单节段颈椎减压融合个性化与成品零切迹融合器比较

Personalized zero profile devices versus finished counterpart for single-level anterior cervical decompression and fusion

摘要:

[目的] 探讨颈椎前路椎间盘切除融合（anterior cervical discectomy and fusion, ACDF） 联合3D 打印零切迹融合器（Cage） 治疗单节段颈椎病的临床效果。[方法] 回顾性分析本院2019 年1 月—2022 年9 月收治的46 例需行ACDF 患者的临床资料，根据医患沟通结果，12 例采用3D 打印零切迹Cage（个性化组），34 例采用聚醚醚酮（poly-ether-etherke-tone, PEEK）零切迹Cage（成品组），比较两组围手术期、随访及影像资料。[结果] 两组手术时间、切口总长度、术中失血量、透视次数、下地行走时间、住院时间的差异均无统计学意义（P＞0.05）。个性化组Cage 置入时间[(8.6±0.8) min vs (9.4±0.9) min, P=0.007] 显著少于成品组。随访平均时间（34.1±13.2） 个月，两组完全负重活动时间的差异无统计学意义（P＞0.05）。术后随时间推移，两组NDI 评分、JOA 评分、锥体束征均显著改善（P＜0.05）。术后6 个月，个性化组JOA 评分[(16.4±0.8) vs (15.9±0.7) , P=0.034] 显著优于成品组；末次随访时，个性化组NDI 评分[(0.8±2.0) vs (1.3±1.4) , P=0.027] 和JOA 评分[(16.7±0.7) vs (16.0±0.8) ,P=0.008] 均显著优于成品组。影像方面，末次随访时，个性化组椎间高度[(8.4±0.7) mm vs (7.4±0.8) mm, P＜0.001] 显著优于成品组，相应时间点，两组颈椎前凸角、椎管矢状径、Bridwell 评级差异均无统计学意义（P＞0.05）。[结论] 对于行ACDF 治疗单节段的颈椎病患者，3D 打印零切迹Cage 置入时间更短、融合质量更好、能更好地维持椎间高度、更有效地缓解术前症状，早期临床疗效更好。

Abstract:

[Objective] To compare the clinical outcomes of anterior cervical discectomy and fusion (ACDF) with personalized (3Dprinted) zero profile fusion device (the PZPD) versus the finished zero profile fusion device (the FZPD) in the treatment of single-level cer-vical myelopathy. [Methods] A retrospective study was conducted on 46 patients who underwent ACDF for single-level cervical myelopa-thy in our hospital from January 2019 to September 2022. According to doctor-patient communication, 12 patients had ACDF performedwith the PZPD, while other 34 patients were treated with poly-ether-etherke-tone (PEEK) FZPD. The data of the perioperative period, fol-low-up and images were compared between the two groups. [Results] There were no significant differences in operation time, total incisionlength, intraoperative blood loss, fluoroscopy times, ambulation time and hospital stay between the two groups (P＞0.05), but the PZPDgroup consumed significantly less device placement time than the FZPD group [(8.6±0.8) min vs (9.4±0.9) min, P=0.007]. The mean followuptime was (34.1±13.2) months, and there was no significant difference in time to return full weight-bearing activity between the twogroups (P＞0.05). The NDI and JOA scores, as well as pyramidal tract sign were significantly improved in both groups over time postopera-tively (P＜0.05). The PZPD group proved significantly superior to the FZPD group in terms of JOA score [(16.4±0.8) vs (15.9±0.7), P=0.034]6 months postoperativwly, JOA score [(16.7±0.7) vs (16.0±0.8), P=0.008] and NDI score [(0.8±2.0) vs (1.3±1.4), P=0.027] at the latest fol-low-up. Radiographically, the PZPD group had significantly greater intervertebral height than the FZPD group at the last follow-up [(8.4±0.7) mm vs (7.4±0.8) mm, P＜0.001], although there were no statistically significant differences in cervical lordosis angle, spinal canal sagit-tal diameter and Bridwell fusion grade between the two groups at any corresponding time points (P＞0.05). [Conclusion] The personalizedzero profile fusion device has advantages of quick device placement, better intervertebral height maintenance, more effective relief of preop-erative symptoms, and better early clinical efficacy over the finished counterpart in ACDF for cervical myelopathy.