齊鵬 毛克亞 肖嵩華 張西峰 張永剛 王征 王巖 崔賡
.臨床研究與實(shí)踐 Clinical research and practice.
術(shù)中三維 CT 導(dǎo)航輔助下微創(chuàng)經(jīng)椎間孔腰椎椎體間融合術(shù)的可行性研究
齊鵬毛克亞肖嵩華張西峰張永剛王征王巖崔賡
目的 通過(guò)對(duì)比術(shù)中三維 CT 導(dǎo)航輔助下微創(chuàng)經(jīng)椎間孔腰椎椎體間融合術(shù) (minimally invasive transforaminal lumbar interbody fusion with intraoperative computed tomography,iCT-MIS-TLIF)、單純微創(chuàng)經(jīng)椎間孔腰椎椎體間融合術(shù) (minimally invasive transforaminal lumbar interbody fusion,MIS-TLIF)與傳統(tǒng)開(kāi)放經(jīng)椎間孔腰椎椎體間融合術(shù) (conventional open transforaminal lumbar interbody fusion,COTLIF)治療單節(jié)段腰椎退行性疾病的臨床效果差異,探討術(shù)中三維 CT 導(dǎo)航輔助下 MIS-TLIF 的可行性。方法 2009 年 4 月至 2011 年9 月,我院收治 45 例單節(jié)段腰椎間盤(pán)突出患者,根據(jù)患者自己的治療意愿及術(shù)前資料的綜合分析,11 例采用iCT-MIS-TLIF 進(jìn)行治療,15 例采用 MIS-TLIF 進(jìn)行治療,19 例采用 COTLIF 進(jìn)行治療。比較三組患者在手術(shù)時(shí)間、術(shù)中出血量、術(shù)后引流量、術(shù)后平均住院日和術(shù)后下床時(shí)間的差異,統(tǒng)計(jì)術(shù)前、術(shù)后 3 天、1.5 個(gè)月、3 個(gè)月、6 個(gè)月、12 個(gè)月、24 個(gè)月 Oswestry 功能障礙指數(shù) (oswestry disability index,ODI),疼痛視覺(jué)模擬評(píng)分 (visual analogue scale,VAS)和 X 線評(píng)價(jià)治療效果。同時(shí),考慮到術(shù)中三維 CT 導(dǎo)航對(duì)手術(shù)時(shí)間的影響,單獨(dú)記錄了術(shù)中三維 CT 導(dǎo)航掃描、注冊(cè)等所需時(shí)間。結(jié)果 術(shù)后平均隨訪 24 個(gè)月,三組患者術(shù)前一般資料、VAS 和 ODI 評(píng)分差異無(wú)統(tǒng)計(jì)學(xué)意義。術(shù)后 45 例均未出現(xiàn)手術(shù)相關(guān)并發(fā)癥。iCT-MIS-TLIF 組手術(shù)時(shí)間顯著高于 MIS-TLIF 組和 COTLIF 組,差異有統(tǒng)計(jì)學(xué)意義 (P<0.05);iCT-MIS-TLIF 組和 MIS-TLIF 組術(shù)中平均出血量、術(shù)后平均引流量、術(shù)后平均住院日、術(shù)后下床時(shí)間差異無(wú)統(tǒng)計(jì)學(xué)意義 (P>0.05),且均明顯低于 COTLIF組 (P<0.05)。三組 VAS 和 ODI 評(píng)分的隨訪結(jié)果與術(shù)前相比均有顯著改善,但 iCT-MIS-TLIF 組和 MIS-TLIF組術(shù)后 3 天腰痛 VAS 評(píng)分、術(shù)后 1.5 個(gè)月 ODI 評(píng)分顯著低于 COTLIF 組,其余時(shí)間點(diǎn)三組之間評(píng)分差異無(wú)統(tǒng)計(jì)學(xué)意義,且 iCT-MIS-TLIF 和 MIS-TLIF 組間術(shù)后各時(shí)間點(diǎn) VAS 和 ODI 評(píng)分差異無(wú)統(tǒng)計(jì)學(xué)意義。術(shù)后 X 線評(píng)價(jià)融合率,三組差異無(wú)統(tǒng)計(jì)學(xué)意義。單獨(dú)記錄的術(shù)中三維 CT 導(dǎo)航自動(dòng)圖像注冊(cè)平均時(shí)間為 45.5 s,CT 掃描平均時(shí)間為 9 s,各患者平均進(jìn)行 3.1 次的 CT 掃描。由于術(shù)中三維 CT 導(dǎo)航導(dǎo)致的手術(shù)暫停時(shí)間平均為 5.8 min。結(jié)論 iCT-MIS-TLIF 組和 MIS-TLIF 組均可獲得和傳統(tǒng) COTLIF 組相當(dāng)?shù)闹委熜Ч?,但相較于傳統(tǒng) COTLIF組,兩組對(duì)患者的損傷程度更小,且術(shù)后短期腰背痛程度較低。iCT-MIS-TLIF 和 MIS-TLIF 組間相關(guān)指標(biāo)差異無(wú)統(tǒng)計(jì)學(xué)意義,雖然術(shù)中三維 CT 導(dǎo)航會(huì)增加患者的放射線暴露劑量,但在解剖結(jié)構(gòu)復(fù)雜的患者中,術(shù)中三維 CT 導(dǎo)航的輔助顯示出其實(shí)時(shí)性與精確性的特點(diǎn),有利于螺釘?shù)陌踩萌搿?/p>
體層攝影術(shù),X 線計(jì)算機(jī);外科手術(shù),計(jì)算機(jī)輔助;腰椎;椎間盤(pán)移位;外科手術(shù),微創(chuàng)性
雖然傳統(tǒng)的腰椎開(kāi)放融合手術(shù)目前仍廣泛應(yīng)用于腰椎退行性疾病的手術(shù)治療中[1-3],但隨著越來(lái)越多的醫(yī)療工作者開(kāi)始重視減少醫(yī)源性肌肉和軟組織的損傷[4],各種微創(chuàng)術(shù)式隨之逐步應(yīng)用于臨床,其中微創(chuàng)經(jīng)椎間孔腰椎椎體間融合術(shù) (minimally invasive transforaminal lumbar interbody fusion,MIS-TLIF)因其減少了肌肉等軟組織的剝離和牽拉,減少了術(shù)中及術(shù)后出血量,有利于患者早期康復(fù)等優(yōu)勢(shì),獲得了很多醫(yī)療工作者的青睞[5-6]。但是 MIS-TLIF 也存在著醫(yī)務(wù)人員的放射線暴露及學(xué)習(xí)曲線長(zhǎng)的缺點(diǎn)[7],同時(shí),由于解剖標(biāo)志不能得到充分暴露,從而會(huì)造成定位的障礙[8]。隨著科技的進(jìn)步,導(dǎo)航系統(tǒng)的應(yīng)用可以對(duì)應(yīng)性地解決這些問(wèn)題[9]。利用計(jì)算機(jī)導(dǎo)航的優(yōu)勢(shì),可以在降低學(xué)習(xí)曲線和再手術(shù)率的同時(shí),減少術(shù)者及手術(shù)室工作人員的放射線暴露,并且能夠提高置釘?shù)臏?zhǔn)確率和安全性[9-20]。但與此同時(shí),術(shù)中 CT (intraoperative computed tomography,iCT)導(dǎo)航對(duì)于患者的高放射劑量的暴露,導(dǎo)致對(duì) iCT 導(dǎo)航應(yīng)用的爭(zhēng)議[11-14,17-18]。對(duì) 2009 年 4 月至 2011 年 9 月,我科收治的 45 例單節(jié)段腰椎間盤(pán)突出癥 (lumbar disc herniatio,LDH)患者的相關(guān)指標(biāo)的初步對(duì)比分析,探討術(shù)中三維 CT導(dǎo)航輔助下 MIS-TLIF 的可行性。
一、入選與排除標(biāo)準(zhǔn)
1. 入選標(biāo)準(zhǔn):(1)癥狀表現(xiàn)為嚴(yán)重的腰腿痛和間歇性跛行;(2)經(jīng)過(guò)嚴(yán)格保守治療 3 個(gè)月無(wú)效;(3)影像學(xué)表現(xiàn)為單節(jié)段腰椎管狹窄、腰椎間盤(pán)突出。
2. 排除標(biāo)準(zhǔn):(1)多節(jié)段腰椎椎管狹窄;(2)腰部手術(shù)、骨折、腫瘤、感染等病史;(3)腰椎滑脫和峽部裂。
二、一般資料
共 45 例納入本研究。根據(jù)患者自己的治療意愿及術(shù)前資料的綜合分析,11 例采用術(shù)中三維 CT導(dǎo)航下微創(chuàng)經(jīng)椎間孔腰椎椎體間融合術(shù) (minimally invasive transforaminal lumbar interbody fusion with intraoperative computed tomography,iCT-MIS-TLIF)進(jìn)行治療,15 例采用單純 MIS-TLIF 進(jìn)行治療,19 例采用傳統(tǒng)開(kāi)放經(jīng)椎間孔腰椎椎體間融合術(shù)(conventional open transforaminal lumbar interbody fusion,COTLIF)進(jìn)行治療。其中 iCT-MIS-TLIF 組中的 1 例被診斷為 L5~S1腰椎間盤(pán)突出癥并伴有先天性 L5半椎體。本組患者均以神經(jīng)根性疼痛為主訴,表現(xiàn)為典型的神經(jīng)根癥狀和不同程度的下腰部疼痛,經(jīng)規(guī)范保守治療 3~6 個(gè)月無(wú)效。影像學(xué)表現(xiàn)為單節(jié)段腰椎間盤(pán)嚴(yán)重退變合并單側(cè)突出,與癥狀體征對(duì)應(yīng),手術(shù)適應(yīng)證明確。手術(shù)均由同一組高年資醫(yī)師完成,所有患者均對(duì)手術(shù)方案無(wú)異議且均簽訂了手術(shù)知情同意書(shū)。三組患者術(shù)前資料均經(jīng)過(guò)平衡性檢查,組間差異無(wú)統(tǒng)計(jì)學(xué)意義 (P>0.05)。患者的術(shù)前統(tǒng)計(jì)數(shù)據(jù)見(jiàn)表1。
表1 三組患者術(shù)前資料Tab.1 Summary of patients' demographic data
三、iCT 導(dǎo)航系統(tǒng)
在預(yù)制安裝有一臺(tái) 82 cm 大孔徑滑動(dòng)式 40-層CT 掃描機(jī) (Somatom Sensation Open Sliding Gantry;Siemens Medical Solutions,F(xiàn)orchheim,Germany)的手術(shù)室內(nèi),將 CT 與紅外線無(wú)線導(dǎo)航系統(tǒng) (Vector Vision Sky;BrainLab)連接,并將 CT 掃描獲得的影像數(shù)據(jù)轉(zhuǎn)化為三維圖像并傳給導(dǎo)航系統(tǒng),而且,在手術(shù)中可以隨時(shí)根據(jù)手術(shù)情況進(jìn)行 CT 掃描并更新導(dǎo)航信息。
四、手術(shù)方法
1. iCT-MIS-TLIF 組手術(shù)方法:患者全麻后俯臥于透 X 線的手術(shù)臺(tái)上,安裝參考架于髂后上棘后進(jìn)行 CT 掃描 (圖1a)。CT 圖像掃描結(jié)果輸入圖像導(dǎo)航工作站,自動(dòng)注冊(cè)前,麻醉呼吸機(jī)可以暫停 10~20 s 以減少呼吸運(yùn)動(dòng)對(duì)導(dǎo)航精度的影響[17-18]。CT 掃描期間,術(shù)者、助手及麻醉師可以在防護(hù)區(qū)直接觀察到患者的情況,掃描過(guò)程中,所有醫(yī)務(wù)工作者均不暴露于射線下。自動(dòng)注冊(cè)后,通過(guò)體表骨性標(biāo)志和參考架進(jìn)行雙重的精度檢查是非常重要的。術(shù)中如果導(dǎo)航的精準(zhǔn)度不夠或術(shù)者懷疑導(dǎo)航精準(zhǔn)度不夠,有必要再次進(jìn)行 CT 掃描及注冊(cè),直至導(dǎo)航足夠精確為止。雖然出現(xiàn)這樣情況的可能性很小,但仍須慎重對(duì)待。本組僅 1 例因參考架松動(dòng)需要額外的 CT 掃描和注冊(cè)。確定責(zé)任間隙的上下椎弓根入口點(diǎn) (圖1b),先于健側(cè)作切口,切口擴(kuò)大至 1.5 cm,使用克氏針置入上下椎弓根,通過(guò)克氏針進(jìn)行椎弓根的鉆孔和攻絲,留置備用。以上所有的步驟皆在導(dǎo)航下完成。在導(dǎo)航引導(dǎo)下于病變側(cè)上下椎弓根處置入 2 根克氏針,沿 2 針連線切一長(zhǎng)約 3 cm 的切口,然后使用擴(kuò)張通道管系統(tǒng) (X-tube)逐級(jí)擴(kuò)大,在 X-tube 通道內(nèi)進(jìn)行椎板、關(guān)節(jié)突以及椎間隙的處理,充分減壓后,將適當(dāng)大小裝有自體骨的 Cage 置入椎間隙,敲擊至適當(dāng)位置,然后置入雙側(cè)螺釘與鈦棒,通過(guò) iCT 掃描判定螺釘和 Cage 置入的準(zhǔn)確性以及減壓是否充分,所有的螺釘都經(jīng)過(guò) 3 名高年資脊柱外科醫(yī)師評(píng)定,以破壁 2 mm 以內(nèi)為標(biāo)準(zhǔn)[14,20]進(jìn)行評(píng)價(jià),全部合格后行加壓固定,放置引流管,關(guān)閉傷口。
圖1 術(shù)中 CT 導(dǎo)航系統(tǒng)的手術(shù)過(guò)程 a:切口前術(shù)中 CT 掃描顯示腰椎輪廓,參考架連接到髂后上棘;b~e:在 CT 圖像引導(dǎo)下確定病變間隙;f~g:1 例患者術(shù)前被診斷先天性腰椎畸形,使用 1 枚骶骨翼螺釘代替 S1 椎弓根螺釘在導(dǎo)航下置入,腰椎術(shù)后 X線片顯示所有螺釘與椎間融合器位置準(zhǔn)確Fig.1 Surgical procedures during iCT navigation system a: The iCT image before incision showed the general lumbar outline. A percutaneous reference array was attached to the posterosuperior iliac spine; b-e:Under iCT image guidance, to determine the lesions'segment; f-g: One patient was diagnosed congenital lumbar deformity (right hemivertebrae between L5 and S1). As a result, a sacrum ala screw was inserted instead of S1 pedicle screw under navigator guidance. Lumbar postoperative X-ray showed the accurate placement of all screws and interbody fusion cage
2. MIS-TLIF 組手術(shù)方法:患者全麻后取俯臥位,于后正中線旁開(kāi) 3.0~4.0 cm,以病變間隙為中點(diǎn)縱長(zhǎng)約 4 cm 處插入 2 枚克氏針,C 型臂輔助透視確定手術(shù)節(jié)段,確認(rèn)克氏針正位像上位于椎弓根中心連線,側(cè)位像上位于椎弓根延長(zhǎng)線后,切開(kāi)皮膚及筋膜,擴(kuò)張管逐級(jí)擴(kuò)張,最后置入 X-tube 工作套管,采用撐開(kāi)鉗縱向撐開(kāi),然后清理局部殘留軟組織,顯露出椎板外緣和上下關(guān)節(jié)突關(guān)節(jié)。透視確定椎弓根螺釘置入位置,釘?shù)拦ソz后骨蠟封堵備用。首先于一側(cè)切除部分椎板、關(guān)節(jié)突內(nèi)側(cè)緣及黃韌帶,徹底減壓后,置入椎弓根螺釘及鈦棒,適度撐開(kāi)后臨時(shí)固定。于對(duì)側(cè)顯露椎間盤(pán)然后切開(kāi)纖維環(huán),使用合適大小絞刀清除椎間盤(pán)組織,徹底清理椎間盤(pán)及軟骨終板,充分沖洗椎間隙,植入切除的局部自體骨骨粒及 1 枚合適高度 Cage,檢查神經(jīng)根受壓情況,進(jìn)一步止血,同法處理另外一側(cè),雙側(cè)鈦棒加壓固定,C 型臂透視確認(rèn)內(nèi)固定位置良好,探查無(wú)活動(dòng)性出血,拆除工作通道,置引流管后逐層縫合切口。
3. COTILF 組手術(shù)方法:患者全麻后俯臥于手術(shù)臺(tái)上,根據(jù)髂棘與手術(shù)節(jié)段的相鄰關(guān)系,于腰部后正中畫(huà)一長(zhǎng)約 6~8 cm 的垂線。此線僅作參考,不影響手術(shù)過(guò)程。取后正中切口,依次切開(kāi)皮膚、皮下組織及腰背筋膜,沿棘突兩側(cè)剝離椎旁肌肉,直到上下關(guān)節(jié)突關(guān)節(jié)外側(cè),透視定位后于節(jié)段兩側(cè)共置入 4 枚椎弓根螺釘,健側(cè)適當(dāng)撐開(kāi)后上鈦棒以臨時(shí)固定。切除患側(cè)間隙下關(guān)節(jié)突、部分椎板、上關(guān)節(jié)突內(nèi)側(cè)緣和黃韌帶以求徹底減壓,清除患側(cè)椎間盤(pán)和上下軟骨終板。將自體骨修剪成粒植入椎間隙內(nèi),選擇合適椎間融合器植骨后放入椎間隙內(nèi),雙側(cè)上鈦棒并加壓固定,安裝橫連,透視見(jiàn)內(nèi)固定位置良好后放置引流管并關(guān)閉傷口。
五、術(shù)前、術(shù)后處理
三組術(shù)前準(zhǔn)備均一致,根據(jù)手術(shù)需要,術(shù)后均常規(guī)預(yù)防性應(yīng)用抗生素,同等劑量非甾體藥物減少術(shù)后疼痛,采用閉式被動(dòng)引流,術(shù)后 24 h 引流量<50 ml 時(shí)拔出引流管。術(shù)后所有患者均須在腰圍保護(hù)下下床活動(dòng),所有患者須佩戴腰圍 3 個(gè)月并定期隨訪。
六、研究?jī)?nèi)容
比較三組患者在手術(shù)時(shí)間、術(shù)中出血量、術(shù)后引流量、術(shù)后平均住院日和術(shù)后下床時(shí)間的差異,并分別在術(shù)前、術(shù)后 (3 天、1.5、3、6、12、24 個(gè)月)采用 Oswestry 功能障礙指數(shù) (oswestry disability index,ODI),疼痛視覺(jué)模擬評(píng)分 (visual analogue scale,VAS),根據(jù) Bridwell 的方法評(píng)價(jià)腰椎融合分級(jí),I 級(jí):完全融合并伴有骨小梁重建;II 級(jí):融合間隙無(wú)變化,未完全重建但無(wú)透明帶出現(xiàn);III 級(jí):融合間隙無(wú)變化,但出現(xiàn)透明帶;IV 級(jí):沒(méi)有融合,伴有椎間隙塌陷和吸收。同時(shí),單獨(dú)記錄術(shù)中三維 CT 導(dǎo)航掃描、注冊(cè)等所需時(shí)間。
七、統(tǒng)計(jì)學(xué)分析
采用 SPSS 12.0 軟件進(jìn)行統(tǒng)計(jì)學(xué)處理,計(jì)量資料中正態(tài)分布者采用±s 表示,非正態(tài)分布者采用中位數(shù)表示。組間均值比較采用單因素方差分析,分組資料的評(píng)價(jià)以及融合等級(jí)的評(píng)價(jià)采用秩和檢驗(yàn),P<0.05 為差異有統(tǒng)計(jì)學(xué)意義。
iCT-MIS-TLIF 組 11 例共置入 43 枚椎弓根螺釘、1 枚骶骨翼螺釘和 11 枚 Cage;MIS-TLIF 組15 例共置入 60 枚椎弓根螺釘和 15 枚 Cage;COTLIF組 19 例共置入 76 枚椎弓根螺釘和 19 枚 Cage。關(guān)閉傷口前及術(shù)后拔管后的 X 線片均顯示所有螺釘和Cage 的位置良好,所有患者的神經(jīng)根減壓均良好,術(shù)后均未出現(xiàn)手術(shù)相關(guān)并發(fā)癥。45 例疼痛癥狀均較術(shù)前有所改善,iCT-MIS-TLIF 組手術(shù)時(shí)間顯著高于MIS-TLIF 組和 COTLIF 組,差異有統(tǒng)計(jì)學(xué)意義 (P<0.05);iCT-MIS-TLIF 組和 MIS-TLIF 組術(shù)中平均出血量、術(shù)后平均引流量、術(shù)后平均住院日、術(shù)后下床時(shí)間差異無(wú)統(tǒng)計(jì)學(xué)意義 (P>0.05),且均明顯低于COTLIF 組,差異有統(tǒng)計(jì)學(xué)意義 (P<0.05)(表2)。三組 VAS 和 ODI 評(píng)分的隨訪結(jié)果與術(shù)前相比均有顯著改善,但 iCT-MIS-TLIF 和 MIS-TLIF 組術(shù)后3 天腰痛 VAS 評(píng)分、術(shù)后 1.5 個(gè)月 ODI 評(píng)分顯著低于 COTLIF 組,其余時(shí)間點(diǎn)三組之間評(píng)分差異無(wú)統(tǒng)計(jì)學(xué)意義,且 iCT-MIS-TLIF 組和 MIS-TLIF 組之間術(shù)后各時(shí)間點(diǎn) VAS 和 ODI 評(píng)分差異均無(wú)統(tǒng)計(jì)學(xué)意義 (表3~5)。由于術(shù)中三維 CT 導(dǎo)航導(dǎo)致的手術(shù)暫停時(shí)間平均為 5.8 min。iCT-MIS-TLIF 組中 1 例由于右側(cè) S1椎弓根先天異常導(dǎo)致椎弓根螺釘不能置入,采用了 1 枚骶骨翼螺釘替代并于導(dǎo)航下置入(圖1c)。三組術(shù)后 CT 圖像均顯示所有螺釘和 Cage放置良好,神經(jīng)根減壓充分。因 CT 掃描與導(dǎo)航所導(dǎo)致 iCT-MIS-TLIF 組術(shù)中手術(shù)暫停時(shí)間平均為5.8 min,其中每次 CT 掃描平均時(shí)間為 9.0 s,CT 導(dǎo)航自動(dòng)注冊(cè)平均時(shí)間為 45.5 s。術(shù)后長(zhǎng)期隨訪 X 線片顯示三組在融合率方面差異無(wú)統(tǒng)計(jì)學(xué)意義,均獲得穩(wěn)定的融合 (表6、7)。
表2 三組圍手術(shù)期各項(xiàng)指標(biāo)比較Tab.2 Patient clinical outcome data
表3 三組不同隨訪時(shí)間腰痛 VAS 評(píng)分比較 (±s)Tab.3 VAS scores (low back)(±s)
表3 三組不同隨訪時(shí)間腰痛 VAS 評(píng)分比較 (±s)Tab.3 VAS scores (low back)(±s)
注:a與 COTILF 組比較,差異有統(tǒng)計(jì)學(xué)意義 (P < 0.05)Notice: Compare with COTILF,aP<0.05
組別術(shù)后 3 天術(shù)后 6 周術(shù)后 3 個(gè)月術(shù)后 6 個(gè)月術(shù)后 1 年術(shù)后 2 年iCT-MIS-TLIF 組 4.2±3.1a3.2±1.8a2.3±1.81.6±1.21.0±0.71.1±0.3 MIS-TILF 組 4.4±3.0a3.5±2.1 2.0±1.6a1.6±1.21.2±0.81.0±0.4 COTLIF 組6.9±3.73.8±2.32.6±1.71.8±1.11.2±0.91.3±0.3
表4 三組不同隨訪時(shí)間腿痛 VAS 評(píng)分比較 (±s)Tab.4 VAS scores (leg)(±s)
表4 三組不同隨訪時(shí)間腿痛 VAS 評(píng)分比較 (±s)Tab.4 VAS scores (leg)(±s)
組別術(shù)后 3 天術(shù)后 6 周術(shù)后 3 個(gè)月術(shù)后 6 個(gè)月術(shù)后 1 年術(shù)后 2 年iCT-MIS-TLIF 組2.8±3.11.9±1.41.5±1.01.2±0.80.2±0.10.2±0.1 MIS-TILF 組3.0±2.72.1±1.61.5±1.11.1±0.90.2±0.10.2±0.1 COTLIF 組3.2±3.02.2±1.41.7±1.11.4±0.70.3±0.10.2±0.1
表5 三組不同隨訪時(shí)間 ODI 評(píng)分比較 (±s)Tab.5 ODI scores (±s)
表5 三組不同隨訪時(shí)間 ODI 評(píng)分比較 (±s)Tab.5 ODI scores (±s)
注:a與 COTILF 組比較,差異有統(tǒng)計(jì)學(xué)意義 (P < 0.05)Notice: Compare with COTILF,aP<0.05
組別術(shù)后 6 周術(shù)后 3 個(gè)月術(shù)后 6 個(gè)月術(shù)后 1 年術(shù)后 2 年iCT-MIS-TLIF 組 25.00±3.37a21.00±4.1316.00±2.7914.00±3.0215.00±2.54 MIS-TILF 組 27.00±3.12a21.00±3.8718.00±4.0715.00±2.5414.00±2.31 COTLIF 組35.00±5.8823.00±3.9218.00±3.2616.00±2.6816.00±2.17
表6 三組 X 線評(píng)價(jià)融合等級(jí)情況 (例)Tab.6 Fusion level by X-ray (case)
表7 iCT 掃描數(shù)據(jù)Tab.7 iCT scanning data
雖然目前傳統(tǒng)的經(jīng)后入路椎弓根釘固定腰椎椎間融合術(shù)可以很好地治療腰椎退行性疾病,并且可以提供脊柱全方位的穩(wěn)定性[21-22]。但是隨著患者對(duì)術(shù)后效果要求的提高及醫(yī)療工作者對(duì)減少醫(yī)源性肌肉和軟組織損傷的重視[4],人們開(kāi)始重新審視傳統(tǒng)的手術(shù)方式,傳統(tǒng)開(kāi)放 TLIF 由于其大范圍地剝離椎旁肌肉和軟組織并向外側(cè)極度牽拉,導(dǎo)致患者術(shù)中及術(shù)后出血較多,且術(shù)后可能殘留頑固性腰背疼痛[4],使其臨床療效不能滿足于醫(yī)療工作者及患者的需求,隨著 X-tube 的應(yīng)用及 MIS-TLIF 的發(fā)明,更多的醫(yī)師開(kāi)始關(guān)注這一微創(chuàng)術(shù)式,并對(duì)其療效及相關(guān)并發(fā)癥展開(kāi)了研究[23],越來(lái)越多的研究表明,MIS-TLIF 在手術(shù)創(chuàng)傷較小、術(shù)后恢復(fù)較快的基礎(chǔ)上,可以獲得和傳統(tǒng) TLIF 相當(dāng)?shù)寞熜В?4-25]。
然而,隨著腰椎融合術(shù)中微創(chuàng)術(shù)式應(yīng)用普遍開(kāi)展[26-27],其缺點(diǎn)也逐漸顯露出來(lái),對(duì)醫(yī)務(wù)人員的放射性暴露和陡峭的學(xué)習(xí)曲線[8],使其推廣受限,特別是由于缺少明顯的解剖學(xué)暴露,其定位相對(duì)開(kāi)放手術(shù)較為困難,一旦術(shù)中發(fā)生并發(fā)癥,因操作空間狹小,處理起來(lái)相當(dāng)困難[28]。隨著科技的進(jìn)展,導(dǎo)航系統(tǒng)的應(yīng)用降低了這一術(shù)式應(yīng)用的限制,在有效減少醫(yī)務(wù)人員放射線暴露的同時(shí)提高了螺釘置入準(zhǔn)確率[12-14,16,20],而且與傳統(tǒng)開(kāi)放手術(shù)置釘和微創(chuàng)置釘相比,它還可以減少因螺釘錯(cuò)置所帶來(lái)的相關(guān)并發(fā)癥且不增加手術(shù)時(shí)間和改變手術(shù)步驟 [9,17-18,29-32]。
通過(guò)對(duì)各種導(dǎo)航系統(tǒng)的對(duì)比研究,Cui 等[33]認(rèn)為 iCT 導(dǎo)航在注冊(cè)時(shí)間、數(shù)據(jù)獲取時(shí)間、影像質(zhì)量等方面均占優(yōu),在提高螺釘置入準(zhǔn)確率方面明顯占優(yōu)。通過(guò) iCT 可以達(dá)到非常高的導(dǎo)航準(zhǔn)確度與可視化的引導(dǎo),而且 CT 圖像不會(huì)被器械影響[12-14,17-18]。Haberland 等[11]通過(guò) iCT 導(dǎo)航得到了 35 例 161 個(gè)椎弓根釘置入零失誤的結(jié)論。本組 11 例 (43 枚椎弓根螺釘和 1 枚骶骨翼螺釘)均 1 次準(zhǔn)確置入,證明 iCT導(dǎo)航系統(tǒng)在 MIS-TLIF 的可行性與安全性。
雖然 iCT 對(duì)于患者的放射線暴露問(wèn)題頗受爭(zhēng)議,但研究證明患者的有效暴露劑量是可以接受的[32]。本研究中,iCT-MIS-TLIF 組患者的平均 CT 掃描次數(shù)是 3.1 次,姜廷華等[34]的研究顯示,患者掃描3.1 次 CT 的放射線暴露劑量約為 43.5 mGy,相比于 MIS-TLIF 組患者平均放射線暴露劑量 7.3 mGy,COTLIF 組患者平均放射線暴露劑量 3.8 mGy,差異有統(tǒng)計(jì)學(xué)意義 (P<0.05),但 iCT-MIS-TLIF 組完全避免了 MIS-TLIF 中醫(yī)務(wù)人員的放射線暴露問(wèn)題,而且由于省略了術(shù)前的 CT 掃描和術(shù)后確定螺釘置入準(zhǔn)確性的 CT 掃描,其實(shí)際患者放射線暴露劑量并沒(méi)有數(shù)據(jù)上所顯示得那樣突出。iCT-MIS-TLIF 組所有患者術(shù)后腰腿痛均得到不同程度緩解,且遠(yuǎn)期 X 線融合率評(píng)價(jià)與另外兩組差異并無(wú)統(tǒng)計(jì)學(xué)意義。故可以認(rèn)為在 iCT 系統(tǒng)導(dǎo)航輔助下 MIS-TLIF 可以獲得神經(jīng)根減壓的良好效果,同時(shí)達(dá)到傳統(tǒng)開(kāi)放手術(shù)的目標(biāo)。本研究還發(fā)現(xiàn),對(duì)于解剖結(jié)構(gòu)復(fù)雜的患者,術(shù)中三維 CT 導(dǎo)航的輔助可以明顯提高 MIS-TLIF 的置釘準(zhǔn)確率和安全性,降低了因置釘失誤所造成的翻修和相關(guān)并發(fā)癥發(fā)生的可能,同時(shí),減少了切口深部肌肉和軟組織的剝離,避免形成微創(chuàng)手術(shù)切口所造成的口小底大“火山口”樣結(jié)構(gòu)[28],可能有助于減少相關(guān)并發(fā)癥的發(fā)生。
作為回顧性研究,本研究中還存在一些局限性。首先,由于患者病情及個(gè)體的差異性,不能?chē)?yán)格地對(duì)納入病例進(jìn)行手術(shù)方案的隨機(jī)分組;其次,iCT 導(dǎo)航系統(tǒng)的花費(fèi)并未列入觀察范圍內(nèi),忽略了社會(huì)成本對(duì)于患者術(shù)后滿意度的影響。同時(shí),樣本量的不足可能會(huì)造成結(jié)果出現(xiàn)偏倚,因此還需要嚴(yán)格設(shè)計(jì)的前瞻性隨機(jī)大樣本研究來(lái)獲得更為可靠的結(jié)論。
總之,術(shù)中三維 CT 導(dǎo)航系統(tǒng)為 MIS-TLIF 提供了一種更為可靠的輔助手段。本研究初步表明了 iCT導(dǎo)航系統(tǒng)的應(yīng)用是可行的且相對(duì)成熟的,其療效與單純 MIS-TLIF 和傳統(tǒng)開(kāi)放 TLIF 基本相當(dāng),但在解剖結(jié)構(gòu)復(fù)雜的患者中,術(shù)中三維 CT 導(dǎo)航的輔助顯示出其實(shí)時(shí)性與精確性的特點(diǎn),有利于螺釘?shù)陌踩萌搿?/p>
[1]Madan SS, Boeree NR. Comparison of instrumented anterior interbody fusion with instrumented circumferential lumbar fusion. Eur Spine J, 2003, 12(6):567-575.
[2]Kim JS, Kim DH, Lee SH, et al. Comparison study of the instrumented circumferential fusion with instrumented anterior lumbar interbody fusion as a surgical procedure for adult lowgrade isthmic spondylolisthesis. World Neurosurg, 2010,73(5):565-571.
[3]Mayer HM. Discogenic low back pain and degenerative lumbar spinal stenosis - how appropriate is surgical treatment?Schmerz, 2001, 15(6):484-491.
[4]Fan S, Hu Z, Zhao F, et al. Multifidus muscle changes and clinical effects of one-level posterior lumbar interbody fusion:minimally invasive procedure versus conventional open approach. Eur Spine J, 19(2):316-324.
[5]陳博來(lái), 林定坤, 毛克亞, 等. 腰椎后路微創(chuàng)TLIF和開(kāi)放PLIF兩種術(shù)式臨床短期效果報(bào)告. 脊柱外科雜志, 2009, 7(4):226-229.
[6]周亮, 劉鄭生, 毛克亞, 等. MIS-TLIF與PLIF治療單節(jié)段退行性腰椎疾病的療效比較. 解放軍醫(yī)學(xué)院學(xué)報(bào), 2013, 34(12):1221-1224.
[7]Mariscalco MW, Yamashita T, Steinmetz MP, et al. Radiation exposure to the surgeon during open lumbar microdiscectomy and minimally invasive microdiscectomy: a prospective,controlled trial. Spine, 36(3):255-260.
[8]Schwender JD, Holly LT, Rouben DP, et al. Minimally invasive transforaminal lumbar interbody fusion (TLIF): technical feasibility and initial results. J Spinal Disord Tech, 2005,(18 Suppl):S1-6.
[9]Acosta FL Jr, Thompson TL, Campbell S, et al. Use of intraoperative isocentric C-arm 3D fluoroscopy for sextant percutaneous pedicle screw placement: case report and review of the literature. Spine J, 2005, 5(3):339-343.
[10]Kotani Y, Abumi K, Ito M, et al. Accuracy analysis of pediclescrew placement in posterior scoliosis surgery: comparison between conventional fluoroscopic and computer-assisted technique. Spine, 2007, 32(14):1543-1550.
[11]Haberland N, Ebmeier K, Grunewald JP, et al. Incorporation of intraoperative computerized tomography in a newly developed spinal navigation technique. Comput Aided Surg, 2000,5(1):18-27.
[12]Tormenti MJ, Kostov DB, Gardner PA, et al. Intraoperative computed tomography image-guided navigation for posterior thoracolumbar spinal instrumentation in spinal deformity surgery. Neurosurg Focus, 28(3):E11.
[13]Uhl E, Zausinger S, Morhard D, et al. Intraoperative computed tomography with integrated navigation system in a multidisciplinary operating suite. Neurosurgery, 2009,64(5 Suppl 2):231-240.
[14]Zausinger S, Scheder B, Uhl E, et al. Intraoperative computed tomography with integrated navigation system in spinal stabilizations. Spine, 2009, 34(26):2919-2926.
[15]Holly LT, Foley KT. Intraoperative spinal navigation. Spine,2003, 28(Suppl 15):S54-61.
[16]Turgut M, Oktem G, Uslu S, et al. The effect of exogenous melatonin administration on trabecular width, ligament thickness and TGF-beta (1) expression in degenerated intervertebral disk tissue in the rat. J Clin Neurosci, 2006,13(3):357-363.
[17]Scheufler KM, Cyron D, Dohmen H, et al. Less invasive surgical correction of adult degenerative scoliosis, part I:Technique and radiographic results. Neurosurgery, 2010,67(3):696-710.
[18]Scheufler KM, Cyron D, Dohmen H, et al. Less invasive surgical correction of adult degenerative scoliosis. Part II:Complications and clinical outcome. Neurosurgery, 2010,67(6):1609-1621.
[19]Tian NF, Huang QS, Zhou P, et al. Pedicle screw insertion accuracy with different assisted methods: a systematic review and meta-analysis of comparative studies. Eur Spine J, 2011,20(6):846-859.
[20]Rajasekaran S, Vidyadhara S, Ramesh P, et al. Randomized clinical study to compare the accuracy of navigated and nonnavigated thoracic pedicle screws in deformity correction surgeries. Spine, 2007, 32(2):E56-64.
[21]Oxland TR, Lund T. Biomechanics of stand-alone cages and cages in combination with posterior fxation: a literature review. Eur Spine J, 2000, 9(Suppl 1):S95-101.
[22]Huang KF, Chen TY. Clinical results of a single central interbody fusion cage and transpedicle screws fixation for recurrent herniated lumbar disc and low-grade spondylolisthesis. Chang Gung Med J, 2003, 26(3):170-177.
[23]肖波, 毛克亞, 王巖, 等. 微創(chuàng)經(jīng)椎間孔腰椎椎體間融合術(shù)與傳統(tǒng)后路腰椎椎體間融合術(shù)并發(fā)癥的比較分析. 脊柱外科雜志, 2013, 11(1):23-27.
[24]陳育岳, 隋文淵, 石林, 等. X-tube通道下經(jīng)椎間孔入路腰椎椎間融合內(nèi)固定治療單節(jié)段腰椎間盤(pán)突出癥. 實(shí)用醫(yī)學(xué)雜志, 2011, 27(22):4103-4105.
[25]Shunwu F, Xing Z, Fengdong Z, et al. Minimally invasive transforaminal lumbar interbody fusion for the treatment of degeneative lumbar diseases. Spine, 2010, 35(17):161-1620.
[26]Eck JC, Hodges S, Humphreys SC. Minimally invasive lumbar spinal fusion. J Am Acad Orthop Surg, 2007, 15(6):321-329.
[27]Starkweather AR, Witek-Janusek L, Nockels RP, et al. The multiple benefts of minimally invasive spinal surgery: results comparing transforaminal lumbar interbody fusion and posterior lumbar fusion. J Neurosci Nurs, 2008, 40(1):32-39.
[28]蘇鍇, 郭營(yíng), 金大地, 等. 微創(chuàng)與開(kāi)放經(jīng)椎間孔腰椎椎間融合術(shù)對(duì)比研究進(jìn)展. 中國(guó)修復(fù)與重建雜志, 2013, 27(11):1386-1389.
[29]von Jako R, Finn MA, Yonemura KS, et al. Minimally invasive percutaneous transpedicular screw fxation: increased accuracy and reduced radiation exposure by means of a novel electromagnetic navigation system. Acta Neurochir, 2011,153(3):589-596.
[30]Arand M, Teller S, Gebhard F, et al. Clinical accuracy of fluoroscopic navigation at the thoracic and lumbar spine. Z Orthop Unfall, 2008, 146(4):458-462.
[31]Bai YS, Zhang Y, Chen ZQ, et al. Learning curve of computerassisted navigation system in spine surgery. Chin Med J, 2010,123(21):2989-2994.
[32]Francesco C, Andrea C, Ortolina A, et al. Spinal navigation:standard pre-operative versus intra-operative computed tomography data set acquisition for computer-guidance system. Radiological and clinical study in 100 consecutive patients. Spine, 2011, 36(24):2094-2098.
[33]Cui G, Wang Y, Kao TH, et al. Application of intraoperative computed tomography with or without navigation system in surgical correction of spinal deformity: a preliminary result of 59 consecutive human cases. Spine, 2012, 37(10):891-900.
[34]姜廷華, 路偉, 崔賡, 等. 手術(shù)室C形臂裝置劑量率水平調(diào)查及個(gè)人防護(hù)建議. 中國(guó)輻射衛(wèi)生雜志, 2014, 23(1):78-80.
(本文編輯:王萌)
Clinical feasibility of minimally invasive transforaminal lumbar interbody fusion with intraoperative computedtomography-guided navigation system
QI Peng, MAO Ke-ya, XIAO Song-hua, ZHANG Xi-feng, ZHANG Yong-gang,WANG Zheng, WANG Yan, CUI Geng. Institute of Orthopedics, General Hospital of PLA, Beijing, 100853, PRC
CUI Geng, Email: cuigeng@aliyun.com
ObjectiveTo compare clinical outcomes of the minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF)with intraoperative computed tomography (iCT)navigation system, minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF)and conventional open transforaminal lumbar interbody fusion (COTLIF)for single-level lumbar fusion surgery, by which to evaluate clinical effects and feasibility of the MIS-TLIF by assistance of iCT navigation system. MethodsFrom April, 2009 to September, 2011, 45 patients diagnosed as lumbar disc herniation (LDH)were treated by one team of surgeons at a single institution. Minimally invasive transforaminal lumbar interbody fusion with intraoperative computed tomography (iCT-MIS-TLIF)was conducted in 11 cases. MIS-TLIF was conducted in 15 cases. COTLIF was conducted in 19 cases. Patient's condition was considered and the treatment was voluntarily chosen by patients. Detailed procedures, preoperative and intraoperative images were illustrated. Operation time, intraoperative blood loss, postoperative blood loss (drain),mean hospital stay and postoperative ambulation period in 3 groups were compared. Oswestry disability index (ODI),visual analogue scale (VAS)and X-ray 3 days, 1.5, 3, 6, 12, 24 months postoperatively were applied to evaluate clinical effects. Considering the influence of CT guidance on the operation time, the time cost in scanning and registration were recorded. ResultsThe mean follow-up period was 24 months. There were no signifcant differences in routine clinical data, VAS and ODI. No complications occurred in all 45 patients. The operation time in iCT-MIS-TLIF group was signifcantly higher than MIS-TLIF group and COTLIF group (P<0.05). No signifcant differences existed in mean operative blood loss, mean postoperative blood loss (drain), mean postoperative hospital stay and mean postoperative ambulation time (P>0.05)in iCT-MIS-TLIF group and MIS-TLIF group, which were signifcantly lower than COTLIF group (P<0.05). VAS and ODI results in the follow-up were signifcantly improved postoperatively in 3 groups. VAS results of iCT-MIS-TLIF group and MIS-TLIF group 3days postoperatively and ODI results postoperatively were signifcantly lower than COTLIF group. There were no signifcant differences at other time points. No signifcant VAS or ODI differences existed in iCT-MIS-TLIF group and MIS-TLIF group at different time points. There were no signifcant differences in the evaluation of fusion rate by X-ray. The mean automatic image registration time was 45.5 seconds, the mean CT scanning time was 9 seconds, the mean time-out for intraoperative scanning was 5.8 minutes, and the mean total number of CT scans per patient was 3.1 times. ConclusionsMinimally invasive approach causes less change in multifdus, less postoperative back pain and functional disability than conventional open approach. Preliminary experience with the frst 11 patients confrms the feasibility of iCT scanning and integrated navigation system in the minimally invasive lumbar instrumentation. iCT-MIS-TLIF and MIS-TLIF have similar good long-term clinical outcomes and high fusion rates compared with COTLIF with the additional benefts of less early postoperative back pain and functional disability, early rehabilitation, and shorter hospitalization. No signifcant differences exist in iCT-MIS-TLIF and MIS-TLIF although with radiation exposure. However, for complicated anatomical structure, iCT navigation system provides better accuracy and safety for posterior spinal instrumentation.
Tomography, X-ray computed;Surgery, computer-assisted;Lumbar vertebrae;Intervertebral disc displacement;Surgical procedures, minimally invasive
10.3969/j.issn.2095-252X.2015.11.016
R445, R681.5
100853北京,解放軍總醫(yī)院
崔賡,Email: cuigeng@aliyun.com
2015-02-27)