Spine Service, Wilderness Spine Services, The Hughston Clinic, Columbus, Georgia, USA.
J Neurosurg Spine. 2010 Sep;13(3):308-18. doi: 10.3171/2010.3.SPINE09513.
The purpose of this study was to determine long-term clinical outcomes in patients undergoing anterior cervical surgery in which a cervical disc prosthesis was used to treat single-level degenerative cervical disc disease.
In this prospective, nonblinded study, 541 patients at 32 investigational sites were randomly assigned to 1 of 2 treatment groups. The results of the investigational group, in which patients received the Prestige disc prosthesis, were compared with those of the control group, in which patients underwent an instrumented interbody fusion. Data were collected preoperatively, intraoperatively, and at 1.5, 3, 6, 12, 24, 36, and 60 months postoperatively. To date, 271 patients have completed 5 years of clinical follow-up (144 investigational and 127 control patients).
Significant improvements in Neck Disability Index (NDI) scores, Physical Component Summary scores of the 36-Item Short-Form Health Survey, and neck and arm pain scores were achieved by 1.5 months in both groups and sustained at 5 years. The mean NDI improvements from preoperative scores were 35.4, 36.3, and 38.4 at 24, 36, and 60 months, respectively, in the investigational group. The corresponding mean NDI improvements were 33.9, 31.3, and 34.1 in the control group. The intergroup differences at both 36 and 60 months were significant (p = 0.008 and 0.022, respectively). The overall rates of maintenance or improvement in neurological status in the investigational group were 91.6%, 92.8%, and 95.0%, respectively, at 24, 36, and 60 months compared with 83.6%, 83.2%, and 88.9% in the control group (p = 0.006, 0.004, and 0.051, respectively). The implant effectively maintained angular motion, averaging more than 7.3 degrees at 36 months and 6.5 degrees at 60 months after surgery. No implant migration was observed up to 60 months. There were statistically significant differences between the investigational and control groups with regard to the rate of revision and supplemental fixation surgical procedures performed subsequent to the index procedure. Additional surgical procedures for adjacent-segment disease were observed in both treatment groups. Rates for surgery at adjacent levels trended lower in the investigational group (8 patients [11 surgeries]) compared with those in the control group (13 patients [16 surgeries]), but the differences were not statistically significant (p = 0.376). Some of the second surgeries involved both index and adjacent levels.
The Prestige disc maintains improved clinical outcomes and segmental motion after implantation at 5-year follow-up.
本研究旨在确定接受颈椎前路手术治疗单节段退行性颈椎间盘疾病的患者的长期临床结果，其中使用颈椎间盘假体治疗。
在这项前瞻性、非盲法研究中，32 个研究点的 541 名患者被随机分配到 2 个治疗组之一。对接受 Prestige 椎间盘假体治疗的研究组的结果进行了比较，与接受器械椎间融合术治疗的对照组的结果进行了比较。数据在术前、术中以及术后 1.5、3、6、12、24、36 和 60 个月收集。迄今为止，已有 271 名患者完成了 5 年的临床随访（144 名研究组和 127 名对照组患者）。
两组患者在 1.5 个月时均取得了显著的颈椎残障指数（NDI）评分、36 项简短健康状况调查问卷的生理成分综合评分以及颈部和手臂疼痛评分的改善，并持续至 5 年。研究组在 24、36 和 60 个月时，NDI 从术前评分的平均改善分别为 35.4、36.3 和 38.4。对照组相应的平均 NDI 改善分别为 33.9、31.3 和 34.1。两组在 36 个月和 60 个月时的组间差异均具有统计学意义（p = 0.008 和 0.022）。在研究组中，分别有 91.6%、92.8%和 95.0%的患者在 24、36 和 60 个月时保持或改善神经状态，而对照组中分别为 83.6%、83.2%和 88.9%（p = 0.006、0.004 和 0.051）。植入物有效地维持了角度运动，术后 36 个月时平均超过 7.3 度，60 个月时平均超过 6.5 度。在 60 个月的随访中，未观察到植入物迁移。在索引手术后进行修订和补充固定手术的比例方面，研究组和对照组之间存在统计学上的显著差异。在两组中都观察到相邻节段疾病的额外手术。在研究组（8 例[11 次手术]）中，相邻水平手术的发生率低于对照组（13 例[16 次手术]），但差异无统计学意义（p = 0.376）。第二次手术的一些涉及指数和相邻水平。
在 5 年随访时，Prestige 椎间盘假体在植入后保持了改善的临床结果和节段运动。
