骶前蝶形接骨板的设计研制与生物力学研究及有限元分析和临床对比研究
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摘要
研究背景
骶髂复合体由骶髂关节及周围韧带组成,形成吊桥结构稳定骨盆环,是骨盆的主要稳定结构,承载主要的应力负荷。但六分之一的骨盆骨折累及骶髂关节复合体,不同程度地损伤骶髂关节及周围韧带,进一步造成骨盆环的不稳定。因此,重建骶髂关节复合体的稳定性对于治疗骨盆骨折非常重要。
Avila1941年首先提出前路手术入路以来,前路切开复位内固定术在骶髂关节损伤治疗中应用越来越广泛,尤其是在陈旧性骨盆骨折,前路手术已成为骶髂关节损伤的主要方法。目前,前路手术主要采取的内固定方式是重建钢板跨骶髂关节固定,采用两块三或四孔的重建板,跨骶髂关节成角固定。生物力学研究表明,传统重建板固定骶髂关节损伤稳定性良好。
但传统骶髂关节重建板也存在一些缺点。比如：经前路手术创伤大,出血较多,且有较高的腰骶干及股外侧皮神经损伤风险。传统骶髂重建板最初采用两块钢板平行放置,因四边形的不稳定性,导致其生物力学不稳定,不能牢靠固定骶髂关节脱位。研究表明,两枚重建板成60度夹角时具有良好的生物力学稳定性。但因前路手术视野小,操作空间狭窄,难以确定夹角为60度。骶骨侧因安全范围小,容易发生腰骶干损伤或重建板放置位置错误。
为了解决传统重建板的上述缺点,我们设计了一种新型骶髂关节内固定器械：骶前蝶形接骨板(SAPP)。它适合于前路手术治疗骶髂关节损伤。为明确骶前蝶形接骨板的最佳设计、生物力学稳定性及临床应用可靠性,我们分别进行了骶髂关节解剖学研究,有限元分析及生物力学研究和临床随机对照研究。
第一部分：骶前蝶形接骨板的设计与依据
1,设计依据
1.1螺钉安全区域。
骶骨翼高44.1±2.0mm,宽22.3±1.8mm,长49.4±1.4mm。耳状面为倒“L”形,上宽下窄,其短轴对骶骨翼平台,宽29.8±3.2mm；长轴对骶骨腹侧缘,长54.1±4.9mm。虽然骶骨翼平台的宽度为44mm,但其关节面宽度约为30mm。骶骨翼平台前四分之三为螺钉置钉的合适区域。髂骨骨质厚薄不均匀,根据骨盆地形图,髂骨厚度<5mm的区域为圆形,直径约5cm,位于骶髂关节附近。其上下均有厚度大于5mm的脊,两条脊的夹角约为90度。因此,骶前蝶形接骨板上下两翼应位于较厚的脊上,上下两翼部的夹角可设计为90度,长度为25mm。体部长度应为25mm。
1.2神经安全区域。
骶骨翼平台上L4神经根前支与骶髂关节线的距离比L5神经根前支、腰骶干近,其距离由背侧至腹侧为22.2±2.6mm～9.1±1.6mm。最腹侧距离L4神经根前支最近,小于普通钢板的宽度,不宜放置内固定。骶前蝶形接骨板的设计宽度为10mm,在骶骨翼平台上,除最腹侧外,L4神经根距离骶髂关节线的距离均大于10mm,可以安全放置骶前蝶形接骨板。
2,设计规格及材料
骶前蝶形接骨板(SAPP)的设计为半侧蝴蝶形,由上下翼部和体部组成。上下翼部与体部连接,分别成135度夹角,上下翼部夹角为90度。蝴蝶板宽度为10mm,上下翼部与体部的长度均为25mm。六枚钉孔采用滑动加压设计,均采用3.5mm直径螺钉。蝴蝶板体部有一个2.0克氏针的临时固定孔。体部、上下翼部中间部分板两侧有直径为2.0mm的半圆孔。设计材料为Ti-6Al-4V合金。3,设计可行性验证
采用成人男性骨盆标本4具(8侧),全层切开腹壁,切断髂肌,去除腰大肌,充分显露骶髂关节,注意不要损伤神经,并确保神经在其原始位置。置入骶前蝶形接骨板。在体部内侧缘标记A(最前点)、B(中点)及C点(最后点)。测量A、B、C点与L4神经根前支、L5神经根前支的距离。结果：骶前蝶形接骨板内侧缘距离L4神经根的距离最近,距离L5神经根较远。其中骶前蝶形接骨板上C点(骶前蝶形接骨板内侧缘最腹侧点)距离L4神经根最近,距离为2.5±12mm。放置骶前蝶形接骨板时仍有一定的安全空隙。骶前蝶形接骨板骶骨侧的两枚螺钉深度在6mm左右,髂骨侧4枚螺钉深度在3.0mm左右,具有较好的把持力,避免了在髂骨薄弱处置钉,可以提供良好的生物力学稳定性。
第二部分：骶前蝶形接骨板的有限元分析和生物力学研究
第一章：骶前蝶形接骨板的有限元分析
方法：
通过山东省立医院医院伦理委员会审查,招募健康成人男性志愿者1名,男性,23岁,身高172cm,体重70Kg。通过三维CT扫描,得到骨盆的三维扫描图像,导入Mimics软件制作骨盆的三维模型并网格化。应用Solidworks软件绘制两种角度的骶前蝶形接骨板的模型SAPP90、SAPP60,绘制传统重建板模型(三孔),绘制两种螺钉：长螺钉50mm,短螺钉30mm,直径均为3.5mm。将骨盆三维模型及骶前蝶形接骨板、传统重建板、两种螺钉模型导入Abaqus软件中,设置各种材料的属性、杨氏模量等,设置骨盆韧带的数量、位置、刚度等。在双侧髋臼设置边界条件并在S1上终板施加600N载荷,进行模拟分析,得出各个模型的应力分布、位移分布,比较骶前蝶形接骨板和传统重建板固定骶髂关节脱位后的最大位移和旋转位移。
结果：
在S1椎体上终板施加600N的应力后,SAPP90模型的最大位移是0.618mm,旋转位移是0.404度,Von Mises应力值是186N。SAPP60模型的最大位移是0.730mm,旋转位移是0.561度,Von Mises应力值为275N。TP90模型的最大位移是0.886mm,旋转位移是0.769度,Von Mises应力值是251N。TP60模型的最大位移是0.778mm,旋转位移是0.748度,Von Mises应力值是523N。TP30模型的最大位移是0.979mm,旋转位移是0.895度,Von Mises应力值是241N。TP00模型的最大位移是1.101mm,旋转位移是0.936度,Von mises应力值是232N。完整骨盆模型的最大位移是0.478mm,旋转位移是0.298度,Vonmises应力是48.7N。右侧骶髂关节损伤模型的最大位移是1.992mm,旋转位移是3.146度,Von mises应力最大值221N,位于左侧骶髂关节线腹侧。
结论：
在所有骶前蝶形接骨板及传统重建板的测试模型中,骶前蝶形接骨板(SAPP90)的垂直位移及旋转位移均最小,证明了设计的骶前蝶形接骨板(SAPP90)具有最好的生物力学稳定性。SAPP90模型的应力分布,集中在右侧骶髂关节及骶前蝶形接骨板上,以骶前蝶形接骨板下翼部螺钉处最大。在右侧骶髂关节脱位模型中,右侧骶髂关节无稳定结构,应力集中到左侧骶髂关节处。骶前蝶形接骨板重建了骨盆后环的稳定性,将应力分布在两侧,而非集中在健侧。传统重建板模型中,TP60的位移及旋转位移最小,TP00的位移及旋转位移最大,证明成60度夹角放置的传统重建板比其他角度的传统重建板有更好的生物力学稳定性,但生物力学稳定性小于骶前蝶形接骨板。
第二章：骶前蝶形接骨板的生物力学研究
方法：
利用4具带有韧带的骨盆标本(成年男性)和16具成年男性完整骨盆模型(Sawbones1301-1),制作右侧骶髂关节损伤的模型,并将模型连接Instron生物力学测试仪和高精度非接触式磁栅位移测量系统。分别将自制骶前蝶形接骨板和传统重建板模型、钛合金(Ti-6Al-4V合金)制骶前蝶形接骨板和传统重建板模型安装在右侧骶髂关节损伤的模型上,以2mm/s的速度在S1上终板施加载荷,最大载荷设定为600N。测量自制骶前蝶形接骨板和传统重建板断裂时的最大应力和各自的应力-位移曲线。测量Ti合金制骶前蝶形接骨板和传统重建板在600N载荷下的垂直位移和旋转位移,计算其应力-位移曲线,比较分析骶前蝶形接骨板和传统重建板的生物力学稳定性。结果：
在S1上终板施加速度为2mm/s的载荷后,自制骶前蝶形接骨板和传统重建板模型均在载荷小于600N时发生断裂。其断裂时的应力值：SAPP90模型为496.7±100.8N;SAPP60模型为398.6±79.9N,TP90模型为291.5±69.0N,TP60模型为294.9±68.1N,TP00模型为231.1±68.1N。各组间差异具有统计学意义(p=0.047)。
在载荷为600N时,骶前蝶形接骨板(SAPP90Ti)的垂直位移是0.43±0.12mm,旋转位移是0.518±0.145度,位移-应力曲线：y=134.32x+45.474,R2=0.61。传统重建板(TP60Ti)的垂直位移是0.51±0.13mm,旋转位移是0.742±0.214度,位移-应力曲线：y=105.09x+62.808,R2=0.4。两组间最大位移和旋转位移差异有统计学意义(p=0.049,0.032)。结论：
自制骶前蝶形接骨板和传统重建板模型的生物力学比较中,SAPP90能够承受最大的应力载荷,其位移-应力曲线斜率最大,证实其为最优设计方案。TP60在传统重建板中具有最大应力载荷,为最佳传统重建板设计。应用钛合金制作骶前蝶形接骨板(SAPP90)及传统重建板(TP60),进行生物力学测试,骶前蝶形接骨板的位移比较传统重建板更小,证明骶前蝶形接骨板比传统重建板具有更好的生物力学稳定性。
第三部分骶前蝶形接骨板的临床对比研究
方法：
山东省立医院2012年1月至2013年6月治疗了29例30侧骶髂关节损伤,对其临床资料进行了回顾性分析,其中16例16侧骶髂关节损伤行骶前蝶形接骨板内固定,13例14侧骶髂关节损伤行传统重建板内固定。骶前蝶形接骨板组,男7例,女性9例,平均年龄为39.6±9.1岁,Tile B型骨折9例,C型7例；传统重建板组,男7例,女6例,平均年龄为39.1±13.5岁,Tile B型骨折8例,C型5例。两组间比较均无统计学差异。统计手术时间、出血量、钢板放置时间等,术后行X线检查及Matt a评分,随访时行X线检查及Majeed功能评分。
结果：
骶前蝶形接骨板组平均手术时间101.1±31.9min,出血1091.8±302.9ml,骶前蝶形接骨板放置时间6.3±3.1min。传统重建板组平均手术时间110.8±29.6min,出血1154.1±281.2ml,重建板放置时间14.9±1.6min。术后Matta评分,骶前蝶形接骨板组优5例,良8例,传统重建板组优4例,良6例。29例患者随访中出现腰骶干损伤1例,股外侧皮神经损伤7例,术中大出血2例,未出现术后感染。骶前蝶形接骨板组与对照组相比,钢板放置时间明显缩短(p=0.001),Tile B型手术出血量明显减少(p=0.024),其余差异无统计学意义(p>0.05)。
结论：
骶前蝶形接骨板治疗骶髂关节损伤获得了满意的复位结果和良好的固定效果,未发生接骨板断裂、腰骶干损伤及术后感染等并发症。同传统重建板相比较,骶前蝶形接骨板可以简化操作、缩短钢板放置时间、有利于旋转移位的复位、可以减少Tile B型骨折的手术出血量,不增加神经损伤风险及感染率。骶前蝶形接骨板适合于骶髂关节损伤前路手术治疗及固定,可以在临床上推广。
Background
Sacroiliac complex consists of the sacroiliac joint and the surrounding ligaments. It forms a drawbridge structure to stabilize the pelvic ring. It is the major stable structure of the pelvis, carrying the main stress load. About one out of six pelvic fractures implicate the sacroiliac complex. It would result in sacroiliac joint injury and peripheral ligaments damage. It further impairs the instability of pelvic ring. Therefore, the reconstruction of the stability of sacroiliac joint complex is of great importance in the treatment of the pelvic fractures.
Since Avila first reported the anterior surgical approach in1941, it has become popular to perform the open reduction and internal fixation through the anterior approach in the treatment of sacroiliac joint injury. It is the main treatment strategy, especially in the old pelvic fracture. Nowadays, the reconstruction plate is the main internal instrumentation used in surgery through the anterior approach. It uses two reconstruction plates with three or four holes. The two plates are fixed across the sacroiliac joint with a60degree angle. Biomechanical studies have shown that it had great stability to fix the joint.
However, the traditional reconstruction plate has some drawbacks. It might cause serious bleeding and injury of the lumbosacral trunk and the lateral femoral cutaneous nerve. At the beginning, two traditional reconstruction plates were placed in parallel. It is unstable, due to the instability of quadrilateral. Some studies reported that it was more biomechanically stabile to place the two reconstruction plates with60degree angle. But it is difficult to make sure the60degree angle in the small surgery field and the narrow space. Besides, due to the small safety region in the sacral side of sacroiliac joint, the complications occurs commonly, such as lumbosacral nerve injury and imprecise placement of plate.
In order to solve the disadvantages of the conventional reconstruction plates mentioned above, we design a new internal fixation:the sacroiliac anterior papilionaceous plate (SAPP). It's applicable for the treatment of anterior sacroiliac joint injury. To investigate the design parameters, anatomy safety, biomechanical stability and reliability for clinical application, we carry out a series of study, including anatomy studies of the sacroiliac joint, finite element analysis, biomechanical studies and retrospective clinical study.
Part I:The Design and Validation of the Sacroiliac Anterior Papilionaceous Plate
1. The basis of design
1.1Screw Secure Area
The sacralis ala is44.1±2.0mm high,22.3±1.8mm wide and49,4±1.4mm long. The auricular surface is L shaped. Its short axis is29.8±3.2mm wide, parallel to the sacralis ala platform. The long axis is54.1±4.9mm long, parallel to the ventral margin of sacrum. The width of the sacral wing platform is44mm, while the width of the articular surface is approximately30mm. The front three-quarters of the platform is the suitable area to place screw. According to the pelvic terrain map, the iliac bone is less than5mm thick in a round area near the sacroiliac joint. The diameter of the round area is about5cm. There are two ridges forming a90degree angle beyond and beneath the round area. The wings of SAPP should place on the ridges, thus the wings is designed with90degree angle. The length of the body is25mm.
1.2Nerve Safety Region
On the sacral ala platform, the distance between the sacroiliac joint line and the anterior branches of L4nerve root is closer than L5nerve root and the lumbosacral nerve trunk. It is22.2±2.6mm9.1±1.6mm from the dorsal to ventral. The narrowest distance is less than the width of the common plate, it is not appropriate to place internal fixation. The width of SAPP is designed as10mm, which is less than the distance from the anterior branches of L4nerve root to the sacroiliac joint line on the platform. Thus, the SAPP can be placed safely.
2. Design Specifications and Materials
The sacroiliac anterior papilionaceous plate (SAPP) is designed as semi-butterfly shape, consists of the upper and lower wings and the body portion. The wings connect with the body respectively, forming135degree angle and the two wings are90degree angle across each other. The width of the plate is10mm. The length of the body portion and the wings are25mm. There're6screw holes whose diameter is3.5mm. There is a temporary fixing hole on the body portion. At the two sides of the plate, there are3pairs of semi-circular aperture with a diameter of2. Omm. The material is Ti-6A1-4V alloy.
3. Validation of the Design Feasibility
4cadaver pelvis specimens of adult male (8sides) were included. Incite the abdominal wall, cut off the iliac muscle, remove the major psoas muscle, and fully reveal the sacroiliac joint. Carefully not damage the nerves and ensure the nerves in their original location. Then place the SAPP. Point A (the most forward point), point B (midpoint) and point C (the last point) were labeled on the medial edge of the body. The distance between A, B, C and anterior branches of L4, L5nerve root were measured.
Results:SAPP had no touching with nerves. The distance between the medial edge of the plate and L4nerve root is shorter than L5. Point C (the most ventral point of the medial edge of the plate) is nearest to the L4nerve root (about2.5±1.2mm). Thus, it's safe to place the plate. The depth of two sacral-side screws was about6mm and the depth of four iliac-side screws was about3mm. Screws could be placed avoiding the weak area of the ilium. It makes sure the well screw purchase. They can provide good biomechanical stability.
Part II:The Finite Element Analysis and Biomechanical
Study of Sacroiliac Anterior Papilionaceous Plate
Chapter I:Finite Element Analysis
Methods:One healthy volunteer (adult male,23-year-old, height172cm, weight70kg) was recruited. It gained permission from the ethical approval of the hospital ethics committee. Images of the pelvis were obtained by three-dimensional CT scans. Import the images into Mimics software to make three-dimensional model of the pelvis and meshing. Use Solidworks software to draw SAPP models (SAPP90and SAPP60), traditional reconstruction plate models (three holes) and two screws (long screw:50mm long; short screw:30mm long; both with a diameter of3.5mm). The three-dimensional pelvis model, plate models and screw models were imported into Abaqus software. Set properties and Young's modulus of various materials. Set the number, location and stiffness of the pelvic ligaments. Set the boundary conditions in the bilateral acetabulum, bear600N load on the Sl upper endplate. Then get the stress distribution and displacement distribution of each modal. Compare the maximum displacement and rotational displacement angle between the models.
Results:After the application of600N stress on the Sl endplate, the maximum displacement of SAPP90model was0.618mm, the rotational displacement was0.404degrees and the Von Mises stress was186N. For SAPP60, it was0.730mm,0.561degrees and275N respectively. For TP90model, it was0.886mm,0.769degrees and251N respectively. For TP60mode, it was0.778mm,0.748degrees and523N, respectively. For TP30model, it0.979mm,0.895degrees and241N. For TP00model is1.101mm,0.936degrees and232N. The maximum displacement of the whole pelvic model is0.478mm, the rotational displacement is0.298degrees, and Von mises stress is48.7N. The maximum displacement of the right sacroiliac joint injury model is1.992mm, the rotational displacement is3.146degrees; maximum of Von mises stress is221N, located on the ventral of left sacroiliac joint line.
Conclusion:In all the testing models, SAPP90model had the minimal vertical displacement and the rotational displacement. It indicated that SAPP90had the best biomechanical stability. The stress distribution of SAPP90model focused on the plate, especially the lower screws. However, in the right sacroiliac joint dislocation model, stress focused on the left sacroiliac joint, due to no stable structure at the right side. The SAPP could reconstruct the stability of the posterior pelvic ring. It distributes the stress on both the sides. Among the traditional reconstruction plate models, TP60has the smallest vertical and rotation displacement and TP00has the biggest. It indicated traditional reconstruction plate with a60degree angle had better biomechanical stability than other TPs, but it is weaker than that SAPP.
Chapter II:Biomechanical Test
Methods:The right sacroiliac joint injury models were made by4pelvis specimens with ligaments (adult male) and16complete pelvis model (adult male, Sawbones1301-1). The models were connected to Instron biomechanical tester and precision non-contact magnetic grid displacement measurement system. The right sacroiliac joint was fixed with SAPP and TP separately. Then applied load on the S1endplate with speed of2mm/s, and the maximum load was set as600N. Measure the maximum stress and displacement when the SAPP and TP (wood-make) broke. Measure vertical displacement and rotational displacement of Ti-alloy-made SAPP and traditional reconstruction plate and calculate the stress-displacement curve. Compare and analyze the biomechanical stability of the sacroiliac anterior papilionaceous plate and the traditional reconstruction plate.
Results:All wood made SAPP and traditional reconstruction plate ruptured when the load was less than600N. The stress value at the time of break was109.4±22.2N for SAPP90;87.8±17.6N for SAPP60,64.2±15.2N for TP90,64.9±10.2N for TP60,50.9±15.0N for TP00. Difference between the groups was statistically significant (p=0.047).
When the load was600N, for SAPP90Ti, the vertical displacement was0.43±0.12mm, the rotational displacement was0.518±0.145degrees, the displacement-stress curve was:y=134.32x+45.474, R2=0.61. For TP60Ti, the vertical displacement was0.51±0.13mm, the rotational displacement was0.742±0.214mm, the displacement stress curve was:y=10.509x+62.808, R2=0.46. The difference of maximum displacement and rotation between two groups was statistically significant (p=0.049,0.032, respectively).
Conclusion:
According to the biomechanical comparison between wood-made SAPP and TP, SAPP90was able to beat the maximum stress load. Its displacement maximum stress curve slope is the greatest. It is indicated to be the optimal design. TP60bore the maximum stress load among the TPs. According to the biomechanical testing of Ti-alloy made SAPP90Ti and TP60Ti, SAPP90Ti had smaller vertical displacement and rotation displacement than TP60Ti. It indicated SAPP90Ti had better biomechanical stability than TP60Ti.
Part III:The Clinical Application of Sacroiliac
Anterior Papilionaceous Plate
Objective:to evaluate clinical application and short term outcome of Sacroiliac Anterior Papilionaceous Plate (SAPP) in treatment of sacroiliac joint disruption.
Method:16consecutive patients with sacroiliac joint disruption associated with pelvic fracture enrolled in our hospital between2012.01. and2013.06. Detailed physical examination, X-rays, CT and FAST were performed before surgery. Operation was carried out after the patients'condition permitted usually7to14days after accident. All the16patients underwent SAPP fixation.13patients enrolled in last year as control group underwent reconstruction plate. Operation time, blood loss, placing time of SAPP were recorded. X ray films were performed after surgery to evaluate reduction condition by Matta criteria. X ray films and Majeed outcome were performed in follow up.
Results:29patients were included in this study,16patients with16sacroiliac disruptions were treated by SAPP and13patients with14sacroiliac disruptions were treated by reconstruction plate. According to the Tile classification, there were17Type B and12Type C. For SAPP group, operation time was101.1±31.9min, blood loss1091.8±302.9ml, Placing time of SAPP was6.3±3.1min. For control group, operation time was110.8±29.6min, blood loss was1154.1±281.2ml, placing time of reconstruction plate was14.9±1.6min. According to Matta criteria, there were9excellent,14good,5fair,1poor. There were1lumbosacral nerve injury,7lateral femoral cutaneous nerve injury,2massive blood loss occurred, while none posterior infection occurred. Compared with control group, SAPP group experienced shorter placing time of SAPP, and less blood loss in type B pelvic fracture.
Conclusion:As a new instrument, Sacroiliac Anterior Papilionaceous Plate (SAPP) could be well applied in treatment of sacroiliac disruption. Compared with reconstructed plate, SAPP obviously shorten placing time and facilitated placing procedure, while did not increase blood loss, neurological risk and infection rate and did not need different incision and reduction method.
骶髂复合体由骶髂关节及周围韧带组成,形成吊桥结构稳定骨盆环,是骨盆的主要稳定结构,承载主要的应力负荷。但六分之一的骨盆骨折累及骶髂关节复合体,不同程度地损伤骶髂关节及周围韧带,进一步造成骨盆环的不稳定。因此,重建骶髂关节复合体的稳定性对于治疗骨盆骨折非常重要。
Avila1941年首先提出前路手术入路以来,前路切开复位内固定术在骶髂关节损伤治疗中应用越来越广泛,尤其是在陈旧性骨盆骨折,前路手术已成为骶髂关节损伤的主要方法。目前,前路手术主要采取的内固定方式是重建钢板跨骶髂关节固定,采用两块三或四孔的重建板,跨骶髂关节成角固定。生物力学研究表明,传统重建板固定骶髂关节损伤稳定性良好。
但传统骶髂关节重建板也存在一些缺点。比如：经前路手术创伤大,出血较多,且有较高的腰骶干及股外侧皮神经损伤风险。传统骶髂重建板最初采用两块钢板平行放置,因四边形的不稳定性,导致其生物力学不稳定,不能牢靠固定骶髂关节脱位。研究表明,两枚重建板成60度夹角时具有良好的生物力学稳定性。但因前路手术视野小,操作空间狭窄,难以确定夹角为60度。骶骨侧因安全范围小,容易发生腰骶干损伤或重建板放置位置错误。
为了解决传统重建板的上述缺点,我们设计了一种新型骶髂关节内固定器械：骶前蝶形接骨板(SAPP)。它适合于前路手术治疗骶髂关节损伤。为明确骶前蝶形接骨板的最佳设计、生物力学稳定性及临床应用可靠性,我们分别进行了骶髂关节解剖学研究,有限元分析及生物力学研究和临床随机对照研究。
第一部分：骶前蝶形接骨板的设计与依据
1,设计依据
1.1螺钉安全区域。
骶骨翼高44.1±2.0mm,宽22.3±1.8mm,长49.4±1.4mm。耳状面为倒“L”形,上宽下窄,其短轴对骶骨翼平台,宽29.8±3.2mm；长轴对骶骨腹侧缘,长54.1±4.9mm。虽然骶骨翼平台的宽度为44mm,但其关节面宽度约为30mm。骶骨翼平台前四分之三为螺钉置钉的合适区域。髂骨骨质厚薄不均匀,根据骨盆地形图,髂骨厚度<5mm的区域为圆形,直径约5cm,位于骶髂关节附近。其上下均有厚度大于5mm的脊,两条脊的夹角约为90度。因此,骶前蝶形接骨板上下两翼应位于较厚的脊上,上下两翼部的夹角可设计为90度,长度为25mm。体部长度应为25mm。
1.2神经安全区域。
骶骨翼平台上L4神经根前支与骶髂关节线的距离比L5神经根前支、腰骶干近,其距离由背侧至腹侧为22.2±2.6mm～9.1±1.6mm。最腹侧距离L4神经根前支最近,小于普通钢板的宽度,不宜放置内固定。骶前蝶形接骨板的设计宽度为10mm,在骶骨翼平台上,除最腹侧外,L4神经根距离骶髂关节线的距离均大于10mm,可以安全放置骶前蝶形接骨板。
2,设计规格及材料
骶前蝶形接骨板(SAPP)的设计为半侧蝴蝶形,由上下翼部和体部组成。上下翼部与体部连接,分别成135度夹角,上下翼部夹角为90度。蝴蝶板宽度为10mm,上下翼部与体部的长度均为25mm。六枚钉孔采用滑动加压设计,均采用3.5mm直径螺钉。蝴蝶板体部有一个2.0克氏针的临时固定孔。体部、上下翼部中间部分板两侧有直径为2.0mm的半圆孔。设计材料为Ti-6Al-4V合金。3,设计可行性验证
采用成人男性骨盆标本4具(8侧),全层切开腹壁,切断髂肌,去除腰大肌,充分显露骶髂关节,注意不要损伤神经,并确保神经在其原始位置。置入骶前蝶形接骨板。在体部内侧缘标记A(最前点)、B(中点)及C点(最后点)。测量A、B、C点与L4神经根前支、L5神经根前支的距离。结果：骶前蝶形接骨板内侧缘距离L4神经根的距离最近,距离L5神经根较远。其中骶前蝶形接骨板上C点(骶前蝶形接骨板内侧缘最腹侧点)距离L4神经根最近,距离为2.5±12mm。放置骶前蝶形接骨板时仍有一定的安全空隙。骶前蝶形接骨板骶骨侧的两枚螺钉深度在6mm左右,髂骨侧4枚螺钉深度在3.0mm左右,具有较好的把持力,避免了在髂骨薄弱处置钉,可以提供良好的生物力学稳定性。
第二部分：骶前蝶形接骨板的有限元分析和生物力学研究
第一章：骶前蝶形接骨板的有限元分析
方法：
通过山东省立医院医院伦理委员会审查,招募健康成人男性志愿者1名,男性,23岁,身高172cm,体重70Kg。通过三维CT扫描,得到骨盆的三维扫描图像,导入Mimics软件制作骨盆的三维模型并网格化。应用Solidworks软件绘制两种角度的骶前蝶形接骨板的模型SAPP90、SAPP60,绘制传统重建板模型(三孔),绘制两种螺钉：长螺钉50mm,短螺钉30mm,直径均为3.5mm。将骨盆三维模型及骶前蝶形接骨板、传统重建板、两种螺钉模型导入Abaqus软件中,设置各种材料的属性、杨氏模量等,设置骨盆韧带的数量、位置、刚度等。在双侧髋臼设置边界条件并在S1上终板施加600N载荷,进行模拟分析,得出各个模型的应力分布、位移分布,比较骶前蝶形接骨板和传统重建板固定骶髂关节脱位后的最大位移和旋转位移。
结果：
在S1椎体上终板施加600N的应力后,SAPP90模型的最大位移是0.618mm,旋转位移是0.404度,Von Mises应力值是186N。SAPP60模型的最大位移是0.730mm,旋转位移是0.561度,Von Mises应力值为275N。TP90模型的最大位移是0.886mm,旋转位移是0.769度,Von Mises应力值是251N。TP60模型的最大位移是0.778mm,旋转位移是0.748度,Von Mises应力值是523N。TP30模型的最大位移是0.979mm,旋转位移是0.895度,Von Mises应力值是241N。TP00模型的最大位移是1.101mm,旋转位移是0.936度,Von mises应力值是232N。完整骨盆模型的最大位移是0.478mm,旋转位移是0.298度,Vonmises应力是48.7N。右侧骶髂关节损伤模型的最大位移是1.992mm,旋转位移是3.146度,Von mises应力最大值221N,位于左侧骶髂关节线腹侧。
结论：
在所有骶前蝶形接骨板及传统重建板的测试模型中,骶前蝶形接骨板(SAPP90)的垂直位移及旋转位移均最小,证明了设计的骶前蝶形接骨板(SAPP90)具有最好的生物力学稳定性。SAPP90模型的应力分布,集中在右侧骶髂关节及骶前蝶形接骨板上,以骶前蝶形接骨板下翼部螺钉处最大。在右侧骶髂关节脱位模型中,右侧骶髂关节无稳定结构,应力集中到左侧骶髂关节处。骶前蝶形接骨板重建了骨盆后环的稳定性,将应力分布在两侧,而非集中在健侧。传统重建板模型中,TP60的位移及旋转位移最小,TP00的位移及旋转位移最大,证明成60度夹角放置的传统重建板比其他角度的传统重建板有更好的生物力学稳定性,但生物力学稳定性小于骶前蝶形接骨板。
第二章：骶前蝶形接骨板的生物力学研究
方法：
利用4具带有韧带的骨盆标本(成年男性)和16具成年男性完整骨盆模型(Sawbones1301-1),制作右侧骶髂关节损伤的模型,并将模型连接Instron生物力学测试仪和高精度非接触式磁栅位移测量系统。分别将自制骶前蝶形接骨板和传统重建板模型、钛合金(Ti-6Al-4V合金)制骶前蝶形接骨板和传统重建板模型安装在右侧骶髂关节损伤的模型上,以2mm/s的速度在S1上终板施加载荷,最大载荷设定为600N。测量自制骶前蝶形接骨板和传统重建板断裂时的最大应力和各自的应力-位移曲线。测量Ti合金制骶前蝶形接骨板和传统重建板在600N载荷下的垂直位移和旋转位移,计算其应力-位移曲线,比较分析骶前蝶形接骨板和传统重建板的生物力学稳定性。结果：
在S1上终板施加速度为2mm/s的载荷后,自制骶前蝶形接骨板和传统重建板模型均在载荷小于600N时发生断裂。其断裂时的应力值：SAPP90模型为496.7±100.8N;SAPP60模型为398.6±79.9N,TP90模型为291.5±69.0N,TP60模型为294.9±68.1N,TP00模型为231.1±68.1N。各组间差异具有统计学意义(p=0.047)。
在载荷为600N时,骶前蝶形接骨板(SAPP90Ti)的垂直位移是0.43±0.12mm,旋转位移是0.518±0.145度,位移-应力曲线：y=134.32x+45.474,R2=0.61。传统重建板(TP60Ti)的垂直位移是0.51±0.13mm,旋转位移是0.742±0.214度,位移-应力曲线：y=105.09x+62.808,R2=0.4。两组间最大位移和旋转位移差异有统计学意义(p=0.049,0.032)。结论：
自制骶前蝶形接骨板和传统重建板模型的生物力学比较中,SAPP90能够承受最大的应力载荷,其位移-应力曲线斜率最大,证实其为最优设计方案。TP60在传统重建板中具有最大应力载荷,为最佳传统重建板设计。应用钛合金制作骶前蝶形接骨板(SAPP90)及传统重建板(TP60),进行生物力学测试,骶前蝶形接骨板的位移比较传统重建板更小,证明骶前蝶形接骨板比传统重建板具有更好的生物力学稳定性。
第三部分骶前蝶形接骨板的临床对比研究
方法：
山东省立医院2012年1月至2013年6月治疗了29例30侧骶髂关节损伤,对其临床资料进行了回顾性分析,其中16例16侧骶髂关节损伤行骶前蝶形接骨板内固定,13例14侧骶髂关节损伤行传统重建板内固定。骶前蝶形接骨板组,男7例,女性9例,平均年龄为39.6±9.1岁,Tile B型骨折9例,C型7例；传统重建板组,男7例,女6例,平均年龄为39.1±13.5岁,Tile B型骨折8例,C型5例。两组间比较均无统计学差异。统计手术时间、出血量、钢板放置时间等,术后行X线检查及Matt a评分,随访时行X线检查及Majeed功能评分。
结果：
骶前蝶形接骨板组平均手术时间101.1±31.9min,出血1091.8±302.9ml,骶前蝶形接骨板放置时间6.3±3.1min。传统重建板组平均手术时间110.8±29.6min,出血1154.1±281.2ml,重建板放置时间14.9±1.6min。术后Matta评分,骶前蝶形接骨板组优5例,良8例,传统重建板组优4例,良6例。29例患者随访中出现腰骶干损伤1例,股外侧皮神经损伤7例,术中大出血2例,未出现术后感染。骶前蝶形接骨板组与对照组相比,钢板放置时间明显缩短(p=0.001),Tile B型手术出血量明显减少(p=0.024),其余差异无统计学意义(p>0.05)。
结论：
骶前蝶形接骨板治疗骶髂关节损伤获得了满意的复位结果和良好的固定效果,未发生接骨板断裂、腰骶干损伤及术后感染等并发症。同传统重建板相比较,骶前蝶形接骨板可以简化操作、缩短钢板放置时间、有利于旋转移位的复位、可以减少Tile B型骨折的手术出血量,不增加神经损伤风险及感染率。骶前蝶形接骨板适合于骶髂关节损伤前路手术治疗及固定,可以在临床上推广。
Background
Sacroiliac complex consists of the sacroiliac joint and the surrounding ligaments. It forms a drawbridge structure to stabilize the pelvic ring. It is the major stable structure of the pelvis, carrying the main stress load. About one out of six pelvic fractures implicate the sacroiliac complex. It would result in sacroiliac joint injury and peripheral ligaments damage. It further impairs the instability of pelvic ring. Therefore, the reconstruction of the stability of sacroiliac joint complex is of great importance in the treatment of the pelvic fractures.
Since Avila first reported the anterior surgical approach in1941, it has become popular to perform the open reduction and internal fixation through the anterior approach in the treatment of sacroiliac joint injury. It is the main treatment strategy, especially in the old pelvic fracture. Nowadays, the reconstruction plate is the main internal instrumentation used in surgery through the anterior approach. It uses two reconstruction plates with three or four holes. The two plates are fixed across the sacroiliac joint with a60degree angle. Biomechanical studies have shown that it had great stability to fix the joint.
However, the traditional reconstruction plate has some drawbacks. It might cause serious bleeding and injury of the lumbosacral trunk and the lateral femoral cutaneous nerve. At the beginning, two traditional reconstruction plates were placed in parallel. It is unstable, due to the instability of quadrilateral. Some studies reported that it was more biomechanically stabile to place the two reconstruction plates with60degree angle. But it is difficult to make sure the60degree angle in the small surgery field and the narrow space. Besides, due to the small safety region in the sacral side of sacroiliac joint, the complications occurs commonly, such as lumbosacral nerve injury and imprecise placement of plate.
In order to solve the disadvantages of the conventional reconstruction plates mentioned above, we design a new internal fixation:the sacroiliac anterior papilionaceous plate (SAPP). It's applicable for the treatment of anterior sacroiliac joint injury. To investigate the design parameters, anatomy safety, biomechanical stability and reliability for clinical application, we carry out a series of study, including anatomy studies of the sacroiliac joint, finite element analysis, biomechanical studies and retrospective clinical study.
Part I:The Design and Validation of the Sacroiliac Anterior Papilionaceous Plate
1. The basis of design
1.1Screw Secure Area
The sacralis ala is44.1±2.0mm high,22.3±1.8mm wide and49,4±1.4mm long. The auricular surface is L shaped. Its short axis is29.8±3.2mm wide, parallel to the sacralis ala platform. The long axis is54.1±4.9mm long, parallel to the ventral margin of sacrum. The width of the sacral wing platform is44mm, while the width of the articular surface is approximately30mm. The front three-quarters of the platform is the suitable area to place screw. According to the pelvic terrain map, the iliac bone is less than5mm thick in a round area near the sacroiliac joint. The diameter of the round area is about5cm. There are two ridges forming a90degree angle beyond and beneath the round area. The wings of SAPP should place on the ridges, thus the wings is designed with90degree angle. The length of the body is25mm.
1.2Nerve Safety Region
On the sacral ala platform, the distance between the sacroiliac joint line and the anterior branches of L4nerve root is closer than L5nerve root and the lumbosacral nerve trunk. It is22.2±2.6mm9.1±1.6mm from the dorsal to ventral. The narrowest distance is less than the width of the common plate, it is not appropriate to place internal fixation. The width of SAPP is designed as10mm, which is less than the distance from the anterior branches of L4nerve root to the sacroiliac joint line on the platform. Thus, the SAPP can be placed safely.
2. Design Specifications and Materials
The sacroiliac anterior papilionaceous plate (SAPP) is designed as semi-butterfly shape, consists of the upper and lower wings and the body portion. The wings connect with the body respectively, forming135degree angle and the two wings are90degree angle across each other. The width of the plate is10mm. The length of the body portion and the wings are25mm. There're6screw holes whose diameter is3.5mm. There is a temporary fixing hole on the body portion. At the two sides of the plate, there are3pairs of semi-circular aperture with a diameter of2. Omm. The material is Ti-6A1-4V alloy.
3. Validation of the Design Feasibility
4cadaver pelvis specimens of adult male (8sides) were included. Incite the abdominal wall, cut off the iliac muscle, remove the major psoas muscle, and fully reveal the sacroiliac joint. Carefully not damage the nerves and ensure the nerves in their original location. Then place the SAPP. Point A (the most forward point), point B (midpoint) and point C (the last point) were labeled on the medial edge of the body. The distance between A, B, C and anterior branches of L4, L5nerve root were measured.
Results:SAPP had no touching with nerves. The distance between the medial edge of the plate and L4nerve root is shorter than L5. Point C (the most ventral point of the medial edge of the plate) is nearest to the L4nerve root (about2.5±1.2mm). Thus, it's safe to place the plate. The depth of two sacral-side screws was about6mm and the depth of four iliac-side screws was about3mm. Screws could be placed avoiding the weak area of the ilium. It makes sure the well screw purchase. They can provide good biomechanical stability.
Part II:The Finite Element Analysis and Biomechanical
Study of Sacroiliac Anterior Papilionaceous Plate
Chapter I:Finite Element Analysis
Methods:One healthy volunteer (adult male,23-year-old, height172cm, weight70kg) was recruited. It gained permission from the ethical approval of the hospital ethics committee. Images of the pelvis were obtained by three-dimensional CT scans. Import the images into Mimics software to make three-dimensional model of the pelvis and meshing. Use Solidworks software to draw SAPP models (SAPP90and SAPP60), traditional reconstruction plate models (three holes) and two screws (long screw:50mm long; short screw:30mm long; both with a diameter of3.5mm). The three-dimensional pelvis model, plate models and screw models were imported into Abaqus software. Set properties and Young's modulus of various materials. Set the number, location and stiffness of the pelvic ligaments. Set the boundary conditions in the bilateral acetabulum, bear600N load on the Sl upper endplate. Then get the stress distribution and displacement distribution of each modal. Compare the maximum displacement and rotational displacement angle between the models.
Results:After the application of600N stress on the Sl endplate, the maximum displacement of SAPP90model was0.618mm, the rotational displacement was0.404degrees and the Von Mises stress was186N. For SAPP60, it was0.730mm,0.561degrees and275N respectively. For TP90model, it was0.886mm,0.769degrees and251N respectively. For TP60mode, it was0.778mm,0.748degrees and523N, respectively. For TP30model, it0.979mm,0.895degrees and241N. For TP00model is1.101mm,0.936degrees and232N. The maximum displacement of the whole pelvic model is0.478mm, the rotational displacement is0.298degrees, and Von mises stress is48.7N. The maximum displacement of the right sacroiliac joint injury model is1.992mm, the rotational displacement is3.146degrees; maximum of Von mises stress is221N, located on the ventral of left sacroiliac joint line.
Conclusion:In all the testing models, SAPP90model had the minimal vertical displacement and the rotational displacement. It indicated that SAPP90had the best biomechanical stability. The stress distribution of SAPP90model focused on the plate, especially the lower screws. However, in the right sacroiliac joint dislocation model, stress focused on the left sacroiliac joint, due to no stable structure at the right side. The SAPP could reconstruct the stability of the posterior pelvic ring. It distributes the stress on both the sides. Among the traditional reconstruction plate models, TP60has the smallest vertical and rotation displacement and TP00has the biggest. It indicated traditional reconstruction plate with a60degree angle had better biomechanical stability than other TPs, but it is weaker than that SAPP.
Chapter II:Biomechanical Test
Methods:The right sacroiliac joint injury models were made by4pelvis specimens with ligaments (adult male) and16complete pelvis model (adult male, Sawbones1301-1). The models were connected to Instron biomechanical tester and precision non-contact magnetic grid displacement measurement system. The right sacroiliac joint was fixed with SAPP and TP separately. Then applied load on the S1endplate with speed of2mm/s, and the maximum load was set as600N. Measure the maximum stress and displacement when the SAPP and TP (wood-make) broke. Measure vertical displacement and rotational displacement of Ti-alloy-made SAPP and traditional reconstruction plate and calculate the stress-displacement curve. Compare and analyze the biomechanical stability of the sacroiliac anterior papilionaceous plate and the traditional reconstruction plate.
Results:All wood made SAPP and traditional reconstruction plate ruptured when the load was less than600N. The stress value at the time of break was109.4±22.2N for SAPP90;87.8±17.6N for SAPP60,64.2±15.2N for TP90,64.9±10.2N for TP60,50.9±15.0N for TP00. Difference between the groups was statistically significant (p=0.047).
When the load was600N, for SAPP90Ti, the vertical displacement was0.43±0.12mm, the rotational displacement was0.518±0.145degrees, the displacement-stress curve was:y=134.32x+45.474, R2=0.61. For TP60Ti, the vertical displacement was0.51±0.13mm, the rotational displacement was0.742±0.214mm, the displacement stress curve was:y=10.509x+62.808, R2=0.46. The difference of maximum displacement and rotation between two groups was statistically significant (p=0.049,0.032, respectively).
Conclusion:
According to the biomechanical comparison between wood-made SAPP and TP, SAPP90was able to beat the maximum stress load. Its displacement maximum stress curve slope is the greatest. It is indicated to be the optimal design. TP60bore the maximum stress load among the TPs. According to the biomechanical testing of Ti-alloy made SAPP90Ti and TP60Ti, SAPP90Ti had smaller vertical displacement and rotation displacement than TP60Ti. It indicated SAPP90Ti had better biomechanical stability than TP60Ti.
Part III:The Clinical Application of Sacroiliac
Anterior Papilionaceous Plate
Objective:to evaluate clinical application and short term outcome of Sacroiliac Anterior Papilionaceous Plate (SAPP) in treatment of sacroiliac joint disruption.
Method:16consecutive patients with sacroiliac joint disruption associated with pelvic fracture enrolled in our hospital between2012.01. and2013.06. Detailed physical examination, X-rays, CT and FAST were performed before surgery. Operation was carried out after the patients'condition permitted usually7to14days after accident. All the16patients underwent SAPP fixation.13patients enrolled in last year as control group underwent reconstruction plate. Operation time, blood loss, placing time of SAPP were recorded. X ray films were performed after surgery to evaluate reduction condition by Matta criteria. X ray films and Majeed outcome were performed in follow up.
Results:29patients were included in this study,16patients with16sacroiliac disruptions were treated by SAPP and13patients with14sacroiliac disruptions were treated by reconstruction plate. According to the Tile classification, there were17Type B and12Type C. For SAPP group, operation time was101.1±31.9min, blood loss1091.8±302.9ml, Placing time of SAPP was6.3±3.1min. For control group, operation time was110.8±29.6min, blood loss was1154.1±281.2ml, placing time of reconstruction plate was14.9±1.6min. According to Matta criteria, there were9excellent,14good,5fair,1poor. There were1lumbosacral nerve injury,7lateral femoral cutaneous nerve injury,2massive blood loss occurred, while none posterior infection occurred. Compared with control group, SAPP group experienced shorter placing time of SAPP, and less blood loss in type B pelvic fracture.
Conclusion:As a new instrument, Sacroiliac Anterior Papilionaceous Plate (SAPP) could be well applied in treatment of sacroiliac disruption. Compared with reconstructed plate, SAPP obviously shorten placing time and facilitated placing procedure, while did not increase blood loss, neurological risk and infection rate and did not need different incision and reduction method.
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