国产人工颞下颌关节的研发和初步临床应用

摘要

目的 探讨自主研发的国产人工颞下颌关节的初步临床应用效果.方法 自主研发设计和制作人工颞下颌关节,经动物实验、生物力学等检测合格后,分别应用于晚期骨关节病、关节强直、髁突肿瘤患者的关节置换,术中评价假体与骨面的贴合程度和稳定性;术后进行CT检查和临床及影像学随访,观察患者的张口度、假体位置、螺钉周围有无骨吸收以及人工髁突周围有无异位成骨等,评价其初步临床应用效果.结果 6例患者7侧假体术中安装顺利,就位稳定,术后CT显示假体位置与手术设计无明显误差.术后随访6～13个月,平均7.6个月,术后张口度[(31.5±4.8)mm]与术前[(16.2±14.4) mm]相比显著增大(P=0.01),无感染等并发症发生,假体位置稳定、无螺钉松动移位、人工髁突周围无异位成骨.结论 自主研发的国产人工颞下颌关节假体通过初步临床应用效果稳定,远期效果需要进一步观察.%Objective To explore the clinical application of home-made temporomandibular joint (TMJ) prostheses.Methods Self-developed TMJ prostheses were applied for end stage osteoarthritis,TMJ ankylosis,condylar tumors after biomechanical examination.The stability of the prostheses toward bone was evaluated during operation.Post-operative CT scans and clinical follow-ups were taken to check changes of mouth opening,position of the prostheses,bone resorption around the screws,and heterotopic bone formation around artificial condyle.Results There were 6 patients accepted 7 prostheses smoothly without infection and other complications.Post-operative follow-ups were from 6 to 13 months with a mean of 7.6 months.Mouth opening was significantly improved from (16.2± 14.4) mm before operation to (31.5±4.8) mm during follow-ups (P=0.01).All prostheses were stable without screw loose and heterotopic bone formation.Conclusions Home-made TMJ prostheses were stable after primary clinical application,but the long-term results need to be observed.