摘要
目前，颈椎前路手术根据是否行颈椎融合可分为融合手术与非融合手术两种。融合手术主要包括前路椎间盘切除植骨融合术及前路椎体次全切除植骨融合术。这些术式可以达到椎管彻底减压、很好地重建颈椎稳定性的目的。但这种手术方式是一种非生理性的固定方式，牺牲了手术节段的活动度，可导致术后颈椎活动度受限；同时这种手术还可能会引发临近节段负荷增加、椎间盘退变加速。
随着非融合的理念和技术的发展，针对颈椎单节段病变出现了各种类型的颈椎人工椎间盘，其中许多已经开始广泛的临床应用，取得了良好效果。人工颈椎椎间盘置换术不仅可以重建颈椎稳定性，同时也保留了其正常活动度。目前许多颈椎间盘切除植骨融合术已经逐渐被椎间盘置换术这种非融合手术所取代。而目前国内外还没有一种非融合技术来代替椎体次全切除植骨融合术，达到既稳定颈椎又保留活动度的目的。为了弥补这一空白，本课题组研发了一种新型的人工颈椎复合关节系统(Artificial cervical joint complex,ACJC)，经过前期的优化设计及生物力学测试，证实这种假体可以达到既稳定颈椎又保留活动度的目的。然而，该假体仍然是一项初期研究，而要过渡到临床应用，还需要进行进一步优化设计与动物体内相关研究。
目的：
1.对现有的人工颈椎复合关节系统进行优化设计；2.将人工颈椎复合关节系统植入山羊体内，对其安全性及有效性进一步评价，以期为该假体的临床应用提供实验依据。
方法：
1.分析目前假体所存在的缺陷，对其进行优化设计。将假体的关节头和椎体部件等组成部件的相应几何参数导入Solid Works制图软件，将医用钛合金材料按预先的设计在铸造设备及高精度数控机床上加工成型。2.选取12只健康的成年雄性山羊，术前拍摄正、侧位及过屈、过伸位X光片，并测量山羊颈椎尺寸，定制匹配山羊颈椎的假体。行颈前路C3颈椎次全切除，植入人工颈椎复合关节系统假体。3.术后将12只山羊随机分为两组：分别为术后3月组与术后6月组。在山羊处死前，麻醉后拍摄颈椎正、侧位与过屈、过伸位X光片，测量术后颈椎椎体高度、颈椎曲度及颈椎的活动度，并与术前进行比较分析。行CT扫描三维重建进一步了解假体的位置（有无移位），螺钉位置及椎管是否有内占位的情况。4.山羊处死后，取腋下、腹股沟淋巴结、脾脏组织，假体前方纤维组织、假体后方的脊髓组织。之后行HE染色了解有无全身与局部组织的毒副作用。取山羊的颈椎标本进行显微CT(Micro-CT)及硬组织切片染色，评价假体及螺钉与骨的结合情况及骨向内生长的情况。
结果：
1.设计并加工出了新一代的人工颈椎复合关节系统假体。2.颈椎次全切除人工颈椎复合关节系统植入术后，除一只山羊出现一过性的双下肢无力之外，其余山羊术后第二天可以自由行走、进饮食；颈部可以自由活动度。术后所有山羊的手术切口均为甲级愈合。3.术后X线侧位片显示：术后3月组与6月组C2椎体～C4椎体前、后缘及椎体中份的高度较术前均有所减小，但差异无统计学意义(P>0.05)。术后3月组与6月组与术前比较，颈椎曲度均下降，差异有统计学意义(P<0.05)。颈椎动力位片显示：术后3月组与6月组C4～C5节段的屈伸活动度与术前比较，差异均无统计学意义（P>0.05）。术后3月组与6月组C2～C3、C3～C4节段屈伸活动度较术前均有下降，差异有统计学意义(P<0.05)。术后3月组与6月组所有山羊颈椎X线片可见：假体位置良好、螺钉固定良好；均无螺钉退出、断裂及钢板断裂或移位等现象。术后3月组，可见骨小梁从椎体开始逐渐向金属长入，术后6月骨小梁长入更加靠近金属表面。CT三维重建显示：假体及螺钉的位置良好，无移位、断裂等现象。纵切面与轴位影像显示：椎管内无占位等情况。4. HE染色结果显示：术后3月与6月组所有山羊淋巴结组织、脾脏组织、椎前组织及脊髓组织内未发现金属磨损碎屑微粒及细胞凋亡等情况。Micro-CT扫描显示：3月组螺钉与骨之间及假体齿状突起与骨之间骨小梁浓密，部分骨小梁进入螺钉的螺纹之间及齿状突起之间。与3月组相比较，6月组螺钉与骨之间及假体齿状突起与骨之间骨小梁更加浓密，更多的骨小梁进入螺钉的螺纹之间及齿状突起之间。硬组织切片显示：3月组齿状突起及螺钉与骨界面有大量的纤维组织，可见部分软骨细胞；与3月组相比较，6月组有部分纤维组织转变为软骨组织，可见部分骨小梁及较多的软骨细胞。
结论：
人工颈椎复合关节系统在山羊体内植入，既可以维持颈椎的稳定性又保留其颈椎的活动度。初步证实该假体在山羊体内应用是安全、有效的，这为该假体临床应用提供了实验基础。
At present, the anterior cervical approach surgeries can be divided into fusionsurgeries and non-fusion surgeries according to whether the cervical vertebrae arefused. The fusion surgeries include anterior cervical diskectomy and fusion andanterior cervical corpectomy and fusion. These fusion surgical procedures canachieve complete decompression of the spinal canal and a good reconstruction ofthe cervical spine stability. However, these surgeries are not physiological fixingsurgeries. They have sacrificed the segmental motion of the cervical spine. Andthey can lead to lose of movement of the levels. At the same time, this kind ofsurgery may increase the load of the adjacent levels and accelerate thedegenerative change of the adjacent levels.
With the development of non-fusion ideas and technology, there have been many types of artificial cervical discs, many of which are already widely clinicalapplication and achieved good results. The artificial cervical disc replacementsurgery can not only rebuild the cervical spine stability, but also retains its normalactivity. At present, many anterior cervical diskectomy and fusion surgeries havebeen gradually replaced by intervertebral disc replacement surgeries. While thereis not a kind of non-fusion technology can replace the anterior cervicalcorpectomy and fusion surgeries, which can achieve both the stability andmovement of the cervical spine. To solve this problem, our group has developeda new type of artificial cervical joint complex (ACJC). After the optimizationdesign and biomechanical testing of the prosthesis, it confirmed that thisprosthesis can achieve both stability and activity of cervical spine. However, thisprosthesis is still a preliminary products, the transition to clinical application alsoneed further optimize design and in vivo studies.
Objective:
1. Optimized design of the artificial cervical joint complex.
2. Through the in vivo study, further evaluate the safety and effectiveness ofthe artificial cervical joint complex. It will provide experimental basis for clinicaluse of this prosthesis.
Methods:
1. Analyze the defects of the prosthesis and make optimized designs of it.
The corresponding geometric parameters of the joint head and bodycomponent parts of the prosthesis were imported into the Solid Works drawingsoftware. According to a predetermined design, the medical titanium alloymaterial was processed in the casting equipment and high-precision computernumerical controled machine tools.
2. Select12healthy adult male goats. Take X-ray images in normal, neutral,flexing and extending position before surgery. Measure the size of the goatcervical spine and custom prostheses to match the goat cervical spine. Subtotalresection of the C3vertebrae and implant the artificial cervical joint prosthesissystem into the cervical spine.
3. The12goats were randomly divided into two groups after operation:3months group and6months group respectively. Before the goats were killed, takeX-ray photos in normal, neutral, flexing and extending position. Measure thevertebral height, the cervical curvature and the range of movement of the cervicalspine. Compare them with the preoperative values. CT scan and thethree-dimensional reconstruction were used for further understanding of theposition of the prosthesis, the position of the screw and spinal canal.
4. After the goats were sacrificed, remove the lymph nodes of the axilla andgroin area, spleen tissue, fibrous tissue in front of the prosthesis, spinal cord tissubehind the prostheses. Take them for HE stain to understand whether the systemicand local tissue toxicity. Take the goats cervical specimens for Micro-CT scanand hard tissue section staining to evaluate the prosthesis, screw and bone unionand bone ingrowth.
Results:
1. A new generation of artificial cervical joint complex has been designedand processed.
2. After the operation, one goat appeared transient lower extremity weakness.The remaining goats can eat, drink and walk freely. The neck can also movefreely. Surgical incisions of all goats were healed very well.
3. Postoperative lateral X ray showed that the anterior, posterior and middle height of C2~C4vertebral body in both the3months group and6months groupwere decreased when compared with the preoperative values. But the differenceswere not statistically significant (P>0.05). Compared with those preoperativevalues, the cervical curvature in both the3months group and6months groupwere decreased. The difference was statistically significant (P <0.05). Thedynamic cervical radiographs revealed that C4~C5segment flexion-extensionactivity in both the3months group and6months group were decreased whencompared with those before operation. But the differences were not statisticallysignificant (P>0.05). C2~C3and C3~C4segment flexion-extension activity inboth the3months group and6months group were decreased compared withthose before operation. The difference was statistically significant (P <0.05). TheX-ray images also indicated that the position of the prostheses and the screwsfixation were fine in both the two groups. There was no screw pullout or fracture,no plate fracture or shift. The trabecular bone from the vertebral began graduallyingrowthed to the metal in3months group. In6months group, the trabecularbone ingrowth closer to the surface of metal. CT three-dimensional reconstructionimages showed that the position of prostheses and screws were fine. Thelongitudinal and axial images showed the prostheses and screws did not infringethe spinal canal.
4. HE staining results showed that there were no metal wear debris particlesand cell apoptosis in the lymph nodes, spleen, the pre-vertebral tissue and spinalcord tissue in both groups. Micro-CT scan showed that there were densetrabecular between the screws and bone and between the dentate protuberances ofthe prostheses and bone. Compared with the3months group, there were denserand more trabecular between the screws and bone and between the dentateprotuberances of the prostheses and bone in the6month group. Hard-tissue sections indicated that there were a large number of fibrous tissue and a smallamount of cartilage cells between the screws and bone and between the dentateprotuberances and bone in the3months group. In the6months group, part offibrous tissue has changed into the cartilage tissue. There also has visible part ofthe trabecular bone and more cartilage cells.
Conclusions:
Artificial cervical joint complex can maintain the stability of the cervicalspine and retains the activity of the cervical spine in vivo. Preliminary evidenceconfirmed the prosthesis is safe and effective in vivo applications. It provided theexperimental basis for the clinical application of the prostheses.
引文
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