Factors affecting reoperations after anterior cervical discectomy and fusion within and outside of a Federal Drug Administration investigational device exemption cervical disc replacement trial
Factors affecting reoperations after anterior cervical discectomy and fusion within and outside of a Federal Drug Administration investigational device exemption cervical disc replacement trial
复制标题
DOI：
10.1016/j.spinee.2012.02.005
复制
发表时间：
2012-05-01
期刊：
影响因子：
4.5
通讯作者：
Goldberg, Edward J.
中科院分区：
文献类型：
--
作者：
Singh, Kern;Phillips, Frank M.;Goldberg, Edward J.
背景：美国联邦药物管理局（FDA）批准的5项用于颈椎全椎间盘置换术（TDR）的试验（Prestige[美敦力Sofamor Danek，孟菲斯，田纳西州，美国]，Bryan[美敦力Sofamor Danek]， ProDisc-C [Synthes，西Chester，宾夕法尼亚州，美国]，Kineflex垂直棒C [SpinalMotion， Mountain View， CA，美国]和Mobi-C [LDR Spine， Austin，德克萨斯州，美国]）的优异临床结果最近已经发表。在这些前瞻性随机研究中，TDR的优越性或等效性被证实，在对照组前路颈椎椎间盘切除术融合（ACDF）患者中，2年内额外相关颈椎手术的发生率分别为8.7%（23/265）、9.5%（21/221）、8.5%（9/106）、12.2%（14/115）和6.2%(5/81)（平均=9.02%），而接受TDR的患者中，这一比例分别为1.8%（5/276）、5.8%（14/242）、1.9%（2/103）、11%（15/136）和1.2%(2/164)（平均=4.34%）。ACDF术后2年内的再手术率似乎异常高。目的：评估一组接受ACDF作为常规护理一部分的患者在ACDF后早期再手术的比率和具体适应症。这些结果与接受ACDF作为5个FDA试验性器械豁免（IDE）研究的对照组的类似患者进行了对比。研究设计：来自单一机构的多外科医生回顾性临床研究。患者样本：在2001年至2005年期间，有176名患有神经根性脊髓型颈椎病或脊髓病的患者作为临床实践的一部分，由三名外科医生接受了ACDF。所有患者至少随访2年，最终随访时间为研究结束后6个月内。观察指标：随访2年和3.5年的宫颈再手术率。方法：回顾医疗记录和电话交谈，以确定接受颈椎翻修手术的患者人数。结果：在最终随访时，159例ACDF患者获得了完整的数据。在48例接受单级ACDF并符合IDE研究纳入标准的患者中，1例（2.1%）患者在5项已发表的IDE研究随访的2年内需要额外的手术（邻接节段变性）。在平均随访3.5年的159例接受单节段或多节段ACDF的患者中，12例（7.6%）患者接受了颈椎翻修手术，其中3例（1.9%）患者接受了相同节段的翻修（后节段融合），9例（5.7%）患者接受了相邻前节段融合。接受翻修手术的患者通常在第一年（平均11个月）进行干预，而那些需要邻接节段融合的患者通常在晚些时候（平均29个月）进行手术。结论：本研究确定在常规临床实践中进行单级ACDF的2年内重复手术率为2.1%，低于Prestige， ProDisc-C, Bryan， Kineflex vertical bar C和Mobi-C FDA试验的对照组（平均=9%）。即使随访时间较长，包括多节段病例，我们的再手术率（7.6%）也优于IDE的再手术率。与常规临床实践相比，这一差异可能反映了装置IDE研究中控制组的再手术阈值不同。此外，参加单水平IDE试验的患者可能在研究之外接受了多水平手术。这一因素可能导致相邻节段的后续手术率更高，而不是在索引手术中解决。这些数据表明，我们需要更好地了解驱动治疗的因素，特别是在器械试验内外再次手术的决定。(C) 2012爱思唯尔公司版权所有。
BACKGROUND CONTEXT: The excellent clinical re.sults of five US Federal Drug Administration (FDA) trials approved for cervical total disc replacement (TDR) (Prestige [Medtronic Sofamor Danek, Memphis, TN, USA], Bryan [Medtronic Sofamor Danek], ProDisc-C [Synthes, West Chester, PA, USA], Kineflex vertical bar C [SpinalMotion, Mountain View, CA, USA], and Mobi-C [LDR Spine, Austin, TX, USA]) have recently been published. In these prospective randomized studies, superiority or equivalency of TDR was claimed, citing an 8.7% (23/265), 9.5% (21/221), 8.5% (9/106), 12.2% (14/115), and 6.2% (5/81) (mean=9.02%) rate of additional related cervical surgical procedures within 2 years in control anterior cervical discectomy and fusion (ACDF) patients, respectively, compared with 1.8% (5/276), 5.8% (14/242), 1.9% (2/103), 11% (15/136), and 1.2% (2/164) (mean=4.34%) in patients receiving the cervical TDR. The rate of reoperation within 2 years after ACDF seems unusually high.PURPOSE: To assess the rate of and specific indications for early reoperation after ACDF in a cohort of patients receiving the ACDF as part of their customary care. These results are contrasted with similar patients receiving ACDF as the control arm of five FDA investigational device exemption (IDE) studies.STUDY DESIGN: Multisurgeon retrospective clinical series from a single institution.PATIENT SAMPLE: One hundred seventy-six patients with spondylotic radiculopathy or myelopathy underwent ACDF by three surgeons between 2001 and 2005 as part of their clinical practices. All patients had at least 2 years of follow-up with final follow-up within 6 months of completion of this study.OUTCOME MEASURES: Cervical reoperation rates at 2-year follow-up and at 3.5-year follow-up.METHODS: Review of medical records and telephone conversations were completed to determine the number of patients who had undergone a revision cervical procedure.RESULTS: At final follow-up, complete data were available for 159 ACDF patients. Of the 48 patients who underwent single-level ACDF and met criteria for inclusion in the IDE studies, one patient (2.1%) required additional surgery (adjacent-segment degeneration) within 2 years, the duration of follow-up of the five published IDE studies. Of the 159 patients who received single or multilevel ACDF at a mean follow-up of 3.5 years, 12 patients (7.6%) had undergone revision cervical surgery, with three patients (1.9%) undergoing same-level revisions (posterior fusion) and nine patients (5.7%) undergoing adjacent anterior level fusions. Patients who underwent revision same-level surgery typically had the intervention within the first year (mean, 11 months), whereas those requiring adjacent-level fusions typically had surgery later (mean, 29 months).CONCLUSIONS: The present study identifies a 2.1% rate of repeat surgery within 2 years of a single-level ACDF performed during routine clinical practice, which is lower than that reported in the control arm of the Prestige, ProDisc-C, Bryan, Kineflex vertical bar C, and Mobi-C FDA trials (mean=9%). Even with longer follow-up including multilevel cases, our reoperation rate (7.6%) compared favorably with the IDE rates. This discrepancy may reflect different thresholds for reoperation in the control arm of a device IDE study compared with routine clinical practice. Additionally, patients enrolled in the single-level-only IDE trial may have received multilevel procedures outside of the study. This factor could result in a higher rate of subsequent surgeries at adjacent levels not addressed at the index procedure. These data suggest that we need to better understand factors driving treatment and, in particular, decisions to reoperate both in and outside of a device trial. (C) 2012 Elsevier Inc. All rights reserved.