Early migration of tibial components is associated with late revision: A systematic review and meta-analysis of 21,000 knee arthroplasties

Purpose

We performed two parallel systematic reviews and meta-analyses to determine the association between early migration of tibial components and late aseptic revision.

Methods

One review comprised early migration data from radiostereometric analysis (RSA) studies, while the other focused on revision rates for aseptic loosening from long-term survival studies. Thresholds for acceptable and unacceptable migration were determined according to that of several national joint registries: < 5% revision at 10 years.

Results

Following an elaborate literature search, 50 studies (involving 847 total knee prostheses (TKPs)) were included in the RSA review and 56 studies (20,599 TKPs) were included in the survival review. The results showed that for every mm increase in migration there was an 8% increase in revision rate, which remained after correction for age, sex, diagnosis, hospital type, continent, and study quality. Consequently, migration up to 0.5 mm was considered acceptable during the first postoperative year, while migration of 1.6 mm or more was unacceptable. TKPs with migration of between 0.5 and 1.6 mm were considered to be at risk of having revision rates higher than 5% at 10 years.

Interpretation

There was a clinically relevant association between early migration of TKPs and late revision for loosening. The proposed migration thresholds can be implemented in a phased, evidence-based introduction of new types of knee prostheses, since they allow early detection of high-risk TKPs while exposing only a small number of patients.Worldwide, several hundred thousand total knee prostheses (TKPs) are implanted each year and this number is expected to increase by a factor of 6 within the next 2 decades (Kurtz et al. 2005, 2007). Most of the new TKP designs have been introduced to the market without being shown to be safe or effective (Sheth et al. 2009). This has resulted in the widespread use of TKPs with failure rates exceeding 10 times the standard of national joint registries (< 5% failures at 10-year follow-up), such as the Accord, St Leger, and Journey-Deuce (Norton et al. 2002, Gilbert et al. 2009, Sheth et al. 2009, Palumbo et al. 2011 (personal communication)). To guarantee patient safety, several countries have developed guidelines, e.g. the NICE guidelines for total hip prostheses (2003). Furthermore, it has become increasingly evident that a phased, evidence-based introduction, as is common for pharmaceuticals, is needed to regulate the introduction of new TKPs to the market (Malchau 2000, McCulloch et al. 2009, Schemitsch et al. 2010). This should include systematic assessment and early detection of the major cause of TKP failure, which is aseptic loosening of the tibial component necessitating revision surgery (2003, AJR 2010).Although it can take 10 years before loosening causes symptoms, it is possible to detect loosening early postoperatively using radiostereometric analysis (RSA) (Selvik 1989, Grewal et al. 1992, Karrholm et al. 1994, Ryd et al. 1995). Since RSA allows in vivo, 3D measurement of the migration of TKPs with an accuracy of 0.2 mm for translations and 0.5 degrees for rotations, only a small number of patients need be exposed to potentially unsafe TKPs (Grewal et al. 1992, Ryd et al. 1995, Nelissen et al. 1998). RSA could therefore play an important role in the phased, evidence-based introduction of new TKPs (Selvik 1989, Karrholm et al. 1994, Ryd et al. 1995). However, the evidence for the relationship between early migration and TKP revision for aseptic loosening is limited to a few studies from the 1990s (Grewal et al. 1992, Ryd et al. 1995). Furthermore, the applicability of these studies is restricted, because surgical technique, fixation methods, implant design, and polyethylene have evolved since their publication.We hypothesized that early migration of the tibial component, measured through RSA, is associated with late revision for aseptic loosening of TKPs. We therefore systematically reviewed the association between early migration and late aseptic revision for the tibial component in TKPs. This could ultimately lead to clinical guidelines to be used in a phased introduction of new TKPs.     

胶原诱导性关节炎的评定与T细胞受体-热休克蛋白70DNA疫苗的保护作用

目的:纯化制备含有编码T细胞受体(TCR)Vβ5.2/8.2基因片段与结核杆菌热休克蛋白(HSP)70的一段保守序列P111-125的嵌合DNA疫苗,观察其对胶原诱导性关节炎的保护性作用。方法:实验于2006-07/2007-02在首都医科大学免疫学系实验室完成。①实验分组:36只Lewis大鼠随机分为6组,即正常对照组、胶原诱导性关节炎对照组、空质粒组、pTARGET-TCRVβ5.2-HSP70重组质粒治疗组、pTARGET-TCRVβ8.2-HSP70重组质粒治疗组及pTARGET-TCRVβ5.2-HSP70和pTARGET-TCRVβ8.2-HSP70重组质粒联合治疗组,每组6只。②实验方法:大量纯化制备重组DNA疫苗pTARGET-TCRVβ5.2-HSP70、pTARGET-TCRVβ8.2-HSP70和空质粒pTARGET,观察重组DNA疫苗对胶原诱导性关节炎的保护效果,包括关节炎指数评分、Eli-spot法测定脾细胞分泌的干扰素γ和白细胞介素4的水平、ELISA法测定血清中抗Ⅱ型胶原抗体的水平;光镜下观察大鼠后肢足关节的病理学变化。结果:36只Lewis大鼠均进入结果分析。重组DNA疫苗pTARGET-TCRVβ5.2-HSP70和pTARGET-TCRVβ8.2-HSP70对胶原诱导性关节炎有较好的保护性作用,与胶原诱导性关节炎对照组相比,关节炎指数(P<0.05)下降,炎性细胞因子干扰素γ水平(P<0.05)和抗Ⅱ型胶原抗体水平(P<0.01)降低,抑制性细胞因子白细胞介素4水平(P<0.05)升高,病理学改变较轻。且两种重组质粒联合治疗的效果要比单种质粒好。结论:重组DNA疫苗pTARGET-TCRVβ5.2-HSP70和pTARGET-TCRVβ8.2-HSP70能明显减轻胶原诱导性关节炎大鼠的关节炎症状和病理改变,二者联合应用效果更佳。     

Calcium Hydroxylapatite: Over a Decade of Clinical Experience

Background: Calcium hydroxylapatite is one of the most well-studied dermal fillers worldwide and has been extensively used for the correction of moderate-to-severe facial lines and folds and to replenish lost volume. Objectives: To mark the milestone of 10 years of use in the aesthetic field, this review will consider the evolution of calcium hydroxylapatite in aesthetic medicine, provide a detailed injection protocol for a global facial approach, and examine how the unique properties of calcium hydroxylapatite provide it with an important place in today’s market. Methods: This article is an up-to-date review of calcium hydroxylapatite in aesthetic medicine along with procedures for its use, including a detailed injection protocol for a global facial approach by three expert injectors. Conclusion: Calcium hydroxylapatite is a very effective agent for many areas of facial soft tissue augmentation and is associated with a high and well-established safety profile. Calcium hydroxylapatite combines high elasticity and viscosity with an ability to induce long-term collagen formation making it an ideal agent for a global facial approach.Aesthetic medicine has advanced greatly in the past decade in terms of our understanding of facial anatomy; the cumulative effects of the aging process; and how dermal fillers may be used to repair, reduce, and even reverse these changes. Initially, aesthetic practitioners were “chasing lines and wrinkles,” based on experience with bovine collagen injections beginning in the early 1980s. We now appreciate that a natural and more youthful appearance is dependent on reversing the cumulative effect of age-related changes both on the surface and in the subsurface tissues. For surface aging, restoration of textural and pigmentary alterations is of paramount importance; for the subsurface, restoring lost volume and shape is the key to the more youthful proportions desired by our patients. This focus on facial shape and volume to restore balance, symmetry, and the proportions of youth has led to the development and worldwide clinical use of an ever-expanding list of dermal fillers for treatment of facial aging.Dermal fillers as a category of implantable medical devices, consist of a wide array of products that differ significantly in their chemical composition, mechanism of action, duration, safety, and interaction with host tissues. Many different methods of categorization have been proposed, based in part on these differing characteristics; however, no single, universally agreed upon system exists to date. Of the proposed classification systems, one based on primary mechanism of action (MOA) first proposed by Werschler and Narurkar has been widely used.1 In this approach, dermal fillers are placed into categories of either collagen biostimulation or replacement volume as a primary MOA.In this schema, Radiesse® (calcium hydroxylapatite; CaHA, Merz Pharmaceuticals GmbH, Frankfurt, Germany) is a unique product because it provides both replacement volume and collagen biostimulation as a primary MOA. In addition, CaHA is biodegradable and reabsorbed naturally by the host’s metabolic processes. This biostimulatory MOA, with ultimate reabsorption, results in a performance profile that is unique to Radiesse.CaHA is a highly effective agent for many areas of facial soft-tissue augmentation and is associated with a well-established safety profile.2 The year 2013 marked a decade of Radiesse technology, which first received EU approval in 2003 for plastic and reconstructive surgery, including deep dermal and subdermal soft tissue augmentation of the facial area. In the intervening years, the range of uses for CaHA has evolved alongside developments in the field of aesthetic medicine from a surface-oriented two-dimensional approach, concentrating on removal of facial lines and folds, to a three-dimensional approach that also addresses both soft and hard tissue volume loss in both the face and the hands.3With the popularity of dermal fillers demonstrated by increasing numbers of treated patients, public awareness and acceptance of nonsurgical enhancement has greatly increased the treatment options available. Along with botulinum toxin injections and energy-based devices, fillers are the mainstay of most medical aesthetic clinics. With increasing patient demand and the increased availability of aesthetic providers, private practices have become more competitive. Patient retention is now a major objective of most aesthetic businesses. Patient satisfaction is a key element for patient retention and requires a portfolio of safe and effective products. Long-term clinical experience, clinical research, peer-reviewed publications and regulatory approvals have combined to demonstrate the safety and efficacy of CaHA. The product has been evolved to meet the demands of a continuum of aesthetic care in terms of enhancement of youthful patients (ages 25-35); early prevention, rejuvenation, and volume restoration for patients in the middle decades of life (35-55); and for the delay and maintenance as part of restoration for mature (55-75+) patients as well.In this tenth anniversary year, the authors consider the historical milestones of CaHA in aesthetic medicine, propose a protocol for a global facial approach using CaHA, and look at how its unique properties provide it with a place in today’s market and keep it at the forefront of modern aesthetic treatments. Throughout this publication, reference is made to labeled and off-label indications, techniques, and dilution protocols performed by experts in the field of aesthetic medicine. The reader is reminded that some of these are not approved by regulatory authorities and are not endorsed by Merz Pharmaceuticals GmbH.     

Social, emotional, and behavioral functioning of children with cancer

OBJECTIVE: It was hypothesized that children with cancer would have more social problems and difficulties with emotional well-being than case control, same race/gender, similarly aged classmates. STUDY DESIGN: Using a case controlled design, children with any type of cancer requiring chemotherapy except brain tumors (n = 76), currently receiving chemotherapy, ages 8 to 15, were compared with case control classroom peers (n = 76). Peer relationships, emotional well-being, and behavior were evaluated based on peer, teacher, parent, and self-report, and were compared using analysis of variance and structural equation modeling. RESULTS: Relative to case controls, children with cancer were perceived by teachers as being more sociable; by teachers and peers as being less aggressive; and by peers as having greater social acceptance. Measures of depression, anxiety, loneliness, and self-concept showed no significant differences, except children with cancer reported significantly lower satisfaction with current athletic competence. There were also no significant differences in mother or father perceptions of behavioral problems, emotional well-being, or social functioning. Scores on all standardized measures were in the normal range for both groups. Comparisons of the correlation matrices of children with cancer and to the correlation matrix of the comparison children using structural equation modeling suggested they were not significantly different. CONCLUSIONS: Children with cancer currently receiving chemotherapy were remarkably similar to case controls on measures of emotional well-being and better on several dimensions of social functioning. These findings are not supportive of disability/stress models of childhood chronic illness and suggest considerable psychologic hardiness.     

曲古菌素A对小鼠树突状细胞表面配对免疫球蛋白样受体B表达及细胞功能的影响

目的:观察曲古菌素A对树突状细胞表面配对免疫球蛋白样受体B表达及其对细胞功能的影响,验证曲古菌素A的免疫调节作用,为器官移植耐受及自身免疫性疾病治疗开辟新的方向。方法:实验于2005-01/2006-01于华中科技大学同济医学院附属协和医院血液科实验室完成。①以曲古菌素A(100mg/L)诱导小鼠树突状细胞系DC2.4细胞为实验组,正常DC2.4细胞为对照组。②体外化学合成特异性配对免疫球蛋白样受体B小RNA干扰片段转染DC2.4细胞,应用半定量反转录-聚合酶链反应及流式细胞仪检测配对免疫球蛋白样受体B的表达。③以DC2.4细胞为刺激细胞,以异基因BALB/C淋巴细胞为效应细胞,3H-TdR标记法检测曲古菌素A对混合淋巴细胞反应的影响。④酶联免疫吸附法检测各组混合淋巴细胞反应上清中干扰素γ的表达水平。结果:①反转录-聚合酶链反应结果显示,曲古菌素A诱导72h后DC2.4细胞配对免疫球蛋白样受体BmRNA表达水平显著升高(P<0.01);流式细胞仪检测配对免疫球蛋白样受体B的表达阳性率由(28.65±8.12)%升至(58.78±4.70)%(P<0.01)。②DC2.4细胞可刺激异基因淋巴细胞的增殖。曲古菌素A诱导后异基因混合淋巴细胞反应明显受抑,特异干扰配对免疫球蛋白样受体B表达则使异基因混合淋巴细胞反应增强。③与正常组相比,酶联免疫吸附法检测曲古菌素A诱导组异基因混合淋巴细胞反应上清干扰素γ水平明显降低,配对免疫球蛋白样受体B干扰组明显增高(P<0.01)。结论:曲古菌素A上调小鼠树突状细胞配对免疫球蛋白样受体B的表达可能是树突状细胞获得耐受的分子机制之一。曲古菌素A具有免疫调节作用,可用于自身免疫性疾病或器官移植免疫耐受的诱导治疗。     

以消化道症状为首发症状的尿毒症18例

目的：探讨消化道症状在尿毒症患者首诊时的重要性，并观察中药结肠透析治疗缓解消化道症状的疗效。方法：观察尿毒症患者第１次就诊时消化道症状的临床表现，比较是否首发消化道症状患者发病年龄的差异。同时，将需要透析治疗的８７例尿毒症患者分为中药结肠透析组（２２例）和血液透析组（６５例），比较２种透析方法的疗效。结果：首发消化道症状尿毒症患者的年龄明显低于非首发消化道症状者（ｔ＝２．１７０，Ｐ＜０．０５）；中药结肠透析治疗短期内疗效与血液透析无显著性差异（Ｐ＞０．０５）。结论：以消化道症状为首发症状的尿毒症虽不多见，但应引起高度重视。中药结肠透析治疗值得在广大基层医院推广。     

原发性肝癌、肝硬化患者血浆脂质过氧化物和红细胞超氧化物歧化酶活性变化及其临床意义

目的：探讨原发性肝癌、肝硬化患者血浆脂质过氧化物（ＬＰＯ）和红细胞超氧化物歧化酶（ＳＯＤ）活性变化及其临床意义。方法：测定３０例原发性肝癌和３２例肝硬化患者及４０例正常人血浆ＬＰＯ和红细胞ＳＯＤ活性。结果：原发性肝癌、肝硬化患者血浆ＬＰＯ含量分别为（４．６１±０．６９）μｍｏｌ／Ｌ和（５．３４±１．３３）μｍｏｌ／Ｌ，较正常对照组〔（２．４８±０．３５）μｍｏｌ／Ｌ〕明显升高（Ｐ均＜０．００１）；２组红细胞ＳＯＤ活性分别为（１６９５．５±２２９．７）Ｕ／ｇ和（２６５１．５±４４５．６）Ｕ／ｇ，较正常对照组〔（３３３０．２±５５２．２）Ｕ／ｇ〕明显降低，Ｐ均＜０．００１；进一步比较原发性肝癌患者红细胞ＳＯＤ活性较肝硬化患者亦明显降低（Ｐ＜０．０１）。结论：肝硬化时脂质过氧化作用增强造成的细胞损害可能是原发性肝癌的发病机制之一；红细胞ＳＯＤ活性变化可望作为肝硬化转变为肝癌的早期临床诊断的辅助指标     

香港血红蛋白病分析研究——玛丽医院五年经验总结

本研究的目的是分析香港血红蛋白病的类型分布,介绍筛选病例的经验以及用统计学方法找出一些在筛选及鉴别血红蛋白病方面有用的方法。结果显示,香港以HbE为最多(69％),其中杂和性HbE占大多数。RBC在筛选血红蛋白病方面意义不大,而RDW和MCV在筛选血红蛋白病方面较MCH和Hb更为重要。另外,相关分析显示,RDW与MCV,Hb,MCH和RBC呈负相关,这在鉴别某些红细胞疾病方面可能是有用的。     

Endothelial lipase and reverse cholesterol transport in type 2 diabetes mellitus

Aims/Introduction:  Endothelial lipase (EL) plays an important role in high‐density lipoprotein (HDL) metabolism and experimental data suggest that EL might be proatherogenic. We have investigated whether serum EL concentration is associated with changes in serum capacity to induce cholesterol efflux and arterial stiffness in type 2 diabetes.Materials and Methods:  Serum EL was assayed by ELISA in 172 diabetic patients and 175 controls. The ability of serum to induce cholesterol efflux was measured using a cell culture system and arterial stiffness was determined by measuring pulse wave velocity (PWV) between carotid and femoral arteries.Results:  Diabetic patients had significantly higher C‐reactive protein (CRP) and EL (27.7 ± 16.6 ng/mL vs 24.0 ± 11.3, P < 0.05). Cholesterol efflux to serum mediated through scavenger receptor class B type I was impaired (15.1 ± 2.5%vs 16.7 ± 3.1, respectively, P < 0.01). In controls, serum EL correlated with cholesterol efflux to serum (r = −0.16, P = 0.025), but only a trend was seen in the diabetic patients. Linear regression showed that in controls, HDL, serum EL and waist circumference were major independent determinants of cholesterol efflux; whereas in the diabetic cohort, the major independent determinants of cholesterol efflux were HDL, CRP and age. PWV was increased in the diabetic patients (P < 0.01), but no association between serum EL and PWV was seen in either groups.Conclusions:  Serum EL was increased in diabetic patients, but impaired serum capacity to induce cholesterol efflux in these patients was mainly related to low HDL and subclinical inflammation. (J Diabetes Invest, doi: 10.1111/j.2040‐1124.2010.00016.x, 2010)     

Prevalence of left ventricular systolic dysfunction in adults with repaired tetralogy of fallot

Left ventricular (LV) systolic dysfunction has been observed in patients with repaired tetralogy of Fallot (TOF), although its clinical associations are unknown. Adults with repaired TOF were identified from 11 adult congenital heart disease centers. Clinical history was reviewed. Patients with pulmonary atresia were excluded. Echocardiograms were reanalyzed to estimate LV ejection fraction. LV function was defined as normal (LV ejection fraction ≥ 55%) or mildly (45% to 54%), moderately (35% to 44%), or severely (< 35%) decreased. Right ventricular (RV) and LV dimensions and Doppler parameters were remeasured. Function of all valves was qualitatively scored. Of 511 patients studied, LV systolic dysfunction was present in 107 (20.9%, 95% confidence interval 17.4 to 24.5). Specifically, 74 (14.4%) had mildly decreased and 33 (6.3%) had moderately to severely decreased systolic function. Presence of moderate to severe LV dysfunction was associated with male gender, LV enlargement, duration of shunt before repair, history of arrhythmia, QRS duration, implanted cardioverter-defibrillator, and moderate to severe RV dysfunction. Severity or duration of pulmonary regurgitation was not different. In conclusion, LV systolic dysfunction was found in 21% of adult patients with TOF and was associated with shunt duration, RV dysfunction, and arrhythmia.