本文選題：PEEK棒 + 非融合��； 參考：《第二軍醫(yī)大學(xué)》2017年博士論文

【摘要】：背景隨著人口老齡化的進(jìn)展,腰椎退變疾病如腰椎間盤突出癥、腰椎管狹窄癥、腰椎滑脫癥等所導(dǎo)致腰腿痛等嚴(yán)重影響人們的生活質(zhì)量。對病變節(jié)段的固定融合是治療這些疾病的經(jīng)典手術(shù)方式。但隨其應(yīng)用增多,一些融合手術(shù)的并發(fā)癥,如相鄰節(jié)段退變等的報(bào)道逐年增多。很多學(xué)者設(shè)計(jì)了通過非融合手術(shù)的方式預(yù)防融合手術(shù)的并發(fā)癥或通過雜交手術(shù)的方式預(yù)防相鄰節(jié)段退變的發(fā)生。PEEK棒是近年來應(yīng)用較為廣泛的一種新型的半剛性固定,既往文獻(xiàn)報(bào)道PEEK棒應(yīng)用于融合手術(shù)可以取得令人滿意的治療效果。但PEEK棒非融合和雜交手術(shù)于的臨床應(yīng)用尚無報(bào)道。目的通過三維有限元模擬的方式,研究PEEK棒非融合和PEEK棒雜交手術(shù)固定腰椎后,腰椎椎間壓力的變化和椎間活動(dòng)度的變化情況。探討PEEK棒非融合應(yīng)用于腰椎的臨床治療效果、影像學(xué)上的變化和并發(fā)癥的情況。進(jìn)一步對比PEEK棒雜交手術(shù)和傳統(tǒng)鈦棒手術(shù)的臨床療效、影像學(xué)改變和并發(fā)癥,并探討原因及應(yīng)對方法。方法選擇一名正常沒有傷病史的健康男性志愿者,對其進(jìn)行CT掃描,將所有CT圖像數(shù)據(jù)輸入Mimics 13.0(Materialise,Shanghai,China)軟件中,選定合適的CT灰度值(226-2540)后,通過Region Growing功能,再通過Calculate 3D功能,利用像素的不同,重建腰椎。將Mimics中輸出的STL文件導(dǎo)入到Geomagic10(Geomagic,North Carolina,the United States)軟件中,經(jīng)過點(diǎn)云階段-多邊形階段-形狀階段生成體模型。根據(jù)圖紙?jiān)赑ro/E Wildfire 1.0(PTC,the United States)軟件中建立內(nèi)固定系統(tǒng)模型,將L1-S1曲面模型的IGES文件輸入Ansys(Ansys,the United States)中,建立L1-S有限元模型。共包括以下6種模型:完整標(biāo)本,L4/5PEEK棒固定非融合,L4/5PEEK棒固定融合(椎間盤置入cage),L4/5鈦棒固定融合,L3-L5PEEK棒非融合,L3-L5雜交固定融合(L4/5椎間盤置入cage)。在L1椎體上給予350N,在L1椎體的給予40Nm模擬活動(dòng),測試L2至L5節(jié)段在各個(gè)方向活動(dòng)度上椎間壓力和節(jié)段的活動(dòng)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。所有患者行相應(yīng)部位減壓術(shù)和PEEK棒固定術(shù)。紀(jì)錄術(shù)前、術(shù)后1周、3月、6月、12月和24月的歐式功能障礙指數(shù)(Oswestry Disability Index,ODI)和日本骨科協(xié)會(huì)評分(japaneseorthopaedicsassociation,joa)來評價(jià)臨床療效。通過椎間高度指數(shù),觀察椎間高度變化情況,觀察有無螺釘松動(dòng),椎間活動(dòng)度變化情況。末次隨訪時(shí),應(yīng)用ct三維重建,觀察peek棒有無斷裂扭曲。研究2012年9月-2013年6月,58例手術(shù)治療的腰椎退行性疾病的患者。患者設(shè)兩組,peek棒雜交組,鈦棒plif組。首要臨床評價(jià)指標(biāo)為簡體中文版odi指數(shù)。最小臨床有效度(minimalclinicallyimportantdifference,mcid)設(shè)置為10分。應(yīng)用ct重建評價(jià)椎間隙是否骨性融合,標(biāo)準(zhǔn)為上下軟骨終板間有不間斷骨痂形成。末次隨訪通過三維ct重建來觀察peek棒的完整性。相鄰節(jié)段的評價(jià)采用mri上pfirrmann分級來評價(jià)。研究設(shè)計(jì)至少獲得odi8分的改善,odi評分的術(shù)前標(biāo)準(zhǔn)差估計(jì)值為9分,設(shè)置Ⅰ類錯(cuò)誤α為0.05,Ⅱ類錯(cuò)誤β為0.1,預(yù)估的10%的失訪率,計(jì)算一共需要58例患者。計(jì)算fleisskappa值來評估組間和組內(nèi)一致性。結(jié)果建立的有限元模型經(jīng)驗(yàn)證有效。在給定的負(fù)荷及力矩下,屈伸活動(dòng)時(shí)正常l3/4椎間活動(dòng)度為9°,l4/5鈦棒固定后l3/4椎間活動(dòng)度增加到12.5°。當(dāng)應(yīng)用peek棒雜交手術(shù)后,l3/4椎間活動(dòng)度減少至2.5°。側(cè)屈旋轉(zhuǎn)活動(dòng)時(shí)正常l3/4椎間活動(dòng)度為6.7°,l4/5鈦棒固定后l3/4椎間活動(dòng)度增加到7.4°。當(dāng)應(yīng)用peek棒雜交手術(shù)后,l3/4椎間活動(dòng)度減少至2.5°。軸向旋轉(zhuǎn)活動(dòng)時(shí)正常l3/4椎間活動(dòng)度為6.0°,l4/5鈦棒固定后l3/4椎間活動(dòng)度增加到7.4°。當(dāng)應(yīng)用peek棒雜交手術(shù)后,l3/4椎間活動(dòng)度減少至2.6°。在給定的負(fù)荷及力矩下,屈伸活動(dòng)時(shí)正常l3/4椎間應(yīng)力為5.3mpa,l4/5鈦棒固定后l3/4椎間應(yīng)力增加到6.0mpa。當(dāng)應(yīng)用peek棒雜交手術(shù)后,l3/4椎間應(yīng)力減少至2.4mpa。屈伸活動(dòng)時(shí)正常l3/4椎間應(yīng)力為4.3mpa,l4/5鈦棒固定后l3/4椎間應(yīng)力增加到4.8mpa。當(dāng)應(yīng)用peek棒雜交手術(shù)后,l3/4椎間應(yīng)力減少至2.2mpa。軸向旋轉(zhuǎn)活動(dòng)時(shí)正常l3/4椎間應(yīng)力為4.2mpa,l4/5鈦棒固定后l3/4椎間應(yīng)力增加到4.3mpa。當(dāng)應(yīng)用peek棒雜交手術(shù)后,l3/4椎間應(yīng)力減少至2.5mpa。非融合手術(shù)的最終納入31例患者�；颊咂骄挲g56.3歲,男女比例為12/19,平均隨訪23.8個(gè)月。術(shù)前診斷:11例腰椎間盤突出癥,12例腰椎管狹窄癥,6例腰椎不穩(wěn)癥,2例腰椎間盤突出癥術(shù)后復(fù)發(fā)。odi術(shù)前平均51.4(36-70)分,術(shù)后1周降至平均37.8,術(shù)后3個(gè)月降至平均15.2,術(shù)后6個(gè)月降至平均14.4,術(shù)后12個(gè)月降至平均13.2,術(shù)后24個(gè)月降至平均13.0。joa評分術(shù)前平均13.7(7-19)分,術(shù)后1周升至平均15.9,術(shù)后3個(gè)月升至平均22.0,術(shù)后6個(gè)月升至平均22.2,術(shù)后1年升至平均23.4,術(shù)后2年平均23.2分。術(shù)前術(shù)后odi和joa評分差異有統(tǒng)計(jì)學(xué)差異(p0.05)。dhi術(shù)前平均0.30(0.17-0.38),術(shù)后1周升至平均0.32,術(shù)后3個(gè)月平均0.31,術(shù)后6個(gè)月平均0.30,術(shù)后1年平均0.29,術(shù)后2年平均0.27,術(shù)前術(shù)后DHI變化無統(tǒng)計(jì)學(xué)差異(P0.05)。椎間活動(dòng)度術(shù)前平均8.8°,術(shù)后3個(gè)月平均2.1°,術(shù)后6個(gè)月平均2.1°,術(shù)后1年平均2.0°,術(shù)后2年平均1.8°,術(shù)前術(shù)后ROM變化有明顯統(tǒng)計(jì)學(xué)差異(P0.05)。1例患者12個(gè)月隨訪時(shí)發(fā)現(xiàn)螺釘松動(dòng)的影像學(xué)表現(xiàn),但隨訪過程中無臨床癥狀。所有患者術(shù)后24個(gè)月隨訪時(shí)CT重建均未見PEEK棒斷裂。PEEK棒雜交手術(shù)組末次隨訪28例患者資料完整,鈦棒組27例患者資料完整。ODI評分PEEK棒雜交手術(shù)組術(shù)前平均52.5±10.6分,術(shù)后24個(gè)月降至平均14.4±3.2分,鈦棒組術(shù)前平均53.2±9.9分,術(shù)后24個(gè)月平均降至14.9±2.5。重復(fù)測量方差分析兩組間無統(tǒng)計(jì)學(xué)差異(P0.05)。PEEK棒雜交手術(shù)組22例獲得MCID,鈦棒組20例獲得MCID。JOA評分PEEK棒雜交手術(shù)組術(shù)前15.0±2.5分,術(shù)后24個(gè)月降至23.3±0.9分,鈦棒組術(shù)前15.6±2.2分,術(shù)后24個(gè)月降至23.4±1.2,兩組間無統(tǒng)計(jì)學(xué)差異(p0.05)。PEEK棒雜交手術(shù)組1例術(shù)后發(fā)生椎弓根螺釘松動(dòng),鈦棒組2例發(fā)生椎弓根螺釘松動(dòng),2年隨訪過程中均無臨床癥狀。術(shù)后2年CT重建無PEEK棒斷裂,CT重建PEEK棒組19例形成椎間骨性融合,鈦棒組20例形成椎間骨性融合,兩組間無明顯差異(P=0.612)。組間和組內(nèi)一致性kappa值為0.93和0.89。PEEK棒12例臨近椎間盤內(nèi)出現(xiàn)信號(hào)改變,2例由手術(shù)前Pfirrmann 3級退變至4級,10例出現(xiàn)椎間盤再水化現(xiàn)象,6例患者由Pfirrmann 4級變?yōu)?級,4例患者由Pfirrmann 3級變?yōu)?級。而鈦棒組術(shù)后24個(gè)月隨訪時(shí)有4例由術(shù)前Pfirrmann3級退變至4級,2例由術(shù)前Pfirrmann3級退變至5級,2例由Pfirrmann4級退變至5級。PEEK棒組1例患者術(shù)后1個(gè)月時(shí)逐漸出現(xiàn)腰痛,癥狀漸加重。術(shù)后7個(gè)月就診于我院,診斷為椎間融合器塌陷。行翻修手術(shù),椎間植骨更換鈦棒�；颊咝g(shù)后第二天下床活動(dòng)時(shí)訴腰痛明顯緩解,隨訪兩年無明顯不適。結(jié)論P(yáng)EEK棒非融合手術(shù)治療腰椎退行性疾病可以降低相應(yīng)節(jié)段的椎間應(yīng)力,限制節(jié)段的過度活動(dòng)。PEEK棒雜交手術(shù)可以降低相鄰節(jié)段的椎間應(yīng)力,限制異�；顒�(dòng)。PEEK棒非融合手術(shù)治療腰椎退行性疾病可以取得滿意的治療效果,并發(fā)癥少。PEEK棒雜交手術(shù)可以取得同傳統(tǒng)椎弓根螺釘融合手術(shù)相似的治療效果,能夠預(yù)防或改善相鄰節(jié)段退變。
[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.
【學(xué)位授予單位】：第二軍醫(yī)大學(xué)
【學(xué)位級別】：博士
【學(xué)位授予年份】：2017
【分類號(hào)】：R687.3

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