定制型颞下颌关节-颅底联合假体的研发和临床应用

Development and clinical application of custom-made temporomandibular joint-skull base combined prosthesis

目的优化设计并通过三维打印制作定制型颞下颌关节(temporomandibular joint,TMJ)-颅底联合假体,验证其临床应用的安全性、有效性和精确性。方法前瞻性收集2016年10月至2020年11月于上海交通大学医学院附属第九人民医院口腔外科就诊的TMJ-颅底联合病损患者,将术前颌面部CT数据导入Mimics 18.0软件,根据颅颌面骨应力分布、TMJ和颅底解剖结构与关节运动特征,个性化设计TMJ-颅底联合假体,主要包括颅底、关节窝、关节头和下颌柄4个部件。通过五轴精加工和三维打印等技术制作假体。手术选择改良耳颞前切口[必要时附加下颌后和(或)下颌下切口],显露TMJ-颅底联合病变后,在导板辅助下精准切除病变,固定假体。术中和术后分别对常规评价、颅颌关节结构及功能评价等指标进行记录和评估。结果10例患者[男性4例,女性6例,年龄(43.2±13.6)岁]术中假体均顺利就位且与骨面贴合紧密。随访(29.4±17.3)个月(6~54个月)后,术后患者咬合关系稳定,切口愈合良好,面形得到较好维持,均未发生头晕、头痛、脑脊液漏及永久性面神经损伤等不良症状;术后疼痛、饮食、下颌运动功能、开口度和患侧侧方运动均有明显改善,但前伸和健侧侧方运动恢复欠佳;术后曲面体层X线片和CT检查均显示假体未见明显松动、移位、断裂等;术后假体位置与设计位置相比,功能区最大误差为(0.52±0.17)mm,非功能区最大误差为(1.62±0.26)mm。结论本项研究自主研发的定制型TMJ-颅底联合假体在临床应用中具有较好的安全性、有效性和精确性。

Objective To introduce the design,manufacture and clinical application of the custom-made temporomandibular joint(TMJ)-skull base combined prosthesis and evaluate its safety,effectiveness and accuracy.Methods The patients diagnosed with the TMJ-skull base lesion in Department of Oral Surgery,Shanghai Ninth People′s Hospital from October 2016 to November 2020 were recruited in this study.The maxillofacial CT data for all the patients were obtained and transformed into the Mimics 18.0 software preoperatively.The custom-made TMJ-skull base combined prosthesis,included four components,was designed based on the anatomy,stress distribution and movement of the TMJ and skull base,and fabricated by three-dimensional printing and 5-axis milling technologies.The TMJ-skull base lesion was excised completely with the help of digital templates from modified preauricular and/or post and submandibular incisions.The combined prosthesis were implanted and fixed after the lesion resection.The examinations including general situation,cranio-maxillofacial structure and function were taken during and after surgery to assess its using effect.Results Ten patients[6 females and 4 males,(43.2±13.6)years old]were included and all prostheses were positioned accurately and fixed excellently.After(29.4±17.3)months follow-up,the occlusion relationship was stable and no adverse symptoms such as dizziness,headache,meningeal irritation and permanent facial nerve injury occurred.The pain,diet,mandibular movement function,lateral movement to diseased side and mouth opening had significant improvements.The forward movement and lateral movement to normal side were not improved significantly.There were no prosthesis displacement,loosening and fracture in X-ray and CT postoperatively.With the pre and postoperative craniomaxillofacial model merging,the maximal implanted error was(0.52±0.17)mm for fossa and condyle and(1.62±0.26)mm for skull base and mandibular handle in surface deviation analysis.Conclusions The custom-made TMJ-skull base combined prosthesis with customized design and 3D printing fabrication is safe,effective and precise in clinical application.