前路颈椎间盘切除3D打印微孔钛合金椎间融合器与聚醚醚酮椎间融合器椎间融合术治疗脊髓型颈椎病的疗效对比

Comparison of the efficacy of ACDF in the treatment of cervical spondylotic myelopathy using 3D printed intervertebral fusion cage and Polyether-ether-ketone(PEEK) intervertebral fusion cage

中文关键词:  脊髓型颈椎病  椎间融合器  聚醚醚酮  3D打印

英文关键词:Cervical spondylotic myelopathy  Interbody fusion cage  Polyether-ether-ketone  3D printing

中文摘要:

  【摘要】 目的：比较前路颈椎间盘切除后应用3D打印微孔钛合金椎间融合器或聚醚醚酮（PEEK）椎间融合器行椎间融合术治疗脊髓型颈椎病（CSM）的疗效。方法：2017年5月~2019年3月我院收治的需行前路颈椎间盘切除椎间融合术的CSM患者71例，按照随机数字表法将患者随机分为观察组（行颈前路椎间盘切除减压、3D打印微孔钛合金椎间融合器置入内固定术，35例）和对照组（行颈前路椎间盘切除减压、PEEK椎间融合器置入内固定术，36例）。观察组男性26例、女性9例，年龄46.4±4.9岁，病程2.5±0.2年，单节段病变19例、双节段病变16例。对照组男性23例、女性13例，年龄46.1±4.3岁，病程2.5±0.2年，单节段病变20例，双节段病变16例。两组患者术前资料无统计学差异（P>0.05）。在术前、术后3个月及末次随访时，对患者进行JOA评分及颈椎正侧位、过伸过屈位X线片检查，在X线片上测量融合节段的椎体高度及Cobb角并观察植骨融合情况。比较两组患者在术前、术后3个月及末次随访时的JOA评分及改善率、融合节段的椎体高度变化及Cobb角变化、植骨融合情况。结果：患者手术顺利，术后出现颈部吞咽不适症状8例（观察组3例，对照组5例），1~2周后上述症状消失。两组均无钢板螺钉断裂、移位发生，12个月随访时均骨性融合。观察组手术时间94.6±18.0min、术中出血量117.8±41.9ml、住院时间10.0±2.2d，对照组手术时间89.2±18.5min、术中出血量127.5±39.0ml、住院时间10.3±2.5d，两组手术时间、术中出血量、住院时间的对比差异均无统计学意义（P>0.05）。观察组JOA评分由术前9.3±1.7分提高至术后12个月时的14.5±1.6分，改善率为（67.5±4.7）%，对照组JOA评分由术前的8.2±2.8分提高至术后12个月时的13.3±1.5分，改善率为（58.1±4.1）%。两组改善率比较差异无统计学意义（t=1.292，P=0.200）。观察组单节段（19例）融合节段椎体高度术前为31.21±0.94mm、术后3个月时为34.01±1.09mm、末次随访时为33.02±1.32mm；观察组双节段（16例）融合节段术前椎体高度为49.25±1.13mm、术后3个月时为53.75±1.34mm、末次随访时为51.96±1.04mm。对照组单节段（20例）融合节段椎体高度术前为31.45±1.00mm、术后3个月时为33.21±1.00mm、末次随访时为31.28±1.28mm；对照组双节段（16例）融合节段术前椎体高度为49.55±2.13mm、术后3个月时为52.45±1.27mm、末次随访时为50.72±1.36mm。在术后3个月及末次随访时，观察组单节段和双节段的颈椎融合节段椎体高度和Cobb角均大于对照组，差异均有统计学意义（P<0.05）；观察组单节段和双节段的融合节段椎体高度和Cobb角均较术前改善，差异有统计学意义（P<0.05）；末次随访时观察组51个融合器中4个融合器（单节段病变2例，双节段病变1例）发生沉降，沉降率7.8%，对照组52个融合器中16个融合器（单节段病变8例，双节段病变4例）发生沉降，沉降率30.8%，差异有统计学意义（P<0.05）。结论：两种手术方式均能重建颈椎稳定性，具有良好的椎间融合率。微孔钛合金椎间融合器与PEEK椎间融合器相比，手术时间短，假体下沉率低。应用3D打印微孔钛合金椎间融合器行椎间融合内固定术是一种治疗脊髓型颈椎病的较好手术方式。

英文摘要:

  【Abstract】 Objectives: To compare the efficacy of 3D-printed interbody fusion cage and PEEK cage in the treatment of cervical spondylotic myelopathy(CSM). Methods: From May 2017 to March 2019, 71 patients suffered from CSM were randomly divided into observation group(35 with anterior cervical discectomy and interbody fusion with 3D-printed intervertebral cage) and the control group(36 with anterior cervical discectomy interbody fusion with PEEK cage). There were 26 males and 9 females in the observation group, with an average age of 46.4±4.9 years and a course of disease of 2.49±0.24 years. There were 23 males and 13 females in the control, with an average age of 46.1±4.3 years and a course of disease of 2.53±0.21 years. There was no statistically significant difference in preoperative data between the two groups(P>0.05). All of them completed the operation successfully, and the follow-up time was 12-23 months. 8 patients(3 in the observation group and 5 in the control) showed dysphagia after the operation, however, the symptoms disappeared after 1-2 weeks. JOA score and X-ray were performed before surgery, 3 months postoperatively, and at the final follow-up. The vertebral body height and Cobb Angle of the fusion segment were measured on the X-ray to observe the bone graft fusion. T-test, χ2 test and ANOVA were used for comparison between the two groups, P<0.05 was considered statistically significant. Results: No plate and screw fracture or displacement occurred in both groups, and bone healing was observed at 12 months of follow-up. There were no statistically significant differences between the observation group and control group in operation time(94.6±18.0min vs 89.2±18.5min), intraoperative blood loss(117.8±41.9ml vs 127.5±39.0ml), and hospital stay (10.0±2.2d vs 10.3±2.5d), respectively(P＞0.05). At final follow-up, the JOA score of the observation group was increased from 9.3±1.7 preoperatively to 14.5±1.6 after 12 months, with the improvement rate of 67.5%, while that in the control was increased from 8.16±2.8 preoperatively to 13.3±1.5 after 12 months, with the improvement rate of 58.1%. There was no significant difference in improvement rates between the two groups(t=1.292, P=0.200). The height of the vertebral body in single segment case(19 cases) was 31.21±0.94mm before surgery, 34.01±1.09mm three months after operation, and 33.02±1.32mm at final follow-up, while the height of the vertebral body in double segment case(16 cases) was 49.25±1.13mm, 53.75±1.34mm three months after the operation, and 51.96±1.04mm at final follow-up in observation group. Nevertheless, in the control, the height of the vertebral body in single segment case (20 cases) was 31.45±1.00mm before surgery, 33.21±1.00mm three months after surgery, and 31.28±1.28mm at final follow-up, while that in double segment case(16 cases) was 49.55±2.13mm before the operation, 52.45±1.27mm three months after the operation, and 50.72±1.36mm at final follow-up. Three months after surgery and at final follow-up, no matter single or double fusion segments, the height and Cobb angle were bigger in the observation group than in the control, and the differences were statistically significant(P<0.05). The fusion segment vertebral body height and Cobb angle in the observation group were improved compared with those before surgery, and the differences were statistically significant(P<0.05). 4 of 51 cages in observation group sank at final follow-up(2 single segmental cases, 1 double segmental) with prosthesis sedimentation rate 7.8%, while 16 of 52 cages in the control(8 single segmental cases, 4 double segmental) settling with prosthesis subsidence rate 30.8%, and the difference between the two groups was statistically significant(P<0.05). Conclusions: The stability of cervical can be reconstructed by both methods, and the fusion rate of intervertebral fusion is good. Compared with PEEK, 3D-printed intervertebral fusion cage has shorter operation time and lower prosthesissubsidence rate. Therefore, 3D-printed intervertebral fusion cage may be a better surgical method for CSM.