Pimenta Luiz, McAfee Paul C, Cappuccino Andy, Cunningham Bryan W, Diaz Roberto, Coutinho Etevaldo
St. Joseph Hospital Scoliosis and Spine Center, Baltimore, MD, USA.
Spine (Phila Pa 1976). 2007 May 20;32(12):1337-44. doi: 10.1097/BRS.0b013e318059af12.
STUDY DESIGN/SETTING: Class 2 level of evidence: This is a prospective, consecutive series of 229 prosthetic implantations that were concurrently enrolled between single-level versus multilevel cervical arthroplasty comprising an FDA Pilot Study.
This study investigated multilevel cervical disc replacement in relation to single-level cervical arthroplasty to find if the same reduction in clinical success would occur with this alternative treatment.
Usually, the clinical outcomes of instrumented cervical fusions deteriorate as the number of vertebral levels of involvement increases.
A total of 229 patients presented with cervical herniated nucleus pulposus, cervical spondylosis, and/or adjacent segment disease with cervical radiculopathy or myelopathy. Following anterior cervical neurologic decompression seventy-one patients required porous coated motion (PCM) cervical arthroplasties from C3-C4 to C7-T1 (Group S, single level). Sixty-nine patients underwent 158 multilevel PCM cervical arthroplasties (Group M, multilevel) during the same time interval, for the same indications, performed by the same surgeons under the same clinical protocol: double level, 53 cases; three levels, 12 cases: and 4 levels, 4 cases.
The self-assessment outcomes instruments showed significantly more improvement for the multilevel cases. The mean improvement in the NDI for the single cases was 37.6% versus the multilevel cases mean improvement in NDI was 52.6% (P = 0.021). The difference between the two was statistically significant. The mean improvement in the VAS showed the same association: single-level mean improvement 58.4% versus the multilevel cases mean VAS improvement was 65.9%. The Odom's were also more improved for the multilevel versus the single-level group: 93.9% versus 90.5% in the excellent, good, and fair categories. The reoperation rates and serious adverse events were similar between the single-level (S = 3) to the multilevel arthroplasty (M = 2) groups. Kaplan-Meier implant survivorship analysis at 3 years for the cohort of 229 prostheses was 94.5% (confidence interval, 1.00-0.820).
This prospective study of cervical arthroplasty is the first report to date showing significantly improved clinical outcomes for multilevel cervical arthroplasty compared with single-level cervical disc replacement using an FDA validated outcome instrument.
研究设计/背景：证据等级为2级：这是一项前瞻性、连续性研究，纳入了229例假体植入手术病例，这些病例同时参与了一项由美国食品药品监督管理局开展的单节段与多节段颈椎置换术的试点研究。
本研究探讨多节段颈椎间盘置换术与单节段颈椎置换术相比，这种替代治疗方法在临床成功率上是否会出现相同程度的降低。
通常情况下，随着受累椎体节段数量的增加，颈椎前路融合术的临床效果会逐渐恶化。
共有229例患者，患有颈椎间盘突出症、颈椎病和/或伴有神经根病或脊髓病的相邻节段疾病。在进行颈椎前路神经减压术后，71例患者需要进行从C3 - C4至C7 - T1的多孔涂层活动（PCM）颈椎置换术（S组，单节段）。在相同时间段内，由相同外科医生按照相同临床方案，对69例患者进行了158例多节段PCM颈椎置换术（M组，多节段），适应症相同：双节段53例；三节段12例；四节段4例。
自我评估结果工具显示多节段病例的改善更为显著。单节段病例的颈部残疾指数（NDI）平均改善率为37.6%，而多节段病例的NDI平均改善率为52.6%（P = 0.021）。两者之间的差异具有统计学意义。视觉模拟评分（VAS）的平均改善情况也显示出相同的关联：单节段平均改善率为58.4%，而多节段病例的VAS平均改善率为65.9%。多节段组的奥多姆（Odom）评级在优秀、良好和中等类别中也比单节段组有更大改善：分别为93.9%和90.5%。单节段（S = 3）与多节段置换术（M = 2）组之间的再次手术率和严重不良事件相似。对229个假体队列进行的3年Kaplan - Meier植入物生存率分析为94.5%（置信区间，1.00 - 0.820）。
这项颈椎置换术的前瞻性研究是迄今为止的首份报告，表明与使用美国食品药品监督管理局验证的结果工具进行的单节段颈椎间盘置换相比，多节段颈椎置换术的临床效果有显著改善。
