Nunley Pierce D, Hisey Michael, Smith Micah, Stone Marcus B
Spine Institute of Louisiana, Shreveport, LA, USA
Texas Back Institute, Plano, TX, USA.
Int J Spine Surg. 2023 Apr;17(2):230-240. doi: 10.14444/8431. Epub 2023 Apr 6.
BACKGROUND: Over the past 20 years, multiple randomized controlled trials have shown cervical disc arthroplasty (CDA) to be safe and effective for treating 1- and 2-level degenerative disc disease (DDD). The purpose of this postmarket study is to compare 10-year outcomes between CDA and anterior cervical discectomy and fusion (ACDF) from a randomized study at 3 centers. METHODS: This study was a continuation of a randomized, prospective, multicenter clinical trial comparing CDA with the Mobi-C cervical disc (Zimmer Biomet) vs ACDF. Following completion of the 7-year US Food and Drug Administration study, 10-year follow-up was obtained from consenting patients at 3 high-enrolling centers. The clinical and radiographic endpoints collected at 10 years included composite success, Neck Disability Index, neck and arm pain, short form-12, patient satisfaction, adjacent-segment pathology, major complications, and subsequent surgery. RESULTS: A total of 155 patients were enrolled (105 CDA; 50 ACDF). Follow-up was obtained from 78.1% of patients eligible after 7 years. At 10 years, CDA demonstrated superiority to ACDF. Composite success was 62.4% in CDA and 22.2% in ACDF ( < 0.0001). The cumulative risk of subsequent surgery at 10 years was 7.2% vs 25.5% ( = .001), and the risk of adjacent-level surgery was 3.1% vs 20.5% ( = .0005) in CDA vs ACDF, respectively. The progression to radiographically significant adjacent-segment pathology at 10 years was lower in CDA vs ACDF (12.9% vs 39.3%; = 0.006). At 10 years, patient-reported outcomes and change from baseline were generally better in CDA patients. A higher percentage of CDA patients reported they were "very satisfied" at 10 years (98.7% vs 88.9%; = 0.05). CONCLUSIONS: In this postmarket study, CDA was superior to ACDF for treating symptomatic cervical DDD. CDA was statistically superior to ACDF for clinical success, subsequent surgery, and neurologic success. Results through 10 years demonstrate that CDA continues to be a safe and effective surgical alternative to fusion. CLINICAL RELEVANCE: The results of this study support the long-term safety and effectiveness of cervical disc arthroplasty with the Mobi-C.
背景：在过去20年中，多项随机对照试验表明颈椎间盘置换术（CDA）治疗1级和2级退行性椎间盘疾病（DDD）安全有效。这项上市后研究的目的是比较来自3个中心的一项随机研究中CDA与颈椎前路椎间盘切除融合术（ACDF）的10年疗效。 方法：本研究是一项随机、前瞻性、多中心临床试验的延续，该试验比较了CDA与Mobi-C颈椎间盘（捷迈邦美）和ACDF。在美国食品药品监督管理局7年研究完成后，从3个高入组中心的同意患者中获得了10年随访。10年时收集的临床和影像学终点包括综合成功率、颈部功能障碍指数、颈部和手臂疼痛程度、简明健康状况调查简表（SF-12）、患者满意度、相邻节段病变、主要并发症和后续手术情况。 结果：共纳入155例患者（105例CDA；50例ACDF）。7年后从符合条件的78.1%的患者中获得了随访。10年时，CDA显示出优于ACDF。CDA的综合成功率为62.4%，ACDF为22.2%（P<0.0001）。10年时后续手术的累积风险在CDA组为7.
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