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髋关节表面置换术的临床与实验研究及骨科病例登记系统的开发
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摘要
髋关节表面置换术是一种保留股骨头、颈骨量的治疗髋关节炎的术式,但它并不是一种新的观念和尝试,它最早出现在20世纪50年代。当代金属对金属髋关节表面置换假体是为了避免把股骨侧假体插入股骨干内的第三次尝试。第一代假体由无骨水泥型髋臼和无短柄的股骨侧假体组成。在经过了短暂的流行后,由于股骨颈骨折、股骨侧假体松动和晚期髋臼假体松动等并发症的高发生率,该技术的失败率较高,最终被人们所废弃。在许多需要翻修的表面置换术失败的患者中,髋臼侧骨量的大量缺少为翻修增加了极大的困难。第二代表面置换假体由非骨水泥的多孔涂层的髋臼假体和无短柄的股骨侧假体构成,其中髋臼假体通过其柱状凹槽固定。但是,这种假体设计从来就没有被广泛运用过。由于假体由直径大的股骨头和聚乙烯内衬构成,在年轻和术后活动量大的患者中,在运用这种假体后,术后会产生大量的磨损微粒子碎屑,由于聚乙烯磨损表面的存在,17%患髋存在髋臼侧大量溶骨病变并导致手术失败。第三代表面置换假体被称作所谓的混合型假体,它由非骨水泥、多孔涂层、非模块型的髋臼假体和骨水泥型的有颈的股骨侧假体组成。
     新一代的经过改良设计的金属对金属假体使髋关节表面置换术作为髋关节病变的另一种可供选择的手术治疗方案重新并逐渐得到了广泛的运用。早期的表面置换术为现代假体的设计提供了经验和教训,认为髋臼侧应该用非骨水泥固定和股骨侧假体用干骺端短柄调整位置。当前,只有金属假体能作为单片外壳有足够的硬度、良好的耐磨特性,因而它被加工制造作为较大直径的股骨头假体和髋臼侧的骨保存装置。这些新的设计假体早期的疗效令人鼓舞,但是设计程序的快速发展需要正确的培训规划来控制,以保证其更远未来的成功。髋关节表面置换术已经被认为是髋关节置换史上的最重要的现代革命之一。
     当前,由于金属假体的发展和手术技术的改进,髋关节表面置换术的短、中期疗效令人鼓舞。髋关节表面置换术逐渐得到广泛的运用,特别对于年轻和对活动量要求大的患者。从2005年8月3日起到2007年5月1日,我科共进行了13例髋关节表面置换术。所有患者定期随访,没有1例失访。没有1例发生术中并发症、伤口感染、周围神经麻痹、髋关节脱位和临床上明显的静脉栓塞。所有患者的疼痛得到完全或大部分缓解,近期的结果令人满意。同时,与髋关节表面置换术相关的术后并发症已经引起人们的注意,包括股骨颈骨折、股骨头无菌性坏死、血中金属离子水平升高和长期的固定问题等。其中,术后股骨颈骨折已经成为当前研究的热点问题之一。
     骨科病例登记系统的开放与运用,有利于骨科临床资料的收集与分析。规范、全面、简例的临床资料收集,有行于骨科临床工作中的回顾性分析,并可实现对于骨科不同治疗方法及临床实用器械的有效评估,可有力的促进骨科临床工作的进步:与之同时,作为一网络工作的平台,可有利骨科临床工作者之间的交流,并具有运用于骨科临床教学工作的广泛前景。
     第一部分髋关节表面置换术的临床研究及其应力分布的有限元分析
     第一章金属对金属髋关节表面置换术的研究和短期临床随访
     背景:从1988年起,欧洲国家重新兴起金属对金属全髋关节表面置换术以来,我院从2005年起也开展金属对金属关节表面置换术。在此,对我院早期开展的13例金属对金属髋关节表面置换术的患髋在临床疗效和影像学方面进行研究,平均随访时间2年。
     目的:1.评价金属对金属表面置换术的短期疗效,分析可能影响疗效的因素。2.比较术后髋关节力学方面的改变,为术后髋关节动力学的改进提供依据。
     方法:从2005年8月3日起到2007年5月1日,我科共进行了13例金属对金属髋关节表面置换术。假体均来自Zimmer公司的表面置换假体系统。均采用后侧入路,术中切开臀大肌和周围关节囊。术前,对所有患者运用影像学资料对照模板进行测量。所有患者都定期随访,无1例失访。通过Harris髋关节评分对治疗结果进行评价。术后进行标准位置的正位X线片检查,即以耻骨联合为中心的骨盆正位片,然后根据影像学结果进行测量比较。术后对患侧和健侧的髋关节影像学资料进行比较,以消除术前患侧髋关节生物力学的变化。
     统计学分析:定量数据全部用均数士标准差(M±SD)表示,全部数据用SPSS11.0进行统计学处理,显著性水准(a)均设为0.5。
     结果:金属对金属髋关节表面置换术的短期结果令人鼓舞。没有1例发生术中并发症、伤口感染、周围神经麻痹、髋关节脱位和临床上明显的静脉栓塞。所有患者的疼痛得到完全或大部分缓解,近期的结果令人满意。在临床评价方面,Harris评分从术前的36.69±7.16显著提高到术后的89.63±3.36,差异具有显著性(t=24.377,p<0.000)。术后拄拐最长4周。所有患者目前都能不拄拐负重行走。
     术后患侧和健侧的绝对差别很小。最大的差别在于股骨偏心距,髋关节表面置换术后其平均减少5.45mm,从术前的51.04±3.83减少到术后的45.59±3.61,差异具有显著性(t=8.502,p=0.001)。
     结论:1)髋关节表面置换术相对于年轻和对活动要求高的患者是一种更明智的选择;2)尽管其短中期疗效良好,但由于缺乏足够的长期随访资料,因此这种术式的运用术前需谨慎评估;3)术后髋关节力学重建没有预期的效果理想;表面置换技术存在许多差异,这些差异会导致术后不同的改变,并且这些变化我们已经发现。虽然偏心距的减少对正常功能来说是有害的,但这种差异在临床上可能是无关紧要的。
     第二章髋关节表面置换系统有限元模型的建立及生物力学分析
     目的:1.建立髋关节表面置换系统的有限元模型,在生理性载荷下测试应力分布:2.分析髋关节表面置换术后股骨颈周围的应力分布,为提高髋关节表面置换术的手术计划提供生物力学方面的依据;
     3.分析髋关节表面置换术后股骨颈的不同部位的不同应力变化,分析股骨头应力屏效应存在与否。
     方法:三维有限元模型的建立:对完整的无病变的右侧近端股骨和表面置换术后的股骨头的近端股骨假体,进行电子计算机体层(CT)扫描,并把扫描数据输入abaqus(6.5)有限元分析软件进行模型建立。股骨侧植入直径为48mm的股骨头表面置换假体(Zimmer公司产品)。用骨水泥(聚甲基丙烯酸甲脂,PMMA)将假体内表面和股骨进行固定。假体短柄置入适当的位置,在模型上被认为是完全去带环的。PMMA和假体的弹性模量分别被设定为2500 MPa和235000 MPa。所有材料的泊尔松比值根据文献赋值。
     用Simpleware2.1和abaqus 6.5软件对网孔进行产生和分割。我们把模型分为5部分:髋臼侧假体,股骨侧假体,骨水泥,皮质骨和松质骨。模型用六面体单位进行分割。髋臼侧假体包含5465个单位和11062个节点,股骨侧假体包含6883个单位和9880个节点,骨水泥包含9829个单位和12295个节点,皮质骨包含80222个单位和104306个节点,松质骨包含62346个单位和73689个节点,模型用abaqus 6.5软件进行分析。这些载载条件跟在静止载荷条件下一样,被运用于有限元模型上。体重设定为70千克。这些载荷均布接触区域。位于远端股骨的节点在每个方向上都进行约束。股骨侧的模型被分割成8个部分进行应力分布测量。测量不同位点的Von Misses应力。
     统计学分析:定量数据全部用均数士标准差(M±SD)表示,所有数据用方差分析检验,全部数据用SPSS11.0进行统计学处理,显著性水准(a)均设为0.5。
     结果:1.在表面置换术后的股骨上,峰应力分布在股骨颈的上面,存在于骨的重建的整个过程;2.术后应力遮挡发生在近侧股骨头内。与正常的股骨模型相比较,在股骨头上方应力减少。
     结论:
     1.峰应力存在与股骨颈和头颈连接处的上方和下方,为了减少术后股骨颈骨折的发生率,股骨颈的骨质,特别是股骨颈上面的骨质在术中应特别小心。
     2.髋关节表面置换术后,应力遮挡存在于股骨头内,它会引起置换术后的股骨头骨密度的改变,并导致骨的重建,最后导致股骨头上部区域的骨密度降低。
     第二部分骨科病历登记分析系统的开放与运用
     背景:随着科技技术的进一步发展和生物学研究的进一步深入,更多的假体及更多的治疗方法在临床上得以了进一步的推广运用.各种评价方法在临床上的运用随着时间的延长,也显示出为一定的滞后现象.而对于骨科学的发展过程中,形成一定形式的资料登记及临床评价系统成为了一种发展前进方向上的必需。当前在市场上尚无一种成孰及广泛推广运用的骨科病例系统。本研究的目的拟在于开发一个基于网络登记的开放式免费骨科病例登记系统,便于临床医生系统的登记、评价各种治疗方法及各种器械在于临床上的实际治疗效果。并基于临床实用基础上的对于传统评价方法改进基础上的新式评价方法的前期评估。
     方法:本软件开发基于。NET技术上的网络登记平台,采用数据库管理技术,运用C#语言编辑此软件,本软件包含三大模块,病人信息部分,病例初次登记及复诊部分及评分资料部分。使用用户登入权限进行管理,尽可能保证录入数据的真实性及有效性。在病人信息部分详细的个人信息是保证数据真实的第二部分,基于网络技术的广泛运用,个人一固定的E-MAIL地址成为一个必需。同时便于后期的随访跟踪。初诊病例与后期的复诊病例模块管理,使对于同一病人的多次录入成为可能,并便于对于同一病人不同疾病的跟踪评价,方便实现科学的管理相应的数据。因为基于对于科研教学的需要,及多媒体软件在各方面的广泛运用,本系统具有简捷的图片及视频导入系统,便于教学科研工作的开展。而一规范开放的评估系统是本软件的特色之一,本软件的评价系统所录入评价方法为当前被广泛接受及公认的方法;考虑医学实践的快速发展,本系统允许自编评价方法在网络上的试行与前期评估。
     结果:一人机对话便易,系统管理科学,在线开放免费的骨科病例登记系统软件开放成功,并在局域网上得以了有效运行。可自由实现数据录入与管理,自由多样的数据搜索方式,保证了系统评价的方便性及科学性。
     结论:在线骨科病历系统具有在骨科临床科研研究及临床教学上的广泛运用前景,同时提供了为骨科临床交流一有效的平台,可实现对于新技术及新治疗方法在骨科疾病治疗上运用的科学评价。开放式登记评价方法的运用,可有利促进临床上评价方法的改进及新评价方法的运用。
Hip resurfacing is not a new concept and attempts to treat hip arthritis without resetting the femoral head and neck have been made since the 1950s.The current generation of metal-on-metal hip resurfacing arthroplasty components is the third attempt by their pro-ponents to eliminate a femoralcomponent inserted into the diaphysis.The first generation involved cemented poly-ethylene acetabular and stemless femoral components.After initial enthusiasm,the high rate of failure, resulting from femoral neck fracture,femoral component loosening,and late acetabular component loosening,led to its abandonme nt Revision of failed resurfacing was problem-atic as a result of large acetabular deficiencies in many hips. These condgeneration of resurfacing involved the use of porous-coated uncemented components with a chamfered cylinder for acetabular fixation and a stemless femoral component.However,this prosthesis was never widely used.Large osteolytic lesions in the pelvisoc-curred in 17%of hips with this prosthesis,and failure of this generation of resurfacing was related to the polyethylene bearing surface.With a large-diameter femoral head and a polyethylene liner,the generation of particulate wear debris was substantial in these generally young and active patients.The third generation of resurfacing involved a so-called hybrid concept;acementless, porous-coated,nonmodular acetabular component;and a stemmed femoral component implanted with bone cement.
     The resurgence of new and better-engineered metal-on-metal bearings has provided the means to develop aviable prosthetic solution from a concept that was once abandoned.The lessons drawn from the early resurfacing era led to modern designs allusing a cementless fixation of the acetabula component and a short metaphyseal stem designed for component alignment on the femoral side.Currently,only metallic devices can be manufactured with sucient strength as a thin one-piece shell,combining excellent wear properties for large femoral heads and a bone conserving device on the acetabular side.The early results of these new designs are extremel encouraging but the rapid development of the procedure needs to be controlled by appropriate training programmes to ensure its future success.and the techniche has been looked on as one of the most important recent evolutions of hip arthroplasty.
     At present,owing to the improvement of metal-on-metal beatings and surgical techniques,short- and mid-term results are very good and encourage wider use of this technique,especially in the younger and more active patients.13 cases at our department between August 3,2005,and May 1,2007.All patients reported for the scheduled follow-up and were included in the study,there were no intraoperative complications,infections,peripheral nerve palsy,hip dislocations or clinically overt vein thrombosis.All of the patients reported complete or major pain relief.the short term result of the groups are good.
     At the same time,complications associated with hip resurfacing include fracture of femoral neck,avascular necrosis(AVN) of the head,raised the levels of metal ions in the blood,and long term of fixation cause people noticed,especially the problem of femoral neck fracture after hip resuring has become one of hot study points at present.
     Although at first sight all designs of resurfacing femoral head look the same,there are subtle variations in design that may influence the load transfer with in the femoral head.There are a number of factors likely to influence the loads.The finite element method is an ideal tool to study the stress distribution in all parts of the device.and the result can help doctors and engineering to find the factors influence the femoral neck fracture after hip resuring.
     Part 1 Clinical Research of Revision and Stress Finite Elemental Analysis of hip resurfacing arthroplasty
     Chapter one The study and short-term clinical follow-up of mental on mental hip resurfacing arthroplasty
     BACKGROUND:Following the reintroduction of metal-on-metal articulating surfaces for total hip arthroplasty in Europe in 1988,from 2005 we developed a surface arthroplasty prosthetic system using a metal-on-metal articulation.The present study describes the clinical and radio-graphic results of the first 13 hips treated with metal-on-metalhybrid surface arthroplasties at an average follow-up of 24 months.
     Objective:1.To evaluate the short-term result of mental on mental hip resurfacing arthroplasty and analyses factors affecting the result.
     2.To compare the restoration of hip mechanics after resurfacing and account for the improved dynamics.
     METHODS:We performed 13 hip resurfacing arthroplasties at our department between August 3,2005,and May 1,2007.The implants used were the zimmer-duron Hip Resurfacing arthroplasty.A posterior approach was used with release of the insertion of gluteus maximus and circumferential capsulotomy.Radiographs were templated before surgery in all patients.
     All patients reported for the scheduled follow-up and were included in the study. Treatment outcomes were assessed according to the Harris Hip Score. Measurements were taken from standardised post-operative anteroposterior radiographs of the pelvis centred on the symphysis pubis,The post-operative radiograph of the operated hip was compared with the contralateral hip,in order to eliminate the changes in the hip biomechanics from pre-operative morbidity in the operated hip.
     Stastical analyses:the qualitation data would be described by mean±standard deviation;before been analysised;all datas should be tested by independence sample T test;all these test would be finished by SPSS11.0 stastical soft.
     RESULTS:The short-term outcomes of hip resurfacing arthroplasties are encouraging.In the study group there were no intraoperative complications, infections,peripheral nerve palsy,hip dislocations or clinically overt vein thrombosis. All of the patients reported complete or major pain relief.Clinical assessment according to the Harris Hip Score revealed improvement from an average of 36.69±7.16 points preoperatively to an average of 89.63±3.36 points after the surgery..Compared the post-operation Harris Hip Score with the pre-operation Harris Hip Score;significant difference could be found(t=24.377,p<0.001).Crutches were used for a maximum of 4 weeks postoperatively.All of the patients are currently able to walk without crutches with full weight-bearing.
     The absolute differences in the post-operative and control measurements were small.The greatest change was in femoral offset which was reduced in the hip resurfacing artroplasty group by a mean of 5.45 mm.the pre-operative femoral offset is 51.04±3.83,the post-operative femoral offset is 45.59±3.61.the femoral offset was significantly reduced(t=8.50,p<0.001).
     CONCLUSIONS:1) Hip resurfacing arthroplasty seems to be an advisable method of operative management of younger,active patients,2) Despite the good short- and mid-term results,the utility of this method should be evaluated with caution due to the lack of adequate long-term follow-up data.3) Reproduction of hip mechanics after resurfacing are not as good as has been suggested.There are a number of variations in the surgical technique which could produce the changes which we have demonstrated.Although the reduced offset should bedetrimental to normal function,the difference,is likely to be clinically insignificant.
     Chapter two The Setup Finite Element Model of hip resurfacing arthroplasty System and Biomechanics Analysis
     Objective:1.Set up the hip resurfacing arthroplasty systems' finite element model,and master the stress distribution under physiological loads.
     2.To analyze the stress distribution on the femoral neck after the hip resurfacing arthroplasty to provide biomechanical evidence for the improvement of hip resurfacing arthroplasty surgical plan.
     3.To analyze the different stress distribution on the different part of femoral neck after the hip resurfacing arthroplasty,and analyses Stress shielding inside the femoral head exist or not.
     Method Three-dimensional FE model sofan intact right proximal femur and aproximal femur with resurfaced femoral head were developed using computed tomography(CT) scan data and the solid modeler of abaqus(6.5)FE software.The femur was implanted with a 48 mm diameter femoral head resurfacing prosthesis(zimmer duron).The inner surface of the implant was fixed to the bone using bone-cement(PMMA).The tapered stem was inserted into aparallel side hole and was modeled as completely debonded.The Young's modulus for the PMMA and the implant were assumed to be 2500 and 235000 MPa,respectively.A Poisson's ratio of 0.3 was assumed for all materials.
     Mesh generation and solutions were obtained using simpleware 2.1 and abaqus 6.5 software.the model were divided into 5 parts:acetabular prosthesis,femoral prosthesis,bone cement,os integumentale and cancellous bone.The model were divided by hexahedron unit.the part of acetabular prosthesis contains 5465unit and 11062 nodes,the part of femoral prosthesis contains 6883 unit and 9880 nodes.the part of bone cement contains 9829 units and 12295 nodes;the part of os integumentale contains 80222 units and 104306 nodes,the part of cancellous bone contains 62346 units and 73689 nodes.the FE model were analysed by abaqus 6.5.These loading conditions were applied to the FE model as static load cases.The body weight was assumed to be 70kg.these loads were uniformly distributed over the area of contact(for the hip joint reaction force).Nodes located on the distal end of the femur were constrained in all directions.
     The femoral part of model were divided into 8 parts,the stress distribution and straining were measured;measure the Yon Misses stress on different points;the qualitation data would be described by mean±standard deviation;before been analysised;all datas should be tested by one-way anova;all these test would be finished by SPSS11.0 stastical soft.
     Result:1.Peak strain throughout the bone remodeling process is presented in the superior femoral neck in the resurfaced femur.
     2.Post-operatively,strainshielding was observed inside the proximal femoral head.Reduction of strain was observed in the superior femoral head as compared to the intact femur
     Conclusion:1.Peak strain concentrations occurr at neck of femoral,inferiorly and superiorly at the head-neck junction,in order to reduce the ratio of bone fracture of fermoral neck,the bone of femoral neck especially superiorly part of neck should be noticed during the operation.
     2.Stress shielding exists inside the femoral head after hip resurfacing plasty. Which caused changes in bone density within the resurfaced femoral head,and would lead to bone remodeling and consequently reduction in bone density in the superior femora head region.
     Part 2 The exploitation and apply of orthopedics cases registration analytical system
     Background:following the development of science and technology and the advancement of biology research,more and more artificial implants and treatments are being applied for clinical use.While the evaluation methods exhibit some extent of hysteresis,due to the prolongation of their clinical application.However,it is essential to build some form of document registration and clinical evaluation system for the development of orthopedics.Nowadays there hasn't been a systematic commercial orthopedic case file registration system which has been generally used yet.The aim of this research is to develop a free-of-charge open orthopedic case file registration system that is based on network registration,and can facilitate the registration of the clinical doctor's workstation,as well as could be used as the evaluation of the actual clinical therapeutic efficacy of new treatments and new instruments.The pre-assessment of new evaluation method based on improvement of the traditional evaluation method could be achieveed on the platform.
     Methods:this software is programmed by C# language,use database, and is based on the.NET network registration platform.It is constitute of three major modulars:the patients' information,the primary registration of the case file,and the follow-up and evaluation modular.The administration authority is used to ensure the validity and efficacy of the imported data.In the patients' information part,detailed personal information is the guarantee of the data validity.In the second part,stabile personal E-MAIL address is essential on account of the widespread application of network technology.And it facilitate the follow-up visit.The separation administration of the first visit case modular and the return visit case modular makes it possible to record one patient's data for many times,it facilitate the track evaluation for different diseases on the same patient,and finally,it makes the exactitude administration of the corresponding data come true.For research and teaching needs. To comply with the widespread application of the multi-media software,this system integrates a simple picture and video import system.Another special feature of this software is a standard,open evaluation system.The methods used in the evaluation system of this software are the commonly accepted standards.Considering the fast development of the medical practice,this system allows self composed evaluation methods to be carried out the preliminary evaluation on internet.
     Results:we successfully build up an easy to operate,free-of-charge,online, open and exactitude orthopedic case file registration software,it provides multiple data searching method,with it we can import and administrate data freely,and ensure the convenience and exactitude of the systematic review.
     Conclusion:online orthopedic case file system has great prospect in orthopedic clinical research and teaching,It provides an effective platform for orthopedic clinical communication,as well as an exactitude evaluation to the new technology and new treatments for orthopedic diseases.The application of the open registration and evaluation methods can effectively promote the improvement of the clinical evaluation methods and introduction of new methods.
引文
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