Issani Ali, Karakash William J, Avetisian Henry, Ahsan Zeeshan, Patel Dil, Riopelle David, Kashanchi Kevin, Gallo Matthew, Hah Raymond J, Malik Amyn A, Alluri Ram K, Liu John C, Wang Jeffrey C
Department of Orthopaedic Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA.
Department of Emergency Medicine, Aga Khan University, Karachi, Pakistan.
Global Spine J. 2025 Sep 25:21925682251383169. doi: 10.1177/21925682251383169.
Study designRetrospective comparative cohort study.ObjectiveTo validate FDA IDE-sponsored trial findings on cervical disc replacement (CDR) and anterior cervical discectomy and fusion (ACDF) by comparing reoperation outcomes with real-world data.MethodsPatients undergoing one- or two-level ACDF or CDR from 2010-2022 were identified in the PearlDiver (PD) database. FDA IDE trials were retrieved through review of databases. Subsequent surgeries and sample sizes were extracted at 2-, 4-, 5-, 7-, and 10-year intervals. Event rates were calculated as reoperations divided by patients at risk, and survival probabilities as S(t) = 1-event rate. Kaplan-Meier-style survival curves were reconstructed using the Guyot algorithm with a monotonicity constraint. Pooled FDA survival probabilities were weighted by number at risk. Hazard ratios (HRs) were derived from log-transformed survival probabilities, and statistical significance was tested using Pearson's chi-square or Fisher's exact test. Analyses were stratified by surgical level (1- vs 2-level) and procedure type (CDR vs ACDF).ResultsIn total, 277 146 ACDF and 25 957 CDR patients from PD and 46 FDA trials were analyzed. CDR reoperation risks were similar between FDA and PD cohorts, though differences were significant at 2-, 7-, and 10-year follow-up for 1-level procedures. ACDF reoperation risks were consistently and significantly lower in PD (eg, HR 0.4 at 7 years).ConclusionReoperation risks for CDR were broadly comparable, while ACDF outcomes were superior in practice compared with trials. These differences may reflect trial selection bias or stricter adjudication of ACDF outcomes. Validation against real-world data supports long-term safety assessment and personalized surgical decision-making.
研究设计
回顾性比较队列研究。
目的
通过将再次手术结果与真实世界数据进行比较，验证美国食品药品监督管理局（FDA）器械研究豁免（IDE）赞助试验关于颈椎间盘置换术（CDR）和颈椎前路椎间盘切除融合术（ACDF）的研究结果。
方法
在PearlDiver（PD）数据库中识别出2010年至2022年接受单节段或双节段ACDF或CDR手术的患者。通过检索数据库获取FDA IDE试验。在2年、4年、5年、7年和10年的时间间隔提取后续手术情况和样本量。事件发生率计算为再次手术患者数除以处于风险中的患者数，生存概率计算为S(t)=1 - 事件发生率。使用具有单调性约束的Guyot算法重建Kaplan - Meier式生存曲线。汇总的FDA生存概率按风险数量加权。风险比（HRs）从对数转换后的生存概率得出，使用Pearson卡方检验或Fisher精确检验进行统计学显著性检验。分析按手术节段（单节段与双节段）和手术类型（CDR与ACDF）分层。
结果
总共分析了来自PD数据库的277146例ACDF患者和25957例CDR患者以及46项FDA试验。FDA队列和PD队列之间CDR再次手术风险相似，不过在单节段手术的2年、7年和10年随访时差异具有显著性。PD队列中ACDF再次手术风险持续且显著更低（例如，7年时HR为0.4）。
结论
CDR的再次手术风险大致可比，而ACDF在实际中的结果优于试验。这些差异可能反映试验选择偏倚或对ACDF结果更严格的判定。与真实世界数据进行验证有助于长期安全性评估和个性化手术决策。
