Neurosurgical Center Holland, Leiden University Medical Center & Haaglanden MC & Haga Teaching Hospital, Albinusdreef 2, Leiden, 2300, NH, The Netherlands.
Neurosurgical Center Holland, Leiden University Medical Center & Haaglanden MC & Haga Teaching Hospital, Albinusdreef 2, Leiden, 2300, NH, The Netherlands.
Spine J. 2023 Mar;23(3):350-360. doi: 10.1016/j.spinee.2022.11.006. Epub 2022 Nov 15.
BACKGROUND CONTEXT: Motion preserving anterior cervical disc arthroplasty (ACDA) in patients with cervical radiculopathy was introduced to prevent symptomatic adjacent segment disease as compared to anterior cervical discectomy and fusion (ACDF). PURPOSE: To evaluate the long-term outcome in patients with cervical radiculopathy due to a herniated disc undergoing ACDA, ACDF or ACD (no cage, no plate) in terms of clinical outcome measured by the Neck Disability Index (NDI). Likewise, clinically relevant adjacent segment disease is assessed as a long-term result. STUDY DESIGN: Double-blinded randomized controlled trial. PATIENT SAMPLE: A total of 109 patients with one level herniated disc were randomized to one of the following treatments: ACDA, ACDF with intervertebral cage, ACD without cage. OUTCOME MEASURES: Clinical outcome was measured by patients' self-reported NDI, Visual Analogue Scale (VAS) neck pain, VAS arm pain, SF36, EQ-5D, perceived recovery and reoperation rate. Radiological outcome was assessed by radiographic cervical curvature and adjacent segment degeneration (ASD) parameters at baseline and up until five years after surgery. METHODS: To account for the correlation between repeated measurements of the same individual Generalized Estimated Equations (GEE) were used to calculate treatment effects, expressed in difference in marginal mean values for NDI per treatment group. RESULTS: Clinical outcome parameters were comparable in the ACDA and ACDF group, but significantly worse in the ACD group, though not reaching clinical relevance. Annual reoperation rate was 3.6% in the first two years after surgery, declined to 1.9% in the years thereafter. The number of reoperations for ASD was not lower in the ACDA group, while the number of reoperations at the index level was higher after ACD, when compared to ACDF and ACDA. CONCLUSIONS: A persisting absence of clinical superiority was demonstrated for the cervical disc prosthesis five years after surgery. Specifically, clinically relevant adjacent level disease was not prevented by implanting a prosthesis. Single level ACD without implanting an intervertebral device provided worse clinical outcome, which was hypothesized to be caused by delayed fusion. This stresses the need for focusing on timely fusion in future research.
背景：与颈椎前路椎间盘切除融合术（ACDF）相比，颈椎前路间盘置换术（ACDA）用于治疗神经根型颈椎病，可预防症状性邻近节段疾病。
目的：通过颈椎残障指数（NDI）评估颈椎间盘突出症患者行 ACDA、ACDF 或 ACD（无 cage，无 plate）治疗后的长期疗效。同样，评估临床上相关的邻近节段疾病作为长期结果。
研究设计：双盲随机对照试验。
患者样本：共 109 例单节段椎间盘突出症患者随机分为以下治疗组之一：ACDA、ACDF 椎间 cage、ACD 无 cage。
结果测量：临床结果通过患者自我报告的 NDI、视觉模拟量表（VAS）颈部疼痛、VAS 手臂疼痛、SF36、EQ-5D、感知恢复和再手术率进行评估。影像学结果通过基线和术后 5 年的颈椎曲度和邻近节段退变（ASD）参数进行评估。
方法：为了考虑到同一患者的重复测量的相关性，使用广义估计方程（GEE）计算治疗效果，以每个治疗组的 NDI 边际均值差异表示。
结果：ACDA 和 ACDF 组的临床结果参数相当，但 ACD 组明显更差，尽管未达到临床相关水平。术后前 2 年的年再手术率为 3.6%，此后降至 1.9%。在 ACDA 组中，ASD 的再手术数量并未减少，而与 ACDF 和 ACDA 相比，在 ACD 后，索引水平的再手术数量更高。
结论：颈椎间盘假体术后 5 年仍未显示出持续的临床优势。具体来说，植入假体并不能预防临床上相关的邻近节段疾病。未植入椎间设备的单节段 ACD 提供了更差的临床结果，这被假设是由于延迟融合所致。这强调了在未来研究中需要关注及时融合的必要性。
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