Metal-on-Metal Joint Prostheses

  • 文章类型: Journal Article
    随着髋关节和膝关节置换术的发展,金属关节假体的发展已经持续了一个多世纪。在使用的材料中,钴-铬-钼(Co-Cr-Mo)和钛-铝-钒(Ti-Al-V)合金在关节假体结构中占主导地位,主要是由于它们值得称赞的生物相容性,机械强度,和耐腐蚀性。尽管如此,随着时间的推移,身体的磨损,电化学腐蚀,植入后由这些合金引起的炎症可导致各种金属成分的释放。释放的金属可以在体内流动和代谢,随后造成潜在的局部或系统性伤害。这篇评论首先详细介绍了关节假体的开发,并承认了假体金属的释放。第二,我们概述了金属的浓度,生物分布,以及释放的假体金属的消除途径。最后,我们讨论可能的器官,细胞,关键生物分子,以及暴露于这些金属引起的显着信号通路毒性和不利影响。
    The development of metallic joint prostheses has been ongoing for more than a century alongside advancements in hip and knee arthroplasty. Among the materials utilized, the Cobalt-Chromium-Molybdenum (Co-Cr-Mo) and Titanium-Aluminum-Vanadium (Ti-Al-V) alloys are predominant in joint prosthesis construction, predominantly due to their commendable biocompatibility, mechanical strength, and corrosion resistance. Nonetheless, over time, the physical wear, electrochemical corrosion, and inflammation induced by these alloys that occur post-implantation can cause the release of various metallic components. The released metals can then flow and metabolize in vivo, subsequently causing potential local or systemic harm. This review first details joint prosthesis development and acknowledges the release of prosthetic metals. Second, we outline the metallic concentration, biodistribution, and elimination pathways of the released prosthetic metals. Lastly, we discuss the possible organ, cellular, critical biomolecules, and significant signaling pathway toxicities and adverse effects that arise from exposure to these metals.
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  • 文章类型: Journal Article
    本研究旨在评估金属对金属(MoM)植入物继发的假瘤形成史与假体周围感染(PJI)率之间的关系,以及建立提示这些患者感染的ESR和CRP阈值。我们假设假瘤患者的感染风险增加。
    回顾性分析了2000年8月至2014年3月共有1,171例MoM关节全髋关节置换术(THA)患者。其中,328例患者接受了金属伪影减少序列MRI检查,并进行了至少两年的临床随访,符合我们的入选标准.收集的数据包括人口统计细节,手术适应症,偏侧性,使用的植入物,假瘤的历史,和相应的术前ESR(mm/hr)和CRP(mg/dl)水平。多因素logistic回归模型用于评估PJI和假瘤病史,建立受试者工作特征曲线,以评估ESR和CRP的诊断能力,从而确定翻修手术患者是否存在感染.
    所有确定的MoMTHA的PJI率为3.5%(41/1,171),平均随访10.9年(2.0至20.4年)。在最终队列中的患者中,8.2%(27/328)患有PJI,平均随访12.2年(2.3至20.4年)。在这个群体中,31.1%(102/328)有假瘤史。这些患者的PJI率为14.7%(15/102),比没有假瘤的人更大,5.3%(12/226)(p=0.008)。此外,logistic回归分析显示假瘤病史与PJI之间存在关联(比值比4.36(95%置信区间1.77~11.3);p=0.002).在有假瘤病史的患者中,与没有假瘤病史的患者相比,PJI的最佳诊断截止值ESR为33.1mm/hr和24.5mm/hr,CRP为7.37mg/dl和1.88mg/dl,分别。
    有MoMTHA继发假瘤病史的患者比没有假瘤病史的患者有更高的感染可能性。虽然这些患者对感染的怀疑应该很高,欧洲骨与关节感染协会公布的ESR和CRP截止值可能不适用于有假瘤病史的患者。因为提示PJI的ESR和CRP水平可能高于无假瘤患者.额外的调查,如愿望,除非临床怀疑和实验室标志物低,否则强烈建议这些患者。
    UNASSIGNED: This study aims to assess the relationship between history of pseudotumour formation secondary to metal-on-metal (MoM) implants and periprosthetic joint infection (PJI) rate, as well as establish ESR and CRP thresholds that are suggestive of infection in these patients. We hypothesized that patients with a pseudotumour were at increased risk of infection.
    UNASSIGNED: A total of 1,171 total hip arthroplasty (THA) patients with MoM articulations from August 2000 to March 2014 were retrospectively identified. Of those, 328 patients underwent metal artefact reduction sequence MRI and had minimum two years\' clinical follow-up, and met our inclusion criteria. Data collected included demographic details, surgical indication, laterality, implants used, history of pseudotumour, and their corresponding preoperative ESR (mm/hr) and CRP (mg/dl) levels. Multivariate logistic regression modelling was used to evaluate PJI and history of pseudotumour, and receiver operating characteristic curves were created to assess the diagnostic capabilities of ESR and CRP to determine the presence of infection in patients undergoing revision surgery.
    UNASSIGNED: The rate of PJI for all identified MoM THAs was 3.5% (41/1,171), with a mean follow-up of 10.9 years (2.0 to 20.4). Of the patients included in the final cohort, 8.2% (27/328) had PJI, with a mean follow-up of 12.2 years (2.3 to 20.4). Among this cohort, 31.1% (102/328) had a history of pseudotumour. The rate of PJI in these patients was 14.7% (15/102), which was greater than those without pseudotumour, 5.3% (12/226) (p = 0.008). Additionally, logistic regression analysis showed an association between history of pseudotumour and PJI (odds ratio 4.36 (95% confidence interval 1.77 to 11.3); p = 0.002). Optimal diagnostic cutoffs for PJI in patients with history of pseudotumour versus those without were 33.1 mm/hr and 24.5 mm/hr for ESR and 7.37 mg/dl and 1.88 mg/dl for CRP, respectively.
    UNASSIGNED: Patients with history of pseudotumour secondary to MoM THA had a higher likelihood of infection than those without. While suspicion of infection should be high for these patients, ESR and CRP cutoffs published by the European Bone and Joint Infection Society may not be appropriate for patients with a history of pseudotumour, as ESR and CRP levels suggestive of PJI are likely to be higher than for those without a pseudotumour. Additional investigation, such as aspiration, is highly recommended for these patients unless clinical suspicion and laboratory markers are low.
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  • 文章类型: Journal Article
    伯明翰髋关节表面置换术(BHR)于1997年推出,旨在使用历史悠久的大直径金属对金属(MoM)轴承来满足年轻活跃患者的需求。以前曾报道过一位设计师外科医生连续的130名患者(144髋)在五年和十年中,报告三次和十次失败,分别。这项研究的目的是将该原始队列的随访时间延长至25年。
    该研究扩展了130例患者中所有适应症的首次连续144例表面置换手术的报告。所有行动都是在1997年8月至1998年5月期间进行的。手术平均年龄为52.1岁(SD9.93;17至76),其中女性患者37例(28.5%)。失败被定义为出于任何原因的任一组件的修订。进行Kaplan-Meier生存分析。常规随访血清金属离子水平,射线照片,和牛津髋关节得分(OHSs)进行。
    25年时,植入物的总生存率为83.50%(95%置信区间(CI)0.79至0.90),有风险的人数是79。男性患者25岁时的生存率为89.5%(95%CI0.83至0.96),女性患者为66.9%(95%CI0.51至0.83)。在10到25年的时间内发生了十次额外的故障。这些涉及四名患者对金属碎片的不良反应,影响五名患者的假体周围股骨颈骨折,一名患者无菌性松动。中值铬水平为49.50nmol/l(四分位距(IQR)34至70),钴血清水平中位数为42nmol/l(IQR24.50至71.25)。末次随访时OHS中位数为35(IQR10至48)。在25年的研究期间,29例患者死亡。患者25年生存率为75.10%(95%CI0.67~0.83)。
    这项研究表明,使用BHR的MoM髋关节置换术提供了全髋关节置换术(THA)的持久替代方案,特别是希望维持高水平功能的年轻男性骨关节炎患者。这些结果与THA的最佳结果相比是有利的。
    UNASSIGNED: The Birmingham Hip Resurfacing (BHR) was introduced in 1997 to address the needs of young active patients using a historically proven large-diameter metal-on-metal (MoM) bearing. A single designer surgeon\'s consecutive series of 130 patients (144 hips) was previously reported at five and ten years, reporting three and ten failures, respectively. The aim of this study was to extend the follow-up of this original cohort at 25 years.
    UNASSIGNED: The study extends the reporting on the first consecutive 144 resurfacing procedures in 130 patients for all indications. All operations were undertaken between August 1997 and May 1998. The mean age at operation was 52.1 years (SD 9.93; 17 to 76), and included 37 female patients (28.5%). Failure was defined as revision of either component for any reason. Kaplan-Meier survival analysis was performed. Routine follow-up with serum metal ion levels, radiographs, and Oxford Hip Scores (OHSs) was undertaken.
    UNASSIGNED: Overall implant survival was 83.50% (95% confidence interval (CI) 0.79 to 0.90) at 25 years, and the number at risk was 79. Survival in male patients at 25 years was 89.5% (95% CI 0.83 to 0.96) compared to 66.9% for female patients (95% CI 0.51 to 0.83). Ten additional failures occurred in the period of ten to 25 years. These involved an adverse reaction to metal debris in four patients, a periprosthetic femoral neck fracture affecting five patients, and aseptic loosening in one patient. The median chromium levels were 49.50 nmol/l (interquartile range (IQR) 34 to 70), and the median cobalt serum levels were 42 nmol/l (IQR 24.50 to 71.25). The median OHS at last follow-up was 35 (IQR 10 to 48). During the 25-year study period, 29 patients died. Patient survival at 25 years was 75.10% (95% CI 0.67 to 0.83).
    UNASSIGNED: This study demonstrates that MoM hip resurfacing using the BHR provides a durable alternative to total hip arthroplasty (THA), particularly in younger male patients with osteoarthritis wishing to maintain a high level of function. These results compare favourably to the best results for THAs.
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  • 文章类型: Journal Article
    髋关节表面置换术(HRA)已被提倡为年轻人的一种有吸引力的疗法,更苛刻的患者人群与衰弱的髋关节骨关节炎。围绕金属对金属(MoM)髋关节表面重铺的争议,然而,导致HRA的受欢迎程度大幅下降。尽管如此,大量证据支持在选定的一组患者中使用特定的植入物。这是对伯明翰髋关节置换术(BHR)的单个外科医生系列的持续回顾性分析。最初的中期分析是在2011年完成的,由VanderBracht等人13发表。这项分析包括7至12年的长期随访,包括功能评分(HHS,HOOS和UCLA活动得分),金属离子评估和生存分析。失败被定义为任何原因的修订。在247例患者中,总共包括267例BHR的表面置换程序。我们平均随访了8.3年。10年总生存率为94.8%(男性为97.2%,女性为90.1%)。随访时平均HHS评分有统计学上的显着增加(56.03-IQR47-65至96.07-IQR96-100)。金属离子升高与并发症概率的统计学显着增加相关。这项队列研究进一步证明,采用伯明翰髋关节表面置换植入物的髋关节表面置换为年轻患者的常规全髋关节置换术提供了良好的替代方案。随访时功能评分显著增加。有进一步的证据表明女性患者的预后较差。
    Hip resurfacing arthroplasty (HRA) has been advocated as an attractive therapy for a younger, more demanding patient population with debilitating hip osteoarthritis. Controversies surrounding metal-on-metal (MoM) hip resurfacing have, however, led to a significant decline in the popularity of the HRA. Despite this, substantial evidence supports the use of specific implants in a selected group of patients. This is a continued retrospective analysis of a single surgeon series of the Birmingham Hip Resurfacing (BHR). Initial medium-term analysis was done in 2011 and published by Van der Bracht et al.13. This analysis includes a long-term follow-up of 7 to 12 years, including functional scoring (HHS, HOOS and UCLA activity score), metal ion evaluation and survival analysis. Failure was defined as revision for any cause. A total of 267 resurfacing procedures with the BHR were included in 247 patients. We had a mean follow-up of 8.3 years. Overall survival at ten years was 94.8%(97.2% for males and 90.1% for females). There was a statistically significant increase in mean HHS score at follow-up (56.03 - IQR 47-65 to 96.07 - IQR 96-100). Elevated metal ions were correlated with a statistically significant increase in the probability of complications. This cohort study further proved that hip resurfacing arthroplasty with the Birmingham Hip Resurfacing implant provides a good alternative to conventional total hip arthroplasty in young patients. There was a significant increase in functional scores at follow-up. There is further evidence of less favorable outcomes in female patients.
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  • 文章类型: Journal Article
    这项研究的第一个目的是评估在接受伯明翰髋关节表面置换术(BHR)并使用金属对金属轴承的患者中,术前肾功能是否与术后全血金属离子水平的变化有关。第二个目的是评估十年暴露于钴(Co)和铬(Cr)水平升高是否会对肾功能产生不利影响。
    作为多中心的一部分,前瞻性批准后研究,全血样本被送到一个专门的实验室,以确定Co和Cr水平,和估计的肾小球滤过率(eGFR)。该研究包括117例未经修正的单侧BHR患者。有36名女性(31%)。手术时患者的平均年龄为51.3岁(SD6.5),他们都有术前一个-,four-,五-,和十年的实验室数据。平均随访时间为10.1年(SD0.2)。
    术后1年Co水平中位数与术前相比明显增加,从0.13到1.26ppb(p<0.001),为9.7倍,和中位数Cr水平显着增加了2.5倍,从0.60到1.50ppb(p<0.001)。与术前水平相比,术前eGFRs较低与Co在一年内的显著增加相关(ρ=-0.26;p=0.005),但术前eGFRs与1年Cr的变化之间没有关系(ρ=-0.13;p=0.153)。随着时间的推移,金属水平保持相对恒定,Co的十年中位数为1.12ppb,Cr的十年中位数为1.29ppb。十年随访时的Co和Cr水平与eGFR从术前水平到十年时的变化之间没有显着关系(ρ=-0.02;Co的p=0.827;ρ=-0.008;Cr的p=0.933)。
    尽管术前eGFRs较低的患者在一年时Co水平有较大的增加,在术后前10年,接受单侧BHR的患者的金属水平升高并未对肾功能产生不利影响.
    UNASSIGNED: The first aim of this study was to evaluate whether preoperative renal function is associated with postoperative changes in whole blood levels of metal ions in patients who have undergone a Birmingham Hip Resurfacing (BHR) arthroplasty with a metal-on-metal bearing. The second aim was to evaluate whether exposure to increased cobalt (Co) and chromium (Cr) levels for ten years adversely affected renal function.
    UNASSIGNED: As part of a multicentre, prospective post-approval study, whole blood samples were sent to a single specialized laboratory to determine Co and Cr levels, and the estimated glomerular filtration rate (eGFR). The study included patients with 117 unrevised unilateral BHRs. There were 36 females (31%). The mean age of the patients at the time of surgery of 51.3 years (SD 6.5), and they all had preoperative one-, four-, five-, and ten-year laboratory data. The mean follow-up was 10.1 years (SD 0.2).
    UNASSIGNED: Median Co levels at one year postoperatively increased significantly compared with the preoperative values, by a factor of 9.7, from 0.13 to 1.26 ppb (p < 0.001), and the median Cr levels increased significantly by a factor of 2.5, from 0.60 to 1.50 ppb (p < 0.001). Lower preoperative eGFRs were associated with significantly larger increases in Co at one year compared with the preoperative levels (ρ = -0.26; p = 0.005), but there was no relationship between preoperative eGFRs and changes in Cr at one year (ρ = -0.13; p = 0.153). Metal levels remained relatively constant with the passage of time, with a median ten-year value of 1.12 ppb for Co and 1.29 ppb for Cr. There was no significant relationship between the Co and Cr levels at ten-year follow-up and the change in eGFR from the preoperative level to that at ten years (ρ = -0.02; p = 0.827 for Co; ρ = -0.008; p = 0.933 for Cr).
    UNASSIGNED: Although patients with lower preoperative eGFRs tended to have larger increases in Co levels at one year, increased metal levels for patients who underwent unilateral BHR did not adversely affect renal function during the first ten postoperative years.
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  • 文章类型: Journal Article
    继发于金属对金属(MoM)髋关节置换术的血钴水平升高是导致心血管并发症(包括心肌病)的危险因素。使用左心室射血分数(LVEF)评估MoM髋关节患者的临床研究发现钴引起的心肌病的证据相互矛盾。全局纵向应变(GLS)是一种超声心动图测量,在诊断早期心肌病时比LVEF更敏感。心血管损伤的程度,以GLS衡量,在血钴水平升高的患者中,以前没有检查过。
    共有16例血钴离子水平超过13µg/l(13ppb,从区域关节成形术数据库中确定221nmol/l)。他们与八名等待髋关节置换术的患者相匹配。所有患者均行超声心动图检查,包括GLS,研究心肌病的潜在体征。
    患有MoM髋关节置换术的患者的平均血液钴水平为29µg/l(495nmol/l),而对照组为0.01µg/l(0.2nmol/l)。GLS读数可用于MoM队列中的七个,与对照组相比,显着降低(-15.5%vs-18%(MoMvs对照组);p=0.025))。Pearson相关性显示GLS与血钴水平显著相关(r=0.8521;p<0.001)。然而,其他超声心动图测量没有差异或相关性,包括LVEF(64.3%vs63.7%(MoMvs对照组);p=0.845)。
    这项研究支持以下假设:与等待髋关节置换术的对照组患者相比,在MoM髋关节植入物存在的情况下血钴水平高于13µg/l的患者可能具有心脏功能受损。这是第一项使用GLS更敏感的参数来评估MoM髋关节植入物和正常LVEF患者的任何心脏收缩功能障碍的研究。应进行更大规模的研究,以确定GLS作为MoM关节置换术患者心脏并发症的预测指标。
    UNASSIGNED: Elevated blood cobalt levels secondary to metal-on-metal (MoM) hip arthroplasties are a suggested risk factor for developing cardiovascular complications including cardiomyopathy. Clinical studies assessing patients with MoM hips using left ventricular ejection fraction (LVEF) have found conflicting evidence of cobalt-induced cardiomyopathy. Global longitudinal strain (GLS) is an echocardiography measurement known to be more sensitive than LVEF when diagnosing early cardiomyopathies. The extent of cardiovascular injury, as measured by GLS, in patients with elevated blood cobalt levels has not previously been examined.
    UNASSIGNED: A total of 16 patients with documented blood cobalt ion levels above 13 µg/l (13 ppb, 221 nmol/l) were identified from a regional arthroplasty database. They were matched with eight patients awaiting hip arthroplasty. All patients underwent echocardiography, including GLS, investigating potential signs of cardiomyopathy.
    UNASSIGNED: Patients with MoM hip arthroplasties had a mean blood cobalt level of 29 µg/l (495 nmol/l) compared to 0.01 µg/l (0.2 nmol/l) in the control group. GLS readings were available for seven of the MoM cohort, and were significantly lower when compared with controls (-15.5% vs -18% (MoM vs control); p = 0.025)). Pearson correlation demonstrated that GLS significantly correlated with blood cobalt level (r = 0.8521; p < 0.001). However, there were no differences or correlations for other echocardiography measurements, including LVEF (64.3% vs 63.7% (MoM vs control); p = 0.845).
    UNASSIGNED: This study supports the hypothesis that patients with elevated blood cobalt levels above 13 µg/l in the presence of a MoM hip implant may have impaired cardiac function compared to a control group of patients awaiting hip arthroplasty. It is the first study to use the more sensitive parameter of GLS to assess for any cardiac contractile dysfunction in patients with a MoM hip implant and a normal LVEF. Larger studies should be performed to determine the potential of GLS as a predictor of cardiac complications in patients with MoM arthroplasties.
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  • 文章类型: Journal Article
    为了提高铰接金属关节内置假体的耐磨性,表面可以涂覆有氮化钛铌(TiNbN)。在恶劣的摩擦学条件或不对准的情况下,磨损可以发生在这些植入物表面的原位。这项研究调查了人成骨细胞对TiNbN涂层髋关节植入物产生的磨损颗粒的生物学反应。根据ISO14242-1/-2在髋关节模拟器中产生磨料颗粒,并用蛋白酶K提取。通过电子显微镜和能量色散X射线光谱(EDS)评估颗粒特征,电感耦合等离子体质谱(ICP-MS)和动态光散射(DLS)测量。人成骨细胞暴露于不同的颗粒稀释度(1:20、1:50和1:100),4和7天后分析细胞活力和成骨标志物和炎症介质的基因表达水平。使用ICP-MS,EDS,和DLS测量,约70%的颗粒被鉴定为TiNbN,范围从39到94nm。颗粒表现出平坦和近角度的形态。暴露于颗粒不会影响细胞活力和成骨细胞分化能力。胶原蛋白1型,骨保护素的蛋白质水平,核因子κB受体活化因子配体几乎不受影响。此外,通过白细胞介素6和8的促炎反应在颗粒接触后是轻微诱导的.与金属颗粒相比,大量的TiNbN磨损颗粒仅对成骨细胞的分化能力和炎症反应有轻微影响。然而,进一步的研究应该研究这些颗粒在种植体周围骨组织中的作用,特别是关于其他细胞类型。
    To improve the wear resistance of articulating metallic joint endoprostheses, the surfaces can be coated with titanium niobium nitride (TiNbN). Under poor tribological conditions or malalignment, wear can occur on these implant surfaces in situ. This study investigated the biological response of human osteoblasts to wear particles generated from TiNbN-coated hip implants. Abrasive particles were generated in a hip simulator according to ISO 14242-1/-2 and extracted with Proteinase K. Particle characteristics were evaluated by electron microscopy and energy dispersive x-ray spectroscopy (EDS), inductively coupled plasma mass spectrometry (ICP-MS) and dynamic light scattering (DLS) measurements. Human osteoblasts were exposed to different particle dilutions (1:20, 1:50, and 1:100), and cell viability and gene expression levels of osteogenic markers and inflammatory mediators were analyzed after 4 and 7 days. Using ICP-MS, EDS, and DLS measurements, ~70% of the particles were identified as TiNbN, ranging from 39 to 94 nm. The particles exhibited a flat and subangular morphology. Exposure to particles did not influence cell viability and osteoblastic differentiation capacity. Protein levels of collagen type 1, osteoprotegerin, and receptor activator of nuclear factor κB ligand were almost unaffected. Moreover, the pro-inflammatory response via interleukins 6 and 8 was minor induced after particle contact. A high number of TiNbN wear particles only slightly affected osteoblasts\' differentiation ability and inflammatory response compared to metallic particles. Nevertheless, further studies should investigate the role of these particles in peri-implant bone tissue, especially concerning other cell types.
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  • 文章类型: Journal Article
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  • 文章类型: Case Reports
    方法:假体髋关节植入物周围金属碎片的不良反应越来越受到重视。我们提供了一例病例报告,该患者在先前的全髋关节置换术前后疼痛加剧,磁共振成像发现与假瘤一致。血清金属离子水平没有升高,最初的活检结果尚无定论。患者在翻修全髋关节置换术后被诊断为骨外软骨肉瘤,随后接受了切缘阴性的外部半盆切除术。
    结论:本报告强调了对髋关节置换周围表现为假瘤的恶性肉瘤保持警惕的重要性,特别是在没有异常金属离子水平或明确活检结果的情况下。
    METHODS: There is an increasing emphasis on adverse reactions to metal debris around prosthetic hip implants. We present a case report of a patient with increasing pain around a previous total hip arthroplasty and magnetic resonance imaging findings consistent with a pseudotumor. Serum metal ion levels were not elevated and initial biopsy findings inconclusive. The patient was diagnosed with an extraskeletal chondrosarcoma after revision total hip arthroplasty and subsequently underwent external hemipelvectomy with negative margins.
    CONCLUSIONS: This report highlights the importance of remaining vigilant for malignant sarcomas presenting as pseudotumors around hip replacements, particularly in the absence of abnormal metal ion levels or definitive biopsy results.
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  • 文章类型: Journal Article
    背景:假瘤形成是金属对金属(MoM)THA中众所周知的并发症。假瘤合并血清离子水平升高和患者主诉可导致较高的翻修率。从比较大头MoMTHA和常规金属对聚乙烯(MoP)THA的随机试验获得的长期(>10年)结果缺乏关于修订和生存率的研究。假瘤形成,功能结果,和血清离子水平。
    目标:随访10年,(1)大头(38至60毫米)MoMTHA和常规28毫米MoPTHA之间的生存率和翻修率差异是什么?(2)大头MoMTHA和MoPTHA之间的假瘤形成有什么区别?(3)大头MoMTHA和MoPTHA之间的功能结局有差异吗?(4)2006年12月MoTHA和MoTHA之间结果:有了可用的数字,MoP组和MoM组10年时无任何原因翻修的生存率无差异(95%[95%CI85%~98%]对92%[95%CI82%~98%];p=0.6).MoM组的CT假瘤患者比例高于MoP组,但在两组中均观察到假瘤(MoM组56%[36个中的20个]与MoP组22%[45个中的10个],相对风险1.8[95%CI1.2至2.6];p=0.002)。在MoM组中发现较高比例的钴和铬含量(19%和14%,分别)比MoP组(钴和铬均为0%)(钴:RR1.2[95%CI1.1至1.5];p=0.002;铬:RR1.2[95%CI1.0至1.3];p=0.01)。在25%的假瘤患者中(20名患者中有5名),血清钴水平升高。没有假瘤的23例患者中没有一个钴水平升高(RR1.3[95%CI1.0至1.7];p=0.01)。研究组之间的功能结局没有差异,假瘤患者和无假瘤患者之间也没有区别。
    结论:这项研究表明,大头MoMTHA患者的生存率较高,与MoPTHA患者的生存率相当,这与其他人报告的高修订率形成鲜明对比。尽管一些患有MoPTHA的患者经历了假瘤,MoM臀部假瘤的风险要大得多,接受MoMTHA的患者血清离子水平较高。由于这些原因和未知的未来并发症,持续监测MoMTHA患者似乎很重要。
    方法:一级,治疗性研究。
    BACKGROUND: Pseudotumor formation is a well-known complication in metal-on-metal (MoM) THA. Pseudotumors combined with elevated serum ion levels and complaints from patients can lead to high revision rates. Long-term (> 10 years) results obtained from randomized trials comparing large-head MoM THA and conventional metal-on-polyethylene (MoP) THA are lacking regarding revision and survival rates, pseudotumor formation, functional outcomes, and serum ion levels.
    OBJECTIVE: At 10 years of follow-up, (1) what is the difference in survival and revision rates between large-head (38 to 60 mm) MoM THA and conventional 28-mm MoP THA? (2) What is the difference in pseudotumor formation between large-head MoM THA and MoP THA? (3) Is there a difference in functional outcome between large-head MoM THA and MoP THA? (4) What is the difference in serum ion levels between large-head MoM THA and MoP THA?
    METHODS: Between January 2006 and December 2008, 104 patients were randomized to receive either cementless MoM THA (50 patients) or cementless MoP THA (54 patients). In all, 78% (81 of 104) of patients completed the 10-year postoperative follow-up: 36 patients with MoM THA (72%; six patients lost to follow-up) and 45 with MoP THA (83%; four lost to follow-up). In the MoM group, 47% (17) were men, and the patients had a mean ± SD age of 60 ± 5 years. In the MoP group, 38% (17) were men, and the patients had a mean age of 61 ± 5 years. All baseline characteristics were similar between the groups. At 10 years of follow-up, all patient records were screened for revision surgery or complications, and the primary endpoint was survivorship free from revision for any cause at the 10-year follow-up interval, which we analyzed using a Kaplan-Meier survival analysis. All patients had a CT scan to determine the pseudotumor classification, which was reviewed by an independent radiologist. Functional outcome was measured using the patient-reported Oxford Hip Score and Harris Hip Score; the latter was assessed by a blinded nurse practitioner. Finally, serum ion cobalt and chrome concentrations were measured at 10 years postoperatively. Because the a priori sample size calculation for this randomized controlled trial was based on a different endpoint, a post hoc power analysis was performed for this long-term follow-up study, with survival as the primary outcome. It showed that considering the number of included patients, this study would have sufficient power (one-sided testing, alpha 0.05, power 80%) to discern a difference of 20% in the survival rate between the MoP and MoM groups (95% versus 75%).
    RESULTS: With the numbers available, there was no difference in survivorship free from revision for any cause between the MoP group and MoM group at 10 years (95% [95% CI 85% to 98%] versus 92% [95% CI 82% to 98%]; p = 0.6). A higher percentage of patients in the MoM group had pseudotumors on CT than those in the MoP group did, but pseudotumors were observed in both groups (56% [20 of 36] in the MoM group versus 22% [10 of 45] in the MoP group, relative risk 1.8 [95% CI 1.2 to 2.6]; p = 0.002). A higher proportion of elevated cobalt and chrome levels was found in the MoM group (19% and 14%, respectively) than in the MoP group (0% for both cobalt and chrome) (cobalt: RR 1.2 [95% CI 1.1 to 1.5]; p = 0.002; chrome: RR 1.2 [95% CI 1.0 to 1.3]; p = 0.01). In 25% of the patients with pseudotumors (5 of 20 patients), there were elevated serum cobalt levels. None of the 23 patients without pseudotumors had elevated cobalt levels (RR 1.3 [95% CI 1.0 to 1.7]; p = 0.01). There was no difference in functional outcome between study groups, nor a difference between patients with a pseudotumor and those without.
    CONCLUSIONS: This study showed that the survival of patients with large-head MoM THA was high and comparable to that of those with MoP THA, which contrasts with the high revision rates reported by others. Although some patients with MoP THAs experienced pseudotumors, the risk of a pseudotumor was much greater in MoM hips, and serum ion levels were higher in patients who received an MoM THA. For these reasons and unknown future complications, continued surveillance of patients with MoM THAs seems important.
    METHODS: Level I, therapeutic study.
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