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多孔钛颈椎椎间融合器治疗退行性颈椎病根病变;前瞻性对照试验 1 年结果。

Porous titanium cervical interbody fusion device in the treatment of degenerative cervical radiculopathy; 1-year results of a prospective controlled trial.

机构信息

Deptartment of Neurosurgery, Haaglanden Medical Center, PO Box 432, 2501 CK, The Hague, The Netherlands.

Deptartment of Neurosurgery, Haaglanden Medical Center, PO Box 432, 2501 CK, The Hague, The Netherlands.

出版信息

Spine J. 2020 Jul;20(7):1065-1072. doi: 10.1016/j.spinee.2020.03.008. Epub 2020 Mar 20.

DOI:10.1016/j.spinee.2020.03.008
PMID:32205276
Abstract

BACKGROUND CONTEXT

Anterior cervical discectomy with an interbody cage (ACDF) to obtain fusion is a common procedure in cervical spine surgery. Presently, polyetheretherketone (PEEK) with (auto) graft is frequently used for interbody fusion although alternative implant technology like 3-D printing titanium has been introduced recently.

PURPOSE

Reporting the clinical and quantitative radiological outcome of a prospective cohort of 3-D printed porous titanium implants.

STUDY DESIGN/SETTING: Prospective study of patients with single level ACDF using 3-D printed porous titanium cervical implants. These data were compared with 48 patients from the PEEK with autograft group of the previously performed CAncellous Structured Ceramic Arthrodesis DEvice trial.

PATIENT SAMPLE

Fourty-nine patients were included.

OUTCOME MEASURES

Neck disability index (NDI), visual analog scale (VAS), self-reported perceived recovery, and fusion status.

METHODS

The clinical outcomes and fusion rates were documented at 3, 6, and 12 months. Dynamic X-rays were analyzed to determine range of motion (ROM) of the operated level. Fusion was defined as rotation ≤4° and ≤1.25 mm translation on flexion-extension films.

RESULTS

The mean NDI improved from 41.2 preoperatively to 19.4 at 12 months postoperatively. Both VAS arm and VAS neck improved significantly after surgery and 77.1% of the patients reported complete or nearly complete recovery at 12 months. The mean ROM of the affected disc level decreased from 8.7° (range 2.6-21.4) before surgery to 1.6° (0.0-4.6°) after 12 months. The fusion rate at 3, 6, and 12 months was 84%, 89%, and 91% respectively, compared with 67%, 72%, and 90%, in the PEEK group.

CONCLUSIONS

3-D printed porous titanium cervical implants resulted in significant clinical improvement after surgery. The fusion rate of porous titanium compared with PEEK with autograft at 12 months was similar, although porous titanium resulted in faster consolidation. In addition, one level anterior cervical fusion can be successfully achieved without additional plating.

摘要

背景

颈椎前路椎间盘切除椎间融合术(ACDF)以获得融合是颈椎手术中的常见手术。目前,聚醚醚酮(PEEK)与(自体)移植物被广泛用于椎间融合,尽管最近已经引入了替代植入物技术,如 3D 打印钛。

目的

报告使用 3D 打印多孔钛植入物的单节段 ACDF 的前瞻性队列的临床和定量影像学结果。

研究设计/设置:使用 3D 打印多孔钛颈椎植入物对单节段 ACDF 患者进行前瞻性研究。这些数据与之前进行的 CAncellous Structured Ceramic Arthrodesis DEvice 试验中 PEEK 自体移植物组的 48 名患者进行了比较。

患者样本

纳入 49 名患者。

结果测量

颈残障指数(NDI)、视觉模拟量表(VAS)、自我报告的恢复感知和融合状态。

方法

在 3、6 和 12 个月时记录临床结果和融合率。动态 X 射线分析用于确定手术水平的活动范围(ROM)。融合定义为屈伸位片旋转≤4°和≤1.25mm 平移。

结果

NDI 平均值从术前的 41.2 改善至术后 12 个月的 19.4。术后手臂 VAS 和颈部 VAS 均显著改善,77.1%的患者在 12 个月时报告完全或几乎完全恢复。受影响椎间盘水平的平均 ROM 从术前的 8.7°(范围 2.6-21.4)降至术后 12 个月的 1.6°(0.0-4.6°)。3、6 和 12 个月时的融合率分别为 84%、89%和 91%,与 PEEK 组的 67%、72%和 90%相比。

结论

3D 打印多孔钛颈椎植入物术后可显著改善临床效果。与 PEEK 自体移植物相比,多孔钛在 12 个月时的融合率相似,尽管多孔钛融合更快。此外,无需额外的钢板即可成功实现单节段颈椎前路融合。

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