Metal-on-Metal Joint Prostheses

  • 文章类型: Letter
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  • 文章类型: Journal Article
    背景:金属伪影减少序列(MARS)MRI已被建立为用于诊断不良局部组织反应(ALTR)的横截面成像模式。本研究旨在评估由于ALTR而接受THA翻修的患者中与术中组织坏死和术后并发症相关的MARSMRI特征的最新文献。
    方法:我们系统检索了文献,包括报告THA失败的ALTR的MRI特征及其与术中发现和术后结果的相关性。
    结果:共评估了617项研究,15项研究符合纳入标准.滑膜壁厚与ALVAL等级增加相关,然而,弱组织坏死。混合或固体特征的滑膜组成和外展肌破裂的存在与并发症和组织坏死相关。组织水肿是无菌淋巴细胞显性血管炎相关病变(ALVAL)等级或组织坏死的不良预测指标。
    结论:MARSMRI滑膜成分包括混合和实体特征以及外展肌破裂的存在提供了与术中软组织坏死和翻修手术结果相关的最佳预后特征。MRI的这些预后特征可以帮助外科医生改善干预和术前患者咨询的标准。
    BACKGROUND: Metal artifact reductions sequence (MARS) MRI has been established as a cross-sectional imaging modality for diagnosis of adverse local tissue reaction (ALTR). This study aims to evaluate the current literature regarding the characteristics of MARS MRI associated with intraoperative tissue necrosis and postoperative complications in patients undergoing revision THA because of ALTR.
    METHODS: We systematically searched the literature that included reporting MRI characteristics of ALTR in failed THA and their correlation with intraoperative findings and postoperative outcomes.
    RESULTS: A total of 617 studies were assessed, and 15 studies met the inclusion criteria. Synovial wall thickness correlated with increasing ALVAL grade, however, weakly with tissue necrosis. Synovial composition of mixed or solid features and the presence of abductor disruption correlated with complications and tissue necrosis. Tissue edema was a poor predictor of aseptic lymphocyte-dominant vasculitis-associated lesion (ALVAL) grade or tissue necrosis.
    CONCLUSIONS: MARS MRI synovial composition including mixed and solid features and the presence of abductor disruption provide the best prognostic characteristics associated with intraoperative soft-tissue necrosis and revision surgery outcome. These prognostic characteristics on MRI may assist surgeons with improved criteria for intervention and preoperative patient counseling.
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  • 文章类型: Journal Article
    BACKGROUND: Medicines and Healthcare products Regulatory Agency (MHRA) guidance for patients with metal-on-metal (MoM) hip replacements was provided in 2012 and updated in 2017 to assist in the early detection of soft-tissue reactions due to metal wear debris. A large number of MoM hip replacements were undertaken at our hospital trust. A program of recall for all patients with MoM hip replacements was undertaken and MHRA guidelines were implemented. In this study, we aimed to investigate the effectiveness of the revised MHRA guidelines in the detection of early adverse reactions to metal debris and to re-evaluate the indications for metal artifact reduction sequence magnetic resonance imaging (MARS-MRI) and revision surgery.
    METHODS: Identification and recall of all patients with MoM hip replacements from 2001 were conducted by using theatre logs, patient records, clinical coding information, and consultant logbooks. Two senior arthroplasty consultants reviewed X-rays and patient records. Postal questionnaires were forwarded to patients, together with requests for general practitioners to complete cobalt and chromium blood tests. The two consultant-led review of MOM replacements was undertaken with further radiological investigations (X-rays, MARS-MRI) performed according to the 2017 guidance with support of consultant radiologists.
    RESULTS: Of 674 identified patients, 297 were available for review: 26 patients did not have MoM implants, 36 were untraceable, 59 refused follow-up, 87 moved out of area, 147 had died, and 22 already had revision. Of 297 patients, 126 were women and 171 were men; age range was 39 to 95 years (mean age, 69 years); 126 had resurfacing and 171 had MoM replacements. Twenty-six patients had elevated metal ions. Thirty-three patients underwent MARS-MRI: MARS-MRI results were positive in 17 and negative in 16. Of 17 patients with positive MARS-MRI, 10 patients were asymptomatic and seven were waiting revision.
    CONCLUSIONS: Positive MARS-MRI can often occur in the absence of elevated metal ion levels; elevated blood metal ion levels do not mean MARS-MRI will be positive. All patients with MoM replacements were at risk. It is imperative to assess patients regularly for symptoms that may raise clinical suspicion and maintain a low threshold to performing MARS-MRI.
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  • 文章类型: Journal Article
    Hard-on-hard bearings require a meticulous implantation technique but may be associated with lower wear rates in young active patients. Among them, metal-on-metal (MoM) bearings have been blamed for specific complications including adverse reactions to metal debris and metal hypersensitivity. These complications have been chiefly reported with large-head MoM implants (except when used for hip resurfacing). Most of the published data on small-head MoM implants were obtained using uncemented stems. To our knowledge, no information on outcomes beyond 15 years is available for small-head MoM implants with cemented cobalt-nickel-chromium (Co-Ni-Cr) stems, which might increase the risk of complications. The objective of this study was to collect long-term follow-up data on patients who underwent hybrid total hip arthroplasty (THA) with 28-mm MoM Metasul™ bearings in order to assess: (1) long-term survival (based on the revision rate), (2) and the occurrence of adverse reactions to metal debris documented during revision.
    Survival of 28-mm Metasul™ bearings used with hybrid THA is acceptable.
    A single-centre retrospective study was conducted in consecutive patients managed using 28-mm Metasul™ bearings in a press-fit cup, with a cemented Co-Ni-Cr stem. Follow-up was at least 17 years. The clinical and radiographic data were analysed. Mean age at surgery was 57.3±7.9 years (range, 29.6-75.3 years).
    The study included 115 hips with a mean follow-up of 20.3±0.8 years (range, 17.8-21.6 years). Survival to revision for any reason was 86.10% (95% CI, 79.8-92.4%) and survival to revision for aseptic loosening was 92.6% (95% CI, 87.7-97.6). Half the specimens obtained during revision showed a macrophage reaction and a non-specific inflammatory infiltrate. No patient experienced complications specifically related to the use of Metasul™ bearings with a cemented Co-Ni-Cr stem.
    Long-term survival of 28-mm MoM Metasu™ bearings was close to that of metal-on-polyethylene bearings and lower than that of ceramic-on-ceramic or small-head MoM bearings in other studies. No complications specifically related to the use of small-head MoM bearings with a cemented Co-Ni-Cr stem were recorded.
    IV, retrospective study.
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  • 文章类型: Journal Article
    Hip implants have improved the mobility and quality of life in millions of individuals. This review presents the evolution of scientific knowledge regarding the history and understanding of systemic and local metal toxicological concerns of hip implants designs utilizing metal-on-metal (MoM) bearing surfaces used in hip resurfacing arthroplasty (HRA) and total hip arthroplasty (THA). This analysis addresses: (1) the history of the development of MoM hip implants; (2) the clinical and toxicological rationale for introducing second-generation MoM implants in the early 2000s as an alternative to metal-on-polyethylene bearings; (3) the subsequent history regarding success and failure of second-generation MoM devices; (4) a detailed review of the history of MoM toxicology, including carcinogenic potential, metal blood levels, hypersensitivity, and release of wear particles; and (5) a review of local tissue effects and MoM patient management. We have included an analysis of MoM THA and HRA survivorship trends aggregated from over 200 studies. By around 2008, HRA continued to be a challenging procedure with variable success rates, and concurrently, some THA devices began to experience higher than expected revision rates based on annual registry reports. The unexpected THA outcomes and continued challenges with HRA devices prompted many surgeons to question the role of toxicological effects in device performance. Regarding hypersensitivity, while conversion to metal sensitized status in some MoM patients occurs based on the skin patch or lymphocyte transformation testing, there is no evidence of a causal relationship between positive test results and device failure. The weight of evidence indicates that nanoparticles released from MoM implants are cleared from the local synovial space under normal wear conditions. The available data indicate that there are no discernible increases in local or systemic tumors following CoCr alloy implantation. Systemic health effects are rarely reported in MoM implant patients and are unlikely when blood concentrations are below 300 µg/L except when patients have specific risk factors. Over time, patient management evolved to include assays aimed at predicting implant function (blood monitoring) and soft tissue reactions (MRI and ultrasound imaging). Validation of these biomarkers as a diagnostic tool for implant function, patient pain, and, ultimately, implant survival, remains lacking. After the introduction of these biomarkers, differences in implant revision decisions emerged based on imaging abnormalities, increased serum metal ion levels, and overall clinical presentation. Discrepancies in patient management algorithms and the lack of consensus in local biological effects terminology have contributed to variability in reporting incidence, etiology, and dose effects on local tissue responses in MoM implants. This variability has contributed to a debate regarding the benefit or risk of revising asymptomatic patients. Therefore, while toxicological assessments of normal functioning MoM implants indicate that MoM implants are relatively safe because of low wear and clearance of metal, more analysis of revision data is needed in order to best inform patient management decisions, particularly for asymptomatic patients, as well as patients with minor symptoms under consideration for conservative pain management treatments.
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  • 文章类型: Journal Article
    目的比较不同种植体组合用于初次全髋关节置换术(THR)的存活情况。设计系统评价和网络荟萃分析。数据源Medline,Embase,科克伦图书馆,ClinicalTrials.gov,世卫组织国际临床试验注册平台,和欧盟临床试验注册。综述方法公布的随机对照试验比较不同的植入物组合。植入物组合由轴承表面材料定义(聚乙烯上的金属,聚乙烯上的陶瓷,陶瓷对陶瓷,或金属对金属),头部尺寸(大尺寸≥36mm或小尺寸<36mm),和固定技术(水泥,未固定,混合动力车,或反向混合)。我们的参考植入物组合是聚乙烯上的金属(非高度交联),小脑袋,和水泥。主要结果是原发性THR后0-2年和2-10年的翻修手术。次要结果是临床医生报告的Harris髋关节评分。结果77项研究纳入系统评价,15项研究(3177例髋关节)在网络荟萃分析中进行修订。与参考植入物组合相比,没有证据表明其他植入物组合可降低翻修手术的风险。虽然估计不精确,金属对金属,小脑袋,与参考植入物组合相比,胶结植入物(风险比4.4,95%可信区间1.6至16.6)和表面置换(12.1,2.1至120.3)增加了初次THR后0-2年的翻修风险。在2-10年期间观察到类似的结果。31项研究(2888例患者)纳入Harris髋关节评分分析。没有植入物组合具有比参考植入物组合更好的评分。结论未发现较新的植入物组合优于参考植入物组合(聚乙烯上金属(非高度交联),小脑袋,骨水泥)在翻修手术风险或Harris髋关节评分方面。金属对金属,小脑袋,与参考植入物组合相比,胶结植入物和表面置换增加了翻修手术的风险。结果与观察证据一致,并在敏感性分析中重复,但由于研究报告不佳而受到限制。系统审查注册PROSPEROCRD42015019435。
    Objective To compare the survival of different implant combinations for primary total hip replacement (THR). Design Systematic review and network meta-analysis. Data sources Medline, Embase, The Cochrane Library, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and the EU Clinical Trials Register.Review methods Published randomised controlled trials comparing different implant combinations. Implant combinations were defined by bearing surface materials (metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic, or metal-on-metal), head size (large ≥36 mm or small <36 mm), and fixation technique (cemented, uncemented, hybrid, or reverse hybrid). Our reference implant combination was metal-on-polyethylene (not highly cross linked), small head, and cemented. The primary outcome was revision surgery at 0-2 years and 2-10 years after primary THR. The secondary outcome was the Harris hip score reported by clinicians.Results 77 studies were included in the systematic review, and 15 studies (3177 hips) in the network meta-analysis for revision. There was no evidence that the risk of revision surgery was reduced by other implant combinations compared with the reference implant combination. Although estimates are imprecise, metal-on-metal, small head, cemented implants (hazard ratio 4.4, 95% credible interval 1.6 to 16.6) and resurfacing (12.1, 2.1 to 120.3) increase the risk of revision at 0-2 years after primary THR compared with the reference implant combination. Similar results were observed for the 2-10 years period. 31 studies (2888 patients) were included in the analysis of Harris hip score. No implant combination had a better score than the reference implant combination.Conclusions Newer implant combinations were not found to be better than the reference implant combination (metal-on-polyethylene (not highly cross linked), small head, cemented) in terms of risk of revision surgery or Harris hip score. Metal-on-metal, small head, cemented implants and resurfacing increased the risk of revision surgery compared with the reference implant combination. The results were consistent with observational evidence and were replicated in sensitivity analysis but were limited by poor reporting across studies.Systematic review registration PROSPERO CRD42015019435.
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  • 文章类型: Journal Article
    Cobalt (Co) and its compounds are widely distributed in nature and are part of numerous anthropogenic activities. Although cobalt has a biologically necessary role as metal constituent of vitamin B12, excessive exposure has been shown to induce various adverse health effects. This review provides an extended overview of the possible Co sources and related intake routes, the detection and quantification methods for Co intake and the interpretation thereof, and the reported health effects. The Co sources were allocated to four exposure settings: occupational, environmental, dietary and medical exposure. Oral intake of Co supplements and internal exposure through metal-on-metal (MoM) hip implants deliver the highest systemic Co concentrations. The systemic health effects are characterized by a complex clinical syndrome, mainly including neurological (e.g. hearing and visual impairment), cardiovascular and endocrine deficits. Recently, a biokinetic model has been proposed to characterize the dose-response relationship and effects of chronic exposure. According to the model, health effects are unlikely to occur at blood Co concentrations under 300μg/l (100μg/l respecting a safety factor of 3) in healthy individuals, hematological and endocrine dysfunctions are the primary health endpoints, and chronic exposure to acceptable doses is not expected to pose considerable health hazards. However, toxic reactions at lower doses have been described in several cases of malfunctioning MoM hip implants, which may be explained by certain underlying pathologies that increase the individual susceptibility for Co-induced systemic toxicity. This may be associated with a decrease in Co bound to serum proteins and an increase in free ionic Co2+. As the latter is believed to be the primary toxic form, monitoring of the free fraction of Co2+ might be advisable for future risk assessment. Furthermore, future research should focus on longitudinal studies in the clinical setting of MoM hip implant patients to further elucidate the dose-response discrepancies.
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  • 文章类型: Journal Article
    With metal-on-metal (MoM) bearings, fluid film lubrication is disrupted when the contact patch area between the femoral head and the cup is close to the edge of the acetabular component, making the calculation of the contact patch to rim (CPR) distance a key variable in the study of the performance of MoM bearings. A few research centers have used models of varying complexity to calculate the CPR distance and determine its relationship with assessments of component wear. In this review, we aimed to summarise the current knowledge related to the application of CPR distance calculations in the study of in vivo performance of MoM bearings. Our systematic search of the US National Library of Medicine yielded 9 relevant publications in which 3 different models were used for the computation of the CPR distance. The 3 models show different levels of complexity and their use is mainly dependent upon the size of the subject sample and the nature of the data collected as a dependent variable. The studies reviewed consistently showed a strong inverse correlation between CPR distance and wear or metal ion levels suggesting that any study aiming to determine the risk factors for MoM hip devices needs to include an assessment of CPR distance. Cup anteversion can be measured reliably with various tools and should not be an obstacle to the use of this essential variable that is CPR distance.
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  • 文章类型: Case Reports
    A number of previous studies have reported a potential risk of malignancy, particularly hematological malignancy, developing in patients receiving a metal-on-metal (MoM) hip replacement. We report a case of malignant lymphoma that arose in a patient who had an MoM hip arthroplasty complicated by development of a pseudotumour. The tumour was a B cell follicular lymphoma that involved lymph nodes and bone. Metal ions are known to have a genotoxic effect on lymphoid cells. Although epidemiological studies have not established that there is an increased risk of lymphoma associated with MoM implants, only a relatively short time period has elapsed since re-introduction of this type of implant and long-term follow-up of patients with MoM implants is indicated.
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  • 文章类型: Journal Article
    OBJECTIVE: To compare revision rates of metal-on-metal (MoM) hip resurfacing (HRS) and MoM total hip arthroplasty (THA), as well as the primary causes for revisions.
    METHODS: The PubMed database was queried for potentially relevant articles addressing MoMTHA and MoMHRS, a total of 51 articles were included.
    RESULTS: The review includes a total number of 5,399 MoMHRS and 3,244 THA prosthesis and the reasons for prosthesis failure were divided into 7 categories and the main causes discussed. The overall MoMTHA revision rate was 4.7% after 6.9 years. MoMHRS revision rate was 5.9% after 5.7 years. The odds ratio was 1.25 (1.03:1.53) 95% CI (p = 0.03) (MoMHRS vs. MoMTHA).The studies of hip prostheses were separated into 2 categories of short- and long-term (more or less than 5 years). Short-term revision rate for MoMTHA was 4.5% after 4.8 years, and for MoMHRS 4.0% after 4.2 years. The odds ratio was 1.09 (0.82:1.43) 95% CI (0 = 0.56) (MoMTHA vs. MoMHRS). Long-term revision rate for MoMTHA was 5.2% after 7.7 years and 8.2% after 7.6 years for MoMHRS. The odds ratio was 1.58 (1.53:1.96) 95% CI (p = 0.0001) (MoMHRS vs. MoMTHA).Revision causes were divided into 7 main categories. The most common cause for revision for both MoMTHA and MoMHRS was loosening 47.6% vs. 37.7%, fracture (MoMTHA 7.69%; MoMHRS 19.62%), metal reactions (MoMTHA 7.69%; MoMHRS 26.92%) infection (MoMTHA 12.08%; MoMHRS 6.54%), instability (MoMTHA 9.13%; MoMHRS 2.69%), manufacturer defect 6.73% for MoMTHA and nonreported for MoMHRS, and miscellaneous (MoMTHA 7.69%; MoMHRS 6.54%) was stated.
    CONCLUSIONS: The comparison of MoMHRS and MoMTHA revision rates showed no difference in the short term, however in the longer term, the revision rate of MoMHRS was significantly higher than for MoMTHA. The linear increase in revision rate of MoMHRS may indicate a progression in failure.
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