国产3D打印个性化全颞下颌关节的临床初步应用

Clinical application of domestic customized 3D-printing total temporomandibular joint prostheses

目的·初步验证国产3D打印个性化全颞下颌关节假体临床应用的安全性、有效性和精确性。方法·收集2例颞下颌关节骨关节病患者,术前拍摄颌面部CT。将CT数据导入Mimic 18.0软件中,个性化设计符合患者关节的解剖结构全颞下颌关节假体,并通过3D打印等技术加工生产。经过力学性能检测符合标准后,进行临床手术。手术选择改良耳颞切口,显露关节后切除病变的关节结节和髁突,放入该假体并固定,检查咬合关系良好后关创、缝合。术后1周、1个月和3个月时进行临床随访和影像学检查;并将术前CT设计的假体位置和术后CT中假体的植入位置进行拟合,分析假体植入位置的偏差。结果·假体静态下的平均最大承载力为3 100 N;疲劳性能检测中未见裂纹或断裂;消毒灭菌后生物监测均合格。2例患者术中假体均就位顺利,与骨面贴合且固位稳定;术后1周、3个月的X线片均未见假体移位、松动和断裂等;术后3个月,患者的疼痛、饮食和张口度都有明显的改善。术前与术后拟合结果显示:关节窝假体植入的平均误差为(0.904±0.292)mm,下颌假体植入的平均误差为(0.528±0.198)mm,总体平均误差为(0.878±0.259)mm。结论·自行研制的3D打印个性化全颞下颌关节假体在临床应用中具有较好的安全性和有效性。

Objective· To verify the safety,efficiency,and precision of the clinical application of domestic customized 3D-printing total temporomandibular joint prostheses.Methods·2 patients with temporomandibular joint osteoarthrosis were included in this study.The maxillofacial computed tomography(CT) was performed before surgery and the CT data were input into the Mimics 18.0 software.The customized total joint prostheses were designed according to the anatomy of patients’ temporomandibular joints and were made with 3D printing.The surgeries were performed after the mechanical performance test for the prostheses.The modified preauricular approach was used and the prosthesis was placed and fixed after removing affected joint nodules and condyles.The wound was closed and sutured after occlusion was examined.The clinical follow-up and radiography examinations were performed 1 week,1 month,and 3 months after surgery.The preoperative designed position and postoperative implant position of prosthesis in CT images were compared and the deviation was analyzed.Results· The average static yield strength of the prosthesis was 3100 N.No cracks or fractures were detected during fatigue tests.Biological examinations were qualified after disinfection and sterilization.All prostheses were positioned smoothly and firmly attached to bone surfaces.Prostheses showed no displacement,loosening,and fracture in X-ray images 1 week and 3 months after surgery.The pain,diet,and mouth opening of patients were significant improved 3 months after surgery.The fitting results of preoperative and postoperative CT images indicated that the mean error between preoperative designed position and postoperative implant position of prosthesis was(0.904 ± 0.292) mm at the fossa and(0.528 ± 0.198) mm at the ramus.The overall mean error was(0.878 ±0.259) mm.Conclusion · The domestic customized 3D-printing total temporomandibular joint prosthesis is safe and efficiency for the clinical application.