Department of Neurosurgery, Leiden University Medical Center, Leiden, the Netherlands.
Computational Neuroscience Outcomes Center (CNOC), Department of Neurosurgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Spine (Phila Pa 1976). 2022 Jan 1;47(1):67-75. doi: 10.1097/BRS.0000000000004113.
Retrospective analysis was performed on data from 251 patients that were included in two randomized, double-blinded clinical trials comparing clinical results of anterior cervical discectomy and arthroplasty (ACDA) to anterior cervical discectomy and fusion (ACDF), and anterior cervical discectomy (ACD), for single-level disc herniation.
This study aimed to investigate whether the ACDA procedure offers superior clinical results 2 years after surgery, to either ACDF or ACD without instrumentation, in the entire group of patients or in a particular subgroup of patients.
The cervical disc prosthesis was introduced to provide superior clinical outcomes after ACD.
Neck Disability Index (NDI), and subscales of the 36-item short-form health survey (SF-36) and McGill pain score were collected at baseline, 1 year and 2 years after surgery. Reoperations and complications were also evaluated. A preliminary subgroup analysis was performed for age, disc height, body mass index (BMI), smoking, and sex.
The NDI decreased comparably in all treatment arms to circa 50% of the baseline value and marginal mean NDI differences varied from 0.4 to 1.1 on a 100 point NDI scale, with confidence intervals never exceeding the 20-point minimal clinical important difference (MCID). Secondary outcome parameters showed comparable results. Preliminary subgroup analysis could not demonstrate clinically relevant differences in NDI between treatments after 2 years.
After combining data from two Randomized Controlled Trials it can be concluded that there is no clinical benefit for ACDA, when compared with ACDF or ACD 2 years after surgery. Preliminary subgroup analysis indicated outcomes were similar between treatment groups, and that no subgroup could be appointed that benefited more from either ACD, ACDF, or ACDA.Level of Evidence: 1.
对 251 例患者的资料进行回顾性分析，这些患者均纳入两项随机、双盲临床试验，比较了前路颈椎间盘切除和融合术（ACDF）与前路颈椎间盘切除和人工椎间盘置换术（ACDA）、前路颈椎间盘切除术（ACD）治疗单节段椎间盘突出的临床结果。
本研究旨在探讨在整个患者群体或特定亚组患者中，与 ACDF 或无器械固定的 ACD 相比，ACDA 手术在术后 2 年是否能提供更好的临床结果。
颈椎间盘假体的引入是为了在 ACD 后提供更好的临床结果。
在基线、术后 1 年和 2 年收集颈痛残疾指数（NDI）以及 36 项简短健康调查问卷（SF-36）和麦吉尔疼痛问卷的子量表评分，并评估再次手术和并发症。还进行了初步的亚组分析，包括年龄、椎间盘高度、体重指数（BMI）、吸烟和性别。
所有治疗组的 NDI 均显著降低，接近基线值的 50%，边际平均 NDI 差异在 100 分 NDI 量表上为 0.4 至 1.1，置信区间从未超过 20 分的最小临床重要差异（MCID）。次要结局参数也显示出相似的结果。初步亚组分析显示，2 年后 NDI 治疗之间无临床相关差异。
结合两项随机对照试验的数据，可以得出结论，与 ACDF 或 ACD 相比，ACDA 在术后 2 年无临床获益。初步亚组分析表明，各组之间的治疗结果相似，没有任何亚组可以从 ACD、ACDF 或 ACDA 中获益更多。
1 级。
