Objectives. The high revision rates of the DePuy Articular Surface Replacement (ASR) and the DePuy ASR XL (the total hip arthroplasty (THA) version) have led to questions over the viability of metal-on-metal (MoM) hip joints. Some designs of MoM hip joint do, however, have reasonable mid-term performance when implanted in appropriate patients. Investigations into the reasons for implant failure are important to offer help with the choice of implants and direction for future implant designs. One way to assess the performance of explanted hip prostheses is to measure the wear (in terms of material loss) on the joint surfaces. Methods. In this study, a coordinate measuring machine (CMM) was used to measure the wear on five failed cementless Biomet Magnum/ReCap/ Taperloc large head MoM THAs, along with one Biomet ReCap resurfacing joint. Surface roughness measurements were also taken. The reason for revision of these implants was pain and/or adverse reaction to metal debris (ARMD) and/or elevated blood metal ion levels. Results. The mean wear rate of the articulating surfaces of the heads and acetabular components of all six joints tested was found to be 6.1 mm. 3. /year (4.1 to 7.6). The mean wear rate of the femoral head tapers of the five THAs was 0.054 mm. 3. /year (0.021 to 0.128) with a mean maximum wear depth of 5.7 µm (4.3 to 8.5). Conclusion. Although the taper wear was relatively low, the wear from the articulating surfaces was sufficient to provide concern and was potentially large enough to have been the cause of failure of these joints. The authors believe that patients implanted with the ReCap system, whether the resurfacing prosthesis or the THA, should be closely monitored. Cite this article: S. C. Scholes, B. J. Hunt, V. M. Richardson, D. J. Langton, E. Smith, T. J. Joyce. Explant analysis of the Biomet Magnum/ReCap metal-on-metal hip joint. Bone Joint Res 2017;6:113–122. DOI: 10.1302/2046-3758.62.BJR-2016-0130.R2

INTRODUCTION: Metal-on-metal alloarthroplasty of the hip is gaining popularity in order to avoid complications associated with polyethylene wear. On the other hand, metal-on-metal articulations release metal ions, the biological effects of which remain unclear. Genetic and immunological changes have been associated with increased metal ion levels in arthroplasty patients. We intended to study the outcome after metal-on-metal arthroplasty of the hip with a focus on the toxicologically and immunologically relevant metal ions chromium, cobalt, nickel, and manganese. PATIENTS AND METHODS: A prospective, randomised study was designed where all patients received a cemented arthroplasty of the hip, either with a metal-on-metal bearing (Metasul ®; 28 patients) or with a metal-on-polyethylene bearing (Protasul ®, 26 patients). Only patients with primary osteoarthritis of the hip and without other metallic implants were included (mean age 65 years, range 45–74). Follow-up was performed after a minimum of two years. Clinical outcome was measured by the Harris hip score and the SF36, and radiographic analysis was undertaken by plain radiography. Metal ion concentrations in patient serum were analysed by high-resolution plasma mass spectrometry. RESULTS: It was found that the clinical outcome was almost identical in both groups with respect to Harris hip score and SF36, and radiographic signs of osteolyses or loosening did not occur in any group. In the metal-on-metal group, chromium concentrations increased 4.1 fold and cobalt concentrations increased 7.6 fold when compared to preoperative values (p< 0.05; Wilcoxon Mann Whitney Test), whereas nickel and manganese concentrations did not change significantly. In the metal-on-polyethylene group, no significant increase in the concentration of any ion occurred. DISCUSSION: In conclusion, metal-on-metal and metal-on-polyethylene arthroplasties of the hip provide equal clinical and radiographic outcomes in the medium term, but the concentrations of chromium and cobalt increase considerably after metal-on-metal arthroplasty. Importantly, the allergogenic and previously not assessed ions nickel and manganese show no significant changes in the medium term after any type of hip alloarthroplasty. To our knowledge, this is the first study that addresses manganese and nickel concentrations in a prospective, randomized setting, and our patients will be followed further with respect to possible immunological and genetic changes

Previous scientific studies have highlighted how coupling is an important element affecting total hip arthroplasty's survival. This study aims to evaluate whether metal-on-metal (MOM) coupling could be a statistically significant risk factor. The data from the regional joint registry (Registro dell'Impiantologia Protesica Ortopedica, RIPO) was used for analysis. The data collection accuracy of this registry was 97.2% in 2017. We retrospective evaluate all MOM total hip arthroplasties (THAs) implanted in our department between January 01st 2000 and December 31st 2011. We used a control group composed by all other prosthesis implanted in our Department in the same time lapse. We registered 660 MOM THAs. Mean age of patients was 66.9 years. 603 patients have a >36mm head, while 78 a <36 mm one. Neck modularity was present in half of patients. 676 implants were cementless. We registered 69 revisions, especially due to aseptic mobilization (16 THAs), implant breakage (9 THAs) and periprosthetic fracture (6 THAs). The MOM THAs overall Kaplan-Meier survival rate was 87.2 at 15 years, and the difference between MOM THAs and other implants two curves is statistically significant (p<0.05). Male sex is a significant risk factors. Further evaluations are in progress to establish the presence of any additional risk factors. We think weight and/or BMI may be included in this category. Our study confirms the data currently present in the literature regarding a lower survival of metal-on-metal hip prostheses. The male sex is a statistically significant risk factor (p<0.05), while age, head size and modularity of the prosthetic neck are not statistically significant (p>0.05). Any new finds will be presented at the congress venue

The aim of this study was to investigate the possible benefit of large-head metal-on-metal bearing on a stem for primary hip replacement compared with a 28 mm diameter conventional metal-on-polyethylene bearing in a prospective randomised controlled trial. We investigated cemented stem behaviour between these two different bearings using Einzel-Bild-Röntgen-Analyse, clinical and patient reported measures (Harris hip score, Western Ontario and McMaster Universities osteoarthritis index, Short Form-36 and satisfaction) and whole blood metal ion levels at two years. A power study indicated that 50 hips were needed in each group to detect subsidence of > 5 mm at two years with a p-value of < 0.05. . Significant improvement (p < 0.001) was found in the mean clinical and patient reported outcomes at two years for both groups. Comparison of outcomes between the groups at two years showed no statistically significant difference for mean stem migration, clinical and patient reported outcomes; except overall patient satisfaction which was higher for metal-on-metal group (p = 0.05). Metal ion levels were raised above the Medicines and Healthcare products Regulatory Agency advised safety level (7 µg per litre) in 20% of the metal-on-metal group and in one patient in metal-on-polyethylene group (who had a metal-on-metal implant on the contralateral side). Two patients in the metal-on-metal group were revised, one for pseudotumour and one for peri-prosthetic fracture. . Use of large modular heads is associated with a risk of raised whole blood metal ion levels despite using a proven bearing from resurfacing. The head-neck junction or excess stem micromotion are possibly the weak links warranting further research

Purpose: In 1988, metal-on-metal bearing surfaces were reintroduced in hip replacement surgery with a 28 mm diameter femoral head. These bearings have potential advantages such as improved durability, absence of polyethylene particles and no secondary periprosthetic osteolysis. Tribological studies suggest that larger metal-on-metal articulations would produce less wear than smaller diameter components. But recent clinical studies revealed increased release of circulating ions in metal-metal hip resurfacing compared to 28 mm metal-metal articulation. The aim of the present study is to describe whole blood Chrome and Cobalt ions concentration after non-cemented metal-metal total hip arthroplasty (THA) and hybrid metal-metal surface replacement arthroplasty (SRA). Method: All patients eligible for the study were randomised to receive uncemented THA or a hybrid SRA. Whole blood samples were collected pre-operatively, at three, six months and one year post operatively. Chrome and Cobalt concentration were measured using a spectrophotometer. Summary of Results: Blood samples have been taken from 78 patients and are pending analysis. Discussion: Considering the influence of activity level, weight, time after surgery, the renal function, etc. on the wear behaviour of bearing surfaces, a prospective randomised study is important to obtain a valid comparison. To our knowledge, this is the only randomised study comparing whole blood ions concentration in metal-metal THA and SRA. Significance: We strongly believe that this subject warrants special attention considering the possible toxicity associated with high levels of circulating metal ions

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

In 1997 the Birmingham Hip Resurfacing was introduced to address the needs of young active patients. Alternative designs were introduced to try and improve wear performance. The aim of this study was a comparative cohort study of two types of metal-on-metal bearing to determine the mechanism of failure at 15 years. The study reviewed 91 Brimingham Hip Resurfacings (BHR) (Smith and Nephew) and 715 DUROM hip resurfacing (Zimmer) procedures in prior to 2009. Failure was defined as revision of either component for any reason. Kaplan-Meyer survivorship analysis performed. Routine follow-up with serum metal ion levels and radiographs. Mean follow-up was 17.9 years (range 15.2 – 25.1). The mean age at operation was 51.6 years (SD 8.6, range 20.7 to 70.2), including 299 women (37.1%). The Birmingham resurfacing demonstrated 92.3% survivorship at 15 years (SE 2.8, 95% CI 3.9 – 7.8) and 90.0% at latest follow-up (SE 3.5, 95% CI 4.9 to 9.4). By comparison, the DUROM survivorship at 15 years was 89.1% at 15 years (SE 1.2, 95% CI 2.0 to 2.5) and 87.4% (SE 1.3, 95% CI 2.5 to 2.3) at latest follow-up. There was no statistically significant difference in survivorship between groups (p= 0.32). Survival in male patients was 92.7% compared to 80.0% in females. The reported failures occurred from Adverse Reaction to Metal Debris (32 patients), periprosthetic femoral neck fracture (6) and aseptic loosening (41), PJI (12) and undiagnosed pain (6). The mean cobalt and chromium levels at last follow-up were 33.4 nmol/L and 36.5 nmol/L respectively. This study demonstrates two differently designed metal-on-metal hip resurfacing provided a durable alternative to total hip replacement, particularly in younger male patients with osteoarthritis. Differences in design did determine the reason for revision with acetabular fixation being one of the principal failure mechanisms for the DUROM compared to elevated ion levels

Elevated blood cobalt secondary to metal-on-metal (MoM) hip arthroplasties has been shown to be a risk factor for developing cardiovascular complications including cardiomyopathy. Published case reports document cardiomyopathy in patients with blood cobalt levels as low as 13µg/l. Clinical studies have found conflicting evidence of cobalt-induced cardiomyopathy in patients with MoM hips. The extent of cardiovascular injury, measured by global longitudinal strain (GLS), in patients with elevated blood cobalt levels has not previously been examined. Sixteen patients with prospectively collected blood cobalt ion levels above 13µg/l were identified and matched with eight patients awaiting hip arthroplasty with no history of cobalt implants. Patients underwent echocardiogram assessment including GLS. Patients with MoM hip arthroplasties had a mean blood cobalt level of 29µg/l compared to 0.01µg/l in the control group. There was no difference or correlation in EF, left ventricular (LV) end systolic dimension, LV end diastolic dimension, fractional shortening, ventricular wall thickness or E/e’ ratio. However, GLS was significantly reduced in patients with MoM hip arthroplasties compared to those without (−15.2% v −18%, (MoM v control) p= 0.0125). Pearson correlation demonstrated that GLS is significantly correlated with blood cobalt level (r= 0.8742, p=0.0009). For the first time, this study has demonstrated reduced cardiac function in the presence of normal EF as assessed by GLS in patients with elevated cobalt above 13µg/l. As GLS is a more sensitive measure of systolic function than EF, routine echocardiogram assessment including GLS should be performed in all patients with MoM hip arthroplasties and elevated blood cobalt

Elevated blood cobalt secondary to metal-on-metal (MoM) hip arthroplasties has been shown to be a risk factor for developing cardiovascular complications including cardiomyopathy. Published case reports document cardiomyopathy in patients with blood cobalt levels as low as 13µg/l (13ppb, 221nmol/l). Clinical studies have found conflicting evidence of cobalt-induced cardiomyopathy in patients with MoM hips. Global longitudinal strain (GLS) is an echocardiography measurement known to be more sensitive than ejection fraction at diagnosing early cardiomyopathies. The extent of cardiovascular injury, as measured by GLS, in patients with elevated blood cobalt levels has not previously been examined. Sixteen patients with documented blood cobalt ion levels above 13µg/l were identified from a regional arthroplasty database. They were matched with eight patients awaiting hip arthroplasty with no history of cobalt implants. All patients underwent electrocardiogram and echocardiogram assessment for signs of cardiomyopathy including GLS. Patients with MoM hip arthroplasties had a mean blood cobalt level of 29µg/l (495nmol/l) compared to 0.01µg/l (0.2nmol/l) in the control group. There was no difference or correlation in ejection fraction (EF), left ventricular (LV) end systolic dimension, LV end diastolic dimension, fractional shortening, ventricular wall thickness or E/e’ ratio. However, GLS was significantly reduced in patients with MoM hip arthroplasties compared to those without (−15.2% v −18%, (MoM v control) p= 0.0125). Pearson correlation demonstrated that GLS is significantly correlated with blood cobalt level (r= 0.8742, p=0.0009). For the first time, this study has demonstrated reduced cardiac function in the presence of normal EF as assessed by GLS in patients with elevated cobalt above 13µg/l. As GLS is a more sensitive measure of systolic function than EF, routine echocardiogram assessment including GLS should be performed in all patients with MoM hip arthroplasties and elevated blood cobalt above 13µg/l. Further work is recommended to assess if these cardiac changes are present in patients with elevated blood cobalt levels below 13µg/l

Background. Second-generation high-carbon CoCrMo-alloy metal-on-metal total hip arthroplasty (THA) was introduced in the late 1980s following reports of early loosening, impingement, pronounced wear, and hypersensitivity in the first-generation metal-on-metal articulations. There has been inconsistent data that specifically addresses the clinical performance and longevity of second-generation metal-on-metal THA. The purpose of this study was to evaluate the survival of second-generation metal-on-metal primary THA and to assess the influence of demographic factors on implant survival in a large patient cohort. Methods. One thousand two hundred and seventy second-generation 28 mm metal-on-metal primary THA in 1121 patients were performed at one institution from 1994 to 2004. According to the International Documentation and Evaluation System patients were followed routinely at one year, two years and every five years thereafter. Clinical and radiographic outcome data was prospectively recorded using a hospital joint registry. At a mean follow-up of 6.8 years postoperatively, the probability of survival of THA was estimated using the method of Kaplan and Meier. Relative risk factors for implant failure that included age, gender, BMI, type of implant fixation and size of implant components were calculated using the Cox proportional-hazards model. Results. Sixty three (5%) hips were revised because of aseptic loosening (28 hips), infection (8 hips), periprosthetic fracture (8 hips), recurrent dislocation (8 hips), pain without implant loosening (7 hips) and breakage of the cup (4 hips). The probability of survival at ten years, with revision for any reason as the endpoint, for the THA as a whole was 0.90 (95% confidence interval, 0.87 to 0.94). The probability of survival for the cup was 0.90 (95% confidence interval, 0.86 to 0.93) and for the stem 0.94 (95% confidence interval, 0.91 to 0.97). No demographic factors or covariates were found to significantly affect survivorship. Conclusion. Second-generation metal-on-metal primary THA did not demonstrate a superior probability of survival at ten years compared with previous reports on other weight-bearing surfaces. Based on these findings and with consideration of concerns that relate to putative local and systemic toxicity of metal debris, the use of second-generation metal-on-metal articulations for primary THA remains moot

The use of large-diameter metal-on-metal (MoM) components in total hip arthroplasty (THA) is associated with an increased risk of early failure due to adverse local tissue reaction to metal debris (ARMD) in response to the release of metal ions from the bearing couple and/or head-neck taper corrosion. The aim of this paper was to present a review of the incidence and natural history of ARMD and the forms of treatment, with a focus on the need for and extent of resection or debulking of the pseudotumour. An illustrative case report is presented of a patient with an intra-pelvic pseudotumour associated with a large diameter MoM THA, which was treated successfully with revision of the bearing surface to a dual mobility couple and retention of the well-fixed acetabular and femoral components. The pseudotumour was left in situ. Resolution of the intra-pelvic mass and normalisation of metal ion levels was observed seven months post-operatively. Cite this article: Bone Joint J 2016;98-B:736–40

The peri-prosthetic tissue response to wear debris is complex and influenced by various factors including the size, area and number of particles. We hypothesised that the ‘biologically active area’ of all metal wear particles may predict the type of peri-prosthetic tissue response. . Peri-prosthetic tissue was sampled from 21 patients undergoing revision of a small diameter metal-on-metal (MoM) total hip arthroplasty (THA) for aseptic loosening. An enzymatic protocol was used for tissue digestion and scanning electron microscope was used to characterise particles. Equivalent circle diameters and particle areas were calculated. Histomorphometric analyses were performed on all tissue specimens. Aspirates of synovial fluid were collected for analysis of the cytokine profile analysis, and compared with a control group of patients undergoing primary THA (n = 11) and revision of a failed ceramic-on-polyethylene arthroplasty (n = 6). . The overall distribution of the size and area of the particles in both lymphocyte and non-lymphocyte-dominated responses were similar; however, the subgroup with lymphocyte-dominated peri-prosthetic tissue responses had a significantly larger total number of particles. . 14 cytokines (interleukin (IL)-1ß, IL-2, IL-4, IL-5, IL-6, IL-10, IL-13, IL-17, interferon (IFN)-γ, and IFN-gamma-inducible protein 10), chemokines (macrophage inflammatory protein (MIP)-1α and MIP-1ß), and growth factors (granulocyte macrophage colony stimulating factor (GM-CSF) and platelet derived growth factor) were detected at significantly higher levels in patients with metal wear debris compared with the control group. . Significantly higher levels for IL-1ß, IL-5, IL-10 and GM-CSF were found in the subgroup of tissues from failed MoM THAs with a lymphocyte-dominated peri-prosthetic response compared with those without this response. . These results suggest that the ‘biologically active area’ predicts the type of peri-prosthetic tissue response. The cytokines IL-1ß, IL-5, IL-10, and GM-CSF are associated with lymphocyte-dominated tissue responses from failed small-diameter MoM THA. Cite this article: Bone Joint J 2015;97-B:917–23

Metal-on-metal resurfacing of the hip (MoMHR) has enjoyed a resurgence in the last decade, but is now again in question as a routine option for osteoarthritis of the hip. Proponents of hip resurfacing suggest that its survival is superior to that of conventional hip replacement (THR), and that hip resurfacing is less invasive, is easier to revise than THR, and provides superior functional outcomes. Our argument serves to illustrate that none of these proposed advantages have been realised and new and unanticipated serious complications, such as pseudotumors, have been associated with the procedure. As such, we feel that the routine use of MoMHR is not justified. Cite this article: Bone Joint J 2014;96-B(11 Suppl A):17–21

Objectives. Previous studies have suggested that metal-on-metal (MoM) Pinnacle (DePuy Synthes, Warsaw, Indiana) hip arthroplasties implanted after 2006 exhibit higher failure rates. This was attributed to the production of implants with reduced diametrical clearances between their bearing surfaces, which, it was speculated, were outside manufacturing tolerances. This study aimed to better understand the performance of Pinnacle Systems manufactured before and after this event. Methods. A total of 92 retrieved MoM Pinnacle hips were analyzed, of which 45 were implanted before 2007, and 47 from 2007 onwards. The ‘pre-2007’ group contained 45 implants retrieved from 21 male and 24 female patients, with a median age of 61.3 years (interquartile range (IQR) 57.1 to 65.5); the ‘2007 onwards’ group contained 47 implants retrieved from 19 male and 28 female patients, with a median age of 61.8 years (IQR 58.5 to 67.8). The volume of material lost from their bearing and taper surfaces was measured using coordinate and roundness measuring machines. These outcomes were then compared statistically using linear regression models, adjusting for potentially confounding factors. Results. There was no significant difference between the taper and bearing wear rates of the ‘pre-2007’ and ‘2007 onwards’ groups (p = 0.67 and p = 0.39, respectively). Pinnacles implanted from 2007 onwards were revised after a mean time of 50 months, which was significantly earlier than the ‘pre-2007’ hips (96 months) (p < 0.001). A reduction in the time to revision was present year on year from 2003 to 2011. Conclusion. We found no difference in the wear rate of these implants based on the year of implantation. The ‘pre-2007’ hips had a two-fold greater time to revision than those implanted after 2007; this may be due to the increased surveillance of MoM hips following UK regulatory advice and several high-profile failures. Interestingly, we observed a decreasing trend in the mean time to revision every year from 2003 onwards. Cite this article: S. Bergiers, H. S. Hothi, J. Henckel, A. Eskelinen, J. Skinner, A. Hart. Wear performance of retrieved metal-on-metal Pinnacle hip arthroplasties implanted before and after 2007. Bone Joint Res 2018;7:595–600. DOI: 10.1302/2046-3758.711.BJR-2018-0143.R1

Aims. This study presents the long-term survivorship, risk factors for prosthesis survival, and an assessment of the long-term effects of changes in surgical technique in a large series of patients treated by metal-on-metal (MoM) hip resurfacing arthroplasty (HRA). Patients and Methods. Between November 1996 and January 2012, 1074 patients (1321 hips) underwent HRA using the Conserve Plus Hip Resurfacing System. There were 787 men (73%) and 287 women (27%) with a mean age of 51 years (14 to 83). The underlying pathology was osteoarthritis (OA) in 1003 (75.9%), developmental dysplasia of the hip (DDH) in 136 (10.3%), avascular necrosis in 98 (7.4%), and other conditions, including inflammatory arthritis, in 84 (6.4%). Results. The mean follow-up time was 10.5 years (1 to 20). Using revision for any reason as the endpoint, the overall survivorship at 15 years was 89.4% (95% confidence interval (CI) 86.8 to 91.4). There was a substantial increase between the first and second generation of surgical technique (86.6% vs 90.1%; p = 0.05). Men with idiopathic OA had a 15-year survivorship of 94.5% and women, 82.2% (p = 0.001); gender was not a risk factor after stratification by component size and aetiology. Using revision for excessive wear (ion levels > 7 µg/l associated with symptoms or adverse local tissue reactions) as the endpoint, the 15-year survivorship was 98.5%. Risk factors for revision for all modes of failure were an underlying pathology of hip dysplasia, a contact patch to rim (CPR) distance of 7 mm or less, an age at surgery of 55 years or less, and a femoral component size of 46 mm or less. Specific risk factors for aseptic failure of the femoral component were early surgical technique, a cementless metaphyseal stem, and a body mass index of 24 kg/m. 2. or less. Conclusion. HRA is a viable concept; metal-on-metal bearings are well suited for this procedure when a well-designed device is properly implanted. The best results were obtained in men with OA, but survivorship was better for other underlying pathologies and for women after changes were made to the technique of implantation. Lifetime durability is a possible outcome for many patients despite a high level of activity. Cite this article: Bone Joint J 2018;100-B:1424–33

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

Metal-on-metal bearing was re-introduced with the aim of eliminating polyethylene wear and resulting complications of osteolysis and aseptic loosening in total hip arthroplasty (THA). However, authors of recent studies have reported periprosthetic osteolysis and aseptic failure following second-generation metal-on-metal THA. The purpose of this study is to report the results at a minimum of five years following cementless total hip arthroplasty with a contemporary metal-on-metal articulation. Our study included findings of histologic examination on periprosthetic tissues from revised hips and wear and roughness analysis of retrieved implants. A consecutive series of 158 cementless THAs that were performed in 154 patients using a contemporary metal-on-metal bearing were assessed at a mean of 6.5 years (5 to 8). Their mean age at surgery was 53 years (21 to 80). The patients were assessed clinically with use of the Harris hip score, and the hips were assessed radiographically. Histological analysis was performed on specimens retrieved from the revised hips, and wear and roughness measurements were made for the explanted prostheses. The average Harris hip score improved from 45 points preoperatively to 92 points at the final follow-up examination. There was no aseptic loosening of the femoral or acetabular components. One hip was revised because of recurrent dislocation and one was managed with two-stage re-implantation for deep infection. Thirteen hips (8%) had osteolysis; 11 had osteolysis localized within the greater trochanter and two had both femoral and ace-tabular osteolysis. Of these, five patients who had a persistent pain and osteolysis underwent revision operation for the consideration of bearing exchange to a ceramic-on-ceramic or ceramic-on-polyethylene combination. All these revised hips showed extensive synovial-like tissue hypertrophy and perivascular infiltration of lymphocytes on histological examinations. Annual volumetric wear rate measured on one retrieved femoral head was 1.04mm3/yr, and roughness measured on three retrieved femoral heads was consistently very low between 8nm and 117nm. After the revision surgery, all the patients noticed disappearance of pain as well as radiographic evidence of healing of the osteolytic lesion. Our mid-term follow-up of cementless THA using a contemporary metal-on-metal bearing revealed an unexpectedly high rate of periprosthetic osteolysis possibly in association with metal hypersensitivity. In patients with persistent hip pain and osteolysis after contemporary metal-on-metal THA, surgeons should consider an exchange of the articulation surface to a ceramic-on-ceramic or ceramic-on-polyethylene combination because they can be cured only after an elimination of the source of hypersensitivity reaction

Aims. Many case reports and small studies have suggested that cobalt ions are a potential cause of cardiac complications, specifically cardiomyopathy, after metal-on-metal (MoM) total hip arthroplasty (THA). The impact of metal ions on the incidence of cardiac disease after MoM THA has not been evaluated in large studies. The aim of this study was to compare the rate of onset of new cardiac symptoms in patients who have undergone MoM THA with those who have undergone metal-on-polyethylene (MoP) THA. Patients and Methods. Data were extracted from the Standard Analytics Files database for patients who underwent MoM THA between 2005 and 2012. Bearing surface was selected using International Classification of Diseases ninth revision codes. Patients with a minimum five-year follow-up were selected. An age and gender-matched cohort of patients who underwent MoP THA served as a comparison group. New diagnoses of cardiac disease were collected during the follow-up period. Comorbidities and demographics were identified and routine descriptive statistics were used. Results. We identified 29 483 patients who underwent MoM THA and 24 175 matched patients who underwent MoP THA. Both groups had a mean Charlson comorbidity index score of 4. There were no statistically significant differences in 30 of 31 pre-existing comorbidities. Patients undergoing MoM THA had a slightly lower incidence of cardiac failure compared with those undergoing MoP THA at three years (6.60% versus 7.06%, odds ratio (OR) 0.93, 95% confidence interval (CI) 0.87 to 0.99) and four years (8.73% versus 9.49%, OR 0.91, 95% CI 0.86 to 0.97) postoperatively, with no difference in the incidence of new cardiac failure in between the groups at five years. There was no statistically significant difference in the incidence of arrhythmia, myocardial infarction and cardiomyopathy at any time between the two groups. Conclusion. MoM THA is not associated with cardiac complications. Initial reports may have represented individual instances of cardiac disease in patients with a failing MoM articulation rather than an emerging epidemiological trend. Cite this article: Bone Joint J 2018;100-B:28–32

Introduction. Modular neck (MN) components in total hip arthroplasty (THA) offer intraoperative flexibility, but adverse local tissue reactions (ALTR) due to tribocorrosion at modular junctions are a potential complication of such designs. Serum ion levels and metal artifact reduction sequence (MARS) MRI are used to assess ALTR following modular THA. This study investigates serum ion levels and MARS MRI findings in a series of hips with MN components and differing articulating surfaces. Methods. We retrospectively evaluated a cohort of 184 primary THAs in 159 patients implanted with a dual modular femoral stem by one surgeon from 2005–2013. 121 THAs had a cobalt-chromium neck component and non-metal-on-metal articulation, while 63 THAs had a titanium neck component and metal-on-metal (MoM) articulation. Serum ion levels were recorded for all patients. MARS MRI scans were read by musculoskeletal-trained radiologists. Pseudotumor grade and location were measured. Results. Serum cobalt levels as a function of time post-operatively demonstrated no correlation. In THAs with non-MoM articulation, pseudotumors were visualized in 13 of 54 (24.1%) initial MARS MRIs performed 1–40 months post-operatively compared to 5 of 67 (7.5%) performed 41–120 months post-operatively (p=0.02), and findings typically remained consistent across multiple MARS MRI scans. Pseudotumors were generally located lateral to the hip joint in hips with non-MoM articulation compared to anteromedial following MoM arthroplasty. In the cobalt-chrome MN group, cobalt levels were elevated in 11 of 20 (55%) of patients with pseudotumor compared to 15 of 19 (79%) in the MoM group. Conclusion. Generation of ALTR leading to pseudotumor formation is a concern with cobalt-chrome MN designs. Psuedotumor characteristics differ between patients with cobalt-chrome designs versus MoM articulation. Normal serum ion levels did not exclude the presence of a pseudotumor and routine MARS MRI should be included in follow-up of patients with cobalt-chromium MN prostheses

Introduction. In 2010, a widely used metal-on-metal hip implant was voluntarily recalled from the market by the manufacturer. Our lab performed detailed retrieval analysis of 548 of the explanted devices and 165 periprosthetic tissue specimens. We reported a high degree of variability in the multiple measurements that we performed on the components, including volumetric wear. Other studies using semi-quantitative tissue grading methods to describe the histology of the periprosthetic tissues from metal-on-metal hips have looked for relationships between component wear and histological features. Grammatopoulos et al found higher ALVAL scores in 45 hip resurfacing patients with pseudotumors compared to 11 without pseudotumors and a moderately positive correlation between wear and the histological rankings for tissue necrosis and lymphocytic response. We examined correlations between the component wear measurements from retrieval analysis and the tissue features in this large group of one metal-on-metal hip design. Materials and Methods. Tissues were processed routinely into paraffin sections, stained with H&E and characterized with light microscopic semi-quantitative scores for ALVAL features and for the number of macrophages and lymphocytes, extent of metal debris and the estimated percentage of necrosis per slide. Spearman correlation analysis was conducted to evaluate any correlations between retrieval wear measurements and histological findings. Results. The median combined cup and ball wear volume was 17.5mm3 in these 165 cases. The median tissue ALVAL score was 5.5 out of 10. Component total wear volume was not predictive of the ALVAL score (P = 0.09, R = −0.007) or the number of lymphocytes (P= 0.170, R= −0.077) but there was a positive correlation between wear volume and the ranking for macrophages in the tissues (P< 0.001, R=0.215). No other correlations were found for component wear. The median time to revision was 4.84 years. There was a negative correlation between tissue inflammation ranking (P=0.002, R=−0.183) and for lymphocyte ranking and time to revision (P=0.003, R=−0.173). There was a positive correlation between time to revision and the macrophage ranking (P=0.005, R=0.166). Conclusion. From this large-scale retrieval analysis of one design of metal-on-metal total hip, a high degree of variability was observed over the multiple analyses performed, including volumetric wear and tissue features. This likely reflects our previous observation that no single particular failure mechanism was predominant in this large cohort. Funded by DePuy Synthes Companies of Johnson & Johnson