3D打印钛合金骨小梁重建棒治疗早期股骨头坏死的有效性分析

摘要

目的 评估3D打印金骨小梁钛棒的安全性、骨长入能力并评估其临床疗效.方法 早期(ACROⅡ期)股骨头坏死(ONFH)患者合并有严重的髋部疼痛,需要手术保髋治疗的住院患者共60例,随机分为试验组(钛棒组)30例和对照组(钽棒组)30例.术后6、12和24个月进行随访,采用Harris髋关节功能评分和视觉模拟评分(VAS)进行评估.同时观察术前术后X线分期变化.24个月时行影像学评估.结果 本研究无失访病例.仅6个月时钛棒组Harris评分低于钽棒组,其余时间点2组评分差异均无统计学意义;重复测量的方差分析结果亦显示,时间效应差异有统计学意义.2组术前术后X线分期发生变化,Ⅲ期、Ⅳ期随着时间推移逐渐增多,2组术后随着时间的推移ONFH均有进展.2组未出现感染及排异,ⅡA期和ⅡB期改善率高,好转率和保髋率差异均无统计学意义.2组术后6个月时正、侧位X线片分区中透亮线均消失,未出现新的透亮线;2组患者术后随访期间1区均未出现骨质增强:2组各个分区均未出现应力遮挡和骨小梁骨质增强.结论 钛棒治疗操作简单,对于股骨头坏死早期ACROⅡB期之前治疗效果满意,而对于坏死面积相对较大的ACROⅡC期则不建议采用.%Objective To evaluate the safety of 3D printed titanium alloy trabecular reconstruction rod, bone grafts and its clinical efficacy. Methods Sixty patients with osteonecrosis of femoral head (ONFH) stageⅡ(ACROⅡ) were randomly divided into experimental group (titanium rod group) and control group (tantalum rod group). Patients were followed up at 6, 12 and 24 months after the operation. Harris score and visual analogue scale (VAS) were used to evaluate the postoperative function. Changes of X-ray were observed before and after operation. The imaging evaluation was analyzed after 24 months. Results The Harris score was decreased in titanium rod group compared with that of tantalum rod group at six-month. There were no significant differences in Harris scores for other time points between two groups. Repeated measures analysis of variance showed that there was a significant difference in time effect. The X-ray staging results changed gradually before and after operation in two groups, stage Ⅲand stage Ⅳgradually increased with time. There was progress in ONFH after operation in two groups. No infection or rejection was found in the two groups. There were higher improvement rates of stageⅡA and stageⅡB. There were no significant differences in improvement rate and hip preservation rate between two groups. The transparent lines disappeared in the positive and lateral X-ray films 6 months after the operation. No new transparent lines were found. The bone enhancement was not found in two groups of patients during follow-up period. No stress occlusion and bone trabecular bone enhancement were observed in two groups. Conclusion Titanium rods are satisfactory for the treatment of femoral head necrosis in the early stage of ACRO Ⅱ, which is not recommended for the treatment of relatively large ACROⅡC stage of necrotic area.