Mobi-C人工颈椎间盘临床应用初步报告

PRELIMINARY CLINICAL STUDY ON ARTIFICIAL CERVICAL DISC REPLACEMENT BY Mobi-C PROSTHESIS

目的探讨采用Mobi-C人工颈椎间盘假体在颈椎前路椎间盘切除减压、人工椎间盘置换术(artificial disc replacement,ADR)中的临床应用价值。方法 2009年1月-6月,收治符合颈椎间盘置换指征的颈椎退行性疾病患者20例。其中男8例,女12例;年龄29～54岁,平均45.2岁。颈椎间盘突出症13例,神经根型颈椎病7例。病程4d～5年,平均1.2年。病变节段:C3、41例,C4、52例,C5、67例,C6、75例,C4、5合并C5、62例,C5、6合并C6、73例。术前常规行颈椎正侧位、动力位X线片及MRI检查。均行经前路椎间盘切除减压、Mobi-C人工颈椎间盘假体ADR,共植入Mobi-C人工颈椎间盘假体25枚。所有患者术后定期摄X线片测量置换节段活动度(range of motion,ROM);采用北京大学第三医院40分(COA)评分系统评价患者术前及末次随访时的颈脊髓功能;采用颈椎残障功能量表(NDI)评分及疼痛视觉模拟评分(VAS)评价患者生活质量。结果所有患者术后切口均Ⅰ期愈合,术中、术后未出现手术相关并发症。20例均获随访,随访时间14～18个月,平均16.5个月。术前及末次随访时置换节段ROM比较差异无统计学意义(t=0.808,P=0.440)。随访期内未见异位骨化。术前及末次随访时COA评分分别为(32.10±2.96)分和(38.20±1.14)分,差异有统计学意义(t=9.278,P=0.000);末次随访时改善率为77.2%±5.4%。术前及末次随访时VAS评分分别为(5.10±1.29)分和(3.20±1.23)分,差异有统计学意义(t=10.585,P=0.000);NDI评分分别为(39.20±3.80)分和(29.40±4.55)分,差异有统计学意义(t=16.039,P=0.000)。结论在合理选择适应证的前提下,采用Mobi-C人工颈椎间盘假体行ADR治疗退行性颈椎疾患,近期临床疗效满意。

Objective To study the clinical application of Mobi-C prosthesis in treatment of anterior cervical discectomy and artificial disc replacement（ADR）.Methods Between January 2009 and June 2009,20 cases of degenerative cervical disease were treated with anterior discectomy and ADR by Mobi-C prosthesis,including 13 cases of cervical disc herniation and 7 cases of cervical spondylotic radiculopathy,and 25 Mobi-C prosthesis were implanted.There were 8 males and 12 females,aged 29-54 years（mean,45.2 years）.The disease duration was from 4 days to 5 years（mean,1.2 years）.Affected segments of process included C3,4 in 1 case,C4,5 in 2 cases,C5,6 in 7 cases,C6,7 in 5 cases,C4,5 and C5,6 in 2 cases,and C5,6 and C6,7 in 3 cases.Radiographs were taken regularly,and cervical range of motion（ROM） on segments of disc replacements were measured.The functions of cervical spinal cord were evaluated by °40 score ± system（COA） preoperatively,immediately postoperatively,and at follow-up.The quality of life was evaluated by neck disability index（NDI） and visual analogue scale（VAS） score.Results All incisions healed by first intention.No perioperative complication was found.All cases were followed up 16.5 months on average（range,14-18 months）.There was no significant difference in cervical ROM of operatied segment between preoperation and follow-up duration（t=0.808,P=0.440）.No heterotopic ossification was found at follow-up.COA score at last follow-up（38.20± 1.14） was significantly higher than preoperative one（32.10± 2.96）,（t=9.278,P=0.000）,and the improvement rate at last follow-up was 77.2%± 5.4%.VAS score at last follow-up（3.20± 1.23） had significant difference when compared with preoperative one（5.10± 1.29）,（t=10.585,P=0.000）.NDI score at last follow-up（29.40± 4.55） had significant difference when compared with preoperative one（39.20± 3.80）,（t=16.039,P=0.000）.Conclusion A satisfactory short-term curative effect can be obtained by using Mobi-C prosthesis in treatment of anterior cervical discectomy and ADR.