Chinese Journal of Tissue Engineering Research ›› 2020, Vol. 24 ›› Issue (12): 1962-1968.doi: 10.3969/j.issn.2095-4344.2564
Guo Yu1, Feng Dehong1,2, Wang Ling1, Li Yaxin1, Wang Zhidong3, Yang Huilin3
Received:
2019-04-11
Revised:
2019-04-19
Accepted:
2019-06-12
Online:
2020-04-28
Published:
2020-03-03
Contact:
Feng Dehong, Chief physician, Associate professor, Department of Orthopedics, The Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi 214000, Jiangsu Province, China; Wuxi Translational Medicine Institute, Wuxi 214000, Jiangsu Province, China
About author:
Guo Yu, Master, Department of Orthopedics, The Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi 214000, Jiangsu Province, China
Supported by:
CLC Number:
Guo Yu, Feng Dehong, Wang Ling, Li Yaxin, Wang Zhidong, Yang Huilin. Application and progress of three-dimensional printing technology in hip arthroplasty[J]. Chinese Journal of Tissue Engineering Research, 2020, 24(12): 1962-1968.
2.1 3D打印技术 3D打印技术作为一个新兴的技术领域,其利用计算机辅助设计、数控技术、三维 CT 技术等快速成型技术,将数据立体化建模,并运用粉末状的金属或塑料等可黏合材料逐层融合叠加,最终打印出三维实物模型[84]。目前3D打印可利用的工艺技术已有近20种,而在髋关节置换中常用的主要有以下几种[85]:①光固化成型技术,其利用紫外激光逐层扫描液态光敏聚合物,实现液态材料的固化,逐渐堆积成型,主要用于解剖模型打印;②选择性激光烧结技术,其使用高功率激光逐层选择性地融化表面的粉末材料,最后形成所需要的三维形状,可采用塑料、金属等不同材料制备手术器械;③电子束熔融技术,其通过高真空电子束熔融金属粉末来制造零件,可制备具有良好生物相容性的钛合金人工假体植入物。 2.2 3D打印技术在不同髋关节疾病关节置换中的应用 见表1。 "
2.2.1 发育性髋关节发育不良 发育性髋关节发育不良是指出生时由于发育障碍导致髋关节发育缺陷,髋关节应力增加,并在以后继续恶化,导致股骨头软骨退变、脱位,到成人时逐渐出现继发髋关节骨性关节炎的一组先天性疾病。对于成人的发育性髋关节发育不良终末期患者,全髋置换术是一种有效的治疗方法。如何恢复正常的髋臼旋转中心、解决臼杯的充分骨覆盖、恢复髋关节周围软组织的应力平衡是发育性髋关节发育不良全髋置换常遇到的难题[13]。对于Crowe Ⅲ、Ⅳ型的发育性髋关节发育不良患者,患髋病变畸形复杂多样,尤其是髋臼侧的解剖结构异常,髋臼变浅、变小甚至有假臼形成,并伴有不同程度的骨缺损,髋关节旋转中心向外、向上移位,术中难以确定真臼的位置,常造成髋臼侧假体安放位置过高、外翻角过大及髋臼侧骨性包容欠佳等问题[14]。 3D打印技术在发育性髋关节发育不良中的应用较为广泛,均取得了良好的疗效。3D打印解剖模型可以更直观、精准地测量髋臼侧变异的程度,并在体外模型上进行寻找髋臼中心、选择合适尺寸的臼杯、进行假体安放等手术模拟操作,降低了手术难度。XU等[83]运用3D打印模型为发育性髋关节发育不良患者实施全髋关节置换术,发现3D打印组各径线的测量值和术前计划值差异度更小,认为3D解剖模型可以帮助手术医师识别骨盆结构,确定假体大小,提高手术精度。3D打印技术还被用于制作手术导航模板,涂强等[13]应用3D打印个性化手术导航模板对19例发育性髋关节发育不良进行全髋关节置换,术中在导板引导下快速确定真臼位置,假体与打磨好的髋臼窝完全匹配,术后随访Harris评分较术前明显改善,认为3D打印手术导航模板能够实现髋臼的精准定位,提高假体安装精度,从而达到更佳的手术效果。 2.2.2 髋臼骨缺损翻修 伴有髋臼侧严重骨缺损的翻修是全髋翻修术中极具挑战性的手术[63]。临床上髋臼骨缺损分型主要有Paprosky分型和AAOS分型,其中Paprosky分型由Paprosky等[86]于1994年提出,由于这种分型方法可以判断预后并指导治疗,临床应用最为广泛。Paprosky分型主要根据股骨头中心的位移程度和方向、坐骨骨溶解程度、泪滴破坏程度将髋臼骨缺损分为3型,其中Paprosky Ⅲ型属于严重髋臼骨缺损,是全髋关节翻修手术中的一大难题[87]。 近年来,3D打印技术的出现为严重髋臼骨缺损的翻修带来了曙光,极大地降低了手术难度。ZERR等[81]术前打印出患髋3D模型,在体外进行模拟手术,预先确定好髋臼杯假体大小、放置位置和螺钉放置方向,明显减少了时间。传统假体结构单一,标准模块化的形态与宿主骨缺损有时候不能达到良好的匹配,影响假体的初始稳定性和长期使用寿命,而3D打印个体化定制假体基于患者三维CT影像精准设计制造,可以实现对骨缺损的有效重建。刘珂等[29]报道了使用3D打印钛合金填充垫块对11例髋臼严重骨缺损患者进行辅助髋关节翻修,假体和垫块与髋臼面骨缺损达到完美匹配,假体初始稳定性好,并且降低了手术难度,缩短了手术时间。SCHWARTZ等[88]则指出3D打印多孔钛合金垫块能与髋臼周围骨组织紧密结合,避免了骨水泥的使用,增加了假体稳定性,提高了手术精确度。3D打印cage可以根据患者骨缺损形态提供个体化的治疗方案,确保cage获得与宿主骨的直接有效支撑,恢复骨盆的连续性,重建正常的旋转中心。LI等[70]使用快速成型技术制作含有髂骨翼、坐骨翼和耻骨翼的钛合金cage治疗75例PaproskyⅢB型髋臼骨缺损患者,末次随访Harris髋关节评分明显改善,髋关节旋转中心基本位于解剖位置,近中期疗效满意。BAAUW等[57]对16例Paprosky Ⅲ型髋臼骨缺损患者使用3D打印定制钛合金骨小梁假体,术后旋转中心基本得到重建,个性化的钉孔设计避开了重要的解剖结构,螺钉置入更加充分、牢靠。 2.2.3 假体周围感染 髋关节假体周围感染对于髋关节置换患者来说是灾难性的并发症,感染一旦发生,往往最终会导致手术失败,不仅增加了患者的经济负担,更对其生活质量和心理健康产生重大的影响[89]。相关文献报道髋关节初次置换后感染率约为1%,而翻修术后感染率则增至3%[2,90]。对于假体周围感染患者,单独使用抗生素很难在假体病灶周围达到有效药物浓度,国内外学者大多主张Ⅱ期翻修手术治疗[89,91]。Ⅱ期翻修,即Ⅰ期去除假体,彻底清创后置入临时占位器,进行抗感染治疗待炎症完全控制后再Ⅱ期行关节置换手术。目前临时占位器尚无统一的制作标准及制作方法,临床中多用固定型号的模具制作或手工制作抗生素骨水泥占位器,型号不匹配易造成运动时疼痛、异响,并会出现占位器脱位、断裂等并发症[92]。此3D打印技术能够个性化制作抗生素骨水泥占位器,匹配度良好,术后关节功能好,便于二期翻修。孙海滨 等[37]3D打印出患者关节模型,再根据模型制作占位器模具,或直接3D打印出模具,术中在制作占位器时将2枚 3 mm直径斯氏针作为占位器支架,增加股骨柄的强度,通过模具获得与原有假体大小形态一致的抗生素骨水泥临时占位器,术后所有患者无感染复发,关节功能恢复良好,并能早期负重,未发现断裂现象。 2.2.4 髋臼周围肿瘤 髓臼周围恶性肿瘤通常体积较大,侵犯范围较广,以往治疗多以截肢或者半骨盆离断为主。近年来随着诊断技术、新辅助化疗、骨肿瘤综合治疗理念的进展,保肢手术已成为主流治疗方法。然而髋臼周围解剖结构复杂,肿瘤与周围神经、血管、脏器关系密切,肿瘤切除后骨性标志破坏较多及骨缺损较大,骨关节结构重建困难,保肢手术往往失败率和复发率较高,手术极具有挑战性[93]。 近年来随着计算机辅助技术的发展,3D打印在髋臼周围肿瘤的辅助治疗中获得了良好的应用。手术医师在3D打印解剖模型上能够直观地观察肿瘤周围复杂的解剖结构,确定肿瘤侵袭的范围及界限,术前即规划好手术过程,尽可能减少手术失误的发生,降低手术难度。DAI等[61]为9例骨盆肿瘤的患者制作了3D打印骨盆模型,术前通过模型进行手术规划及模拟肿瘤切除,进而进行半骨盆置换,实际手术操作较以往变得精确而简单,减少了手术时间和出血量。3D打印手术导板在髋臼周围肿瘤也应用较为广泛,在手术导板的辅助,截骨的平面和方向以及置钉的进钉点和角度等不再仅仅依靠术者的经验,手术的精度能够明显提高。WONG等[80]为1例髋臼软骨肉瘤患者设计并制作3D打印截骨导板和置钉导板,用于术中辅助引导切除肿瘤及置入假体螺钉,术后标本病理组织学显示切缘阴性,影像学显示肿瘤切除范围及假体位置与术前计划相差不超过4 mm,术后11个月患者可以负重行走,髋关节功能恢复良好,未见肿瘤复发及假体松动迹象。3D打印技术还可以根据肿瘤病变实际情况和治疗要求设计个体化的假体,保证假体形态上与宿主骨达到良好适配,能够最大程度恢复肢体功能,提高手术疗效。WANG等[78]对11例骨盆肿瘤的患者行肿瘤整块切除,并使用3D打印的个体化半骨盆假体进行肿瘤切除后的骨缺损重建,结果发现置入的3D打印假体匹配良好,临床效果满意,未见肿瘤复发及假体松动。 2.2.5 髋关节骨关节炎 对于终末期髋关节原发性骨关节炎和由于股骨头缺血性坏死、髋类风湿性关节炎等疾病引发的终末期继发性骨关节炎患者,全髋关节置换是目前首选的治疗方式。3D打印手术导板在髋骨关节炎中应用较多,SMALL等[76]将36例髋骨关节炎需行全髋置换患者随机分为3D打印导板组和传统技术组,术后行CT比较手术结果与术前计划,发现导板组前倾角、外展角与术前计划差异明显小于传统技术组,认为3D打印导板应用于全髋关节置换能够提高手术精度。SPENCER-GARDNER等[77]为100例原发性或继发性髋骨关节炎行全髋置换,术中在3D打印导板引导下进行操作,术后CT扫描显示91%患者的臼杯位置与术前计划一致,认为3D打印导板能够实现臼杯的精确放置,优于手工操作。目前基于3D打印电子束熔融技术生产的钛合金骨小梁金属臼杯在临床已得到初步应用。程文俊等[43]应用3D打印钛合金骨小梁金属臼杯为10例原发性或继发性髋骨关节炎患者进行了全髋关节置换手术,术后5年影像学评估所有患者臼杯稳定、骨长入优异,无松动及骨溶解,5年生存率为100%,临床效果满意。 2.3 3D打印技术在髋关节置换中的主要应用类型 2.3.1 临床教学 由于骨科手术涉及众多骨骼、肌肉、血管及神经组织结构,对医学生的空间想象能力有一定的要求,骨科的临床教学一直是医学教学的难点[94]。3D打印技术可还原骨骼模型,将真实的解剖结构呈现在眼前,可以直观地了解病变范围及严重程度,分析病因及发病机制,有助于疾病的分型及诊断[95]。韩俊柱等[8]采用3D打印技术进行辅助教学,教学内容统一为发育性髋关节发育不良全髋关节置换的术前规划、手术培训,并对2组学生进行考核评分,结果发现3D打印实验组考核成绩及教学满意度均高于对照组,认为3D打印技术辅助手术教学既能提高学习兴趣,又能提高教学效果,值得在骨科临床教学中推广。 2.3.2 术前规划 对于复杂的关节置换、翻修、骨重建等手术,传统的二维或三维影像学难以准确提供解剖结构、病变范围等具体信息[96]。解剖模型的使用并结合常规二维或三维影像可以帮助医师更好地了解关节及病变周围解剖结构,提高诊断的准确性和不同观察者之间的一致性[97-98]。对于复杂的髋关节手术,将患者的影像资料导入3D打印机,打印出1∶1实物模型,医师在术前能够对病变部位进行全方位的直观观察,了解周围神经血管分布情况,确定骨性解剖标志,进行手术预操作,尽可能避免手术失误的发生。SáNCHEZ-PéREZ等[99]对髋臼骨折后髋臼畸形患者应用3D打印模型模拟髋关节置换术,术中准确确定真臼位置,恢复了髋臼旋转中心,缩短了手术时间和出血量。WIND等[79]在术前打印出19例伴有髋臼侧严重骨缺损翻修患者骨盆模型,通过模型实验选择合适尺寸的髋臼杯,进而减少了手术时间,平均随访31个月未发生再次翻修。 3D打印模型能帮助医师熟悉手术操作过程,提高手术技巧,从而简化手术难度,但同时3D打印模型会增加额外的医疗成本,也使得医师在术前需要花费更多“额外时间”去规划和模拟手术,这些不足限制了3D打印技术在临床中的应用[100]。 2.3.3 手术辅助导板 3D打印技术可按照患者的解剖特点制作个性化辅助导板供术中指导切除病灶、截骨及置钉等,降低手术难度,缩短手术时间和减少术中出血量 等[101]。刘融等[16]将51例成人发育性髋关节发育不良分为3D打印导板组和传统手术组,发现使用导板组可缩短手术及住院时间,减少术中出血量。SCHNEIDER等[75]对30例采用直接上方入路(经梨状肌入路)进行全髋关节置换患者,术中使用3D打印个性化辅助导板进行截骨,术后影像学对比发现所有患者股骨颈截骨面与术前计划相差不到3 mm,使用3D打印导板能够辅助精确截骨。骨盆肿瘤结构复杂,传统手术过程中依赖术者个人经验,截骨平面及置钉难以准确确认,常需术中反复透视进行调整,手术难度较大。GOUIN等[64]利用3D打印技术为11例骨盆肿瘤患者设计并制作3D打印导板,术中在导板引导下进行肿瘤切除,术后所有患者标本组织学显示切除边界阴性,肿瘤实际切除面与术前预期平均误差仅为2.5 mm。 导板设计是3D打印导板辅助手术的核心环节,但是并非所有类型手术都适用3D打印导板。导板需与宿主骨性结构尽可能贴合,对于原有骨结构表面缺乏特征标志或难以剥离骨表面软组织导致导板与骨面不能完全贴合的情况,将会增加手术误差,设计及应用辅助导板时均应考虑到这些因素[67]。 2.3.4 植入物、假体 当患者骨结构存在显著畸形或由于感染、肿瘤等原因合并严重骨缺损时,常规标准假体往往不能满足手术要求。3D打印技术以患者影像资料为依据,基于患者的病变实际情况“量身定制”个体化的植入物或假体,保证了植入物或假体在解剖学形态上与患者残余骨结构达到良好适配,最大程度恢复关节功能[53]。LIANG等[72]为35例髋部周围肿瘤患者行肿瘤切除并3D打印个体化假体置换,术中假体与宿主骨匹配良好,术后随访髋关节功能满意、稳定性良好。WANG等[53]应用3D打印技术为17例伴有严重骨缺损全髋置换患者制备个性化定制cage,术后平均随访2年发现3D打印组Harris评分优于传统置换组。 髋关节置换术后维持假体长期稳定性的最重要因素是假体表面与骨界面之间的骨长入状况。3D打印技术能够制作出带有多孔结构表面的个体化植入物假体,既能在形态学上与宿主达到匹配,其表面多孔结构还确保了良好的孔径及孔隙率,为骨长入假体界面创造了良好的环境,提高了假体的远期稳定性和使用寿命[102]。程文俊等[43]使用3D打印钛合金骨小梁金属臼杯进行初次全髋关节置换,术后6个月影像学显示臼杯稳定、骨长入优异,无松动及骨溶解,5年生存率为100%。冯德宏等[103]采用3D打印钛合金骨小梁金属加强环臼杯或臼杯-垫块复合体对7例髋臼侧严重骨缺损患者进行翻修,随访期间影像学检查显示髋臼假体周围无透亮线或可疑松动表现,认为3D打印个性化假体形态与骨缺损匹配后可获得假体初始稳定,其表面多孔结构对于假体远期生物学固定有着较好的预期。 值得注意的是3D打印个性化假体存在一些潜在的弊端[104-105]:①目前尚无统一的制作标准及规范;②3D打印假体的强度难以得到保证;③3D打印假体术前准备时间较长,术中假体不能随意更换,使用灵活性受到一定的限制。此外3D打印假体远期效果的研究报道较少,其安全性、有效性和可靠性仍需要进一步观察。 "
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