Background:. Higher than expected revision rates have been observed in large bearing metal-on-metal total hip replacements. We have introduced a metal on metal hip screening clinic at our unit and report the results. Methods:. All patients who had a metal-on-metal total hip replacement implanted at our unit were recalled to clinic. Screening consisted of clinical examination, Oxford hip score, radiographs, MARS MRI and serum cobalt/chromium ion levels. MRI scans were graded (Norwich Classification) by a single consultant radiologist who was blinded to the history, examination, and metal levels. Patients were sub-classified into 6 groups, which determined further follow up and were either entered into a regular screening programme or referred to a revision arthroplasty surgeon for a decision on whether revision was required. Results:. A total of 278 patients were identified. Four patients had moved away, 2 refused follow-up and 1 patient had died. This left 271 patients in our cohort, having 299 metal-on-metal hip replacements with a M:F ratio of 1.5:1 and a mean age of 61.9 years (29–87). 59 (21.8%) patients complained of a recent deterioration in symptoms. Sixty seven (24.7%) patients had an abnormal xray appearance of their hip replacement (inclination >50 degrees, loosening, or migration of prosthesis). Of the 232 hips which underwent MARS MRI, 118 (50.9%) were group A (normal appearance), 66 (28.4%) C1 (mild MOM disease), 31 (13.4%) C2 (moderate MOM disease), and 17 (7.3%) C3 (severe MOM disease). One hundred and seventeen (38.9%) had a substantial fluid collection around the hip. Serum cobalt/chromium metal ions were raised in 135 patients (49.5%), 46 of which had one (8.8%) or both (8%) above 7 ppb (chromium >134 nmol/L, cobalt > 119 nmol/L). One hundred and forty nine patients (55%) remained under review in the MOM clinic and 122 (45%, 148 hip replacements) were referred to a revision surgeon for specialist opinion. Of these 21 hips (14.2%) have been revised and a further 14 hips (9.5%) are awaiting revision. In total 64 hips (21.3% of all large head metal on metal hips implanted in our unit) have been revised with a further 22 (7.3%) listed for revision. Of these, 13 were histologically proven to be an ALVAL reaction, 19 had the classic clinical findings of ALVAL (but not histologically confirmed), and 1 was a non-specific reaction to metal wear. 53 patients (19.4%, 56 hips) were completely asymptomatic but had evidence of ALVAL soft tissue reaction on MRI and/or rising metal ion levels – 9 of these hips have already been revised for ALVAL and 6 more listed for revision. Conclusions. Our screening programme has identified 53 (19.6%) asymptomatic patients who have evidence of a suspicious reaction to their metal-on-metal hip replacements. 16 (3%) of these have gone on to revision. We would recommend all patients with a metal-on-metal total hip replacement in situ are fully screened for ARMD regardless of symptoms and metal ion levels

Introduction. It has been speculated that impact deformation of thin 1-piece cups used for modern metal-on-metal hip replacement may contribute to early failure. The purpose of this study was to reproduce typical impact deformation and quantify the effect of this on the frictional torque generated at the hip. Methods. We tested nine hip couples of three designs (the ASR, BHR and Durom) and three sizes (42mm, 46mm and 50mm). A custom compression device was designed to replicate the in vivo forces and impact deformation of 1-piece metal cups reported in the literature. Each cup was mounted in the device, which itself was mounted on a mechanical testing machine. The cups were compressed with incremental loads up to a maximum of 2000N. At each increment we measured cup deformation, and then the head component was seated into the cup. The hip was lubricated and the head component rotated 60 degrees axially within the cup and the axial torque was measured. Results. Maximum deformation occurred at the rim for all cups, and was not associated with cup diameter (p = 0.42). However, at all applied loads the BHR cups were deformed significantly less than both the ASR and Durom cups (all p < 0.05). We observed deformation that exceeded the diametric clearance for both the ASR and Durom. Deformation resulted in increased axial torque up to eight times higher than those measured at zero deformation. The maximum torques generated for the BHR cups were significantly lower than those observed for both the ASR and Durom cups. Discussion. Deformation of 1-piece cups, equatorial bearing and subsequent increased frictional torque is likely to have widespread consequences for the performance of metal-on-metal hip replacement. This may include loosening of the cup, mechanical damage at the taper junction and increased early wear of the bearing surface

Background:. Potential systemic toxicity of metal ions from metal-on-metal hip arthroplasties (MoMHA) is concerning. High blood cobalt (Co) levels have been associated with neurological, cardiac and thyroid dysfunctions. Questions/purposes:. The aim of this research was to investigate the prevalence of systemic Co toxicity in a MoMHA population, to identify confounding factors, and to indicate a Co level above which there is a high risk for systemic toxicity. Patients and Methods:. We conducted a cross-sectional study of patients with a MoMHA, using questionnaires validated to detect cobaltism in cobalt industry workers. We retrospectively identified 161 patients with Co levels >4 μg/L and 337 patients with Co levels <4 μg/L and collected 385 completed questionnaires. There were 207 men and 178 women with a mean age of 60 years (24–86). Mean follow-up was 5.7 years (1 to 13). Co levels were subdivided into <4 μg/L, 4–10 μg/L, 10–20 μg/L and >20 μg/L groups. Results:. There were significant correlations (p ≤ 0.003) between increasing Co levels and prevalence of sleeping disorders, cognitive problems, equilibrium disturbances, neuropathic symptoms, fatigue, somatic disorders and mood changes. More frequent and severe symptoms were found with Co > 20 μg/L (p = 0.017). Several years post-revision, some patients still complained of chronic symptoms possibly associated with longer exposure. Female gender and age ≤50 years were confounding factors. Conclusions:. We demonstrated a correlation between increasing Co levels and toxicity symptoms (p ≤ 0.003). As in the published case reports of MoMHA related cobaltism, the highest incidence of symptoms was found with Co > 20 μg/L. Patients with repeated Co measurements >20 μg/L are at risk for systemic toxicity

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

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

Non-large head Metal-on-metal (MoM) hip replacements were seen as a solution to concerns about implant wear in younger patients. Mid-term loosening of once well-fixed hydroxyapatite (HA) coated femoral stems was recently observed in select MoM patients upon revision surgery. Accordingly, an implant retrieval study was undertaken to examine the incidence of aseptic loosening of in HA-coated femoral stems with MoM, ceramic on ceramic (CoC) and metal on polyethylene (MoP) bearing couples.

A single-centre implant retrieval lab reviewed 44 hydroxyapatite (HA)-coated titanium wedge taper stems of the same design retrieved over a period of 9 years. Ten were MoM articulations, 23 MoP and 11 CoC. Head sizes ranged from 28 to 40 with only four 40mm heads, all of which were MoM. Reason for revision, duration of implantation, femoral head size, patient age and body mass index was recorded for each retrieval. Goldberg corrosion scores were determined for the taper surfaces of each retrieval, with ‘0’ indicating no corrosion and ‘3’ indicating severe corrosion. Logistic regression analysis, Wilcoxan Rank Sum and Fischer's exact test were used for statistical analysis.

Aseptic loosening was the listed reason for revision in 18 of 44 cases. MoM bearing was associated with increased probability of aseptic loosening (Odds ratio 7.1 (95%CI 1.1–47.0) p=0.042). Severity of corrosion was also associated with aseptic loosening (Odds ratio 2.75 (95%CI 1.1–6.6) p=0.02). Head size and patient age had no correlation. Median time to revision of implants for aseptic loosening was 4.5 years (range: 4.2–7.0 years) for MoM versus 1.4 years (range: 0.3–3.0) for other bearing couples (p=0.004). Aseptic loosening was categorised as early (<=2 years) or mid-term (>2 years). No MoM hips were revised for aseptic loosening in the first 2 years while 8 of the 11 mid-term revisions had MoM articulations (p=0.004). Taper corrosion was more severe in mid-term aseptic loosing cases (p=0.049).

MoM HA-coated hip replacements appear to be associated with increased mid-term aseptic loosening compared to other bearing couples. Patients with MoM HA-coated hip replacements should be monitored regularly beyond the initial 1 to 2 years following surgery. Future analyses will examine the presence and progression of femoral radiolucency prior to revision surgery to determine an approximate timeline of stem loosening in this patient cohort. This research highlights the importance of implant retrieval programs to assess post-revision implant characteristics for early identification of possible device issues.

Introduction

The Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK have published guidelines for annual follow up of patients with metal on metal hip replacements following widespread concern regarding metallosis

This study examined whether TiNbN surface characteristics can reduce corrosion and wear of Chrome Cobalt Molybdenum Metal-on Metal bearings.

Two series of patients had plasma concentrations of chromium and cobalt at intervals following surgery. The First Series comprised a retrospective analysis of 52 consecutive cases (49 patients, 73–96 months following operation; age at surgery: 33–78) who had undergone an ACCIS (Implantcast, Germany) Modular Large Head hip replacement. The Second Series comprised a prospective, consecutive series of 125 cases (109 patients, 1–61 months following operation; age at surgery: 24–75) who had undergone an ACCIS Resurfacing Hip Replacement in whom pre-operative samples and periodic post-operative metal ion analysis was obtained. Cup inclination and anteversion angles, patient outcome and Harris hip scores at last follow-up were also recorded.

The first series revealed medians for [Cr] of 1.2 (range <0.5–2.4) ug/l and [Co] of 3.3 (range <0.15–8.18) ug/l. Four patients were not available for measurement. The second series gave one year [Cr] of 0.8 (range <0.5–1.6) ug/l and [Co] of 0.2 (range <0.15–0.9) ug/l and at two years [Cr] of 0.2 (range <0.5–1.5) ug/l and [Co] of 0.8 (range <0.15–1.0) ug/l. There was no correlation with cup inclination (38° to 62°) or anteversion (0° to 32°) in either group. Mean Harris Hip Scores were 80.9 and 92.3 respectively.

Low median levels of metal ions were found in the First Series (despite differing stem type usage). The low median ion levels were more consistent in the Resurfacing patients of the Second Series. The Titanium Niobium Nitride Ceramic Surface Engineering Metal-on-Metal bearing implants appear to protect against raised plasma [Cr] and [Co] both over time and with outlying cup positions. The Harris Hip Scores suggest a good patient outcome for the hip replacements in both series. Further study by a randomised controlled prospective analysis is suggested.

The ACCIS system comprises a bearing of a 5 micron surface ceramic upon a Chrome Cobalt Molybdenum (CrCoMo) substrate which allows for a homogeneous couple. The Titanium Niobium Nitride (TiNbN) microceramic applied by Plasma Vapour Deposition. In comparison with CrCoMo alloy, TiNbN gives a hard (2800 vs 489V), smooth (0.23 vs 0.55Rz), low friction (0.079–0.1 vs 0.11–0.56mu pin on disk test), wetable surface which when combined allows for the potential of gaining fluid film lubrication (lambda>3) on a smaller head diameter than an untreated surface. These properties are postulated to reduce wear and hence lower the release of Cr and Co ions in vivo. The surface microceramic also prevents exposure to release of Cr and Co by corrosion. The surface modified implants were first used in 2003 in large head arthroplasty and later in 2005 with resurfacing implants. Two series of patients implanted by a single surgeon were examined to elucidate the metal ion release of the ACCIS system. The first series retrospectively examined 52 consecutive Large Head Arthroplasty cases for [Cr], [Co] and [Mo] levels. A mean follow-up time of 7.5 yrs (77–101mths) with 9 patients being lost to revision and death by the time of the study. Median levels of [Cr] 1.6, [Co] 4.76 and [Mo] 2.5 µg/l were obtained. The second series prospectively examined the [Cr] and [Co] levels with the pre-operative values as controls in 125 resurfacing cases with the ACCIS microceramic. The second series gave no rising trend observed at up to 5 years ([Cr & Co] (range < 0.5–1.6 µg/l). It is postulated that the ACCIS surface microceramic reduces wear and also reduces the effective patch size for a given load thus allowing for a greater Patch to Edge Distance allowing a greater tolerance to cup positioning. A RCT is currently underway.

The contemporary metal-on-metal (MoM) bearings were reintroduced due to their lower volumetric wear rates in comparison to conventional metal-on-polyethylene bearings. This has the potential to substantially reduce wear-induced osteolysis as the major cause of failure and greater implant stability with the use of large femoral heads. It has been estimated that since 1996 more than 1,000,000 MoM articular couples have been implanted worldwide. However, with increasing clinical experience, the national joint registries have recently reported the failure rate of THA with MoM bearings to be 2–3 fold higher than contemporary THA with non-metal-on-metal bearings. Moreover, adverse periprosthetic tissue reactions have emerged as an important reason for failure in MoM patients. A painful MoM hip arthroplasty has various intrinsic and extrinsic causes. As in all painful THA, a thorough clinical history, a detailed physical examination, as well as radiographic and laboratory tests are essential to delineate potential cause(s) of pain in patients with MoM hip arthroplasty. While specialised tests such as metal ion analysis are useful modalities for assessing MoM hip arthroplasty, over-reliance on any single investigative tool in the clinical decision-making process should be avoided. There should be a low threshold to perform a systematic evaluation of patients with MoM hip arthroplasty as early recognition and diagnosis will facilitate the initiation of appropriate treatment prior to significant adverse biological reactions. A systematic risk stratification recommendation, for multiple modes of failure including adverse local tissue reactions, based on the currently available evidence will be presented to optimise management

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

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

Background. Revision surgery for a failed metal on metal (MoM) hip arthroplasty is often unpredictable and challenging due to associated massive soft tissue and bony lesions. We present the analysis and early outcomes of revision surgery in failed MoM hip arthroplasties at our institution. Methods. We have retrospectively analysed the findings and outcomes of revision surgery in 61 failed MoM hip arthroplasties performed between 2009 and 2014. These patients were identified in the special MoM hip surveillance pathway. All these patients underwent clinical assessment and relevant investigations. Intra-operative and histopathological findings were analysed. Results. There were 24 male and 37 female patients with an average age 63.67 yrs. Of the 61 patients, 39 were revised for pseudocysts, 10 for painful hip with raised metal ion levels and the remaining cases for aseptic loosening, malposition and periprosthetic fracture. Average follow up was 12 months. Pre-op and Post-op Oxford hip scores were recorded. One death and one intra-operative periprosthetic fracture was observed. There were no dislocations but one post-op infection was observed. Conclusions. A dedicated MoM pathway helps to identify early failures. A thorough knowledge of failure mechanisms combined with appropriate early and effective surgical intervention may help achieve good clinical outcomes

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).

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

Background. The changes in surface roughness occurring during the wear process at the bearing surface are of great importance in trying to understand the failure mechanism of large head metal-on-metal hip replacements. The aim of the study is to identify and characterise the areal surface parameter variation between the worn and unworn areas. Surface topography variations at the bearing surface have an effect on the lubrication regime [1]. In vitro tests of these components have suggested a “self-polishing” of the surface [2]. Traditionally Ra has been used as a descriptor of surface texture. Considering the high standard of manufacturing to which these components are produced, Ra is not sufficient to describe surface morphology which requires spatial information which can only be achieved through the use of areal parameters. Methods. A total of 50 retrieved metal-on-metal hip replacements were assessed using white light scanning interferometry (Talysurf CCI, Ametek, UK) to determine the difference in the areal surface topography parameters between the worn and unworn regions of the bearing surface. The worn area was identified by use of a previously described method [3] to produce a wear map of the bearing surface, this allows the identification of the regions of interest. A series of six measurements were taken on each component (figure 1) comprising of: 2 measurements at the equator of the head representing the unworn region, one measurement at the pole and just off centre from the pole and the rest of the measurements were taken inside and at the boundary of the wear area. Each measurement covered an area of 1 mm. 2. therefore it is crucial that the location of the measurement be established as accurately as possible. Data was analysed to determine the most relevant parameters that could be used to describe and highlight the changes in surface roughness that occur during the wear process. Discussion. The measurement methodology developed shows a clear correlation between the areal surface parameters and the wear regions. The parameters show that areas of wear can be identified when the correct suite of parameters are utilised. This information is invaluable in developing a more advanced model of change in the lubrication regimes due to morphological changes during wear

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. 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

Ceramic-on-ceramic bearings are considered in several European and Asian countries a reliable alternative to metal-on-polyethylene, ceramic-on-polyethylene, or metal-on-metal (with small diameter heads) for total hip arthroplasty (THA) management. Reduced joint wear and limited peri-prosthetic osteolytic changes are the main reasons supporting the use of ceramic. So far, the available observational data show a low rate of revision following the use of Ceramic-on-Ceramic bearings, but concern remains regarding the risk of fracture and the prevalence of squeaking noises from the joint. The objective of this study was to use a national arthroplasty registry to assess whether the choice of bearings – metal-on-polyethylene (MoP), ceramic-on-polyethylene (CoP), ceramic-on-ceramic (CoC), or metal-on-metal (MoM) – is associated with differences in the risk of revision. Data from primary THAs were extracted from the New Zealand Joint Registry over a 15-year period. 97,889 hips were available for analysis. The mean age of patients was 68 years (SD +/− 11 years), and 52% were women. The median followup period in this patient population was 9 years (range, 1 to 15 years). The primary endpoint was revision for any reason. Inclusion criteria were degenerative joint disease (84,894), exclusion criteria were previous surgery, trauma, and any other diagnosis (12,566). We also excluded patients operated on with a Ceramic-on-Metal THA, because of the small recorded number (429). There were 54,409 (64.1%) MoP, 16,503 (19.4%) CoP, 9,051 (10.7%) CoC and 4,931 (5.8%) MoM hip arthroplasties. 3,555 hips were revised during the 15-year observation period. A multivariate assessment was carried out including the following risks factors available for analysis: age, gender, surgeon experience, use of cement. Analysis of bearing surface type and revision showed a statistically significant lower risk for CoC hips (265 THAs, p≤0.01) when compared with CoP (537 THAs, HR 1.07, CI 0,92–1,26), MoP (2186 THAs, HR 1.39, CI 1.19–1,62), and MoM (576 THAs, HR 2.15, CI 1.84–2.51). The 15-year follow-up Kaplan-Meier survival analysis shows a 92% revision-free rate for CoC THAs (Figure 1). In particular, CoC THAs showed the lowest rates of revision for dislocation and for deep infection, when compared with the other bearings. This registry study showed that the bearing surface is associated with the risk of revision. MoM bearing surfaces showed a high rate of revisions, while CoC THAs showed the lowest rate of revision compared to other bearing surfaces. Low wear and less osteolysis are the possible reasons for reduced risk of revision for aseptic loosening. We postulate that the healthy, fibrotic synovial-like pseudocapsule found in CoC THAs preserves the long-term stability of the joint and reduces the bio-burden for late deep infection. Future studies with larger data sets and longer follow-up should continue to investigate this query. For any figures or tables, please contact the authors directly

The role of metal sensitivity or allergy in causing persistent symptoms or failure and need for a revision of a total joint replacement has been the topic of debate and controversy for decades. There was renewed interest in this area with the rise of metal-on-metal hip arthroplasty and the advent of adverse local tissue reactions. This led to an increase in metal ion testing as well as metal sensitivity testing. With the decline of the use of metal-on-metal hip components, this is now mostly an issue in knee arthroplasty. It is well known that a substantial percentage of patients have persistent symptoms following knee replacement. What remains in question is whether allergy to metal or other materials such as PMMA may be a contributing factor. It is accepted that the incidence of positive skin patch tests is higher in symptomatic failed joint replacements. Nickel sensitivity is most common as a positive skin test with up to 15% of patients demonstrating this followed by chromium and cobalt. A recent review by Lachiewicz et al. concluded that there was insufficient evidence to recommend routine or widespread cutaneous or in vitro hypersensitivity testing before primary TKA, that there is no evidence-based rationale to recommend a routine metal allergy screening questionnaire, that there is only anecdotal support for Ni-free implants, and that local dermatitis should be treated with topical steroids. In another article, routine screening for metal allergy was not recommended, however, selective screening for history of sensitivity or unexplained pain or early loosening was suggested. Other experts have recommended a role for utilizing a commercially available alternative to components containing nickel or cobalt in patients thought to be hypersensitive. A recent study, however, concluded that there was no difference in complications, revisions, or reoperations among patients who tested positive with patch testing whether they were treated with standard components or nickel free components. Likewise, a consensus panel published results from the United Kingdom in which cobalt chrome implants were recommended regardless of the patients metal allergy status. Patient perception is important, however, and among patients who report multiple allergies of any kind, a higher percentage are likely to be dissatisfied with their knee replacement. Of more importance are those reporting a specific allergy to metal are substantially more likely to express some dissatisfaction with their components. Metal allergy as a cause of chronic pain and/or early failure of joint replacement is rare if it exists at all. It is always a diagnosis of exclusion. Patients who think they are allergic are probably more likely to be more symptomatic following joint replacement. Whether or not to use a nickel free or hypoallergenic component in such patients remains an area of controversy