had level of 2.9. Five patients had pseudotumor by MRI (2 type I, 1 type II, and 2 type III pseudotumors). CONCLUSION:. It appears that an unintended consequence of changing from titanium to chrome cobalt modular neck may be occurring secondary to corrosion at neck-stem junction. SIGNIFICANCE: This reaction does not appear to be design-specific as these findings are similar to our findings in Stryker Rejuvenate stems. Surgeons evaluating patients with these and other similar stems should be aware of this complication and consider ion testing and MARS MRI

Demand for TKR surgery is rising, including a more diverse patient demographic with increasing expectations [1]. Therefore, greater efforts are being devoted to laboratory testing. As a result, laboratory testing may set a clinical performance presumption for surgeons and patients. For example, oxidized ZrNB (Oxinium) femoral components have been projected to show 85% less wear than CoCr femoral components in bench-top testing [2]. However, recent clinical data show no difference in outcomes between Oxinium® and CoCr for the same design [3]. While it does not show lagging peformance for the Oxinium components, it does call into question the predictive ability of simulation. To better understand the performance of these two materials, a non standardized simulator evaluation was conducted. One commercially available design (Legion PS) was evaluated with two variations of femoral component material (n = 3/material) Oxinium® and Cobalt Chromium. All testing was conducted using a 7.5 kGy moderately crosslinked UHMWPE (XLPE). A 6-station knee simulator was utilized to simulate stair-climbing kinematics. The lubricant used was Alpha Calf Fraction serum which was replaced every 0.5 million cycles for a total of 5 million cycles. Soak controls were used to correct for fluid absorption and statistical analysis was performed using the Student's t-test. Total wear rate results for the tibial inserts are shown in Figure 1. There was no statistical difference in volume loss (p = 0.8) or wear rate (p = 0.9) for the Oxinium® system when compared to the CoCrsystem under stair-climbing kinematics. Visual examination revealed typical wear scars and features on the condylar surfaces, including burnishing. These results corroborate the recent clinical data showing no difference between Oxinium® components and their CoCr analogs [3]. The kinematics used here are not a combination of normal level walking with stair-climbing conditions as was published originally for the Oxinium® material [2], but stair-climbing kinematics only. Even though the stair-climbing profile utilized here does not represent standardized kinematics, it provided results that are in line with clinical observations for these femoral materials. Logic suggests that a combined duty cycle is more representative of patient behavior so there must be additional test factors contributing to the prediction previously reported. The goal of bench top testing is to simulate actual clinical performance so test models must be validated as clinicaly relevant in order to be predictive. Furthermore, the results of this test indicate that the different femoral materials evaluated in this study do not alter the wear characteristics of this TKR. This is further supported by a similar previous study showing the relative contribution of design versus materials in terms of wear behavior [4]. The main determination comes from clinical evidence, and as it has been demonstrated by Kim, et al [3], there is no significant difference in the clinical results of the two TKR devices analyzed

Trunnionosis in modular hip arthroplasty has recently been recognised to be clinically important. Gaining an understanding of how the material interface at the head-trunnion affects the tribology at the modular junctions has current clinical implications as well as an implication on future implant selection and material choice. This matched-cohort study aims to compare tribocorrosion between ceramic and cobalt-chromium trunnions and to investigate other factors that contribute to the difference in tribocorrosion if present.

All hip prostheses retrieved between 1999 and 2015 at one centre were reviewed. Fifty two ceramic heads were retrieved, and these were matched to a cobalt-chromium cohort according to taper design, head size, neck length and implantation time in that order. The two cohorts were similar in male:female ratio (p=0.32) and body mass index (p=0.15) though the ceramic group was younger than the cobalt-chromium group (56.6 (+/−)13.5 years for ceramic group vs 66.3 (+/−14.4) years for cobalt-chromium group; p=0.001). There was no significant difference in the reasons for revision between the two groups (p=0.42). The femoral head trunnions were examined by two independent observers using a previously published 4-point scoring technique. The trunnions were divided into three zones: apex, middle and base. The observers were blinded to clinical and manufacturing data where possible.

Ceramic head trunnions demonstrated a lower median fretting and corrosion score at the base zone (p<0.001), middle zone (p<0.001) and in the combined score (p<0.001). In a subgroup analysis by head size, ceramic heads had a lower fretting and corrosion score at 28mm head diameter (p<0.001). Within the ceramic group, taper design had a significant effect on fretting and corrosion in the apex zone (p=0.04). Taper design also had a similar effect in the cobalt-chromium group in the apex zone (p=0.03). For the ceramic trunnions, the largest effect was contributed by the difference between the 11/13 taper and the 12/14 taper. For the cobalt-chromium trunnions, the largest effect was contributed by the difference between the 5 degree 38′ 37″ taper and type 1 taper.

Ceramic head trunnions showed a significantly lower fretting and corrosion score as compared to cobalt-chromium trunnions. Ceramic heads had a lower score than cobalt-chromium heads at 28mm head diameter. Taper design had an effect on fretting and corrosion within each cohort.

Introduction

Silicon nitride (SiN) is a recently introduced bearing material for THR that has shown potential in its bulk form and as a coating material on cobalt-chromium (CoCr) substrates. Previous studies have shown that SiN has low friction characteristics, low wear rates and high mechanical strength. Moreover, it has been shown to have osseointegration properties. However, there is limited evidence to support its biocompatibility as an implant material. The aim of this study was to investigate the responses of peripheral blood mononuclear cells (PBMNCs) isolated from healthy human volunteers and U937 human histiocytes (U937s) to SiN nanoparticles and CoCr wear particles.

Implant related hypersensitivity is an infrequent complication after total knee replacement. It remains a relatively unpredictable and poorly understood cause of failure of an implant.

We present a report of five patients who presented with persistent hypertrophic synovitis after total knee replacement using a cobalt chrome component. Extensive preoperative and intraoperative attempts ruled out infection as a cause of symptoms. The knees had good ligamentous balance and were well aligned and fixed.

The clinical condition improved after revision to a zirconium femoral and titanium metal backed tibial components. Intraoperative histopathology revealed thickened synovium with a predominantly monocellular (lymphocytic or histiocytic) response.

Where infection has been excluded as a cause of persistent pain and swelling, consideration should be given to metal allergy as a cause of failure in primary knee replacement surgery.

Introduction. Metal-on-Metal (MoM) bearing surfaces were historically used for young patients undergoing total hip arthroplasty, and remain commonplace in modern hip resurfacing. In theory, it has been postulated that metal ions released from such implants may cross the placental barrier and cause harm to the fetus. In light of this potential risk, recommendations against the use of MoM components in women of child-bearing age have been advocated. The purpose of this systematic review was to evaluate: 1) the Metal-on-Metal bearing types and ion levels found; 2) the concentrations of metals in maternal circulation and the umbilical cord; and 3) the presence of abnormalities in the fetus. Methods. A comprehensive literature review was conducted of studies published between January 1st, 1975 and April 1st, 2019 using specific keywords. (See Fig 1). We defined the inclusion criteria for qualifying studies for this review as follows: 1) studies that reported on the women who experienced pregnancy and who had a Metal-on-Metal hip implant; 2) studies that reported on maternal metal ions blood and umbilical cord levels; and 3) studies that reported on the occurrence of fetal complications. Data on cobalt and chromium ion levels in the maternal blood and umbilical cord blood, as well as the presence of adverse effects in the infant were collected. Age at parturition and time from MoM implant to parturition were also collected. A total of 6 studies were included in the final analysis that reported on a total of 21 females and 21 infants born. The mean age at parturition was 40 years (range, 24–41 years), and the mean time from MoM implantation to parturition was 47.2 months (range, 11–119 months). Results. Maternal blood cobalt levels were found as a weighted average of 33.94ug/L (0.972–143), while umbilical cord blood cobalt levels were found to be 22.07 ug/L(0.486–75). Cobalt levels were reduced by an average of 35% between maternal and umbilical cord blood. Maternal cord blood chromium levels were found as a weighted average of 9.25 ug/L (1–25), while umbilical cord chromium levels were found to be 1.30 ug/L(0.288–2.3). Chromium levels were reduced by an average of 86% between maternal and umbilical cord blood. No cobalt or chromium was detected in the umbilical cord blood of three patients. Out of the 21 infants born to women with MoM implants, 20 were born healthy with no adverse effects or complications. Conclusion. To date, there is a lack of consensus as to whether Metal-on-Metal hip arthroplasty implants are to be avoided in the child-bearing female population and whether it constitute a hazard to the fetus in-utero. Both chromium and cobalt ions were markedly reduced in levels when transitioning from maternal to cord blood. In particular, chromium showed a greater reduction on average than cobalt (86% vs. 35%). Based on the current evidence, there appears to be no correlation between the presence of metal ions in umbilical cord blood and complications, particularly congenital malformations in the fetus, as none of the infants experienced abnormalities uniquely attributable to the presence of metal ions. For any figures or tables, please contact the authors directly

Introduction. Metal ion and particle release, particularly cobalt, has become an important subject in total hip arthroplasty, as it has shown to induce metal hypersensitivity, adverse local tissue reactions and systemic ion related diseases. The purpose of the following study was compare the ion release barrier function of a zirconium nitride (ZrN) multilayer coated hip stem for cemented use, designed for patients with metal ion hypersensitivity, against its uncoated version in a test configuration simulating the worst case scenario of a severely debonded hip stem. The ZrN multilayer coating is applied on a CoCrMo hip stem and consists of a thin adhesive chromium layer, five alternating intermediate layers out of chromium nitride (CrN) and chromium carbonitride (CrCN) and a final zirconium nitride (ZrN) shielding layer [1]. Methods. Hip stems with a ZrN multilayer coating (CoreHip AS, Aesculap AG, Germany) were tested in comparison with a cobalt-chrome uncoated version (CoreHip, Aesculap AG, Germany). In order to create a worst case scenario, the smallest stem size with the biggest offset in combination with an XL ceramic head (offset +7 mm) was used. The stems were embedded according to the ISO 7206-6 test in a bone cement sheet. Once the bone cement was bonded, the stem was pulled out and a PMMA grain was placed inside the femoral cavity in order to uprise the hip stem above its embedding line and simulate a debonded cemented hip stem with a severe toggling condition. The dynamic test was performed under bovine serum environment with an axial force of 3.875 kN [2] at 11.6 Hz for 15 million cycles. The test was interrupted after 1, 3, 5, 10 and 15 million cycles and the surfaces of the stems were analyzed through scanning electron microscopy (SEM) with energy dispersive X-Ray (EDX). Moreover, the test medium was analyzed for metal ion concentration (cobalt, chromium and molybdenum) using ICP-MS. Results. The SEM/EDX analysis demonstrated that the ZrN multilayer coating kept its integrity, as no trace of the substrate material (CoCrMo) could be detected. Furthermore, the taper of the ZrN group showed less fretting and corrosion than the taper of the CoCrMo stem (Fig.1). Moreover, the ion concentration analysis showed a reduction of up to two orders of magnitude in the release of cobalt, chromium and molybdenum in the ZrN coated stems in comparison with the uncoated version. Discussion. The results showed that, even in a worst case scenario of high micro-motion due to a severe stem debonding within the cement mantle, the hip stems with a ZrN multilayer coating substantially reduce the release of ions from the substrate material. For any figures or tables, please contact the authors directly

Aims. This study aims to enhance understanding of clinical and radiological consequences and involved mechanisms that led to corrosion of the Precice Stryde (Stryde) intramedullary lengthening nail in the post market surveillance era of the device. Between 2018 and 2021 more than 2,000 Stryde nails have been implanted worldwide. However, the outcome of treatment with the Stryde system is insufficiently reported. Methods. This is a retrospective single-centre study analyzing outcome of 57 consecutive lengthening procedures performed with the Stryde nail at the authors’ institution from February 2019 until November 2020. Macro- and microscopic metallographic analysis of four retrieved nails was conducted. To investigate observed corrosion at telescoping junction, scanning electron microscopy (SEM) and energy dispersive x-ray spectroscopy (EDX) were performed. Results. Adjacent to the nail’s telescoping junction, osteolytic changes were observed in bi-planar radiographs of 20/57 segments (35%) after a mean of 9.5 months (95% confidence interval 7.2 to 11.9) after surgery. A total of 8/20 patients with osseous alterations (40%) reported rest and ambulation pain of the lengthened segment during consolidation. So far, 24 Stryde nails were retrieved and in 20 (83%) macroscopic corrosion was observed at the nail’s telescoping junction. Before implant removal 11/20 radiographs (55%) of lengthened segments with these 20 nails revealed osteolysis. Implant retrieval analysis by means of SEM showed pitting and crevice corrosion. EDX detected chromium as the main metallic element of corrosion. Conclusion. Patients are exposed to the risk of implant-related osteolysis of unclear short- and long-term clinical consequences. The authors advocate in favour of an early implant removal after osseous consolidation. Cite this article: Bone Joint Res 2021;10(7):425–436

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

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

Summary. We report the first use of synchrotron xray spectroscopy to characterize and compare the chemical form and distribution of metals found in tissues surrounding patients with metal-on-metal hip replacements that failed with (Ultima hips) or without (current generation, large diameter hips) corrosion. Introduction. The commonest clinical category of failure of metal-on-metal (MOM) hip replacements is “unexplained” and commonly involved a soft tissue inflammatory response. The mechanism of failure of the Ultima MOM total hip replacement includes severe corrosion of the metal stem and was severe enough to be removed from clinical use. Corrosion is not a feature that we have found in the currently used MOM bearings. To better understand the biological response to MOM wear debris we hypothesized that tissue from failed hips with implant corrosion contained a different type of metal species when compared to those without corrosion. Method. Tissue from patients with two types of MOM hip arthroplasty were analysed: Ultima that failed with severely corroded femoral stems (n=12); and large diameter, current generation MOM hips that failed without visible corrosion (n=7). Comparison was also made to samples of cobalt, chromium and molybedanum standards. We used a high energy synchrotron xray beam to map and characterise the type of metal within the tissues. This enabled us to analyse the type of chemical in a situation that is as realistic as possible: without staining; without the use of a vacuum; and the use of fresh frozen tissue sections with metals at relatively low concentrations. This could not have been achieved without a synchrotron. Results. Comparison with standards revealed the chemical form of the chromium in the tissues surrounding metal-on-metal hip replacements was chromium (III). This was similar for both corroded (Ultima MOM) and non-corroded (large diameter, current generation MOM) hips. This was chromium (III) phosphate in the non-corroded hips but because the concentration of chromium was lower in the corroded hips it was difficult to differentiate chromium phosphate from oxide. There was some evidence of localistaion of cobalt and chromium, both in metallic form. One sample from corroded hips contained chromium (VI). Conclusion. Chromium (III) phosphate was the predominant metallic species in the tissues surrounding metal-on-metal hip replacements. This may have arisen from corrosion, wear or a combination of both

There are numerous benefits of femoral head/neck modularity in both primary and revision surgery. Taper corrosion necessitating revision surgery was recognised decades ago, and there are concerns that the incidence is increasing. Variables in design, manufacturing, biomechanics, and modular head assembly have all been implicated. While the incidence of clinically significant taper corrosion is unknown, the adverse local tissue reaction (ALTR) does not appear to occur absent a cobalt chromium interface. The utilization of ceramic heads has increased in recent years. Domestically, more than 50% of femoral heads are now ceramic. This is due, at least in part, to a reduction in patient age at the time of surgery. A stronger influence, however, may be the concern for an adverse local tissue reaction (ALTR) due to taper corrosion with a cobalt chromium femoral head. Ceramic heads have a small risk of in-vivo fracture and cost more. Compared to cobalt chromium alloy, ceramic femoral heads wear less against UHMWPE, although the reduction may not be clinically significant when paired with a crosslinked polyethylene. In the Australian National Joint Replacement Registry, of the five bearing combinations with 14-year cumulative percent revision (CPR) data, the lowest is metal femoral heads with crosslinked polyethylene (5.4%). In-vivo taper assembly technique is variable and can play a role in clinical success or failure, regardless of the head material: taper corrosion with cobalt chromium heads, or fracture of ceramic heads. Standardization of head-neck taper assembly is desirable

ARMD (Adverse Reaction to Metal Debris) is an increasingly recognised complication of metal on metal hip replacements. The MHRA (Medical and Healthcare Related Devices Agency) have advised a blood cobalt or chromium level above 7 mg/L is a threshold for further investigation, stating that “low levels are reassuring and strongly predict not having an adverse outcome”. Cross-sectional imaging should be performed when levels are above 7 mg/L. We have performed a study investigating the specificity and sensitivity of chromium and cobalt metal ion levels as a screening measure for ARMD. 79 ASR hip replacements were performed at our hospital and 75 (95%) of these underwent a Metal Artefact Reduction Sequence (MARS) MRI scan. All patients (64 hips) who had not undergone revision were invited to take part in this study. 57 patients with 62 hip replacements completed hip and activity scores, had blood cobalt and chromium ion level measurements and 3D-CT to measure acetabular component position. Acetabular component inclination (>50 degrees), small head size (< 51mm) and female gender were significantly correlated with raised chromium (Cr) and cobalt (Co) ion levels. An ARMD was detected using MRI in 18 (29%) of the hips in this study. The incidence of ARMD was significantly higher when chromium concentration was above 7 mg/l (p = 0.02). Chromium ion levels >7 mg/L had a sensitivity of 56% and specificity of 83% for ARMD, and cobalt ion levels >7 mg/L 56% and 76% respectively. 40 patients had cobalt levels <7 mg/L and 33 had chromium levels <7 mg/L, but 8 of these had an ARMD on MRI. All 8 patients had minimal symptoms (Oxford Hip Score ≥ 44 out of 48). The Medicines and Healthcare Products Regulatory Agency (MHRA) has recommended that cobalt and chromium levels be measured in patients with a metal-on-metal hip replacement and cross-sectional imaging performed when these levels are above 7 μg/L. This study has shown that by using this threshold, in patients with this implant combination, the sensitivity and specificity for the detection of ARMD is low and patients with soft tissue disease may be missed. Furthermore the presence of MRI detected ARMD, in the absence of significant clinical symptoms and with metal ion levels <7 μg/L is of concern. MoM implants at risk of failure are associated with raised cobalt and chromium levels. However metal ion analysis alone is not reliable as a screening tool for ARMD, which is often clinically “silent”. We recommend the routine use of MARS MRI as the safest method of ARMD diagnosis in patients with MoM implants