Greater Baltimore Neurosurgical Associates, Baltimore, Maryland;
J Neurosurg Spine. 2013 Nov;19(5):532-45. doi: 10.3171/2013.6.SPINE12527. Epub 2013 Sep 6.
Cervical total disc replacement (TDR) is intended to treat neurological symptoms and neck pain associated with degeneration of intervertebral discs in the cervical spine. Anterior cervical discectomy and fusion (ACDF) has been the standard treatment for these indications since the procedure was first developed in the 1950s. While TDR has been shown to be a safe and effective alternative to ACDF for treatment of patients with degenerative disc disease (DDD) at a single level of the cervical spine, few studies have focused on the safety and efficacy of TDR for treatment of 2 levels of the cervical spine. The primary objective of this study was to rigorously compare the Mobi-C cervical artificial disc to ACDF for treatment of cervical DDD at 2 contiguous levels of the cervical spine.
This study was a prospective, randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc conducted at 24 centers in the US. The primary clinical outcome was a composite measure of study success at 24 months. The comparative control treatment was ACDF using allograft bone and an anterior plate. A total of 330 patients were enrolled, randomized, and received study surgery. All patients were diagnosed with intractable symptomatic cervical DDD at 2 contiguous levels of the cervical spine between C-3 and C-7. Patients were randomized in a 2:1 ratio (TDR patients to ACDF patients).
A total of 225 patients received the Mobi-C TDR device and 105 patients received ACDF. At 24 months only 3.0% of patients were lost to follow-up. On average, patients in both groups showed significant improvements in Neck Disability Index (NDI) score, visual analog scale (VAS) neck pain score, and VAS arm pain score from preoperative baseline to each time point. However, the TDR patients experienced significantly greater improvement than ACDF patients in NDI score at all time points and significantly greater improvement in VAS neck pain score at 6 weeks, and at 3, 6, and 12 months postoperatively. On average, patients in the TDR group also maintained preoperative segmental range of motion at both treated segments immediately postoperatively and throughout the study period of 24 months. The reoperation rate was significantly higher in the ACDF group at 11.4% compared with 3.1% for the TDR group. Furthermore, at 24 months TDR demonstrated statistical superiority over ACDF based on overall study success rates.
The results of this study represent the first available Level I clinical evidence in support of cervical arthroplasty at 2 contiguous levels of the cervical spine using the Mobi-C cervical artificial disc. These results continue to support the use of cervical arthroplasty in general, but specifically demonstrate the advantages of 2-level arthroplasty over 2-level ACDF. Clinical trial registration no.: NCT00389597 (ClinicalTrials.gov).
颈椎间盘置换术（TDR）旨在治疗与颈椎间盘退行性变相关的神经症状和颈部疼痛。自 20 世纪 50 年代首次开发以来，前路颈椎间盘切除融合术（ACDF）一直是这些适应证的标准治疗方法。虽然 TDR 已被证明是治疗单节段颈椎退行性疾病（DDD）的安全有效的替代方法，但很少有研究关注 TDR 治疗 2 个节段颈椎的安全性和有效性。本研究的主要目的是严格比较 Mobi-C 颈椎人工椎间盘与 ACDF 治疗颈椎 DDD 的 2 个连续节段。
这是一项在美国 24 个中心进行的前瞻性、随机、美国 FDA 研究设备豁免性 Mobi-C 颈椎人工椎间盘的关键性试验。主要临床终点是 24 个月时的研究成功综合衡量标准。比较对照治疗是使用同种异体骨和前板的 ACDF。共纳入 330 例患者，进行了随机分组和研究手术。所有患者均被诊断为 C-3 至 C-7 颈椎 2 个连续节段的难治性症状性颈椎 DDD。患者以 2:1 的比例（TDR 患者与 ACDF 患者）随机分组。
共有 225 例患者接受了 Mobi-C TDR 装置治疗，105 例患者接受了 ACDF 治疗。24 个月时只有 3.0%的患者失访。平均而言，两组患者在颈椎残障指数（NDI）评分、视觉模拟量表（VAS）颈部疼痛评分和 VAS 手臂疼痛评分方面均从术前基线到每个时间点均有显著改善。然而，TDR 组患者在所有时间点的 NDI 评分均显著优于 ACDF 组，在术后 6 周、3 个月、6 个月和 12 个月时 VAS 颈部疼痛评分也显著改善。平均而言，TDR 组患者在术后即刻和整个 24 个月研究期间也保持了治疗节段的术前节段活动度。ACDF 组的再次手术率明显高于 TDR 组的 11.4%，为 3.1%。此外，基于总体研究成功率，24 个月时 TDR 显示出比 ACDF 具有统计学优势。
本研究结果代表了首个支持使用 Mobi-C 颈椎人工椎间盘进行颈椎 2 个连续节段关节成形术的一级临床证据。这些结果继续支持颈椎关节成形术的应用，但特别证明了 2 节段关节成形术优于 2 节段 ACDF。临床试验注册号：NCT00389597（ClinicalTrials.gov）。
