Prospective, multicenter study of 2-level cervical arthroplasty with a PEEK-on-ceramic artificial disc.

IF 3 3区农林科学 Q1 ENTOMOLOGY

Annals of The Entomological Society of America Pub Date : 2022-04-01 Print Date: 2022-09-01 DOI:10.3171/2022.1.SPINE211264

Domagoj Coric, Richard D Guyer, Hyun Bae, Pierce D Nunley, K Brandon Strenge, John H Peloza, Margaret O Boltes, Donna D Ohnmeiss

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引用次数: 0

Abstract

Objective: The purpose of this study was to evaluate the safety and efficacy of a PEEK-on-ceramic cervical total disc replacement (cTDR) device for the treatment of 2-level cervical disc disease with radiculopathy and/or myelopathy.

Methods: The study was a prospective, nonrandomized, historically controlled FDA investigational device exemption trial evaluating the Simplify Cervical Artificial Disc for use at 2 levels. The anterior cervical discectomy and fusion (ACDF) control group was derived from a propensity score-matched (using subclassification) cohort of patients who participated in an earlier prospective trial in which similar indications were used. The follow-up duration was 24 months. The primary outcome was a 4-point composite success classification. Other validated clinical and radiographic assessments were also evaluated.

Results: The investigational group (n = 182) was compared with patients who underwent ACDF (n = 170) in a historical control group using propensity score analysis. The overall composite success rate was statistically significantly greater in the cTDR group compared with the ACDF group (86.7% vs 77.1%; p < 0.05). The mean Neck Disability Index scores improved significantly in both groups, with cTDR significantly lower at some follow-up points. At the 24-month follow-up, a minimum 15-point improvement in Neck Disability Index scores was achieved in 92.9% of the cTDR group and 83.5% of the ACDF group (p > 0.05). In both groups, neck and arm pain scores improved significantly (p < 0.05) by 6 weeks and improvement was maintained throughout follow-up. Segmental range of motion was maintained at both treated segments in the cTDR group. MRI performed in the cTDR group at 24 months postoperatively found minimal changes in facet joint degeneration. The rate of subsequent surgical intervention was 2.2% in the cTDR group and 8.8% in the ACDF group.

Conclusions: This study adds to the growing body of literature supporting cTDR for 2-level cervical disc disease with radiculopathy or myelopathy. cTDR showed a superior overall success rate compared to ACDF, while maintaining motion. These results support that the Simplify disc is a viable alternative to ACDF in appropriately selected patients with 2-level cervical spondylosis.

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使用陶瓷基 PEEK 人工椎间盘进行 2 级颈椎关节置换术的前瞻性多中心研究。

研究目的本研究旨在评估陶瓷基 PEEK 颈椎全椎间盘置换（cTDR）装置治疗伴有根性病变和/或脊髓病的 2 级颈椎椎间盘疾病的安全性和有效性：该研究是一项前瞻性、非随机、历史对照的 FDA 研究设备豁免试验，对用于 2 个水平的 Simplify 颈椎人工椎间盘进行评估。前路颈椎椎间盘切除和融合术（ACDF）对照组来自于一个倾向得分匹配（使用亚分类）的患者队列，这些患者参加了早期的前瞻性试验，在该试验中使用了类似的适应症。随访时间为 24 个月。主要结果为 4 点复合成功率分类。此外，还对其他经过验证的临床和放射学评估结果进行了评估：研究组（n = 182）与历史对照组中接受 ACDF 的患者（n = 170）进行了比较，采用倾向得分分析法。与 ACDF 组相比，cTDR 组的总体综合成功率明显更高（86.7% vs 77.1%；P < 0.05）。两组患者的颈部残疾指数平均得分均有明显改善，而 cTDR 在某些随访点的得分明显更低。在 24 个月的随访中，92.9% 的 cTDR 组和 83.5% 的 ACDF 组的颈部残疾指数评分至少提高了 15 分（p > 0.05）。两组患者的颈部和手臂疼痛评分在 6 周前均有明显改善（p < 0.05），并在整个随访期间保持改善。在 cTDR 组中，两个治疗节段的活动范围均得以保持。cTDR 组术后 24 个月时进行的核磁共振成像发现，面关节退行性变的变化极小。cTDR 组的后续手术干预率为 2.2%，ACDF 组为 8.8%：这项研究为越来越多支持 cTDR 治疗伴有根性病变或脊髓病的 2 级颈椎间盘疾病的文献增添了新的内容。与 ACDF 相比，cTDR 显示出更高的总体成功率，同时还能保持运动。这些结果证明，对于经过适当选择的 2 级颈椎病患者，Simplify 椎间盘是 ACDF 的可行替代方案。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of The Entomological Society of America 生物-昆虫学

CiteScore

4.90

自引率

0.00%

发文量

审稿时长

6-12 weeks

期刊介绍： The Annals of the Entomological Society of America exists to stimulate interdisciplinary dialogue across the entomological disciplines and to advance cooperative interaction among diverse groups of entomologists. It seeks to attract and publish cutting-edge research, reviews, collections of articles on a common topic of broad interest, and discussion of topics with national or international importance. We especially welcome articles covering developing areas of research, controversial issues or debate, and topics of importance to society. Manuscripts that are primarily reports of new species, methodology, pest management, or the biology of single species generally will be referred to other journals of the ESA. The most important criteria for acceptance are quality of work and breadth of interest to the readership.