PEEK棒杂交手术治疗腰椎退行性疾病的三维有限元分析和临床研究

发布时间：2018-07-07 07:45

本文选题：PEEK棒 + 非融合　；参考：《第二军医大学》2017年博士论文

【摘要】：背景随着人口老龄化的进展,腰椎退变疾病如腰椎间盘突出症、腰椎管狭窄症、腰椎滑脱症等所导致腰腿痛等严重影响人们的生活质量。对病变节段的固定融合是治疗这些疾病的经典手术方式。但随其应用增多,一些融合手术的并发症,如相邻节段退变等的报道逐年增多。很多学者设计了通过非融合手术的方式预防融合手术的并发症或通过杂交手术的方式预防相邻节段退变的发生。PEEK棒是近年来应用较为广泛的一种新型的半刚性固定,既往文献报道PEEK棒应用于融合手术可以取得令人满意的治疗效果。但PEEK棒非融合和杂交手术于的临床应用尚无报道。目的通过三维有限元模拟的方式,研究PEEK棒非融合和PEEK棒杂交手术固定腰椎后,腰椎椎间压力的变化和椎间活动度的变化情况。探讨PEEK棒非融合应用于腰椎的临床治疗效果、影像学上的变化和并发症的情况。进一步对比PEEK棒杂交手术和传统钛棒手术的临床疗效、影像学改变和并发症,并探讨原因及应对方法。方法选择一名正常没有伤病史的健康男性志愿者,对其进行CT扫描,将所有CT图像数据输入Mimics 13.0(Materialise,Shanghai,China)软件中,选定合适的CT灰度值(226-2540)后,通过Region Growing功能,再通过Calculate 3D功能,利用像素的不同,重建腰椎。将Mimics中输出的STL文件导入到Geomagic10(Geomagic,North Carolina,the United States)软件中,经过点云阶段-多边形阶段-形状阶段生成体模型。根据图纸在Pro/E Wildfire 1.0(PTC,the United States)软件中建立内固定系统模型,将L1-S1曲面模型的IGES文件输入Ansys(Ansys,the United States)中,建立L1-S有限元模型。共包括以下6种模型:完整标本,L4/5PEEK棒固定非融合,L4/5PEEK棒固定融合(椎间盘置入cage),L4/5钛棒固定融合,L3-L5PEEK棒非融合,L3-L5杂交固定融合(L4/5椎间盘置入cage)。在L1椎体上给予350N,在L1椎体的给予40Nm模拟活动,测试L2至L5节段在各个方向活动度上椎间压力和节段的活动度。研究2012年2月至10月,38例住院行PEEK棒非融合固定的患者。所有患者行相应部位减压术和PEEK棒固定术。纪录术前、术后1周、3月、6月、12月和24月的欧式功能障碍指数(Oswestry Disability Index,ODI)和日本骨科协会评分(japaneseorthopaedicsassociation,joa)来评价临床疗效。通过椎间高度指数,观察椎间高度变化情况,观察有无螺钉松动,椎间活动度变化情况。末次随访时,应用ct三维重建,观察peek棒有无断裂扭曲。研究2012年9月-2013年6月,58例手术治疗的腰椎退行性疾病的患者。患者设两组,peek棒杂交组,钛棒plif组。首要临床评价指标为简体中文版odi指数。最小临床有效度(minimalclinicallyimportantdifference,mcid)设置为10分。应用ct重建评价椎间隙是否骨性融合,标准为上下软骨终板间有不间断骨痂形成。末次随访通过三维ct重建来观察peek棒的完整性。相邻节段的评价采用mri上pfirrmann分级来评价。研究设计至少获得odi8分的改善,odi评分的术前标准差估计值为9分,设置Ⅰ类错误α为0.05,Ⅱ类错误β为0.1,预估的10%的失访率,计算一共需要58例患者。计算fleisskappa值来评估组间和组内一致性。结果建立的有限元模型经验证有效。在给定的负荷及力矩下,屈伸活动时正常l3/4椎间活动度为9°,l4/5钛棒固定后l3/4椎间活动度增加到12.5°。当应用peek棒杂交手术后,l3/4椎间活动度减少至2.5°。侧屈旋转活动时正常l3/4椎间活动度为6.7°,l4/5钛棒固定后l3/4椎间活动度增加到7.4°。当应用peek棒杂交手术后,l3/4椎间活动度减少至2.5°。轴向旋转活动时正常l3/4椎间活动度为6.0°,l4/5钛棒固定后l3/4椎间活动度增加到7.4°。当应用peek棒杂交手术后,l3/4椎间活动度减少至2.6°。在给定的负荷及力矩下,屈伸活动时正常l3/4椎间应力为5.3mpa,l4/5钛棒固定后l3/4椎间应力增加到6.0mpa。当应用peek棒杂交手术后,l3/4椎间应力减少至2.4mpa。屈伸活动时正常l3/4椎间应力为4.3mpa,l4/5钛棒固定后l3/4椎间应力增加到4.8mpa。当应用peek棒杂交手术后,l3/4椎间应力减少至2.2mpa。轴向旋转活动时正常l3/4椎间应力为4.2mpa,l4/5钛棒固定后l3/4椎间应力增加到4.3mpa。当应用peek棒杂交手术后,l3/4椎间应力减少至2.5mpa。非融合手术的最终纳入31例患者。患者平均年龄56.3岁,男女比例为12/19,平均随访23.8个月。术前诊断:11例腰椎间盘突出症,12例腰椎管狭窄症,6例腰椎不稳症,2例腰椎间盘突出症术后复发。odi术前平均51.4(36-70)分,术后1周降至平均37.8,术后3个月降至平均15.2,术后6个月降至平均14.4,术后12个月降至平均13.2,术后24个月降至平均13.0。joa评分术前平均13.7(7-19)分,术后1周升至平均15.9,术后3个月升至平均22.0,术后6个月升至平均22.2,术后1年升至平均23.4,术后2年平均23.2分。术前术后odi和joa评分差异有统计学差异(p0.05)。dhi术前平均0.30(0.17-0.38),术后1周升至平均0.32,术后3个月平均0.31,术后6个月平均0.30,术后1年平均0.29,术后2年平均0.27,术前术后DHI变化无统计学差异(P0.05)。椎间活动度术前平均8.8°,术后3个月平均2.1°,术后6个月平均2.1°,术后1年平均2.0°,术后2年平均1.8°,术前术后ROM变化有明显统计学差异(P0.05)。1例患者12个月随访时发现螺钉松动的影像学表现,但随访过程中无临床症状。所有患者术后24个月随访时CT重建均未见PEEK棒断裂。PEEK棒杂交手术组末次随访28例患者资料完整,钛棒组27例患者资料完整。ODI评分PEEK棒杂交手术组术前平均52.5±10.6分,术后24个月降至平均14.4±3.2分,钛棒组术前平均53.2±9.9分,术后24个月平均降至14.9±2.5。重复测量方差分析两组间无统计学差异(P0.05)。PEEK棒杂交手术组22例获得MCID,钛棒组20例获得MCID。JOA评分PEEK棒杂交手术组术前15.0±2.5分,术后24个月降至23.3±0.9分,钛棒组术前15.6±2.2分,术后24个月降至23.4±1.2,两组间无统计学差异(p0.05)。PEEK棒杂交手术组1例术后发生椎弓根螺钉松动,钛棒组2例发生椎弓根螺钉松动,2年随访过程中均无临床症状。术后2年CT重建无PEEK棒断裂,CT重建PEEK棒组19例形成椎间骨性融合,钛棒组20例形成椎间骨性融合,两组间无明显差异(P=0.612)。组间和组内一致性kappa值为0.93和0.89。PEEK棒12例临近椎间盘内出现信号改变,2例由手术前Pfirrmann 3级退变至4级,10例出现椎间盘再水化现象,6例患者由Pfirrmann 4级变为3级,4例患者由Pfirrmann 3级变为2级。而钛棒组术后24个月随访时有4例由术前Pfirrmann3级退变至4级,2例由术前Pfirrmann3级退变至5级,2例由Pfirrmann4级退变至5级。PEEK棒组1例患者术后1个月时逐渐出现腰痛,症状渐加重。术后7个月就诊于我院,诊断为椎间融合器塌陷。行翻修手术,椎间植骨更换钛棒。患者术后第二天下床活动时诉腰痛明显缓解,随访两年无明显不适。结论PEEK棒非融合手术治疗腰椎退行性疾病可以降低相应节段的椎间应力,限制节段的过度活动。PEEK棒杂交手术可以降低相邻节段的椎间应力,限制异常活动。PEEK棒非融合手术治疗腰椎退行性疾病可以取得满意的治疗效果,并发症少。PEEK棒杂交手术可以取得同传统椎弓根螺钉融合手术相似的治疗效果,能够预防或改善相邻节段退变。
[Abstract]:Background with the progress of population aging, lumbar degeneration diseases such as lumbar intervertebral disc herniation, lumbar spinal stenosis, lumbar spondylolisthesis, etc. lead to low back and leg pain, such as low back and leg pain, which seriously affect people's quality of life. The fixed fusion of the segmental lesions is a classic surgical method for the treatment of these diseases. Many scholars have designed a new type of semi rigid fixation which has been widely used in recent years. Many scholars have designed a new type of semi rigid fixation which has been widely used in recent years. Many scholars have designed a new type of semi rigid fixation which has been widely used in recent years. Many scholars have designed.PEEK rods to prevent the complications of fusion surgery through non fusion surgery or to prevent the occurrence of adjacent segment degeneration through hybrid surgery. Satisfactory therapeutic effects can be achieved by combined operation, but the clinical application of PEEK rod non fusion and hybrid surgery is not yet reported. Objective to study the changes of lumbar intervertebral pressure and intervertebral activity after PEEK rod non fusion and PEEK rod hybridization, and to explore the non thawing of PEEK rods by three-dimensional finite element simulation. The clinical therapeutic effect, imaging changes and complications should be used in the treatment of lumbar vertebrae. The clinical effects, imaging changes and complications of PEEK rod hybrid surgery and traditional titanium rod surgery are further compared, and the causes and coping methods are discussed. A healthy male volunteer with no history of injury is selected and CT scan is performed. All CT image data are inputted into Mimics 13 (Materialise, Shanghai, China) software, and after selecting the appropriate CT gray value (226-2540), the function of Region Growing, and then the function of Calculate 3D, is used to reconstruct the lumbar vertebrae by the difference of pixels. In the software, the body model is generated through the point cloud stage - the polygon stage - shape phase. Based on the drawing, the internal fixed system model is built in Pro/E Wildfire 1 (PTC, the United States) software. The IGES file of the L1-S1 surface model is entered into the Ansys (Ansys, the United), which includes the following 6 models: complete Specimens, L4/5PEEK rod fixation non fusion, L4/5PEEK rod fixed fusion (intervertebral disc implantation cage), L4/5 titanium rod fixed fusion, L3-L5PEEK rod non fusion, L3-L5 hybrid fixed fusion (L4/5 intervertebral disc implantation cage). 350N on the L1 vertebral body and 40Nm simulation activity in the L1 vertebral body. From February 2012 to October, 38 patients were hospitalized with PEEK rod non fusion fixation. All patients were treated with corresponding position decompression and PEEK stick fixation. The preoperative, 1 weeks, March, June, December and 24 months (japaneseorthopaedicsas Disability Index, ODI) and the Japanese Department of orthopedics association score (japaneseorthopaedicsas) were recorded (japaneseorthopaedicsas Sociation, JOA) to evaluate the clinical effect. Through the intervertebral height index, observe the change of intervertebral height, observe whether there is screw loosening and change of intervertebral activity. At the last follow-up, three dimensional reconstruction of CT was used to observe the fracture and distortion of the peek bar. In the study of 58 cases of lumbar degenerative disease in June, September 2012, patients with surgical treatment of lumbar degenerative diseases. There were two groups, peek bar hybrid group and titanium rod PLIF group. The primary clinical evaluation index was the simplified Chinese version of ODI index. The minimum clinical validity (minimalclinicallyimportantdifference, MCID) was set to 10 points. CT reconstruction was used to evaluate the bone fusion in the intervertebral space. The standard was the formation of no intervertebral scab between the upper and lower soft bone endplates. The last follow-up was three T reconstruction was used to observe the integrity of PEEK rods. The evaluation of adjacent segments was evaluated by Pfirrmann classification on MRI. The study design was improved at least odi8 score. The pre operation standard deviation of ODI score was 9 points, class I error alpha was 0.05, class II error beta was 0.1, and the estimated 10% loss rate was estimated, and a total of 58 patients were calculated Fleiss. Calculation Fleiss was needed. Fleiss Kappa values were used to evaluate intergroup and intra group consistency. Results the established finite element model was validated. Under the given load and torque, the normal l3/4 interbody activity was 9 degrees at the flexion and extension activity and the l3/4 intervertebral activity increased to 12.5 degrees after the l4/5 titanium rod fixation. When the peek rod hybrid operation was used, the l3/4 interbody activity decreased to 2.5 degrees. The lateral flexion rotation was reduced. The activity of normal l3/4 intervertebral body was 6.7 degrees and the activity of l3/4 intervertebral body increased to 7.4 degrees after l4/5 titanium rod fixation. When peek rod hybridization was used, the intervertebral activity of l3/4 was reduced to 2.5 degrees. The normal l3/4 intervertebral activity was 6 degrees in the axial rotation, and the l3/4 intervertebral activity increased to 7.4 degrees after the l4/5 titanium rod fixation. When the peek rod hybrid operation was applied. After a given load and moment, the normal l3/4 intervertebral stress at the flexion and extension of the l3/4 was 5.3mpa, and the l3/4 intervertebral stress of the l3/4 was increased to 6.0mpa. after the l4/5 titanium rod was fixed to 6.0mpa.. When the l3/4 intervertebral stress decreased to the 2.4mpa. flexion and extension, the normal l3/4 intervertebral stress was 4.3mpa, and the l4/5 titanium rod was fixed. /4 intervertebral stress increased to 4.8mpa. when the l3/4 intervertebral stress was reduced to 2.2mpa. axial rotation after the application of PEEK rod hybridization. The normal l3/4 intervertebral stress was 4.2mpa, and the l3/4 intervertebral stress increased to 4.3mpa. after the l4/5 titanium rod was fixed to 4.3mpa.. When the peek rod hybrid operation was applied, the decrease of the l3/4 intervertebral stress to the non fusion operation was finally included in 31 cases. The average age of the patients was 56.3 years old, the proportion of men and women was 12/19, and the average follow-up was 23.8 months. Preoperative diagnosis: 11 cases of lumbar intervertebral disc herniation, 12 cases of lumbar spinal stenosis, 6 cases of lumbar instability, 2 cases of lumbar intervertebral disc protrusion with an average of 51.4 (36-70) before the operation, the average of 37.8 after the operation for 1 weeks, and the average of 15.2 after the operation in 3 months, 6 months after the operation. Average 14.4, 12 months after the operation to an average of 13.2, 24 months after the operation to average 13.0.joa score before the average 13.7 (7-19) points, 1 weeks to average 15.9 after the operation, 3 months to average 22, 6 months to average 22.2, postoperative 1 to average 23.4, postoperative average score. The difference between preoperative and postoperative ODI and JOA scores was statistically significant The mean difference (P0.05).Dhi was 0.30 (0.17-0.38) before operation, 1 weeks after operation to an average of 0.32, 3 months postoperatively, 0.31, 6 months after operation, 0.30 after operation, 0.29 in 1 years after operation, and 2 years after operation, without statistical difference (P0.05). The average annual 2 degree was 2, the average 2 years after the operation was 1.8 degrees. There was significant difference between the preoperative and postoperative changes (P0.05) the imaging findings of screw loosening were found in the 12 months follow-up of.1 cases, but no clinical symptoms were observed during the follow-up period. All patients were followed up for 24 months after the CT reconstruction, and no PEEK rod fracture.PEEK rod hybrid operation group was followed up for the last follow-up of 28 patients. Data integrity, 27 patients in the titanium bar group, 27 patients with complete PEEK score, average 52.5 + 10.6 points before operation, 24 months after operation to an average of 14.4 + 3.2 points, an average of 53.2 + 9.9 in the titanium bar group, and 24 months after the operation to 14.9 + 2.5. repeated measurements of variance analysis between the two groups (P0.05).PEEK rod hybrid operation group. In the group of MCID, 20 cases of titanium rod group were 15 + 2.5 minutes before operation in PEEK rod hybrid operation group, 23.3 + 0.9 points in 24 months after operation, 15.6 + 2.2 before operation in titanium bar group and 23.4 + 1.2 in 24 months after operation. There was no statistical difference between the 2.5 groups (P0.05). The pedicle screw loosening occurred after the operation in the.PEEK bar hybrid operation group, and the vertebral arch occurred in the titanium bar group. There were no clinical symptoms during the 2 year follow-up of root screw loosening. 2 years after operation, there was no PEEK rod fracture in CT reconstruction, 19 cases of CT reconstruction in PEEK bar group were formed intervertebral fusion, 20 cases of titanium rod group formed intervertebral fusion, and there was no significant difference between the two groups (P=0.612). The consistency of kappa value between group and group was 0.93, and 12 cases of 0.89.PEEK stick were near intervertebral disc. Change, 2 cases were changed from grade Pfirrmann 3 to grade 4 before operation, 10 cases had rehydration of intervertebral disc, 6 patients changed from Pfirrmann 4 to 3, and 4 patients changed from Pfirrmann 3 to 2. 1 patients with grade 5.PEEK stick group gradually appeared low back pain at 1 months after operation. The symptoms gradually worsened. 7 months after operation, the patients were diagnosed as intervertebral fusion cage collapse. Refurbishment operation, intervertebral bone graft replacement of titanium rods were performed. The patients complained of low back pain in second days after operation, and no obvious discomfort was observed in the follow-up for two years. Conclusion PEEK stick non fusion. Surgical treatment of degenerative lumbar disease can reduce the intervertebral stress in the corresponding segment, limiting the overactivity of the segment to reduce the intervertebral stress in the adjacent segments, and limit the abnormal activity of.PEEK rods for the treatment of lumbar degenerative disease with satisfactory results, and fewer complications of the complication of.PEEK rod hybrid surgery. In order to achieve the same therapeutic effect of the same pedicle screw fusion surgery, we can prevent or improve adjacent segment degeneration.
【学位授予单位】：第二军医大学
【学位级别】：博士
【学位授予年份】：2017
【分类号】：R687.3

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