Chinese Journal of Tissue Engineering Research ›› 2022, Vol. 26 ›› Issue (4): 631-636.doi: 10.12307/2022.103
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Wang Zhiqiang1, Lin Lu1, Chen Xiaolin2, Ke Zhenyong2
Received:
2020-09-21
Revised:
2020-09-23
Accepted:
2020-10-30
Online:
2022-02-08
Published:
2021-12-06
Contact:
Ke Zhenyong, Associate chief physician, Master’s supervisor, Associate professor, Department of Orthopedics of The Second Affiliated Hospital of Chongqing Medical University, Chongqing 400000, China
About author:
Wang Zhiqiang, Master candidate, Chongqing Medical University, Chongqing 400000, China
CLC Number:
Wang Zhiqiang, Lin Lu, Chen Xiaolin, Ke Zhenyong. Percutaneous vertebral augmentation for osteoporotic vertebral compression fractures: navigation, fracture reduction system, bone cement leakage, and material modification[J]. Chinese Journal of Tissue Engineering Research, 2022, 26(4): 631-636.
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2.1 术中定位及手术入路方式 2.1.1 O-arm导航系统 O-arm导航系统能够在短时间内获得较高质量的三维CT图像,然后导航计算机通过自动匹配、注册,能够使术者在近乎“直视下”的条件下精准地完成手术操作,被公认为目前脊柱外科领域最先进的导航技术[4]。O-arm导航系统操作大致可分为:拍摄病椎正侧位X射线片、固定参考架(有小切口暴露邻近椎体棘突固定、经皮附着于髂后上嵴或胶布固定在皮肤上3种方法)、3D导航模式下穿刺并建立通道、2D引导模式下完成扩张球囊、注入水泥等步骤[5]。在导航下穿刺并建立通道的步骤中,因为不需要反复透视确定穿刺针的位置,可以大幅减少操作时间及射线辐射,同时准确率较传统C臂更有优势。SCHILS等[6-8]发现与传统C型臂相比,O-arm导航系统能使手术时间、透视时间降低40%。SEMBRANO等[5]的结果显示,C臂组探针误置率为27%(3/11),而O-arm组为3%(1/36)。 O-arm导航系统较目前传统C臂具有提高穿刺准确率、减少透视辐射、缩短手术时间等优势,但需要额外切口固定参考架的步骤,一定程度上违背了微创理念,尽管已有学者尝试使用各种新型无创的固定于皮肤表面的参考架来解决额外切口问题[9-10],但尚待验证其有效性,且O臂的高昂造价一定程度上限制了其推广。 2.1.2 3D打印技术 3D打印技术诞生于20世纪80年代中期,属于快速成型技术。目前临床使用的3D打印技术可分为两种:一种需在术前进行CT薄层扫描并导入计算机,利用3D打印技术制作出1∶1的伤椎三维实体模型,全方位观察伤椎骨折严重程度、具体位置、终板破裂情况等,根据术前CT测得穿刺角度并在模型上进行演练后再对患者行手术操作[11]。曹臣等[11]的研究结果显示,3D打印技术辅助经皮椎体成形治疗老年重度OVCF可明显缩短手术时间[辅助组(28.0±3.4) min,常规组(30.9±5.3) min],降低骨水泥渗漏率(辅助组为11%,常规组为37%)。另一种同样需在术前进行薄层CT扫描,不同的是需在背部放置不透射线的标志物以定位,同时通过手提式激光扫描仪(有学者使用CT扫描[12])获得背部皮肤数据,将数据导入到Mimics等软件中,设计出导向模板的虚拟模型并打印。模板由1个底座(与皮肤形状完全匹配)、2个定位孔(与不透射线的标志物匹配)、导向圆柱体(用于引导穿刺)组成,然后在模板的引导完成手术[13-14]。LI等[13]认为导向模板可以提高穿刺精度,减少穿刺相关并发症、手术时间和放射暴露。倪鹏辉等[12]对42例OVCF患者进行经皮椎体成形手术治疗并进行病例对照研究,结果显示3D打印导向模板能够减少透视次数、缩短手术时间、增加手术安全性。 随着医疗技术不断进步,个体化、精准化治疗是未来骨科手术的发展趋势,3D打印技术辅助手术治疗将数字骨科、个体化治疗、精准化治疗合为一体,已经逐步应用于颌面外科、神经外科、关节外科等多个外科手术中[15],有理由相信3D打印技术将会在脊柱外科治疗中扮演越来越重要的角色。但该项技术需要额外的扫描及打印制作费用,仍需要进一步的研究确定其增加的成本是否能与其优势相平衡。 2.1.3 单侧与双侧入路的选择 在临床操作中,经皮椎体强化常分为单侧入路及双侧入路,而哪种入路更加具有优势一直是争论的焦点。大量文献报道,在恢复伤椎高度、目测类比评分、邻近椎体骨折率及骨水泥渗漏率等并发症等方面单侧与双侧椎弓根入路无明显统计学差异,均能获得良好的临床及放射学结果[16-18]。然而,CHEN等[18]认为在不增加并发症风险的情况下,单侧入路经皮后凸椎体成形较双侧需要的手术时间更短、骨水泥量及照射次数更少,从而在术后短期随访中能够提供更好的疼痛缓解和生活质量。SUN等[19]、CHEN等[16]也鼓励使用单侧入路经皮后凸椎体成形作为治疗OVCF的首选手术方式。但LIEBSCHNER等[20]则认为在单侧椎弓根穿刺椎体强化时,若内倾角过小可能导致骨水泥偏侧分布会增加伤椎再塌陷风险;若内倾角过大,则易穿破椎弓根内壁导致硬膜外血肿或脊髓损伤[21]。同时也有观点认为双侧入路经皮后凸椎体成形较单侧有着更好的伤椎高度恢复率[22]。 对于单侧入路还是双侧入路的选择,目前多数观点认为单侧入路较双侧更具有优势,因为其手术时间更短、所需骨水泥量更少且手术创伤更少,但仍需要大规模的随机对照试验来验证这一观点。而在临床操作中,作者认为袁宏等[23]提出的观点对入路的选择有一定帮助:病变椎体一侧塌陷严重,穿刺困难,则采用对侧椎弓根穿刺;病变椎体塌陷不重,椎体呈一侧塌陷,则采用塌陷侧椎弓根穿刺;病变椎体呈均匀塌陷,塌陷程度≤原椎体高度1/2时可采用任何一侧,但当塌陷程度>1/2时则不宜采用单侧穿刺。总之,手术入路的选择应根据患者具体情况,准确完善术前评估,合理选择单侧或双侧穿刺入路。 2.2 骨折复位系统及防骨水泥渗漏技术 2.2.1 可弯曲椎体成形器 可弯曲椎体成形器是由国内首先提出并自行研发的一种能在椎体内实现头端弯曲并扩大操作范围的适用于经皮椎体强化术的一种手术工具,其通过在单侧穿刺时可使针尖到达椎体对侧并建立弧形空腔,通过旋转手柄实现多向扩张建立椎体内树状通道,并有利于骨水泥的均匀扩散[24]。李玉伟等[25]通过对78例患者进行回顾性分析发现,可弯曲骨水泥注入器在不增加手术时间、照射次数、骨水泥渗漏率的情况下,远期目测类比评分、伤椎相对高度及Cobb角均优于传统直形骨水泥注入器。熊森等[26]通过纳入60例病例进行前瞻性自身对照,得出了弯曲椎体成形器可确保骨水泥双侧对称分布,是种简单、安全的新方法的结论。而郑博隆等[24]也认为可弯曲椎体成形器在采取类似双侧穿刺中较安全内倾角的同时,也能通过单侧穿刺获得满意的骨水泥分布,使椎体得到均匀支持不易塌陷,从而获得远期的伤椎椎体强度。 可弯曲椎体成形器是国内提出的一种使头端弯曲从而实现骨水泥对称分布的一种骨折复位系统,其在保留了单侧椎弓根穿刺的优点同时克服了传统直形骨水泥注入器骨水泥分布不佳的缺陷,但目前相关研究仍不足且造价相对昂贵,仍需要大样本多中心随机对照试验来证实其优势。 2.2.2 KIVA系统 KIVA系统通过向骨折椎体内放入镍钛合金线圈,然后将弹性模量与骨皮质相近的聚醚醚酮材料构成的可卷曲的空心植入物展开在线圈上,收回线圈并往中空通道注入骨水泥,骨水泥从植入物内侧间隙里渗出先将柱状体的中心进行填充,填充完成后骨水泥便向外渗弥散至周围的松质骨形成稳定的结构[27-28]。TUTTON等[28]对300例OVCF患者进行了球囊系统及KIVA系统前瞻性、多中心、随机、非劣势对照临床试验,发现在疼痛缓解、功能恢复、恢复椎体高度上双方无明显差异,但KIVA系统在减少骨水泥渗漏率及邻近椎体骨折率方面优于球囊系统。KOROVESSIS等[29]通过对190例OVCF患者行球囊系统及KIVA系统的前瞻性随机对照研究发现,KIVA系统和球囊系统均在短期内恢复了类似的椎体高度,但KIVA系统骨水泥渗漏率明显低于球囊系统(0.03% vs. 0.098%)。而BEALL等[30]则利用KAST的临床数据以及已发表文献的单位成本数据比较了KIVA系统和球囊系统治疗初始OVCF的手术成本、再手术成本、设备市场成本以及其他医疗成本,发现KIVA系统能够通过降低发生邻近椎体骨折的风险,节省了医院资源与成本。 KIVA系统通过在椎体中置入一个弹性模量与骨皮质相似的空心柱状物,一定程度上减少了骨水泥注入量和骨水泥渗漏率,同时降低了邻近椎体的骨折风险,这对节省医疗资源、降低患者痛苦及再次手术率有着重要的意义。同时KIVA系统且具备一定后凸复位能力,有助于急性骨折后凸畸形的恢复[31],其线圈每增加一个环路椎体抬高约1 mm,可精确掌握椎体恢复的高度。目前该系统多应用于国外(美国加利福利亚州等),国内罕有相关研究,具有较广阔的应用前景和研究空间。 2.2.3 椎体支架 椎体支架是一种钛网支架,通过球囊经椎弓根到达椎体骨折部位后,扩张球囊撑开支架并将其留在椎体内,最后填充骨水泥将支架与周围松质骨固定[32]。与传统经皮后凸椎体成形主要不同点在于:椎体支架在球囊放气后支架仍处于撑开状态,从而达到维持椎体高度的目的。WANG等[33]对传统球囊和椎体支架对比后发现,两种方式在球囊退出后都会出现一定程度的高度再丢失,但椎体支架组球囊放气后的二次复位损失明显小于经皮后凸椎体成形组[(0.34±0.43) mm vs. (2.36±0.63) mm],后凸角度增益椎体支架组明显高于经皮后凸椎体成形组[(95.60±6.12)% vs. (77.0±4.94)%]。SCHüTZENBERGER等[34]纳入49例新发的胸腰椎骨折患者进行病例对照分析,发现椎体支架组在伤椎高度恢复率及远期Cobb角纠正方面优于经皮后凸椎体成形组,但在骨水泥渗漏率、随访中目测类比评分及Oswestry功能障碍指数评分方面无显著差异。WERNER等[35]在进行了50例病例的前瞻性随机对照试验后认为与经皮后凸椎体成形相比,椎体支架对后凸矫正、骨水泥渗漏、辐射暴露时间或神经系统后遗症均无有益影响,且椎体支架可能导致更多的材料相关并发症。 理论而言,椎体支架在球囊撤出时的支持作用确实可避免恢复的椎体高度再降低,但就并发症发生率及远期随访而言椎体支架优势并不明显,且可能需要面对更多材料相关并发症,故需结合患者具体情况合理选择。 2.2.4 Osseofix系统 Osseofix系统同样是一种可永久植入的钛金属网,通过钛网在椎体内扩张并压缩周围骨小梁来恢复椎体高度,并选择性联合骨水泥应用对伤椎起到固定及稳定的作用,同时它也可以作为支架,有利于骨折稳定和骨折复位的同时有助于骨水泥在椎体松质骨内的弥散[36]。UPASANI等[37]将Osseofix系统与球囊系统应用于人体新鲜椎体制造出的前楔形骨折中,结果显示Osseofix系统在生物力学上等同于球囊,但能够用更少的骨水泥恢复更多的椎体高度。ENDER等[38]的研究显示,使用Osseofix系统治疗后患者疼痛症状和Cobb角均能得到有效改善且并发症发生率低。且与上文椎体支架系统及传统经皮后凸椎体成形相比,Osseofix系统最大的不同是可以不使用骨水泥而达到治疗效果。有研究表明,在人造绵羊骨质疏松椎体骨折的Osseofix系统不联合骨水泥治疗中,钛网植入物为骨折复位及愈合提供了良好的力学基础[39]。同时ESCHLER等[36]对4例平均年龄为72.3岁的A1.3分型(AO分型)急性腰椎椎体压缩性骨折患者采用Osseofix系统不联合骨水泥治疗,平均随访27.7个月,结果显示在减轻疼痛、改善功能方面非常有效且复位效果与经皮后凸椎体成形相似,这表明Osseofix系统并不过于依赖骨水泥的加固。 Osseofix系统已被证明是治疗OVCF安全有效的方式,由于其可以脱离骨水泥使用的特性,可完全消除骨水泥相关并发症,将来也许可以用于无骨水泥的伤椎撑开复位,但该系统脱离骨水泥后的长期稳定性仍待探究,且目前仍缺乏大规模前瞻性随机对照研究以证明其优越性。 2.2.5 脊椎支架 脊椎支架通过置入“工”字形的钛金属支架在椎体内,像千斤顶般对压缩椎体进行复位,并用骨水泥将其固定,且在对椎体进行扩张过程中当压力达到一定程度时脊椎支架就会锁定,可避免过度扩张导致损伤椎体终板[40]。KRüGER等[41]通过对新鲜人体椎体进行生物力学实验发现,与经皮后凸椎体成形相比,脊椎支架的椎体高度恢复效果明显更好。ROTTER等[42]通过将新鲜人体椎体制造为压缩性骨折后分别模拟球囊扩张及脊椎支架治疗,发现在创伤性楔形骨折中恢复相同的高度时脊椎支架需要的骨水泥比球囊更少。NORIEGA等[40]于2016年发起一项30例关于球囊扩张和脊椎支架治疗OVCF的安全性和临床表现的前瞻性、随机、单中心研究,结果表明,随着时间推移,脊椎支架在恢复和维持椎体高度方面具有更高的潜力。之后,NORIEGA等[43]再次发表了此前病例3年随访的结果,脊椎支架的前路平均矫正[(10±13)% vs. (2±8)%]、中心高度平均矫正[(10±11)% vs.(3±7)%]、椎体角度平均矫正[(?5.0±5.1)°vs. (0.4±3.4)°]均优于球囊,提示脊椎支架的椎体高度恢复及后凸矫正效果较传统经皮后凸椎体成形更好。 与传统经皮后凸椎体成形相比,脊椎支架在恢复相同椎体高度的同时所需骨水泥更少,理论上这有利于减少骨水泥渗漏率。而脊椎支架不需要移除的特性也解决了经皮后凸椎体成形技术球囊放气时椎体恢复高度再丢失的问题[44-45],但这也造成了对医生穿刺定位及操作技术要求更高的后果,若装置被定位的位置错误或撑开失败,就难以再次重新定位或取出支架。 2.2.6 射频椎体后凸成形 射频椎体后凸成形通过术中使用能够变向的铰链骨凿对伤椎进行预处理,在制造充盈空间的同时也有利于椎体的复位,然后经单侧椎弓根通过独特的液压输送系统以恒定速率输入射频活化的高黏度骨水泥,从而进行椎体增强[46]。ACHATZ等[47]通过体位生物力学研究显示,经皮后凸椎体成形与射频椎体后凸成形在骨折稳定与椎体高度恢复方面无明显差异,但射频椎体后凸成形有更短的骨水泥强化时间和更少的对骨小梁的损伤,这对伤椎的远期预后有着积极意义。GEORGY[46]对80例OVCF病例进行回顾性分析,认为射频椎体后凸成形骨水泥渗漏率明显低于经皮后凸椎体成形,能减少50%的骨水泥渗漏发生。FENG等[48]对833例患者进行了Meta分析,结果显示射频椎体后凸成形比经皮后凸椎体成形更加有效和安全,同时在骨水泥渗漏方面,目前所有非随机对照试验中射频椎体后凸成形均优于经皮后凸椎体成形。 有学者描述有3个要素可以影响骨水泥的流动:骨形态和骨折类型、骨水泥黏度、注射方式[49]。而射频椎体后凸成形通过有针对性地形成骨通道与以受控的恒定速率输送高黏度水泥,在骨水泥黏度及注射方式方面目前几乎做到了最优,显著降低了骨水泥渗漏率并优化了骨水泥的分布,对降低骨水泥并发症有着重要意义。但目前报道数据有限,随机对照试验较缺乏,还需要更多的临床研究来评价射频椎体后凸成形的疗效和并发症。 2.2.7 骨填充网袋技术 骨填充网袋技术与经皮后凸椎体成形相似,建立操作通道后在伤椎植入骨填充网袋并注入骨水泥使网袋呈椭圆状,直到骨水泥开始沿囊袋微孔发生外渗时停止注入,完成手术[50]。许勇等[51]对62例病例进行回顾性分析,显示两组在改善目测类比评分及Oswestry功能障碍指数评分方面无差异,但网袋组骨水泥渗漏率明显低于经皮后凸椎体成形(6% vs. 39%)。HE等[52]对80例单发性OVCF病例进行随机对照临床研究,结果显示骨填充网袋及经皮后凸椎体成形均可以有效缓解疼痛并矫正Cobb角,而骨填充网袋骨水泥渗漏率显著优于经皮后凸椎体成形(0% vs. 22.5%)。骨填充网袋的低骨水泥渗漏率使其治疗伴后壁缺损的OVCF患者成为可能。白明等[53]对40例OVCF伴有后壁不同程度缺损的患者行骨填充网袋治疗,均顺利完成手术,未出现骨水泥渗漏及相关并发症。 骨填充网袋通过限制骨水泥的流动仅允许少量骨水泥通过网孔渗入骨小梁,形成微观的扭锁结构与骨组织发生紧密的耦合,达到降低骨水泥渗漏率的目的,在不会出现球囊撤出时复位高度再丢失情况的同时,可用于治疗后壁缺损的椎体骨折。总之,骨填充网袋在克服经皮后凸椎体成形缺陷的同时几乎具有经皮后凸椎体成形术所有优势,但是其作为一种新技术存在囊袋留存椎体内远期稳定性及并发症尚不明确、造价高昂等缺点,还需要更多、更长时间的临床研究来证明其优势。 2.3 骨水泥材料 聚甲基丙烯酸甲酯是目前使用最广泛、也是最经典的骨水泥材料,具有强度高、稳定性好、成本低廉等优势,但也存在无法生物降解、固化时导致热损伤、杨氏模量较松质骨过高易引起继发性骨折、残留单体具有心脏毒性、渗漏时易导致肺栓塞等缺点。为克服这些缺点,有学者将羟基磷灰石微球作为添加剂与聚甲基丙烯酸甲酯骨水泥混合,发现其在保留较高的强度同时生物相容性和骨传导性明显增强[54]。TAI等[55]在聚甲基丙烯酸甲酯骨水泥中加入蓖麻油后进行预冷却,形成了模量低、聚合温度低、处理时间长、适应性强、安全性好的较理想骨水泥材料,但该材料尚处于实验室研究阶段,尚未进行临床研究,还需要进一步研究来证实其安全性及有效性。 相比于聚甲基丙烯酸甲酯骨水泥,磷酸钙骨水泥不仅具有良好的椎体成形能力,还具备骨传导性良好、组织相容性好、固化时无明显放热反应等特点[56],临床应用时不会产生严重的炎症反应和排异反应,但磷酸钙骨水泥的主要缺点为强度不足。有学者使用磷酸钙骨水泥作为填充物分别用椎体支架及经皮后凸椎体成形治疗新发胸腰椎骨折,发现磷酸钙骨水泥的确有助于获得良好的临床效果,且并发症发生率低,但远期随访却出现了恢复高度再丢失的现象[57]。同时与聚甲基丙烯酸甲酯相比,磷酸钙骨水泥的碎裂会产生更多的微栓子,从而加重心血管疾病,尸检的肺CT结果证实了这一点[58]。DHIVYA等[59]发现与单纯磷酸钙骨水泥相比,聚磷酸钙骨水泥不仅可以促进羟基磷灰石矿化,且可以抑制破骨细胞,而含有生物活性陶瓷的壳聚糖/聚硫酸钙支架可以促进小鼠间充质干细胞向成骨细胞的增殖和分化,这些特性对受伤椎体的重建具有重大意义。LODE等[60]已研究出预混合的含锶磷酸钙骨水泥,拥有更强的机械性能、更好的射线图像对比度及刺激体外骨祖细胞增殖和成骨分化等优势,且已在人体尸体脊椎先导实验中证实了其在经皮后凸椎体成形手术中的通用性。 聚甲基丙烯酸甲酯骨水泥仍是目前应用于椎体强化术的主要材料,但磷酸钙骨水泥因为其更好的可注射性、骨传导性、组织相容性及适当的生物降解性在未来经过改良后很可能会逐步替代聚甲基丙烯酸甲酯骨水泥。而另一种硫酸钙骨水泥材料虽然拥有磷酸钙骨水泥诸多优势且机械强度更高,但由于其植入体内6周即被完全吸收与骨形成过程不匹配[61],故临床应用有限。 "
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