纳米羟基磷灰石/聚酰胺66椎间融合器用于腰椎退变性侧凸椎间融合的疗效

Effectiveness of nano-hydroxyapatite/polyamide-66 Cage in interbody fusion for degenerative lumbar scoliosis

目的探讨纳米羟基磷灰石/聚酰胺66椎间融合器(nano-hydroxyapatite/polyamide-66 Cage,nHA/PA66 Cage)用于腰椎退变性侧凸椎间融合的疗效。方法回顾性分析2013年1月—2016年6月,采用nHA/PA66 Cage行后路侧凸矫形、椎间植骨融合内固定术治疗并获完整随访的43例腰椎退变性侧凸患者临床资料,其中单节段融合18例(单节段组)和双节段融合25例(双节段组)。两组患者性别、年龄、体质量指数、侧凸方向、顶椎旋转度、融合节段、骨质疏松例数以及术前融合节段椎间隙高度、冠状面Cobb角、腰腿痛疼痛视觉模拟评分(VAS)以及改良Oswestry功能障碍指数(ODI)等一般资料比较,差异均无统计学意义(P>0.05)。记录患者手术时间、术中出血量、术后引流量、住院时间以及术后并发症发生情况;采用改良ODI、VAS评分、MacNab标准进行临床疗效评价;影像学检测融合节段椎间隙高度、冠状面Cobb角、Cage植入深度、植骨融合情况等。结果两组手术时间、术中出血量、术后引流量及住院时间比较,差异无统计学意义(P>0.05)。所有患者均获随访,随访时间18~62个月,平均30.9个月。术后4例发生切口相关并发症(单节段组2例、双节段组2例),单节段组1例出现谵妄,双节段组1例发生Cage移位。两组术后融合节段椎间隙高度均较术前明显改善(P<0.05),末次随访时双节段组椎间隙高度高于单节段组(P<0.05)。两组术后冠状面Cobb角均较术前明显矫正(P<0.05),术后各时间点两组间比较差异均无统计学意义(P>0.05)。两组术后3 d、6个月及末次随访时Cage植入深度比较,差异均无统计学意义(P>0.05);各时间点组间比较差异亦无统计学意义(P>0.05)。末次随访时,两组患者均达骨性融合。两组术后VAS评分、改良ODI均较术前改善(P<0.05);末次随访时双节段组VAS评分高于单节段组,差异有统计学意义(P<0.05);其余各时间点VAS评分、改良ODI组间比较差异无统计学意义(P>0.05)。末次随访时,按照腰椎功能MacNab标准,单节段组优良率为94.4%、双节段组为84.0%,差异无统计学意义(P>0.05)。结论采用n-HA/PA66椎间融合器可有效恢复、维持腰椎退变性侧凸患者的融合节段椎间隙高度、重建脊柱稳定性,获得较好疗效。其中,双节段患者椎间隙高度维持优于单节段患者。

Objective To explore the effectiveness of nano-hydroxyapatite/polyamide-66(n-HA/PA66) Cage in interbody fusion for degenerative lumbar scoliosis. Methods A retrospective analysis was designed and conducted for 43 patients, who underwent posterior decompression and n-HA/PA66 Cage interbody fusion with correction of deformity between January 2013 and June 2016. Eighteen cases were single-level fusion(single-level group) and 25 cases were double-level fusion(double-level group). There was no significant difference in gender, age, body mass index, direction of convex, degree of apical rotation, fusion level, the number of osteoporotic patients, pre-operative intervertebral height of fusion segments, coronal Cobb angle, visual analogue score(VAS), and modified Oswestry Disability Index(ODI)between 2 groups(P>0.05). The operation time, intraoperative blood loss, postoperative drainage, hospital stay,and complications of the operation were recorded. Modified ODI, VAS score, and MacNab criteria were adopted to assess clinical outcomes. Radiographic indexes, including intervertebral height of fusion segments, coronal Cobb angle, disc insertion depth, and the bone graft fusion rate, were also evaluated. Results There was no significant difference in operation time, intraoperative blood loss, postoperative drainage, and hospital stay between 2 groups(P>0.05). All patients were followed up 18-62 months(mean, 30.9 months). Wound complications, postoperative delirium, and Cage retropulsion occurred in 4 cases(2 cases in single-level group, 2 cases in double-level group), 1 case of single-level group,and 1 case of double-level group, respectively. The intervertebral height of fusion segments after operation significantly improved compared with preoperative ones in both groups(P<0.05). At last follow-up, the intervertebral height in doublelevel group was superior to which in single-level group(P<0.05). The coronal Cobb angles after operation significantly improved compared with preoperative ones(P<0.05), and no significant difference was found between 2 groups at each time point(P>0.05). The disc insertion depth showed no significant difference between different time points after operation in 2 groups(P>0.05) and between 2 groups at each time point after operation(P>0.05). Bony fusion was obtained in all patients at last follow-up. The VAS score and modified ODI after operation in both groups were superior to those before operation(P<0.05). The VAS score in double-level group was higher than that in single-level group(P<0.05)at last follow-up, and no significant difference was found in VAS score and modified ODI between 2 groups at other time points(P>0.05). According to the MacNab criteria, the excellent and good rates at last follow-up were 94.4% and 84.0% in single-level group and double-level group, respectively. Conclusion The n-HA/PA66 Cage can effectively restore and maintain the disc height of fusion segment, normal sequence, and biomechanical stability of the spine, and gain favorable effectivenss for degenerative lumbar scoliosis. And double-level fusion is superior to single-level fusion in maintaining disc height of fusion segment.