脊髓型颈椎病前路减压两种固定融合方法比较（开放获取）

Comparison of two instrumented fusion techniques in anterior cervical decompression and fusion for cervical spondylotic myelopathy (Open Access)

摘要:

[目的]比较零切迹自稳型颈椎融合器（zero notch self stabilizing cervical fusion cage, ROI-C）与钛板-融合器（platecage, PC） 颈椎前路减压融合术 （anterior cervical decompression and fusion, ACDF） 治疗脊髓型颈椎病 （cervical spondylotic my- elopathy, CSM） 的临床效果。[方法] 2021 年 1 月—2022 年 7 月就诊于本院的 CSM 患者 112 例，抽签法随机分为两组，其中 56 例采用 ROI-C 的 ACDF，另外 56 例采用 PC 内固定。比较两组围手术期、随访及影像学资料。[结果]ROI-C 组手术时间 [(105.8±24.6) min vs (128.2±30.5) min, P＜0.001]、术中出血量 [(26.0±4.3) ml vs (31.0±5.8) ml, P＜0.001] 、术后下地行走时间 [(1.3±0.4) d vs (1.6±0.5) d, P＜0.001] 及早期并发症发生率（7.1% vs 26.8%, P=0.006）均显著优于 PC 组。两组恢复完全负重活动时间差异无统计学意义 （P＞0.05）。随时间推移，两组 JOA、NDI 评分及锥体束征均显著改善 （P＜0.05）。术后 3 个月 ROI-C 组 NDI 评分 [(18.6±4.2) vs (20.8±4.5), P=0.009] 显著优于 PC 组，其他相应时间点，两组间上述指标的差异均无统计学意义（P＞0.05）。影像方面，与术前相比，末次随访时两组颈椎前凸角、最小椎管矢状径均显著增加（P＜0.05），而颈椎 ROM 显著减小（P＜0.05）。对应时间点，两组上述影像学指标的差异均无统计学意义（P＞0.05）。至末次随访时，融合器下沉两组间差异无统计学意义（12.5% vs 3.6%, P=0.164）。[结论] 两种固定融合方法的 ACDF 的临床结果近似，相比之下，ROI-C 手术创伤小，早期并发症发生率低， 早期临床结果优于 PC。

Abstract:

[Objective] To compare the clinical outcomes of anterior cervical decompression and fusion (ACDF) with zero notch self-stabilizing cervical fusion cage (ROI-C) versus titanium plate-cage system (PC) for cervical spondylotic myelopathy (CSM). [Methods] A total of 112 patients who admitted to our hospital for CSM from January 2021 to July 2022 were included into this study and randomly divided into two groups by lottery. Among them, 56 patients received ROI-C, while the other 56 patients received PC as instrumented fusion implant in ACDF. The perioperative period, follow-up and imaging data of the two groups were compared. [Results] The ROI-C group proved significantly superior to the PC group in terms of surgery time [(105.8±24.6) min vs (128.2±30.5) min, P＜0.001], intraoperative blood loss [(26.0± 4.3) ml vs (31.0±5.8) ml, P＜0.001], time to resume postoperative walking [(1.3±0.4) days vs (1.6±0.5) days, P＜0.001] and the incidence of early complications (7.1% vs 26.8%, P=0.006). There was no significant difference in time to return full weight-bearing activities between the two groups (P＞0.05). The JOA and NDI scores, as well as pyramidal tract sign were significantly improved in both groups over time (P＜ 0.05). The NDI score in ROI-C group was significantly better than that in the PC group 3 months postoperatively [(18.6±4.2) vs (20.8±4.5), P=0.009], which became not statistically significant since then between them (P＞0.05). In addition, there were no statistically significant differences in the JOA score and pyramidal tract sign between the two groups at any time points accordingly (P＞0.05). In terms of imaging, compared with pre-operation, the cervical lordosis angle and minimum sagittal spinal canal diameter were significantly increased in both groups at the last follow-up (P＜0.05), while the cervical ROM was significantly decreased (P＜0.05). At the corresponding time point, there were no statistically significant differences in the above imaging indexes between the two groups (P＞0.05). At the last follow-up, there was no statistically significant difference between the two groups in term of fusion subsidence (12.5% vs 3.6%, P=0.164). [Conclusion] The clinical outcomes of ACDF with both the instrumented-fusion methods were similar. In contrast, the ROI-C had less surgical trauma and lower incidence of early complications, and better the early clinical consequences over the PC.