Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C(C) Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up
Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C(C) Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up
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DOI：
10.14444/4031
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发表时间：
2017-01-01
影响因子：
1.6
通讯作者：
Coric, Dom
中科院分区：
文献类型：
--
作者：
Radcliff, Kris;Davis, Reginald J.;Coric, Dom
背景颈椎全椎间盘置换术（TDR）是一种越来越被接受的治疗症状性颈椎椎间盘退变性疾病的手术。多项I级证据临床试验已证实颈椎TDR在短期内是一种安全有效的手术。本研究的目的是提供一个长期的评估TDR与前路椎间盘切除术和融合治疗的一个和两个级别disc diseases.MethodsThis研究是一个前瞻性的，多中心的，随机的，美国FDA IDE临床试验比较颈椎TDR与C-C（C）颈椎椎间盘与ACDF通过7年的随访的延续。入选标准包括在一个或两个颈椎节段诊断为症状性颈椎退行性椎间盘疾病。TDR患者使用EST-C（C）人工椎间盘（Zimmer Biomet，Austin TX，USA）进行治疗。ACDF与同种异体骨和前路钢板作为对照治疗。在术前和术后6周、3、6、12、18个月、每年直至60个月和84个月时收集结局指标。测量的结局包括总体成功、颈部残疾指数（NDI）、VAS颈部和手臂疼痛、节段性活动度（ROM）、患者满意度、SF-12 MCS/PCS、重大并发症和后续手术率。主要终点是一个FDA的复合定义的成功，包括临床改善和没有重大并发症和二次手术events.ResultsA共599例患者参加和治疗，164与单级TDR治疗，225与两级TDR，81与单级ACDF治疗，105与两级ACDF治疗。7年时，随访率范围为73.5%-84.4%（总体为80.2%）。双节段TDR和ACDF患者的总体成功率分别为60.8%和34.2%（p 0.05）。单节段和双节段TDR和ACDF组均显示NDI评分、VAS颈部和手臂疼痛评分以及SF-12 MCS/PCS评分较基线显著改善（p
BackgroundCervical total disc replacement (TDR) is an increasingly accepted procedure for the treatment of symptomatic cervical degenerative disc disease. Multiple Level I evidence clinical trials have established cervical TDR to be a safe and effective procedure in the short-term. The objective of this study is to provide a long-term assessment of TDR versus anterior discectomy and fusion for the treatment of one-and two-level disc disease.MethodsThis study was a continuation of a prospective, multicenter, randomized, US FDA IDE clinical trial comparing cervical TDR with the Mobi-C(C) Cervical Disc versus ACDF through 7 years follow-up. Inclusion criteria included a diagnosis of symptomatic cervical degenerative disc disease at one or two cervical levels. TDR patients were treated using a Mobi-C(C) artificial disc (Zimmer Biomet, Austin TX, USA). ACDF with allograft and anterior plate was used as a control treatment. Outcome measures were collected preoperatively and postoperatively at 6 weeks, at 3, 6, 12, 18 months, annually through 60 months, and at 84 months. Measured outcomes included Overall success, Neck Disability Index (NDI), VAS neck and arm pain, segmental range of motion (ROM), patient satisfaction, SF-12 MCS/PCS, major complications, and subsequent surgery rate. The primary endpoint was an FDA composite definition of success comprising clinical improvement and an absence of major complications and secondary surgery events.ResultsA total of 599 patients were enrolled and treated, with 164 treated with one-level TDR, 225 treated with two-level TDR, 81 treated with one-level ACDF, and 105 treated with two-level ACDF. At seven years, follow-up rates ranged from 73.5% to 84.4% (overall 80.2%).The overall success rates of two level TDR and ACDF patients were 60.8% and 34.2%, respectively (p0.05). Both the single and two level TDR and ACDF groups showed significant improvement from baseline NDI scores, VAS neck and arm pain scores, and SF-12 MCS/PCS scores (p