Objective: To investigate the efficacy and safety of a new cervical artificial disc prosthesis in the treatment of cervical degenerative diseases. Methods: The clinical data of 18 patients with single-level cervical degenerative diseases who underwent three dimensional printed anatomical bionic cervical disc replacement at Department of Spinal Surgery,Honghui Hospital,Xi'an Jiaotong University from May 2019 to July 2020 were analyzed retrospectively. There were 7 males and 11 females,aged (45±8) years old(range:28 to 58 years).The surgical segment was located at C3－4 level in 2 cases, C4－5 level in 5 cases, C5－6 level in 9 cases, and C6－7 level in 2 cases.The clinical and radiographic outcomes were recorded and compared at preoperative,postoperative times of one month and twelve months.The clinical assessments contained Japanese orthopedic association (JOA) score,neck disability index (NDI) and visual analogue scale (VAS).Imaging assessments included range of motion (ROM) of cervical spine, prosthesis subsidence and prosthesis anteroposterior migration.Repeated measurement variance analysis was used for comparison between groups,and paired t test was used for pairwise comparison. Results: All patients underwent the operation successfully and were followed up for more than 12 months.Compared with preoperative score,the JOA score,NDI and VAS were significantly improved after surgery (all P<0.01).There was no significant difference in postoperative ROM compared with 1-and 12-month preoperative ROM (t=1.570,P=0.135;t=1.744,P=0.099). The prosthesis subsidence was (0.29±0.13) mm (range: 0.18 to 0.50 mm) at 12-month postoperatively.The migration of prosthesis at 12-months postoperatively were (0.71±0.20) mm (range: 0.44 to 1.08 mm).There was no prosthesis subsidence or migration>2 mm at 12-month postoperatively. Conclusion: Three dimensional printed anatomical biomimetic cervical artificial disc replacement has a good early clinical effect in the treatment of cervical degenerative diseases, good mobility can be obtained while maintaining stability.
目的： 探讨一种新型颈椎人工间盘假体应用于人工颈椎间盘置换术的有效性和安全性。 方法： 回顾性分析2019年5月至2020年7月在西安交通大学附属红会医院脊柱病医院采用三维打印解剖仿生型颈椎间盘置换治疗的18例单节段颈椎退行性疾病患者的临床资料。其中男性7例，女性11例，年龄（45±8）岁（范围：28~58岁）。手术节段：C3~4 2例，C4~5 5例，C5~6 9例，C6~7 2例。对术前、术后1个月及12个月随访时的临床效果和影像学指标进行比较。临床疗效评价指标包括日本骨科协会（JOA）评分、疼痛视觉模拟评分（VAS）、颈椎功能障碍指数（NDI）；影像学评估指标包括手术节段活动度（ROM）、假体移位、假体下沉。不同时间点数据的比较采用重复测量方差分析，两两比较采用配对样本t检验。 结果： 所有患者均顺利完成手术并随访大于12个月。手术前后患者JOA评分、VAS、NDI的差异均有统计学意义（P值均<0.01）。术后1个月、12个月手术节段活动度与术前相比差异均无统计学意义（t=1.570，P=0.135；t=1.744，P=0.099）。术后12个月假体下沉距离为（0.29±0.13）mm（范围：0.18~0.50 mm），假体移位距离为（0.71±0.20）mm（范围：0.44~1.08 mm），无假体下沉或移位>2 mm病例。 结论： 三维打印解剖仿生型颈椎人工间盘置换治疗颈椎退行性疾病早期临床疗效良好，能在保留颈椎活动度的同时，获得良好的稳定性。.