正常健康国人腰椎三维结构数据的分析及临床应用
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摘要
研究背景
     椎弓根螺钉内固定系统因其良好的生物力学性能已成为常用的脊柱内固定方法之一,对于脊柱外科的发展和进步起到了不可磨灭的作用。
     椎弓根内固定技术核心是置入螺钉必须按照椎弓根长轴轴线通过这一狭小骨性管道。因此,该技术的关键在于螺钉的进钉部位、方向及深度。在这之前,定量化测量脊柱上每个椎体节段的解剖结构参数对于认识和了解人群总体的脊柱形态学特征及进一步的研究有着至关重要的作用。
     目的
     1.建立科学可靠的定量化测量腰椎椎体及椎弓根峡部相关的解剖结构参数的三维分析模型和测量方法,并探讨该方法的可靠性。
     2.采集正常健康国人腰椎的CT影像数据资料,利用上述方法进行实际测量和数据分析,总结和探讨国人腰椎形态特征和变化规律。
     3.利用三维测量和CAD-RE-RP技术设计并制作个性化椎弓根螺钉置入导向模板(PDGT),探讨PDGT在腰椎椎弓根螺钉内固定手术中的临床应用价值和意义。
     材料和方法
     材料:
     1.经过10%福尔马林处理的正常成人离体腰椎干燥骨标本5例。
     2.研究对象年龄在25-50岁之间,性别、身高体重不限,排除患有使椎骨形态结构发生改变的脊柱疾病及有既往脊柱手术史的患者,总计采集腰椎CT扫描影像数据76例
     3. SIEMENS/Sensation64层CT机,扫描参数:层厚2mm,层距2mm,球管电压120kV,电流225mAs,分辨率512*512pxl。
     4.德国WENZEL—LH65三坐标测量机,精度可达0.1μm。
     5. Objet EDEN250三维重建打印机,精度0.1-0.2mm
     6. FullCure720:Objet公司医用透明成型材料
     方法:
     1.实体接触式测量方法:本研究采用三坐标测量机对离体干燥腰椎骨进行接触式精密测量,其精度可达微米级别,远高于我们所需要的测量精度。
     2.三维重建测量:通过一系列的三维分析及构造空间辅助点、线、面的方法,对正常健康国人腰椎的13项解剖结构数据进行三维测量,精度同样可达微米级别。
     3. CAD-RE-RP技术:运用CAD软件设计双侧定位孔和中间连接部分,再进行空间整合,形成PDGT的三维模型,将该模型利用RP技术和三维打印机制作成型。
     结果
     1.将腰椎骨三维模型测量值与标本解剖测量值比较,在全部测量数据中两种测量方法均无显著性差异。,
     2.腰椎各项解剖结构参数与性别差异的关系:除了L1-L3的椎孔矢状径男性<女性以外,其余的男女之间有显著性差异的测量指标均为男性>女性。
     3.腰椎各项解剖结构参数与年龄差异的关系:我们发现L1-L4的椎弓根间距(DMBP)、L2的右椎弓根钉道长度(RPL)、L4的右椎弓根横断面角(RTSA)、L2和L5的左椎弓根矢状面角(LSSA)、L2的右椎弓根矢状面角(RSSA)等指标在三个年龄组之间存在显著差异,将其均值进行比较,发现三者间的关系大体上满足中龄组>低龄组>高龄组。
     4.腰椎各项解剖结构参数与体重差异的关系:总体来说,腰椎各项解剖结构参数与体重差异的关系不大,仅有的几个有统计学差异的指标也仅局限在个别椎体节段,缺乏代表性。
     5.两侧椎弓根解剖结构参数的对比性研究:L4、L5的椎弓根宽度(PW)左右两侧之间存在显著差异,均值比较发现均为左侧>右侧;L2的左右两侧椎弓根钉道长度(PL)的测量值有显著性差异,均值左侧<右侧;L4、L5的左右两侧椎弓根横断面角(TSA)的测量值有显著性差异,均值比较方面,L4左侧<右侧,L5左侧>右侧。
     6.趋势分析研究发现,腰椎从高位到低位,在椎弓根间距(DMBP)、椎弓根宽度(PW)和椎弓根横断面角(TSA)上呈显著递增趋势,即越靠近低位的腰椎,椎弓根宽度越大,外展角越大;另一方面,椎孔矢状径(SCSD)和椎弓根矢状面角(SSA)随着椎体的下移呈逐渐减小的趋势。
     7.设计并制作完成一套个性化椎弓根螺钉置入导向模板(PDGT)装置,并将其与实体标本相互匹配,发现可以很好的与后椎板和棘突表面紧密连接并完成螺钉置入导向的目的。
     结论
     1.本研究提出的基于CT断层图像重建腰椎骨模型的三维测量方法具有很高的准确性,能真实反映实体解剖学形态,对脊柱的解剖学研究具有重要意义。
     2.影响因素研究发现,年龄和体重对于腰椎解剖形态结构的影响不大,但男女之间存在着差异,男性腰椎比女性略大,但二者的形态结构比例基本相同,内部结构相似。
     3.左右侧比较研究认为高位腰椎形态结构较为对称,而低位腰椎则有一定程度的不对称性。
     4.趋势分析研究发现,腰椎解剖结构的特点与整个脊柱的发育和受力情况以及人类脊髓结构功能和脊柱生理曲度有一定的关系。
     5.此外,值得关注的是,L5的形态结构与其他腰椎节段明显不同,这对于相关脊柱手术方式和评估有重要意义。
     6.根据对脊柱形态结构的分析和总结,认为个性化治疗在脊柱疾病领域有重要价值。
     7.个性化椎弓根螺钉置入导向模板(PDGT)是脊柱个性化治疗的代表,以简单方便、科学可靠、实用性强等特点,在辅助脊柱外科手术方面发挥着重要作用,尽管目前仍存在一些不足,但该领域仍具有很高的临床价值和发展前景。
Background
     Pedicle screws fixation system has become the common method of spinal internal fixation because of its good biological mechanical properties, and plays an important role in the development and progress of spinal surgery.
     The key technology of pedicle internal fixation is the vertebral pedicle screw must drill through the narrow osseous pipeline, which is in accordance with the long axis. Therefore, the most important parts in the technology are the drill point on the back lamina, direction and depth of the screw. Before that, the quantitative measurement of anatomical structure parameters in each vertebral segment plays the vital role for realizing and understanding of the overall population morphological characteristics of the spine and further research.
     Objectives
     1. To establish the3D model and method of measurement, which is supposed to be a scientific and reliable quantitative measurement of lumbar vertebral pedicle isthmus and related parameters of the anatomic structures, and discuss the reliability of the method.
     2. Collection of the normal and healthy people's lumbar CT image data, using the above methods for actual measurement and data analysis, sums up and probes into the variation characteristics of lumbar form in Chinese population.
     3. Using of3D measurement and CAD-RE-RP technology, design and produce the personalized pedicle screws drill guide template (PDGT), and discuss the clinical application value and significance of PDGT in lumbar pedicle screws fixation surgery.
     Materials and Methods
     Materials
     1.5lumbar dry bone specimens of normal adult, which are treated after10%formalin.
     2. The research object aged25to50years old. Gender, height and weight are not in concern. Exclude the people with spine disease which changes the vertebrae structure and the patients the history of the spinal surgery. We collected76cases of lumbar CT scan imaging data in total.
     3. SIEMENS/Sensation64layer CT machine, scanning parameters:layer thickness2mm, layer distance2mm, the tube voltage is120kV, current225mAs, resolution512*512PXL.
     4. The German WENZEL-LH65three coordinate measuring machine, precision can reach0.1u m.
     5. Objet EDEN2503D reconstruction printer, precision is0.1-0.2mm
     6. FullCure720:Objet company medical transparent molding materials
     Methods
     1. The physical contact measurement methods:the study used three coordinate measuring machines to take contact precise measurement on dry bone specimens, the precision can reach micron level, higher than what we need in the measurement accuracy.
     2.3-dimensional reconstruction measures:through a series of three dimensional analysis and the method of make out structural space auxiliary dot, line, plane, measures13parameters of lumbar anatomical structure data in normal healthy Chinese people, the precision can reach the same level of micron.
     3. CAD-RE-RP technology:use CAD software design the guidance holes on both side and the connection part between them, and then after the space integration, PDGT three dimensional model is formed. Then, make out the model by using RP technology and3D printers.
     Results
     1. We compared the3D model measurement and anatomical specimens measurement, there are no significant difference in all the measurement data between two measurement methods.
     2. The performance of lumbar anatomical structure parameters in the gender differences:in addition to SCSD of L1-L3men are less than women, the rest have significant difference between men and women of measuring the parameters were men greater than women.
     3. The performance of lumbar anatomical structure parameters in the age differences:we found that the data of DMBP in L1-L4, RPL in L2, RTSA in L4, LSSA in L2and L5, RSSA in L2, there was significant difference in three age groups. The mean carries on the comparison, found the relation among the three generally meet in mid-age group>young group> elder group.
     4. The performance of lumbar anatomical structure parameters in the weight differences: overall, the differences between the lumbar anatomical structure parameters and the weight is not big, a few statistically significant measures only limits on individual vertebral segment, lack of representative.
     5. The comparative research on both sides of the pedicle anatomical structure parameters: PW in L4and L5have significant difference between both sides, mean comparison find the left side>the right side. Considering the measured value of PL in L2, there has significant difference between left and right side, mean comparison find the left sidethe right side in L5.
     6. Trend analysis research found that lumbar from high to low, DMBP,PW,TSA present a significant increasing trend, that is, the lower lumbar have the greater pedicle width and the greater outreach Angle; On the other hand, SCSD and SSA present a significant decreasing trend with the vertebral get lower.
     7. Design and make a personalized pedicle screws drill guide template (PDGT) device, with the entity specimens are paired, we found that it can fit the lamina and spinous process very well by closely connected to the surface and complete the purpose of the guide the screws drilling.
     Conclusions
     1. This study proposed3D measurement method based on CT image reconstruction of dry bone specimens, which has high accuracy, can really reflect the entity anatomy form, have important meanings in spinal anatomic studies.
     2. The influence factors study found that, the influence of age and weight to lumbar anatomical configuration structure is not big, but there are differences between men and women, men's lumbar is slightly larger than women's, but both of them have the same morphological structure proportion and the similar internal structure.
     3. Comparative study on the left and right side shows that higher lumbar morphological structures are symmetry, and lower ones have a certain degree of asymmetry.
     4. Trend analysis research found that the lumbar's characteristics of the anatomical structure is related to the development and the stress condition of the whole spine, as well as the function of spinal cord and human physiological curvature of the spine.
     5. In addition, there is concern that the morphological structure in L5has markedly difference with other lumbar segmental, this has the important meaning to related spinal surgical procedures and evaluation.
     6. According to the analyzing and summarizing of spine shape and structure, we supposed that personalized treatment have important value in spinal disease areas.
     7. Personalized pedicle screws drill guide template (PDGT) is representative of the spine personalized treatment, with simple, scientific, practicability and other characteristics, plays an important role in auxiliary spinal surgery. Although there are still some shortages, the field is still has the very high clinical value and development prospect.
引文
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