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

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

The 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

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

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

The purpose of this study was to evaluate whether concerns about the release of metal ions in metal-on-metal total hip replacements (THR) should be extended to patients with metal-bearing total disc replacements (TDR). Cobalt and chromium levels in whole blood and serum were measured in ten patients with a single-level TDR after a mean follow-up of 34.5 months (13 to 61) using inductively-coupled plasma mass spectrometry. These metal ion levels were compared with pre-operative control levels in 81 patients and with metal ion levels 12 months after metal-on-metal THR (n = 21) and resurfacing hip replacement (n = 36). Flexion-extension radiographs were used to verify movement of the TDR. Cobalt levels in whole blood and serum were significantly lower in the TDR group than in either the THR (p = 0.007) or the resurfacing group (p < 0.001). Both chromium levels were also significantly lower after TDR versus hip resurfacing (p < 0.001), whereas compared with THR this difference was only significant for serum levels (p = 0.008). All metal ion levels in the THR and resurfacing groups were significantly higher than in the control group (p < 0.001). In the TDR group only cobalt in whole blood appeared to be significantly higher (p < 0.001). The median range of movement of the TDR was 15.5° (10° to 22°). These results suggest that there is minimal cause for concern about high metal ion concentrations after TDR, as the levels appear to be only moderately elevated. However, spinal surgeons using a metal-on-metal TDR should still be aware of concerns expressed in the hip replacement literature about toxicity from elevated metal ion levels, and inform their patients appropriately

We report the clinical and radiological outcome at ten years of 104 primary total hip replacements (100 patients) using the Metasul metal-on-metal bearing. Of these, 52 had a cemented Stuehmer-Weber polyethylene acetabular component with a Metasul bearing and 52 had an uncemented Allofit acetabular component with a Metasul liner. A total of 15 patients (16 hips) died before their follow-up at ten years and three were lost to follow-up. The study group therefore comprised 82 patients (85 hips). The mean Oxford score at ten years was 20.7 (12 to 42). Six of 85 hips required revision surgery. One was performed because of infection, one for aseptic loosening of the acetabular component and four because of unexplained pain. Histological examination showed an aseptic lymphocytic vasculitis associated lesion-type tissue response in two of these. Continued follow-up is advocated in order to monitor the long-term performance of the Metasul bearing and tissue responses to metal debris

Aims . The primary aim of this independent prospective randomised trial was to compare serum metal ion levels for ceramic-on-metal (CoM) and metal-on-metal (MoM) bearing surfaces in total hip arthroplasty (THA). Our one-year results demonstrated elevation in metal ion levels above baseline with no significant difference between the CoM and MoM groups. This paper reviews the five-year data. Patients and Methods. The implants used in each patient differed only in respect to the type of femoral head (ceramic or metal). At five-year follow-up of the 83 enrolled patients, data from 67 (36 CoM, 31 MoM) was available for comparison. Results. The mean serum cobalt (Co) and chromium (Cr) ion levels remained above baseline in both groups (CoM: Co 1.16 μg/l (0.41 to 14.67), Cr 1.05 μg/l (0.16 to 12.58); MoM: Co 2.93 μg/l (0.35 to 30.29), Cr 1.85 μg/l (0.36 to 17.00)) but the increase was significantly less in the CoM cohort (Co difference p = 0.001, Cr difference p = 0.002). These medium-term results, coupled with lower revision rates from national joint registries, suggest that the performance of CoM THA may be superior to that of MoM. . Conclusion. While both bearing combinations have since been withdrawn these results provide useful information for planning clinical surveillance of CoM THAs and warrants continued monitoring. Cite this article: Bone Joint J 2017;99-B:1298–1303

Osteolysis is due to particulate wear debris and is responsible for the long-term failure of total hip replacements. It has stimulated the development of alternative joint surfaces such as metal-on-metal or ceramic-on-ceramic implants. Since 1988 the second-generation metal-on-metal implant Metasul has been used in over 60 000 hips. Analysis of 118 retrieved specimens of the head or cup showed rates of wear of approximately 25 μm for the whole articulation per year in the first year, decreasing to about 5 μm per year after the third. Metal surfaces have a ‘self-polishing’ capacity. Scratches are worn out by further joint movement. Volumetric wear was decreased some 60-fold compared with that of metal-on-polyethylene implants, suggesting that second-generation metal-on-metal prostheses may considerably reduce osteolysis

We have reviewed 42 patients who had revision of metal-on-metal resurfacing procedures, mostly because of problems with the acetabular component. The revisions were carried out a mean of 26.2 months (1 to 76) after the initial operation and most of the patients (30) were female. Malpositioning of the acetabular component resulted in 27 revisions, mostly because of excessive abduction (mean 69.9°; 56° to 98°) or insufficient or excessive anteversion. Seven patients had more than one reason for revision. The mean increase in the diameter of the component was 1.8 mm (0 to 4) when exchange was needed. Malpositioning of the components was associated with metallosis and a high level of serum ions. The results of revision of the femoral component to a component with a modular head were excellent, but four patients had dislocation after revision and four required a further revision

Aims. There are many guidelines that help direct the management of patients with metal-on-metal (MOM) hip arthroplasties. We have undertaken a study to compare the management of patients with MOM hip arthroplasties in different countries. . Methods. Six international tertiary referral orthopaedic centres were invited to participate by organising a multi-disciplinary team (MDT) meeting, consisting of two or more revision hip arthroplasty surgeons and a musculoskeletal radiologist. A full clinical dataset including history, blood tests and imaging for ten patients was sent to each unit, for discussion and treatment planning. Differences in the interpretation of findings, management decisions and rationale for decisions were compared using quantitative and qualitative methods. Results. Overall agreement between the orthopaedic centres and the recommended treatment plans for the ten patients with MOM hip implants was moderate (kappa = 0.6). Full agreement was seen in a third of cases, however split decisions were also seen in a third of cases. Units differed in their interpretation of the significance of the investigation findings and put varying emphasis on serial changes, in the presence of symptoms. Discussion. In conclusion, the management of raised or rising blood metal ions, cystic pseudotumours and peri-acetabular osteolysis led to inconsistency in the agreement between centres. Coordinated international guidance and MDT panel discussions are recommended to improve consensus in decision making. Take home message: A lack of evidence and the subsequent variation in regulator guidance leads to differences in opinions, the clinical impact of which can be reduced through a multi-disciplinary team approach to managing patients with MOM hip implants. Cite this article: Bone Joint J 2016;98-B:179–86

As metal-on-metal arthroplasty becomes more widespread, concerns are being raised about the potential dangers of metal particulate debris. We present the case of a benign psoas mass secondary to the presence of such particles. The mass was excised and the hip resurfacing subsequently revised to a total hip replacement

Bioengineering reasons for increased wear and failure of metal-on-metal (MoM) bearings in hip prostheses have been described. Low wear occurs in MoM hips when the centre of the femoral head is concentric with the centre of the acetabular component and the implants are correctly positioned. Translational or rotational malpositioning of the components can lead to the contact-patch of the femoral component being displaced to the rim of the acetabular component, resulting in a ten- to 100-fold increase in wear and metal ion levels. This may cause adverse tissue reactions, loosening of components and failure of the prosthesis

We determined serum cobalt levels in 55 patients by atomic absorption spectrophotometry before and after implantation of uncemented total hip arthroplasties. In a randomised, prospective trial 27 wrought Co-28Cr-6Mo-0.2C metal-on-metal articulations were compared with 28 ceramic-on-polyethylene hips which did not contain cobalt. Other sources of iatrogenic cobalt loading were excluded. The metal-on-metal group produced detectable serum cobalt levels (median 1.1 μg/l after one year) which were significantly different (p < 0.0001) from those of the ceramic-on-polyethylene control group (median below detection limit of 0.3 μg/l after one year). Our findings indicate that metal-on-metal bearings generate some systemic release of cobalt

A prospective study of serum and urinary ion levels was undertaken in a triathlete who had undergone a metal-on-metal resurfacing arthroplasty of the hip four years previously. The one month study period included the final two weeks of training, the day of the triathlon, and the two weeks immediately post-race. Serum cobalt and chromium levels did not vary significantly throughout this period, including levels recorded on the day after the 11-hour triathlon. Urinary excretion of chromium increased immediately after the race and had returned to pre-race levels six days later. The clinical implications are discussed

We compared the incidence of pseudotumours after large head metal-on-metal (MoM) total hip arthroplasty (THA) with that after conventional metal-on-polyethylene (MoP) THA and assessed the predisposing factors to pseudotumour formation. . From a previous randomised controlled trial which compared large head (38 mm to 60 mm) cementless MoM THA with conventional head (28 mm) cementless MoP THA, 93 patients (96 THAs: 41 MoM (21 males, 20 females, mean age of 64 years, standard deviation (. sd. ) 4) and 55 MoP (25 males, 30 females, mean age of 65 years, . sd. 5) were recruited after a mean follow-up of 50 months (36 to 64). . The incidence of pseudotumours, measured using a standardised CT protocol was 22 (53.7%) after MoM THA and 12 (21.8%) after MoP THA. Women with a MoM THA were more likely to develop a pseudotumour than those with a MoP THA (15 vs 7, odds ratio (OR) = 13.4, p < 0.001). There was a similar incidence of pseudotumours in men with MoM THAs and those with MoP THAs (7 vs 5, OR = 2.1, p = 0.30). Elevated cobalt levels (≥ 5 microgram/L) were only associated with pseudotumours in women with a MoM THA. There was no difference in mean Oxford and Harris hip scores between patients with a pseudotumour and those without. . Contrary to popular belief, pseudotumours occur frequently around MoP THAs. Women with a MoM THA and an elevated cobalt level are at greatest risk. In this study, pseudotumours had no effect on the functional outcome after either large head MoM or conventional MoP THA. Cite this article: Bone Joint J 2015;97-B:1481–7

Aims. The National Joint Registry for England, Wales and Northern Ireland (NJR) has extended its scope to report on hospital, surgeon and implant performance. Data linkage of the NJR to the London Implant Retrieval Centre (LIRC) has previously evaluated data quality for hip primary procedures, but did not assess revision records. . Methods. We analysed metal-on-metal hip revision procedures performed between 2003 and 2013. A total of 69 929 revision procedures from the NJR and 929 revised pairs of components from the LIRC were included. Results. We were able to link 716 (77.1%) revision procedures on the NJR to the LIRC. This meant that 213 (22.9%) revision procedures at the LIRC could not be identified on the NJR. We found that 349 (37.6%) explants at the LIRC completed the full linkage process to both NJR primary and revision databases. Data completion was excellent (> 99.9%) for revision procedures reported to the NJR. Discussion. This study has shown that only approximately one third of retrieved components at the LIRC, contributed to survival curves on the NJR. We recommend prospective registry-retrieval linkage as a tool to feedback missing and erroneous data to the NJR and improve data quality. Take home message: Prospective Registry – retrieval linkage is a simple tool to evaluate and improve data quality on the NJR. Cite this article: Bone Joint J 2016;98-B:33–9

In a double-blinded randomised controlled trial, 83 patients with primary osteoarthritis of the hip received either a ceramic-on-metal (CoM) or metal-on-metal (MoM) total hip replacement (THR). The implants differed only in the bearing surfaces used. The serum levels of cobalt and chromium and functional outcome scores were compared pre-operatively and at six and 12 months post-operatively. Data were available for 41 CoM and 36 MoM THRs (four patients were lost to follow-up, two received incorrect implants). The baseline characteristics of both cohorts were similar. Femoral head size measured 36 mm in all but two patients who had 28 mm heads. The mean serum cobalt and chromium levels increased in both groups, with no difference noted between groups at six months (cobalt p = 0.67, chromium p = 0.87) and 12 months (cobalt p = 0.76, chromium p = 0.76) post-operatively. Similarly, the mean Oxford hip scores, Western Ontario and McMaster Universities Osteoarthritis index and University of California, Los Angeles activity scores showed comparable improvement at 12 months. Our findings indicate that CoM and MoM couplings are associated with an equivalent increase in serum cobalt and chromium levels, and comparable functional outcome scores at six and 12-months follow-up.