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Abstract

The primary aim of this study was to analyse our painful metal-on-metal (MoM) hip resurfacing revisions with evidence of ‘adverse reactions to metal debris’ (ARMD). In our series of 35 revisions the median whole blood Cobalt levels were 58 nmols/l (range 12-1407 nmols/l), and whole blood Chromium levels were 73 nmols/l (range 2-353 nmols/l). Thirty-four of our 35 patients had abnormal imaging on Ultrasound scanning (USS). The mean histological Campbell grading of ARMD was 4, and ranged from 0-9. The mean Oxford Hip Score (OHS) increased from 19 pre-revision (range 4-46) to 33 post-revision surgery (range 23-47). We found no correlation between the preoperative metal ion levels, and the severity of the disease or the outcome. Pain following hip resurfacing may arise from a number of causes and when groin pain arises in conjunction with abnormal cross sectional imaging we have offered our patients revision surgery regardless of raised metal ions or grossly abnormal imaging, with good results.

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... This review was updated to include eligible studies up to the end of 2016 using the methods described (see Supplementary data). Including the 6 initial studies a total of 15 unique studies were eligible for inclusion with 803 MoMHA revisions for ARMD (Grammatopoulos et al. 2009, De Smet et al. 2011, Ebreo et al. 2011, Rajpura et al. 2011, Liddle et al. 2013, Su and Su 2013, Matharu et al. 2014b, Munro et al. 2014, Norris et al. 2014, Pritchett 2014, Cip et al. 2015, Lainiala et al. 2015, Stryker et al. 2015, van Lingen et al. 2015. 1 further study reported the outcomes following 16 ARMD revisions at extended follow-up (median of 10 years) (Matharu et al. 2017b). All included studies were either case-control or cohort studies graded as level 4 evidence (Oxford 2011), with the majority being retrospective. ...
... A number of studies did not specifi cally provide patient demographics and outcomes for the ARMD revision procedures. Some studies reported on complications and re-revision surgery but not on post-revision functional outcomes, or vice versa (Norris et al. 2014, Stryker et al. 2015. ...
... Of the 15 unique studies reviewed, which reported outcomes following ARMD revision, all provided some defi ni-tion for ARMD. However, only 11 studies provided enough details about both the clinical and histopathological features to satisfy our working diagnosis of ARMD (Grammatopoulos et al. 2009, De Smet et al. 2011, Rajpura et al. 2011, Liddle et al. 2013, Matharu et al. 2014b, Munro et al. 2014, Norris et al. 2014, Pritchett 2014, Cip et al. 2015, Lainiala et al. 2015. No study formally stated how it dealt with multiple revision indications (e.g., by using a hierarchy to establish the primary diagnosis for revision). ...
Article
Background and purpose The initial outcomes following metal-on-metal hip arthroplasty (MoMHA) revision surgery performed for adverse reactions to metal debris (ARMD) were poor. Furthermore, robust thresholds for performing ARMD revision are lacking. This article is the second of 2. The first article considered the various investigative modalities used during MoMHA patient surveillance (Matharu et al. 2018aMatharu G S, Judge A, Eskelinen A, Murray D W, Pandit H G. What is appropriate surveillance for metal-on-metal hip arthroplasty patients? A clinical update. Acta Orthop 2018a; 89 (1): 29–39.[Taylor & Francis Online], [Web of Science ®], [Google Scholar]). The present article aims to provide a clinical update regarding ARMD revision surgery in MoMHA patients (hip resurfacing and large-diameter MoM total hip arthroplasty), with specific focus on the threshold for performing ARMD revision, the surgical strategy, and the outcomes following revision. Results and interpretation The outcomes following ARMD revision surgery appear to have improved with time for several reasons, among them the introduction of regular patient surveillance and lowering of the threshold for performing revision. Furthermore, registry data suggest that outcomes following ARMD revision are influenced by modifiable factors (type of revision procedure and bearing surface implanted), meaning surgeons could potentially reduce failure rates. However, additional large multi-center studies are needed to develop robust thresholds for performing ARMD revision surgery, which will guide surgeons’ treatment of MoMHA patients. The long-term systemic effects of metal ion exposure in patients with these implants must also be investigated, which will help establish whether there are any systemic reasons to recommend revision of MoMHAs
... This review was updated to include eligible studies up to the end of 2016 using the methods described (see Supplementary data). Including the 6 initial studies a total of 15 unique studies were eligible for inclusion with 803 MoMHA revisions for ARMD (Grammatopoulos et al. 2009, De Smet et al. 2011, Ebreo et al. 2011, Rajpura et al. 2011, Liddle et al. 2013, Su and Su 2013, Matharu et al. 2014b, Munro et al. 2014, Norris et al. 2014, Pritchett 2014, Cip et al. 2015, Lainiala et al. 2015, Stryker et al. 2015, van Lingen et al. 2015. 1 further study reported the outcomes following 16 ARMD revisions at extended follow-up (median of 10 years) (Matharu et al. 2017b). All included studies were either case-control or cohort studies graded as level 4 evidence (Oxford 2011), with the majority being retrospective. ...
... A number of studies did not specifi cally provide patient demographics and outcomes for the ARMD revision procedures. Some studies reported on complications and re-revision surgery but not on post-revision functional outcomes, or vice versa (Norris et al. 2014, Stryker et al. 2015. ...
... Of the 15 unique studies reviewed, which reported outcomes following ARMD revision, all provided some defi ni-tion for ARMD. However, only 11 studies provided enough details about both the clinical and histopathological features to satisfy our working diagnosis of ARMD (Grammatopoulos et al. 2009, De Smet et al. 2011, Rajpura et al. 2011, Liddle et al. 2013, Matharu et al. 2014b, Munro et al. 2014, Norris et al. 2014, Pritchett 2014, Cip et al. 2015, Lainiala et al. 2015. No study formally stated how it dealt with multiple revision indications (e.g., by using a hierarchy to establish the primary diagnosis for revision). ...
Article
Full-text available
Background and purpose — The initial outcomes following metal-on-metal hip arthroplasty (MoMHA) revision surgery performed for adverse reactions to metal debris (ARMD) were poor. Furthermore, robust thresholds for performing ARMD revision are lacking. This article is the second of 2. The first article considered the various investigative modalities used during MoMHA patient surveillance (Matharu et al. 2018a Matharu G S, Judge A, Eskelinen A, Murray D W, Pandit H G. What is appropriate surveillance for metal-on-metal hip arthroplasty patients? A clinical update. Acta Orthop 2018a; 89 (1): 29–39.[Taylor & Francis Online], [Web of Science ®] [Google Scholar]). The present article aims to provide a clinical update regarding ARMD revision surgery in MoMHA patients (hip resurfacing and large-diameter MoM total hip arthroplasty), with specific focus on the threshold for performing ARMD revision, the surgical strategy, and the outcomes following revision. Results and interpretation — The outcomes following ARMD revision surgery appear to have improved with time for several reasons, among them the introduction of regular patient surveillance and lowering of the threshold for performing revision. Furthermore, registry data suggest that outcomes following ARMD revision are influenced by modifiable factors (type of revision procedure and bearing surface implanted), meaning surgeons could potentially reduce failure rates. However, additional large multi-center studies are needed to develop robust thresholds for performing ARMD revision surgery, which will guide surgeons’ treatment of MoMHA patients. The long-term systemic effects of metal ion exposure in patients with these implants must also be investigated, which will help establish whether there are any systemic reasons to recommend revision of MoMHAs
... Since then, elevated concentrations of ultratrace cobalt and chromium have been reported in the blood of patients with failed total joint replacements [30,65,76,[83][84][85][86][87][88][89][91][92][93][94][114][115][116], and in serum and plasma [40,76,90,[85][86][87][88][89][90][91][92][93][94][95][96][97][98][99][100][101][102][103][105][106][107][108][109][110][111][112]. Elevated urine metal levels in patients with loosening implants were found to generate higher metal levels [83,93,94,103,112]. ...
... Since then, elevated concentrations of ultratrace cobalt and chromium have been reported in the blood of patients with failed total joint replacements [30,65,76,[83][84][85][86][87][88][89][91][92][93][94][114][115][116], and in serum and plasma [40,76,90,[85][86][87][88][89][90][91][92][93][94][95][96][97][98][99][100][101][102][103][105][106][107][108][109][110][111][112]. Elevated urine metal levels in patients with loosening implants were found to generate higher metal levels [83,93,94,103,112]. ...
Article
The use of metallic biomaterials in the medical implant devices has become increasingly prevalent over the past few decades. Patients find themselves being exposed to metals in a variety of ways, ranging from external exposure to instruments such as medical devices to internal exposure via surgical devices being implanted in their bodies. In situ generation of metallic wear nanoparticles, corrosion products and in vivo trace metal ions release from metal and metallic alloys implanted into the body in orthopedic surgery is becoming a major cause for concern regarding the health and safety of patients. The chemical form, particulate vs. ionic, of the metal species in the bodily fluids and tissues is a key to the local nanotoxicity effects arising in the body. Potential health risks are associated with metallic wear debris in the form of nanoparticles in situ generation and the release of in vivo trace metal ions into human biological specimen's circulation. This overview explores how migration of metallic wear nanoparticles and ultratrace metal ions in the area of metal-on-metal orthopedic implants influences the surrounding tissues and bodily fluids, and what the toxicological consequences of this process may be. Specifically, the present article is more informative of indicative multilevel in situ/in vivo/ex vivo analytical/clinical methodologies which will be helpful in a way to plan, understand and lead the analytical innovations in the area of nano-analysis to improve patient outcomes.
Article
Background: Adverse local tissue reactions (ALTR) have been associated with the use of metal-on-metal (MoM) bearings and the monitoring of cobalt (Co) and chromium (Cr) ion levels in blood or serum may be the best way to evaluate in vivo the wear of these bearings. However, the relationship between Co and Cr ion concentrations and the formation of ALTR remains unclear. Methods: We investigated the relationship between ALTR and serum Co and Cr ion levels and identified the clinical factors influencing the formation of ALTR in patients treated with MoM hip resurfacing arthroplasties. 228 patients with unilateral Conserve® Plus MoM hip resurfacing had serum metal ion studies performed more than 1 year after surgery. Metal artifact reduction sequence magnetic resonance imaging (MARS MRI) was performed on subjects at risk for ALTR as determined by a screening protocol. Results: 12 patients had ALTR. Logistic regression showed a strong association of ALTR with elevated ion levels and with low (<10 mm) contact patch to rim distance. Conclusions: MoM bearings require enough functional coverage of the socket by design and then precise implantation to maximise functional coverage of the femoral ball, enhance lubrication, and avoid edge-loading wear.
Article
Purpose: Recent studies of metal-on-metal (MoM) total hip arthroplasty (THA) using metal-artefact-reducing-sequence software for magnetic resonance Imaging (MARS-MRI) have revealed remarkable soft tissue pathology around the hip, usually referred to as pseudotumours. Case reports describe identical pathology in non-MoM THA, but descriptive overviews of MRI abnormalities in patients with non-MoM prosthesis are scarce. Methods: A clinical study in a cohort of 50 ceramic-on-polyethylene (CoP) THA selected for high risk of peri-prosthetic pathology including 2 subgroups: (i) 40 patients with a high polyethylene (PE) wear rate (>0.2 mm per year) and 5-12 years follow-up; (ii) 10 patients with a 2 to 5 years follow-up and a documented history of persistent complaints. All patients were clinically evaluated, MARS-MRIs were completed and chrome and cobalt serum samples were taken. Results: 17 scans were normal (34%). Periprosthetic fluid collections were seen as a bursae iliopsoas (n = 12, 24%), in the trochanter bursae (n = 4, 8%) and in the surgical tract (n = 9, 18%). 1 case demonstrated a cyst on MARS-MRI resembling a pseudotumour as seen with MoM THA (2%). Intraosseous acetabular cysts were seen in 12 cases (24%), intraosseous trochanteric cysts in 10 cases (20%). Conclusions: Soft tissue abnormalities after non-MoM THA are common in selected patients and can be clearly visualised with MARS-MRI. Pseudotumours as seen on MARS-MRI do occur in non-MoM hip arthroplasty but with low prevalence.
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Particle disease is caused by periarticular accumulation of attrition particles and the inflammatory reaction of the body's tissue. This process may result in osteolysis or soft tissue transformation which presents itself symptomless in the beginning and can proceed to aseptic implant loosening, fracture, implant breaking as a result of the inappropriate osseous support and to algetic and destructive soft tissue reactions as well. Attrition particles originate from tribological pairing, and the extent of the attrition or the particle concentration depend on different factors as there are the tribological pairing's material, the head size, the patient's level of activity, and the implant position. Attrition particles can also be found in the range of any modular connection. Particle disease and its resulting morphological alterations of the tribological pairing is one of the most frequent reasons for re-operation in hip endoprosthetics. Georg Thieme Verlag KG Stuttgart · New York.
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Louis Pasteur once said that: “Fortune favours the prepared mind.” As one of the great scientists who contributed to the fight against infection, he emphasised the importance of being prepared at all times to recognise infection and deal with it. Despite the many scientific discoveries and technological advances, such as the advent of antibiotics and the use of sterile techniques, infection continues to be a problem that haunts orthopaedic surgeons and inflicts suffering on patients. The medical community has implemented many practices with the intention of preventing infection and treating it effectively when it occurs. Although high-level evidence may support some of these practices, many are based on little to no scientific foundation. Thus, around the world, there is great variation in practices for the prevention and management of periprosthetic joint infection. This paper summaries the instigation, conduct and findings of a recent International Consensus Meeting on Surgical Site and Periprosthetic Joint Infection. Cite this article: Bone Joint J 2013;95-B:1450–2.
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Adverse reactions to metal debris have been reported to be a cause of pain in metal-on-metal hip arthroplasty. We assessed the incidence of both symptomatic and asymptomatic adverse reactions in a consecutive series of patients with a modern large-head metal-on-metal hip arthroplasty. We studied the early clinical results and results of routine metal artifact-reduction MRI screening in a series of 79 large-head metal-on-metal hip arthroplasties (ASR; DePuy, Leeds, UK) in 68 patients. 75 hips were MRI scanned at mean 31 (12-52) months after surgery. 27 of 75 hips had MRI-detected metal debris-related abnormalities, of which 5 were mild, 18 moderate, and 4 severe. 8 of these hips have been revised, 6 of which were revised for an adverse reaction to metal debris, diagnosed preoperatively with MRI and confirmed histologically. The mean Oxford hip score (OHS) for the whole cohort was 21. It was mean 23 for patients with no MRI-based evidence of adverse reactions and 19 for those with adverse reactions detected by MRI. 6 of 12 patients with a best possible OHS of 12 had MRI-based evidence of an adverse reaction. We have found a high early revision rate with a modern, large-head metal-on-metal hip arthroplasty. MRI-detected adverse rections to metal debris was common and often clinically "silent". We recommend that patients with this implant should be closely followed up and undergo routine metal artifact-reduction MRI screening.
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We sought to establish the incidence of joint failure secondary to adverse reaction to metal debris (ARMD) following metal-on-metal hip resurfacing in a large, three surgeon, multicentre study involving 4226 hips with a follow-up of 10 to 142 months. Three implants were studied: the Articular Surface Replacement; the Birmingham Hip Resurfacing; and the Conserve Plus. Retrieved implants underwent analysis using a co-ordinate measuring machine to determine volumetric wear. There were 58 failures associated with ARMD. The median chromium and cobalt concentrations in the failed group were significantly higher than in the control group (p < 0.001). Survival analysis showed a failure rate in the patients with Articular Surface Replacement of 12.8% [corrected] at five years, compared with < 1% at five years for the Conserve Plus and 1.5% at ten years for the Birmingham Hip Resurfacing. Two ARMD patients had relatively low wear of the retrieved components. Increased wear from the metal-on-metal bearing surface was associated with an increased rate of failure secondary to ARMD. However, the extent of tissue destruction at revision surgery did not appear to be dose-related to the volumetric wear.
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Pseudotumor-like periprosthetic tissue reactions around metal-on-metal (M-M) hip replacements can cause pain and lead to revision surgery. The cause of these reactions is not well understood but could be due to excessive wear, or metal hypersensitivity or an as-yet unknown cause. The tissue features may help distinguish reactions to high wear from those with suspected metal hypersensitivity. We therefore examined the synovial lining integrity, inflammatory cell infiltrates, tissue organization, necrosis and metal wear particles of pseudotumor-like tissues from M-M hips revised for suspected high wear related and suspected metal hypersensitivity causes. Tissue samples from 32 revised hip replacements with pseudotumor-like reactions were studied. A 10-point histological score was used to rank the degree of aseptic lymphocytic vasculitis-associated lesions (ALVAL) by examination of synovial lining integrity, inflammatory cell infiltrates, and tissue organization. Lymphocytes, macrophages, plasma cells, giant cells, necrosis and metal wear particles were semiquantitatively rated. Implant wear was measured with a coordinate measuring machine. The cases were divided into those suspected of having high wear and those suspected of having metal hypersensitivity based on clinical, radiographic and retrieval findings. The Mann-Whitney test was used to compare the histological features in these two groups. The tissues from patients revised for suspected high wear had a lower ALVAL score, fewer lymphocytes, but more macrophages and metal particles than those tissues from hips revised for pain and suspected metal hypersensitivity. The highest ALVAL scores occurred in patients who were revised for pain and suspected metal hypersensitivity. Component wear was lower in that group. Pseudotumor-like reactions can be caused by high wear, but may also occur around implants with low wear, likely because of a metal hypersensitivity reaction. Histologic features including synovial integrity, inflammatory cell infiltrates, tissue organization, and metal particles may help differentiate these causes. Painful hips with periprosthetic masses may be caused by high wear, but if this can be ruled out, metal hypersensitivity should be considered.
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The presence of pseudotumours, which are soft-tissue masses relating to the hip, after metal-on-metal hip resurfacing arthroplasty has been associated with elevated levels of metal ions in serum, suggesting that pseudotumours occur when there is increased wear. We aimed to quantify the wear in vivo of implants revised for pseudotumours (eight) and of a control group of implants (22) revised for other reasons of failure. We found that the implant group with pseudotumours had a significantly higher rate of median linear wear of the femoral component at 8.1 μm/year (2.75 to 25.4) than the 1.79 μm/year (0.82 to 4.15; p = 0.002) of the non-pseudotumour group. For the acetabular component a significantly higher rate of median linear wear of 7.36 μm/year (1.61 to 24.9) was observed in the pseudotumour group compared with 1.28 μm/year (0.81 to 3.33, p = 0.001) in the other group. Wear of the acetabular component in the pseudotumour group always involved the edge of the implant, indicating that edge-loading had occurred. Our findings are the first direct evidence that pseudotumour is associated with increased wear at the metal-on-metal articulation. Furthermore, edge-loading with the loss of fluid-film lubrication may be an important mechanism of generation of wear in patients with a pseudotumour.
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Metal-on-metal hip resurfacing is commonly performed for osteoarthritis in young active patients. We have observed cystic or solid masses, which we have called inflammatory pseudotumours, arising around these devices. They may cause soft-tissue destruction with severe symptoms and a poor outcome after revision surgery. The aim of this study was to determine the incidence of and risk factors for pseudotumours that are serious enough to require revision surgery. Since 1999, 1419 metal-on-metal hip resurfacings have been implanted by our group in 1224 patients; 1.8% of the patients had a revision for pseudotumour. In this series the Kaplan-Meier cumulative revision rate for pseudotumour increased progressively with time. At eight years, in all patients, it was 4% (95% confidence interval (CI) 2.2 to 5.8). Factors significantly associated with an increase in revision rate were female gender (p < 0.001), age under 40 (p = 0.003), small components (p = 0.003), and dysplasia (p = 0.019), whereas implant type was not (p = 0.156). These factors were inter-related, however, and on fitting a Cox proportional hazard model only gender (p = 0.002) and age (p = 0.024) had a significant independent influence on revision rate; size nearly reached significance (p = 0.08). Subdividing the cohort according to significant factors, we found that the revision rate for pseudotumours in men was 0.5% (95% CI 0 to 1.1) at eight years wheras in women over 40 years old it was 6% (95% CI 2.3 to 10.1) at eight years and in women under 40 years it was 13.1% at six years (95% CI 0 to 27) (p < 0.001). We recommend that resurfacings are undertaken with caution in women, particularly those under 40 years of age but they remain a good option in young men. Further work is required to understand the aetiology of pseudotumours so that this complication can be avoided.
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Inflammatory pseudotumours occasionally occur after metal-on-metal hip resurfacing and often lead to revision. Our aim was to determine the severity of this complication by assessing the outcome of revision in these circumstances and by comparing this with the outcome of other metal-on-metal hip resurfacing revisions as well as that of matched primary total hip replacements. We identified 53 hips which had undergone metal-on-metal hip resurfacing and required revision at a mean of 1.59 years (0.01 to 6.69) after operation. Of these, 16 were revised for pseudotumours, 21 for fracture and 16 for other reasons. These were matched by age, gender and diagnosis with 103 patients undergoing primary total hip replacement with the Exeter implant. At a mean follow-up of three years (0.8 to 7.2) the outcome of metal-on-metal hip resurfacing revision for pseudotumour was poor with a mean Oxford hip score of 20.9 (sd 9.3) and was significantly worse (p < 0.001) than the outcome for fracture with a mean Oxford hip score of 40.2 (sd 9.2) or that for other causes with a mean Oxford hip score of 37.8 (sd 9.4). The clinical outcome of revision for pseudotumour was also significantly worse (p < 0.001) than the outcome of matched primary total hip replacements. By contrast, the outcome for fracture and other causes was not significantly different from that of matched primary total hip replacements (p = 0.065). After revision for pseudotumour there were three cases of recurrent dislocation, three of palsy of the femoral nerve, one of stenosis of the femoral artery and two of loosening of the component. Five hips required further revision. In three of these there was evidence of recurrent pseudotumour, and one is currently awaiting further revision. The incidence of major complications after revision for pseudotumour (50%) was significantly higher (p = 0.018) than that after revision for other causes (14%). The outcome of revision for pseudotumour is poor and consideration should be given to early revision to limit the extent of the soft-tissue destruction. The outcome of resurfacing revision for other causes is good.
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Resurfacing metal-on-metal hip arthroplasty is increasing in popularity, especially in younger patients. To date, studies indicate that the procedure is associated with a good outcome in the medium-term. Formation of a peri-articuar mass is a rarely reported complication. In this study we analyse the imaging findings in patients with resurfacing implants presenting to our institution with peri-articular masses identified on cross sectional imaging. All patients with documented peri-articular masses following resurfacing arthroplasty were included. The available imaging related to the masses was reviewed and the findings documented along with the patient's demographics. There were 10 patients (13 joints). All patients were female. Patients presented with periprosthetic anterior or posterolateral solid and cystic masses. The anterior masses involved psoas muscle and were predominately solid. The posterolateral masses were predominately cystic. In the three cases with bilateral arthroplasties, masses were detected in both hips. Histology in six cases showed features compatible with a type IV hypersensitivity reaction. The preponderance of females, the bilateral nature of the masses and the histological features suggest that peri-articular masses following resurfacing arthroplasty is due to the metal hypersensitivity.
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We report 17 patients (20 hips) in whom metal-on-metal resurfacing had been performed and who presented with various symptoms and a soft-tissue mass which we termed a pseudotumour. Each patient underwent plain radiography and in some, CT, MRI and ultrasonography were also performed. In addition, histological examination of available samples was undertaken. All the patients were women and their presentation was variable. The most common symptom was discomfort in the region of the hip. Other symptoms included spontaneous dislocation, nerve palsy, a noticeable mass or a rash. The common histological features were extensive necrosis and lymphocytic infiltration. To date, 13 of the 20 hips have required revision to a conventional hip replacement. Two are awaiting revision. We estimate that approximately 1% of patients who have a metal-on-metal resurfacing develop a pseudotumour within five years. The cause is unknown and is probably multifactorial. There may be a toxic reaction to an excess of particulate metal wear debris or a hypersensitivity reaction to a normal amount of metal debris. We are concerned that with time the incidence of these pseudotumours may increase. Further investigation is required to define their cause.
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Patients with ASR implants (resurfacing and large-diameter (XL) metal-on-metal (MoM) total hip arthroplasty), even if asymptomatic and with a stable prosthesis, may present extremely high blood metal ion levels. We report on a consecutive series of fourteen ASR revisions, focusing on osteolysis and their radiographic correspondence and their correlation with blood metal ion levels. At revision, seven hips revealed severe periacetabular osteolysis which was radiographically undetectable in six and asymptomatic in five. Seven hips with no acetabular osteolysis had significantly lower serum Cr and Co ion concentrations (respectively 25.2, 41.1μg/l) compared to the seven hips with severe acetabular bone loss (respectively 70.1, 147.0μg/l). Elevated blood metal ion levels should be considered as a warning of undetectable and ongoing periprosthetic osteolysis in asymptomatic patients with ASR prosthesis.
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Introduction: There is an ongoing debate about the optimal use of metal-on-metal (MoM) bearings in total hip replacement, since there are uncertainties about local and systemic adverse effects due to wear and corrosion of these bearings. Despite various national recommendations, efforts to achieve international harmonization of specific evidence-based recommendations for best practice are still lacking. Hypothesis: An international consensus study group should be able to develop recommendations on the use and monitoring of MoM bearings, preferably at the European level, through a multidisciplinary approach, by integrating the perspectives of various stakeholders. Materials and methods: Twenty-one experts representing three stakeholder groups and eight countries participated in this European consensus study, which consisted of a consensus meeting, subsequent structured discussion, and consensus voting. Results: The current statement defines first of all benefits, local and systemic risks, as well as uncertain issues related to MoM bearings. Safety assessment after implantation of MoM comprises all patients. A closer follow-up is recommended for large head MoM (≥36mm) and resurfacing. In these implants basic follow-up should consist of x-rays and metal ion measurement of cobalt in whole blood, performed with GF-AAS or ICP-MS. Clinical and/or radiographic abnormality as well as elevated ion levels needs additional imaging (ultrasound, CT-scan and/or MARS-MRI). Cobalt values less than 2 μg/L are probably devoid of clinical concern, the threshold value for clinical concern is expected to be within the range of 2-7 μg/L. Discussion: This is the first multinational, interdisciplinary, and multiprofessional approach for developing a recommendation for the use and monitoring of MoM bearings in total hip replacement. The current recommendations are in partial agreement with previous statements regarding the extent of follow-up and imaging techniques. They however differ from previous communications regarding measurement of metal ions and especially the investigated medium, technique, and eventual threshold levels. Level of evidence: Level V, expert opinion/agreement conference.
Article
Plasma levels of cobalt and chromium ions and Metal Artefact Reduction Sequence (MARS)-MRI scans were performed on patients with 209 consecutive, unilateral, symptomatic metal-on-metal (MoM) hip arthroplasties. There was wide variation in plasma cobalt and chromium levels, and MARS-MRI scans were positive for adverse reaction to metal debris (ARMD) in 84 hips (40%). There was a significant difference in the median plasma cobalt and chromium levels between those with positive and negative MARS-MRI scans (p < 0.001). Compared with MARS-MRI as the potential reference standard for the diagnosis of ARMD, the sensitivity of metal ion analysis for cobalt or chromium with a cut-off of > 7 µg/l was 57%. The specificity was 65%, positive predictive value was 52% and the negative predictive value was 69% in symptomatic patients. A lowered threshold of > 3.5 µg/l for cobalt and chromium ion levels improved the sensitivity and negative predictive value to 86% and 74% but at the expense of specificity (27%) and positive predictive value (44%). Metal ion analysis is not recommended as a sole indirect screening test in the surveillance of symptomatic patients with a MoM arthroplasty. The investigating clinicians should have a low threshold for obtaining cross-sectional imaging in these patients, even in the presence of low plasma metal ion levels.
Article
To describe the histopathology of localised adverse reactions to metal debris (ARMD) seen in association with failed metal on metal (MoM) hip arthroplasties. The nature of aseptic lymphocytic vasculitis associated lesion (ALVAL) is investigated. Periprosthetic soft tissues biopsied at time of revision from failed MoM hip arthroplasties from January 2007 to March 2011 were analysed. The inflammatory cell response was categorised into perivascular lymphocytic cuffing (ALVAL), lymphoid aggregate formation with or without germinal centres, metallosis characterised by sheets of macrophages with intracytoplasmic metallic debris and well-defined granulomas. 123 patient samples were analysed, 36 males (29.2%) and 87 females (70.8%). Three cases showing complete tissue necrosis were excluded. Patients were reviewed between 3.27 to 69.6 months postarthroplasty, with an average of 30.92 months. 103 cases (85.8%) showed ALVAL, 18 cases also showed well-defined granulomas. Of the 103 cases with ALVAL, 60 cases also showed a diffuse chronic lymphocytic synovitis, and 40 cases showed lymphoid aggregates with germinal centres. 17 cases (14.2%) showed pure metallosis. Small vessels showing ALVAL expressed peripheral node addressin. ARMD is a spectrum of changes comprising of pure metallosis, ALVAL and granulomatous inflammation. ALVAL, a distinctive inflammatory response seen in ARMD, is a precursor of lymphoid neogenesis. Lymphoid neogenesis documented in a variety of chronic inflammatory conditions most probably contributes to tissue necrosis and prosthetic failure seen in MoM hip arthroplasties. The role of vascular changes in contributing to necrosis is unclear at this stage.
Article
We compared 47 patients with groin pain following hip resurfacing to a matched control group. Functional scores and plain radiographs were assessed along with measurement of whole blood cobalt and chromium by inductively coupled mass spectrometry. Symptomatic patients underwent ultrasound scan of the affected hip. Mean functional outcomes were poor in those with pain and good in the control group. Groin pain was associated with valgus stem positioning and lower neck:head ratio (relatively narrow neck) (p=0.03, p=0.04 respectively). We classified patients with groin pain into two groups: biological and mechanical. The biological group had soft tissue abnormalities on USS and higher levels of cobalt and chromium (p=0.04, p=0.05 respectively). The mechanical group had normal USS, lower metal ion levels and more retroverted femoral components (p=0.01).
Article
There has been growing concern regarding the systemic and local effects of metal ions released from metal-on-metal hip resurfacings and total hip replacements, including the development of aseptic lymphocyte dominated vasculitis associated lesions (ALVAL). We describe our experience of treating 13 patients with failed metal on metal bearing hip prostheses secondary to this condition. Hip revision occurred at mean of 45 months following primary surgery. Groin pain was present in all patients. Other common features included large bursal swelling and mechanical symptoms. 3 patients developed their symptoms immediately postoperatively. The mean time to presentation was 21 months. Radiographic abnormalities noted included 3 patients with cup loosening and 2 patients with neck thinning. The mean cup inclination was 52 degrees. Surgical findings included bursal swellings and creamy brown fluid. Osteolysis was rarely seen. 12 revisions were achieved with primary implants and all patients had immediate symptomatic improvement. One patient was left with a pseudoarthrosis due to extensive soft tissue destruction. Diagnosis of ALVAL was confirmed histologically. The diagnosis of ALVAL should be considered in patients with unexplained pain from a metal on metal bearing hip arthroplasty. Surgical findings are typical and symptoms tend to resolve reliably following conversion to an alternative bearing surface.
Article
Pseudotumour is a rare but important complication of metal-on-metal hip resurfacing that occurs much more commonly in women than in men. We examined the relationship between head-neck ratio (HNR) and pseudotumour formation in 18 resurfaced hips (18 patients) revised for pseudotumour and 42 asymptomatic control resurfaced hips (42 patients). Patients in whom pseudotumour formation had occurred had higher pre-operative HNR than the control patients (mean 1.37 (sd 0.10) vs mean 1.30 (sd 0.08) p = 0.001). At operation the patients with pseudotumours had a greater reduction in the size of their femoral heads (p = 0.035) and subsequently had greater neck narrowing (mean 10.1% (sd 7.2) vs mean 3.8% (sd 3.2) p < 0.001). No female patient with a pre-operative HNR ≤ 1.3 developed a pseudotumour. We suggest that reducing the size of the femoral head, made possible by a high pre-operative HNR, increases the risk of impingement and edge loading, and may contribute to high wear and pseudotumour formation. As the incidence of pseudotumour is low in men, it appears safe to perform resurfacing in men. However, this study suggests that it is also reasonable to resurface in women with a pre-operative HNR ≤ 1.3.
Article
Despite the increasing interest and subsequent published literature on hip resurfacing arthroplasty, little is known about the prevalence of its complications and in particular the less common modes of failure. The aim of this study was to identify the prevalence of failure of hip resurfacing arthroplasty and to analyse the reasons for it. From a multi-surgeon series (141 surgeons) of 5000 Birmingham hip resurfacings we have analysed the modes, prevalence, gender differences and times to failure of any hip requiring revision. To date 182 hips have been revised (3.6%). The most common cause for revision was a fracture of the neck of the femur (54 hips, prevalence 1.1%), followed by loosening of the acetabular component (32 hips, 0.6%), collapse of the femoral head/avascular necrosis (30 hips, 0.6%), loosening of the femoral component (19 hips, 0.4%), infection (17 hips, 0.3%), pain with aseptic lymphocytic vascular and associated lesions (ALVAL)/metallosis (15 hips, 0.3%), loosening of both components (five hips, 0.1%), dislocation (five hips, 0.1%) and malposition of the acetabular component (three hips, 0.1%). In two cases the cause of failure was unknown. Comparing men with women, we found the prevalence of revision to be significantly higher in women (women = 5.7%; men = 2.6%, p < 0.001). When analysing the individual modes of failure women had significantly more revisions for loosening of the acetabular component, dislocation, infection and pain/ALVAL/metallosis (p < 0.001, p = 0.004, p = 0.008, p = 0.01 respectively). The mean time to failure was 2.9 years (0.003 to 11.0) for all causes, with revision for fracture of the neck of the femur occurring earlier than other causes (mean 1.5 years, 0.02 to 11.0). There was a significantly shorter time to failure in men (mean 2.1 years, 0.4 to 8.7) compared with women (mean 3.6 years, 0.003 to 11.0) (p < 0.001).
Article
Pseudotumours are a rare complication of hip resurfacing. They are thought to be a response to metal debris which may be caused by edge loading due to poor orientation of the acetabular component. Our aim was to determine the optimal acetabular orientation to minimise the risk of pseudotumour formation. We matched 31 hip resurfacings revised for pseudotumour formation with 58 controls who had a satisfactory outcome from this procedure. The radiographic inclination and anteversion angles of the acetabular component were measured on anteroposterior radiographs of the pelvis using Einzel-Bild-Roentgen-Analyse software. The mean inclination angle (47°, 10° to 81°) and anteversion angle (14°, 4° to 34°) of the pseudotumour cases were the same (p = 0.8, p = 0.2) as the controls, 46° (29° to 60°) and 16° (4° to 30°) respectively, but the variation was greater. Assuming an accuracy of implantation of ± 10° about a target position, the optimal radiographic position was found to be approximately 45° of inclination and 20° of anteversion. The incidence of pseudotumours inside the zone was four times lower (p = 0.007) than outside the zone. In order to minimise the risk of pseudotumour formation we recommend that surgeons implant the acetabular component at an inclination of 45° (± 10) and anteversion of 20° (± 10) on post-operative radiographs. Because of differences between the radiographic and the operative angles, this may be best achieved by aiming for an inclination of 40° and an anteversion of 25°.
Article
Evaluation and treatment of pain following hip resurfacing arthroplasty can be challenging, even for the most experienced arthroplasty surgeon. As in any total hip replacement, there are a number of investigative tools at the disposal of orthopaedic surgeons to elicit the underlying causes of pain for diagnosis and treatment. A detailed history and physical examination are the most important first steps in the differential diagnosis of the intrinsic and extrinsic etiologies of hip pain. Serial radiographs from the time of surgery also should be reviewed and compared for changes indicative of loosening, migration, and osteolysis, in combination or alone. Diagnostic injections with local anesthetic agents additionally can be performed to localize the origin of pain. Bone scintigraphy, hip joint aspiration, and laboratory tests, including erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), should be requested routinely to exclude an occult infection. The use of ultrasound (US), magnetic resonance imaging (MRI), and even hip arthroscopy has been suggested as potential diagnostic tools when metal sensitivity is suspected. Relative to cause, femoral neck fractures and the possibility of metal hypersensitivity as sources of persistent groin pain should always be considered in metal-on-metal hip resurfacing. Additionally, iliopsoas tendinopathy and anterior impingement of the femoral neck are well-recognized causes of pain and should be included in the differential diagnosis. Surface arthroplasty is becoming an acceptable alternative to standard total hip replacement in young patients. It is increasingly essential to recognize the different causes of pain following resurfacing in order to make an accurate diagnosis and initiate timely, appropriate treatment.