基于增材制造技术的距骨部分假体设计开发与临床应用研究

Research on design,development,and clinical application of talar partial prosthesis based on additive manufacturing technology

目的 拟通过基于增材制造技术的部分距骨假体的快速设计、制造及临床应用,验证其在距骨骨缺损或伴有囊性变的距骨软骨损伤治疗中的可行性及临床有效性。方法 使用Mimics等软件,基于患者双侧负重CT数据进行了三维结构重建、假体设计和手术截骨导板设计,并通过增材制造技术制造出符合设计的部分距骨假体,并在体外对假体所用多孔小梁结构金属进行抗压、拉伸试验验证其稳定性。对9例大面积距骨软骨和骨组织缺损的患者进行了个性化临床诊断和个性化假体手术植入治疗,并收集术前骨软骨损伤及骨缺损范围,以及术前、末次随访的AOFAS评分、VAS评分、FFI评分。结果 多孔类骨小梁结构平均抗压峰值载荷为6 675.67 N(6 405~6 962 N),平均抗压强度为132.81 MPa(127.42~138.51 MPa),平均抗拉伸峰值载荷1 436 N(1 405~1 456 N)。入组患者平均骨缺损体积(2 621±1 223)mm3(869~4 480 mm3),术前平均AOFAS评分(70.00±10.46)分,VAS评分(3.89±2.42)分,FFI评分(60.56±32.41)分,平均随访时间21.7个月(17~28个月),术后末次随访平均AOFAS评分(89.22±6.99)分,VAS评分(1.11±1.36)分,FFI评分(14.33±7.93)分。结论 在踝关节距骨巨大骨缺损或伴有囊性病变的软骨损伤的治疗中,使用增材制造技术生产的假体能够贴合踝关节,有效重建距骨结构,恢复踝关节功能,达到短期和长期稳定性,提高患者的临床功能评分。

Objective To verify the feasibility and clinical efficacy of rapid design,fabrication and clinical application of partial talar implants based on additive manufacturing technology.Methods Software such as Mimics was used to perform three-dimensional structural reconstruction,prosthesis design,and surgical osteotomy guide plate design based on bilateral WBCT data from patients.Partial talus prostheses that meet the design were manufactured using additive manufacturing technology.The stability of the porous trabecular structure metal used in the prostheses was verified by in vitro compressive and tensile testing.Nine patients with extensive talar cartilage and bone tissue defects underwent personalised clinical diagnosis and personalised implant surgery.The preoperative extent of bone cartilage injury and bone defect,preoperative and postoperative follow-up AOFAS,VAS,FFI were collected.Results The average compressive peak load of porous bone trabecular structure was 6675.67 N(6405-6962 N),the average compressive strength was 132.81 MPa(127.42-138.51 MPa),and the average tensile peak load was 1436 N(1405-1456 N).The average bone defect volume of enrolled patients was(2621±1223)mm³(869-4480 mm³).The preoperative average AOFAS was(70.00±10.46)scores,VAS was(3.89±2.42)scores,and FFI was(60.56±32.41)scores.The average follow-up time was 21.7 months(17-28 months).The average AOFAS at the last postoperative follow-up was(89.22±6.99)scores,the VAS was(1.11±1.36)scores,and the FFI was(14.33±7.93)scores.Conclusion In the treatment of large bone defects or cartilage injuries with cystic lesions in the ankle and talus,prostheses produced using additive manufacturing technology can fit the ankle joint,effectively reconstruct the talus structure,restore ankle joint function,achieve short-term and long-term stability,and improve patient clinical function scores.