Nunley Pierce D, Kerr Eubulus J, Cavanaugh David A, Utter Phillip Andrew, Campbell Peter G, Wadhwa Rishi, Frank Kelly A, Marshall Kyle E, Stone Marcus B
Spine Institute of Louisiana, Shreveport, Louisiana.
Int J Spine Surg. 2020 Jun 30;14(3):269-277. doi: 10.14444/7036. eCollection 2020 Jun.
BACKGROUND: Adjacent segment pathology (ASP) remains a concern following treatment with cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF). Radiographic ASP (RASP) is ASP identified on imaging, which may or may not include clinical symptoms. The risk factors for development of RASP and its clinical effects remain controversial. In part 1 of a 2-part publication we evaluate the incidence and predictors of RASP as well as determine whether any association exists between RASP and patient-reported outcomes (PROs). METHODS: Data were prospectively collected during a US Food and Drug Administration randomized, multicenter, investigational device exemption trial comparing CDA (Mobi-C; Zimmer Biomet, Westminster, CO) with ACDF. Multiple post hoc analyses were conducted on RASP as it related to demographics and patient outcomes. Kaplan-Meier estimates of time to Kellgren-Lawrence (K-L) grade 3/4 were calculated separately for all groups. Multivariate Cox proportional hazard models were used analyze whether RASP was associated with patient preoperative demographic characteristics and preoperative and postoperative radiographic characteristics. The association of RASP with PROs was analyzed using generalized estimating equations and matched, retrospective cohort analysis. RESULTS: The incidence of grade 3/4 RASP was lower for patients treated with CDA when initial treatment was at 1 level (27% vs 47%, < .0001) and at 2 levels (14% vs 49%, < .0001). Kaplan-Meier estimates indicated significantly lower probability of grade 3/4 RASP over time for patients receiving CDA ( < .001). Treatment with ACDF, treatment of 1 level, higher age, body mass index, higher preoperative physical components score, and a lower Cobb angle were associated with elevated risk of grade 3/4 RASP. CDA was shown to be more effective than ACDF (64.4%; 95% CI = 50.9, 74.2; < .0001) at preventing RASP. CONCLUSIONS: The incidence and risk of RASP is decreased when patients are treated with CDA compared with ACDF. Although the mechanism of CDA that generates this protective effect is not understood, PROs remain unaffected through 7 years despite changes in RASP.
背景：颈椎间盘置换术（CDA）和颈椎前路椎间盘切除融合术（ACDF）治疗后，相邻节段病变（ASP）仍是一个令人担忧的问题。影像学上识别出的ASP为影像学相邻节段病变（RASP），其可能有或没有临床症状。RASP发生的危险因素及其临床影响仍存在争议。在一篇分两部分发表的文章的第1部分中，我们评估了RASP的发生率和预测因素，并确定RASP与患者报告结局（PROs）之间是否存在关联。 方法：在美国食品药品监督管理局的一项随机、多中心、研究器械豁免试验中前瞻性收集数据，该试验比较了CDA（Mobi-C；Zimmer Biomet，威斯敏斯特，科罗拉多州）与ACDF。对与人口统计学和患者结局相关的RASP进行了多项事后分析。分别计算所有组达到Kellgren-Lawrence（K-L）3/4级的时间的Kaplan-Meier估计值。使用多变量Cox比例风险模型分析RASP是否与患者术前人口统计学特征以及术前和术后影像学特征相关。使用广义估计方程和匹配的回顾性队列分析来分析RASP与PROs的关联。 结果：当初始治疗为1个节段时，接受CDA治疗的患者3/4级RASP的发生率较低（27%对47%，P<0.0001）；当初始治疗为2个节段时，该发生率也较低（14%对49%，P<0.0001）。Kaplan-Meier估计值表明，接受CDA治疗的患者随着时间推移发生3/4级RASP的概率显著较低（P<0.001）。ACDF治疗、1个节段的治疗、较高年龄、体重指数、较高的术前身体成分评分以及较小的Cobb角与3/4级RASP的风险升高相关。在预防RASP方面，CDA比ACDF更有效（64.4%；95%CI=50.9，74.2；P<0.0001）。 结论：与ACDF相比，CDA治疗患者时RASP的发生率和风险降低。尽管尚不了解CDA产生这种保护作用的机制，但尽管RASP有所变化，但在7年时间里PROs仍未受影响。
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