国产多孔钽棒治疗早期股骨头缺血性坏死的临床疗效

Clinical efficacy of domestic porous tantalum rod in treatment of early avascular necrosis of femoral head

目的探讨国产多孔钽棒治疗早期股骨头缺血性坏死（ANFH）的临床疗效。方法采用前瞻性研究分析2014年7月— 2015年12月应用国产多孔钽棒治疗的早期股骨头缺血性坏死患者18例（19髋），其中男14例，女4例；年龄30～62岁，平均44.2岁。根据改良Ficat分期：Ⅱa期4例，Ⅱb期14例。疗效评估包括术前及术后3，6，12个月患髋的Harris评分、Womac评分、股骨头生存率、影像学变化、术后并发症、骨与钽棒界面情况。结果患者均获随访8～24个月，平均16个月。末次随访未发现局部感染、切口不愈合、排异反应、钽棒断裂、松动或移位等不良事件。术后3，6，12个月Harris评分[（82.7±9.0）分、（84.5±10.8）分、（87.2±10.0）分]较术前[（75.5±11.9）分]均明显升高（P〈0.05），末次随访髋关节Harris评分：优10髋，良3髋，可5髋，差1髋，优良率68%。术后3，6，12个月Womac评分[（17.4±9.4）分、（12.4±7.3）分、（11.1±8.4）分]较术前[（28.3±13.1）分]均明显下降（P〈0.05）。影像学结果显示，17例（18髋）股骨头坏死无明显加重，股骨头生存率为95%（18/19）。其中1例因疼痛加重、股骨头塌陷，最终行人工关节置换。置换术后患髋股骨头大体标本可见钽棒与周围骨组织紧密结合，硬组织切片显示新生骨组织已长入材料的孔隙。结论国产多孔钽棒治疗早期股骨头缺血性坏死，能促进骨长入，有效缓解疼痛，防止股骨头塌陷，延缓人工髋关节置换时间，改善髋关节功能。

Objective To investigate the clinical efficacy of domestic porous tantalum rod in treatment of early avascular necrosis of femoral head （ANFH）. Methods A prospective study was made on 18 cases （ 19 hips） diagnosed as early ANFH treated by domestic porous tantalum rod from July 2014 to December 2015. There were 14 males and four females, with a mean age of 44.2 years （range, 30-62 years）. According to the modified Ficat staging, four cases were identified as stage Ⅱ a and 14 stage Ⅱb. Efficacy of the treatment was evaluated by Harris score, Womac score, radiological images of the hip, complications and bone growth. Results All cases were followed up for 8-24 months （ mean, 16 months）. No complications such as infection, wound healing problems, immunological rejection, tantalum rod breakage, loosening or displacement were observed at last follow-up. Harris score was （82. 7 ± 9.0） points, （84.5 ± 10.8） points and （87.2 ± 10. 0） points at postoperative 3, 6 and 12 months respectively, significantly higher than that pre-operation [ （ 75.5 ± 11.9 ） points ] （ P 〈 0.05 ）. Harris score was rated excellent in 10 cases, good in three, fair in five and poor in one at the last follow-up, with the excellent and good rate of 68%. Womac score was （ 17.4 ± 9.4） points, （ 12.4± 7.3 ） points, and （ 11.1 ± 8.4） points at postoperative 3, 6 and 12 months respectively, significantly lower than that pre-operation [ （ 28.3 ± 13.1 ） points ] （ P 〈 0. 05 ）. Seventeen cases （ 18 hips ） showed no obvious deterioration in femoral head necrosis, with femoral head survival rate of 95%. One case underwent total hip arthroplasty after operation because of progressive hip pain and collapsed femoral head. Bone ingrowth was detected in the porous tantalum biomaterial after operation. Conclusion Domestic porous tantalum rod can effectively promote bone ingrowth, relieve pain, prevent the collapse of the femoral head, delay total hip arthroplasty time and finally improve hip function in treatment of early avascular necrosis of femoral head.