无柄解剖型人工髋关节置换术临床试验24例报告

目的 探讨无柄解剖型人工髋关节置换术的适应症、疗效。方法 针对24例临床应用进行临床结果分析和总结。结果 无柄解剖型人工髋关节置换术后，经1～2．5年的病案随访观察术后患髋疼痛、关节功能恢复满意，优良92％，可8％。结论 无柄解剖型人工髋关节置换术适应征宽，是治疗青壮年股骨头缺血性坏死、股骨头骨折及类风湿性关节炎的有效方法，是有柄人工髋关节置换术的一种补充。无柄解剖型人工髋关节设计符合人体股骨颈自然解剖生理。具有强大的抗压抗弯防旋防松动、低应力高强度的机械力学特征，并且可以达生物愈合的生物力学特性。     

无柄解剖型人工髋关节置换术临床试验24例报告

目的探讨无柄解剖型人工髋关节置换术的适应症、疗效.方法针对24例临床应用进行临床结果分析和总结.结果无柄解剖型人工髋关节置换术后,经1~2.5年的病案随访观察术后患髋疼痛、关节功能恢复满意,优良92%,可8%.结论无柄解剖型人工髋关节置换术适应征宽,是治疗青壮年股骨头缺血性坏死、股骨头骨折及类风湿性关节炎的有效方法,是有柄人工髋关节置换术的一种补充.无柄解剖型人工髋关节设计符合人体股骨颈自然解剖生理.具有强大的抗压抗弯防旋防松动、低应力高强度的机械力学特征,并且可以达生物愈合的生物力学特性.     

在处理的钛表面形成的磷灰石

在处理的钛表面形成的磷灰石［英］／ＢｉｏｍｅｄＭａｔｅｒ．－１９９４，１０．－２经化学处理的钛所具有的生物活性，促使日本研究人员进行在体液的金属表面形成磷灰石的实验。这项研究可使生物医用材料的设计者，用钛或钛合金直接与活性骨结构粘连，由于减少了聚合物...     

文摘

文摘生物医学材料０９８在氨基酸溶液中钛合金的金属溶解和溶解金属的毒性［日］／佐藤和子他／／齿科材料器械．－１９９７，１６（２）．－１２２近年来用纯钛及钛合金制成的牙种植体已广泛应用于临床，由于钛及钛合金表面有稳定的氧化物被膜，具有良好的生物适应性。但...     

无柄解剖型人工股骨头的临床应用54例报告

目的探讨无柄人工股骨头置换术的治疗效果。，方法取患侧外侧切口显露髋关节，使股骨头脱位。用中心定位器定位打入中心钉，用塑骨器塑骨，安装罩体。用中心钉和大小粗隆松质骨螺钉固定安装可调节头复位。结果本组54例平均随访30个月按Harris关节功能评价标准评估：优39．良12．可3．差无、优良95％．结论无柄人工股骨头置换术，由于保留了全部股骨颈和部分股骨头，力学传导与分布更接近于人体自然生物力学状态，近期疗效满意。     

人工股骨头的特殊设计及三维建模

背景：骨水泥型人工髋关节前倾角的调整难度较大,部分地区依靠术中三维导航定向来确保前倾角的准确性,但其高昂的成本使得这一技术的推广前景存在疑问。 目的：设计一种人工股骨头,即具有术中自由调节前倾角、假体柄锁定防止股骨假体脱位、松动的特殊功能,并通过计算机辅助制成三维动态图像,直观展示这种人工股骨头的特殊设计理念。 方法：①根据设计理念采用AutoCAD软件进行绘图,获取人工股骨头设计图纸。②采用3DMAX软件进行三维建模,观察模型的形态及拟真度。 结果与结论：在AutoCAD软件上根据设计要求和设计理念,绘制出人工股骨头设计图纸：①3个锁止孔通道的假体柄,其基底部为刻度盘,旋转刻度盘可改变假体颈的前倾角。②假体颈为齿状圆柱形。使用3D Max软件构建人工股骨头三维模型,其模型的设计、形态及拟真度符合设计要求。说明人工股骨头的三维模型整体结构清晰、设计合理,为人工股骨头的进一步设计提供理论参考依据。     

镍钛形态记忆合金与骨组织相容性的形态学

目的：观察镍钛形态记忆合金植入动物骨组织后局部组织的反应、骨缺损的修复情况，研究镍钛合金与骨的组织相容性，为镍钛合金作为生物医学材料在临床上广泛应用提供理论依据。方法：纯系日本白性兔，实验组在股骨下1／3处植入镍钛合金。于术后4、8、16w，在植入区上下0．5cm处横断取材。将骨块置于4％多聚甲醛-2．5％戊二醛混合液内固定。制作半薄切片，经1％甲苯胺蓝染色，光镜观察；制作超薄切片，透射电镜观察。结果：实验组表现出与对照组相似的骨缺损修复过程。结论：此镍钛形态记忆合金与骨组织具有良好的相容性。     

用于人体关节植入物的多孔纯钛/钛合金研究

目的研究Ti6Al4V合金基体上经钎焊制得的多孔纯钛／钛合金,并对其各项性能进行表征,探讨其是否适用于人体关节植入物。方法制备钎焊多孔纯钛／钛合金表面多孔层,采用SEM观察其形貌及孔径,采用重量法计算其孔隙率,采用Instron 4057材料试验机进行结合强度测试,并根据国家标准GB／T16886-3完成遗传毒性实验。结果纯钛／钛合金多孔层孔径为100μm以上,孔隙率6％以上;多孔层与基体的结合强度达到27MPa。遗传毒性试验结果为阴性。结论经钎焊可制得纯钛／钛合金球形粉末多孔层,其孔隙率和孔径允许骨细胞长入;多孔层与基体的结合强度能够满足植入要求,并具有较好生物相容性;经钎焊制得的纯钛／钛合金多孔层是一种可用于人体关节植入物的表面结构形式。     

人工股骨置换术后股骨再造预测

以骨截面面积吸收率和抗弯截面模量损失率反应力遮挡效应，采用骨再造理论和有限元(Finite element，FEM)相结合的方法，用计算机模拟人工股骨植换术后股骨的再造行为，从而定量的分析人工股骨头对股骨的应力遮挡效应。骨表面再造采用BRSS97程序。有限元模型采用正常股骨的受力状态为模型一，带颈领的人工股骨头骨水泥固定骨受力状态为模型二。结果表明，人工股骨头对骨产生的应力遮挡，股骨发生骨吸收，人工假体柄中段近端区域骨吸收严重。其骨截面积吸收最大，其截面吸收率最大为31．33％，抗弯截面模量损失率最大为54．58％。     

人工股骨头置换治疗严重股骨转子间骨折的有限元分析

目的　建立股骨转子间骨折、人工关节假体的三维数字模型,应用有限元对人工股骨头置换术后的股骨应力分布进行分析,评价置换术后的初始稳定性。 方法　利用螺旋CT对志愿者的左侧股骨进行断层扫描获取图像数据,经Mimics软件和Unigraphics建模软件处理,重建股骨三维模型。在此基础上,建立股骨转子间骨折、标准柄股骨假体三维实体模型,最后利用有限元分析软件Ansys10.0建立人工股骨头置换术治疗股骨转子间骨折的三维有限元模型,并对该模型进行生物力学分析。 结果　应力分析显示：正常股骨的应力由近端向远端逐渐上升,并于中下段达到最高。同时人工股骨头假体的应力集中于中段,与正常股骨的应力变化基本一致。人工股骨头置换没有改变股骨总体的应力模式,股骨距部位未见明显的应力集中区,依然是由近端向远端逐渐增加,应力峰值区域亦于全长股骨的中下段。 结论　标准柄人工股骨头置换治疗股骨转子间骨折不会引起股骨应力分布的明显改变,可以获得重建后的初期稳定。     

The in-vivo wear performance of prosthetic femoral heads with titanium nitride coating

This paper reports the study performed on four titanium nitride (TiN) coated prosthetic femoral heads collected at revision surgery together with patient data. Surface topology has been examined using Scanning Electron Microscopy (SEM) and elemental analysis of both coating and substrate have been evaluated using energy-dispersive X-ray spectrometry. Quantitative assessment of the surface topography is achieved using contacting profilometry. The average Ra roughness value is calculated at five different locations for each femoral head. The UHMWPE counterface worn volume has been measured directly on the acetabular components. TiN fretting and coating breakthrough occurred in two of the four components examined. In the damaged coating areas the surface profile is macroscopically saw-toothed with average tooth height 1.5 microm. The average Ra value is 0.02 microm on the undamaged surfaces and 0.37 microm on the damaged ones. Failure of the coating adhesion resulted in the release of TiN fragments and of metallic particulate from the substrate fretting corrosion and in the increase of the head surface roughness affecting counterface debris production. Our results suggest that TiN-coated titanium alloy femoral heads are inadequate in the task of resisting third body wear mechanisms in vivo.     

喷砂预处理钛合金表面类金刚石薄膜的制备及性能研究

目的利用等离子体增强化学气相沉积(plasma enhanced chemical vapor deposition,PECVD)技术,在不同粗糙度医用钛合金表面制备类金刚石薄膜(diamond-like carbon film,DLC),并对类金刚石薄膜的膜-基结合力、电化学腐蚀行为及生物学行为进行研究,探索基底材料喷砂预处理对于表面制备的类金刚石薄膜是否是一种有效改性方法。方法通过不同粒度的Al2O3在一定条件下喷砂钛合金表面,制备出不同粗糙度表面的钛合金片,采用PECVD技术在其表面制备类金刚石薄膜。通过扫描电子显微镜、X-射线光电子能谱仪、拉曼光谱仪、接触角测量仪、表面性能测试仪和电化学方法检测各组样品的物理化学性能表征;利用MTT比色法、荧光染色法进行薄膜表面生物学行为的评价。结果将DLC沉积在喷砂预处理的钛合金表面,可以明显增强类金刚石的膜-基结合力,最高达到45N;耐腐蚀性研究中,表面沉积DLC的钛合金实验组腐蚀电位均正向大于未沉积DLC的钛合金组(P0.05);生物学行为研究中,在60#Al2O3喷砂处理钛合金表面沉积DLC的S60实验组细胞增殖状况最佳,明显大于未喷砂S0组(P0.05)。结论将钛合金基底喷砂预处理后沉积DLC,可以提高类金刚石薄膜的膜-基结合力、耐腐蚀性及生物相容性,是一种有效的医用钛合金表面改性方法,具有潜在的临床应用价值。     

Tribological characterization of surface-treated commercially pure titanium for femoral heads in total hip replacement: a feasibility study

Most noncemented total hip replacements combine a titanium alloy stem, a CoCrMo femoral head and an ultra-high molecular weight polyethylene (UHMWPE) acetabular cup. In spite of its nickel content of up to 1% and the resulting biocompatibility issues in some clinical situations, the higher cost and some difficulties in machining, CoCrMo alloy is preferred to titanium alloys thanks to its outstanding tribological properties, higher hardness and elastic modulus. Nowadays most of the heads of hip prostheses use CoCrMo as bearing material. The present study investigates the effect of various surface treatments and combinations of treatments, such as electrochemical oxidation (anodization), laser surface melting and barrel polishing, on the tribological properties of commercially pure grade 2 titanium. The aim of the study was to characterize surface treatments capable of improving the tribological properties of titanium surface to the same extent as CoCrMo. The tribological properties were characterized by multidirectional pin-on-flat screening wear tests, using UHMWPE pins as bearing surface. The experiments showed the possibility of improving the wear resistance of titanium to the degree of CoCrMo. Although further efforts will be required to optimize the treatments studied, the results are encouraging enough to warrant pursuing this direction of investigation.     

复合材料与金属材料髋关节假体应力分布的三维有限元分析

目的对钛合金、碳纤维增强聚砜(CFR/PSF)复合材料、CoCrMo合金和小锈钢假体的性能进行对比,研究复合材料与金属材料髋关节假体应力分布情况。方法采用ANSYS软件对髋关节假体进行了静态三维有限元分析,对比了不同材料的假体表面的应力分布情况,分析了正应力和剪切应力对假体的影响。结果假体的下半部和柄颈结合处受力较大,为假体的关键部位。结论钛合金和碳纤维增强聚砜(CFR/PSF)复合材料假体要比CoCrMo合金和不锈钢假体具有更好的应力分布,其临床应用效果将会更加理想。     

个性化3D打印钛合金短柄股骨假体的生物力学评价

目的 评估个性化3D钛合金打印短柄股骨假体的生物力学性能。方法 采用4种不同的短柄股骨假体：3D打印1组(假体A)、3D打印2组(假体B)、BE组(假体C)、SMF组(假体D),分别对12根成人尸体股骨标本实行人工股骨头置换。在万能材料力学试验机上通过初始稳定性测试和静力压缩测试,对比分析4组假体模型变形量、最大压缩载荷、最大压缩位移和抗压缩刚度。结果 初始稳定性测试结果显示,3D打印2组假体变形量略低于3D打印1组,而明显低于SMF组和BE组,但差异无统计学意义(P>0.05)。3D打印2组假体最大压缩载荷、抗压缩刚度均大于其余3组,最大压缩位移小于其余3组,差异仍无统计学意义(P>0.05)。结论 个性化3D打印钛合金短柄股骨假体力学性能与目前临床常用的股骨SMF、BE 1假体相当,力学稳定性较好。     

基于ABAQUS及疲劳试验的烧结股骨柄设计研究

目的确保精锻Ti-6Al-4V钛合金烧结股骨柄柄体能达到植入后支撑人体体重及运动循环载荷的要求。方法通过对Worst Case下的烧结股骨柄进行数值模拟,设计3种烧结涂层区域不同(不同的应力规避区)的股骨柄,并对其分别进行疲劳试验。结果通过数值模拟,Worst Case下的烧结股骨柄的最大主应力为432.8 MPa;方案一中股骨柄外侧烧结涂层至股骨柄肩部的距离为47 mm(规避处的应力值为309.493 MPa),疲劳试验结果为6组全部断裂,循环载荷次数均为2.3×10~6次上下;方案二中股骨柄外侧烧结涂层至股骨柄肩部的距离为44 mm(规避处的应力值为277.673 MPa),疲劳试验结果为2组断裂,循环载荷次数均为4.1×10~6次上下,其余4组通过5×10~6次循环试验;方案三中股骨柄外侧烧结涂层至股骨柄肩部的距离为41 mm(规避处的应力值为240.755MPa),6组均通过5×10~6次循环试验,股骨球头垂直偏移量最大的一组的偏移值为1.55 mm。结论方案三的精锻Ti-6Al-4V钛合金烧结股骨柄在植入后能达到支撑人体体重和运动时循环载荷的要求。     

碳质单杯（碳质股骨头表面置换假体）

碳质单杯是以高强，高密度石墨为基体，外涂含硅低温热解各向同性碳制成．表面光滑，四面粗糙有微孔。具有良好的机械强度，化学性能稳定，质轻、耐压、耐磨、耐腐蚀，生物相容性好。弹性模量近似骨，有生骨活性，表面有润滑性。为目前最佳的表面置换材料．具有推广应用价值。现已批准获得专利。专利号ＺＬ９３２３５６７４．５。     

类金刚石/酪蛋白磷酸肽复合薄膜修饰钛合金表面成骨细胞的增殖

背景：钛合金表面沉积类金刚石薄膜可提高其摩擦和抗腐蚀性能,但缺乏生物活性,在其表面接枝生物蛋白分子是一种新的生物化学改性途径。 目的：观察成骨细胞在类金刚石/酪蛋白磷酸肽复合薄膜修饰钛合金表面的增殖与黏附。 方法：采用非平衡磁控溅射和多步组装方法在钛合金表面制备类金刚石/酪蛋白磷酸肽复合薄膜。将对数生长期的成骨细胞悬液接种于类金刚石/酪蛋白磷酸肽复合薄膜修饰的钛合金与纯钛合金试件上。 结果与结论：类金刚石/酪蛋白磷酸肽复合薄膜修饰钛合金组细胞增殖率和黏附数量高于纯钛合金组(P < 0.05)。扫描电镜显示,类金刚石/酪蛋白磷酸肽复合薄膜修饰钛合金组成骨细胞胞体显著增大,表面粗糙,边界模糊不清,细胞呈充分的铺展状态;纯钛合金组成骨细胞胞体光滑,边界线条锐利清晰,伸展不良。表明类金刚石/酪蛋白磷酸肽复合薄膜可促进钛合金表面成骨细胞的增殖与黏附。     

Vibration transfer in the ball–stem contact interface of artificial hips

Audible squeaking has put the reputation of ceramic bearings for total hip replacements into question. Inter-articular friction induces vibrations in the ceramic head which are transferred through the head–taper interface to the femoral stem. If excited to sufficient amplitudes, squeaking can be emitted by the stem. Hence, the damping and amplification properties of this interface have a crucial influence on stem vibrations.The aim of this study was to determine the vibration transfer behavior between the head and the taper of a femoral stem and its dependence on the assembly force, in order to assess its influence on the development of audible squeaking.A ceramic head was assembled on a titanium femoral stem taper with high and low forces. Frequency response functions characterizing the head–stem interface were determined experimentally.The interface demonstrated negligible influence on vibration transfer in the squeaking frequency range (1–5 kHz). However its damping effect in lower and higher frequency ranges was significant and some areas of amplification were also found.Although squeaking vibration was not influenced by the particular interface studied, the method established can be utilized to trace taper designs with dynamic properties that decrease the susceptibility to squeaking.     

A radiographic study of hip-joint alignment after prosthetic hip arthoplasty

Postoperative hip alignment was studied on radiographs in cases of total hip arthroplasty (THA) and of Bipolar Head Prosthesis(BHP), both with MX-1. Postoperative anteroposterior-view radiographs of hip joints of patients with a normal hip joint on the unoperated side and without pelvic tilt were used. Thirty-nine THA patients (femoral neck fracture), 26 THA patients (osteonecrosis of the femoral head and osteoarthritis of the hip joint), and 34 BHP patients were selected for this study. Lines and points for measurement of 9 parameters were established on radiographs. The position of the greater trochanter upper edge is 6.5 mm (mean) superior to the femoral head center in the normal hip joint of Japanese, unlike in Caucasians. A femoral head prosthesis should be inserted so that its center and the greater trochanter upper edge are level in order to equalize leg lengths. In BHP cases, the insertion is made so that the greater trochanter upper edge is approximately 4-mm superior to the center of the prosthesis. For further securing of the stem and to equalize leg lengths, stems should be available in 11 diameters from 5-15 mm in 1-mm increments. Postoperative hip alignment in MX-1 THA cases was found to be satisfactory.