生物陶瓷系统微创治疗ARCOⅡ、Ⅲ期股骨头坏死  

Minimally invasive treatment for osteonecrosis of the femoral head in ARCO stage Ⅱ and Ⅲ with bioceramic system

作　　者：鲁亚杰 王臻 卢霄 卢建熙 陈献韬 牛东升 冯宪发 张成泉 余进伟[7] 王保苍[8] LU Yajie;WANG Zhen;LU Xiao;LU Jianxi;CHEN Xiantao;NIU Dongsheng;FENG Xianfa;ZHANG Chengquan;YU Jinwei;WANG Baocang(Department of Orthopedics,the First Affiliated Hospital of the Air Force Medical University of Chinese PLA,Xi’an Shaanxi,710032,P.R.China;Shanghai Bio-lu Biomaterials Co.,Ltd.,Shanghai,200000,P.R.China;Department of Orthopedics,Luoyang Orthopedic-Trumatological Hospital of Henan Province (Henan Provincial Orthopedic Hospital),Luoyang Henan,471000,P.R.China;Department of Orthopedics,People’s Hospital of Ningxia Hui Autonomous Region,Yinchuan Ningxia,750021,P.R.China;Department of Orthopedics,Songyuan Central Hospital,Songyuan Jilin,138000,P.R.China;Department of Orthopedics,Hanzhong Central Hospital,Hanzhong Shaanxi,723000,P.R.China;Department of Orthopedics,the Second People’s Hospital of Jiaozuo,Jiaozuo Henan,454150,P.R.China;Department of Orthopedics,the Second Hospital of Tangshan,Tangshan Hebei,063000,P.R.China)

机构地区：[1]中国人民解放军空军军医大学第一附属医院骨科,西安710032 [2]上海贝奥路生物材料有限公司,上海200000 [3]河南省洛阳正骨医院(河南省骨科医院)骨科,河南洛阳471000 [4]宁夏回族自治区人民医院骨科,宁夏银川750021 [5]松原市中心医院骨科,吉林松原138000 [6]汉中市中心医院骨科,陕西汉中723000 [7]焦作市第二人民医院骨科,河南焦作454150 [8]唐山市第二医院骨科,河北唐山063000

出　　处：《中国修复重建外科杂志》2019年第10期1291-1298,共8页Chinese Journal of Reparative and Reconstructive Surgery

摘　　要：目的完善β磷酸三钙(βtricalcium phosphate,β-TCP)生物陶瓷系统微创治疗股骨头坏死(osteonecrosis of the femoral head,ONFH)的理论体系,评估其临床疗效。方法取7~8月龄雄性新西兰大白兔18只制备血管化动物模型,术后4、8、12周采用micro-CT扫描血管三维重建和荧光背景下血管显像观察新生血管形态,并计算血管长入包裹区的深度、血管数目以及血管直径。取9个猪股骨标本随机分为3组(n=3):A组为正常股骨头颈组;B组为空腔组(隧芯减压通道+股骨头内球形骨缺损);C组为植骨组,打压植入混合陶瓷颗粒填充股骨头内球形缺损,骨隧道内植入β-TCP多孔生物陶瓷棒。行生物力学检测计算标本的刚度及屈服载荷。多中心回顾分析2012年1月-2018年7月,国内7所医疗中心行生物陶瓷系统微创保髋治疗的ONFH患者200例(232髋)。其中男145例,女55例;年龄17~76岁,平均42岁。按照国际骨循环协会(ARCO)分期为Ⅱ期150髋,Ⅲ期82髋。术后定期对患者进行影像学评估,采用Harris评分对髋关节功能进行评价,并比较ARCOⅡ期与Ⅲ期患者的临床疗效。结果动物实验结果显示血管可由多孔生物陶瓷棒非包裹区长入包裹区,至12周时可见血管贯穿包裹区。随术后时间延长,血管长入包裹区的深度、血管数目、血管直径均逐渐增加,各时间点间比较差异均有统计学意义(P<0.05)。生物力学检测示,B、C组标本刚度和屈服载荷显著低于A组,B组屈服载荷显著低于C组,差异均有统计学意义(P<0.05);C组股骨头颈的刚度恢复至A组的41.52%±3.96%,屈服载荷恢复至A组的46.14%±7.85%。临床研究显示,200例患者均获随访,随访时间6~73个月,平均22.7个月。至末次随访时有12例(16髋)行全髋关节置换术,髋关节生存率为93.10%;根据影像学评估,184髋(79.31%)影像学稳定,48髋(20.69%)出现影像学进展;Harris评分为(79.3±17.3)分,较术前(57.3±12.0)分显著改善(t=18.600,P=0.000);�Objective To perfect the theory system of minimally invasive treatment for osteonecrosis of the femoral head(ONFH) with β tricalcium phosphate(β-TCP) bioceramic system and evaluate the effectiveness.Methods Eighteen New Zealand white rabbits aged 7-8 months were used to establish an animal model to verify the vascularization of porous β-TCP bioceramic rods. Micro-CT based three-dimensional reconstruction and fluorescence imaging were used to display the new blood vessels at 4, 8, and 12 weeks after operation. The inserting depth, number and diameter of vessels in the encapsulated area were analyzed. Nine pig femoral specimens were randomly divided into3 groups(n=3): group A was normal femur;group B had cavity(core decompression channel+spherical bone defect in femoral head);in group C, mixed bioceramic granules were implanted to fill the defect in femoral head, and porous β-TCP bioceramic rod was implanted into decompression channel. The stiffness and yield load of specimens were analyzed by biomechanical test. A multicenter retrospective study was conducted to analyze 200 patients(232 hips) with femoral head necrosis treated with bioceramic system in 7 hospitals in China between January 2012 and July 2018. There were 145 males and 55 females, with an average age of 42 years(range, 17-76 years). According to the Association Research Circulation Osseous(ARCO) stage, 150 hips were in stage Ⅱ and 82 hips in stage Ⅲ. Postoperative imaging assessment was carried out regularly, and hip function was evaluated by Harris score. The effectiveness of ARCO stage Ⅱ and Ⅲ was also compared. Results Animal experiments showed that blood vessels could grow into the encapsulated area and penetrate it at 12 weeks. The inserting depth, number and diameter of blood vessels in the encapsulated area gradually increased,and there was significant difference between different time points(P<0.05). Biomechanical tests showed that the stiffness and yield load of specimens in groups B and C were significantly lower than those in g

关 键 词：股骨头坏死 生物陶瓷 血管化 生物力学 多中心临床研究 

分 类 号：R687.3[医药卫生—骨科学] R318.08[医药卫生—外科学]