Department of Spine Surgery, Beijing Shijitan Hospital, Capital Medical University, Beijing, People's Republic of China.
Int J Surg. 2023 Apr 1;109(4):905-912. doi: 10.1097/JS9.0000000000000358.
BACKGROUND: The efficacy and noninferior of performing modified double-door laminoplasty (MDDL) (C4-C6 laminoplasty plus C3 laminectomy, alongside a dome-like resection of the inferior part of the C2 lamina and the superior part of the C7 lamina) in patients with multilevel cervical spondylotic myelopathy (MCSM) is equivocal. A randomized, controlled trial is warranted. OBJECTIVE: The objective was to evaluate the clinical efficacy and noninferior of MDDL compared with traditional C3-C7 double-door laminoplasty. STUDY DESIGN: A single-blind, randomized, controlled trial. METHODS: A single-blind, randomized, controlled trial was conducted in which patients who with MCSM with greater than or equal to 3 levels of spinal cord compression from the C3 to the C7 vertebral levels were enrolled and assigned to undergo either MDDL group or conventional double-door laminoplasty (CDDL) group in a 1:1 ratio. The primary outcome was the change in the Japanese Orthopedic Association score from baseline to 2-year follow-up. The secondary outcomes included changes in the Neck Disability Index (NDI) score, the Visual Analog Scale (VAS) for neck pain, and imaging parameters. Operative complications were also collected and reported. The outcome measures were compared between the groups at 3 months, 1 year, or 2 years after surgery. RESULTS: A total of 96 patients (mean age 67 years, 39.8% women) underwent randomization. Of these patients, 93 completed 3-month follow-up, 79 completed 1-year follow-up, and 66 completed 2-year follow-up. The changes in the Japanese Orthopedic Association score did not differ significantly between the study groups at the three time points after surgery. With respect to amelioration of neck pain and disability related to neck pain, patients in the MDDL group had a significantly greater decrease in the VAS and NDI component summary score than did those in the CDDL group at 1-year (VAS: -2.5 vs. -3.2, difference -0.7, 95% CI -1.1 to -0.2, P =0.0035; NDI: -13.6 vs. -19.3, difference -5.7, 95% CI -10.3 to -1.1, P =0.0159) and 2-years (VAS: -2.1 vs. -2.9, difference -0.8, 95% CI -1.4 to -0.2, P =0.0109; NDI: -9.3 vs. -16.0, difference -6.7, 95% CI -11.9 to -1.5, P =0.0127). The changes in the range of motion (ROM), the C2-C7 Cobb angle, and the cervical sagittal vertical axis in the MDDL group were significantly less than those in the CDDL group (ROM: -9.2±6.4 vs. -5.0±6.0, P =0.0079; C2-C7 Cobb angle: -7.9±7.8 vs. -4.1±6.2, P =0.0345; cervical sagittal vertical axis: 0.6±0.9 vs. 0.2±0.6, P =0.0233). The MDDL group had less blood loss (428.1 vs. 349.1, P =0.0175) and a lower rate of axial symptoms (27.3 vs. 6.1%, P =0.0475) than the CDDL group. CONCLUSIONS: Among patients with MCSM, the MDDL produced similar cervical cord decompression compared with the conventional C3-C7 double-door laminoplasty. The modified laminoplasty was associated with meaningful improvement in amelioration of neck discomfort, maintaining a better cervical ROM and sagittal alignment, decreasing blood loss, and reducing the incidence of axial symptoms.
背景：改良双开门椎管成形术（MDDL）（C4-C6 椎管成形术加 C3 椎板切除术，同时进行 C2 椎板下部分和 C7 椎板上部分的穹顶样切除）治疗多节段颈椎病脊髓病（MCSM）的疗效和非劣效性尚不确定。需要进行一项随机对照试验。 目的：评估 MDDL 与传统 C3-C7 双开门椎管成形术相比的临床疗效和非劣效性。 研究设计：单盲、随机、对照试验。 方法：一项单盲、随机、对照试验，纳入了 C3 至 C7 椎体水平有大于或等于 3 个节段脊髓受压的 MCSM 患者，并按照 1:1 的比例将其分为 MDDL 组或传统双开门椎管成形术（CDDL）组。主要结局是从基线到 2 年随访时日本矫形协会评分的变化。次要结局包括颈痛的 Neck Disability Index（NDI）评分、视觉模拟量表（VAS）评分和影像学参数的变化。还收集并报告了手术并发症。在手术后 3 个月、1 年或 2 年时比较了两组之间的结局指标。 结果：共有 96 名患者（平均年龄 67 岁，39.8%为女性）接受了随机分组。其中，93 名患者完成了 3 个月随访，79 名完成了 1 年随访，66 名完成了 2 年随访。手术后三个时间点，研究组之间日本矫形协会评分的变化没有显著差异。在改善颈部疼痛和与颈部疼痛相关的残疾方面，MDDL 组的 VAS 和 NDI 总分评分在 1 年（VAS：-2.5 比-3.2，差值-0.7，95%CI-1.1 至-0.2，P=0.0035；NDI：-13.6 比-19.3，差值-5.7，95%CI-10.3 至-1.1，P=0.0159）和 2 年（VAS：-2.1 比-2.9，差值-0.8，95%CI-1.4 至-0.2，P=0.0109；NDI：-9.3 比-16.0，差值-6.7，95%CI-11.9 至-1.5，P=0.0127）时的下降幅度明显大于 CDDL 组。MDDL 组的活动范围（ROM）、C2-C7 Cobb 角和颈椎矢状垂直轴的变化明显小于 CDDL 组（ROM：-9.2±6.4 比-5.0±6.0，P=0.0079；C2-C7 Cobb 角：-7.9±7.8 比-4.1±6.2，P=0.0345；颈椎矢状垂直轴：0.6±0.9 比 0.2±0.6，P=0.0233）。MDDL 组的出血量（428.1 比 349.1，P=0.0175）和轴向症状发生率（27.3%比 6.1%，P=0.0475）明显低于 CDDL 组。 结论：在 MCSM 患者中，MDDL 与传统 C3-C7 双开门椎管成形术相比，颈椎脊髓减压效果相当。改良的椎管成形术在改善颈部不适、维持更好的颈椎 ROM 和矢状位排列、减少出血量和降低轴向症状发生率方面具有显著意义。
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