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使用羟基磷灰石注入聚醚醚酮椎间融合器行颈椎前路椎间盘切除融合术后1年的中期影像学及临床结果

Interim 1-Year Radiographic and Clinical Outcomes Following Anterior Cervical Discectomy and Fusion Using Hydroxyapatite-Infused Polyetheretherketone Interbody Cages.

作者信息

Kelly Michael J, Gelfand Bradley, Radcliff Kris, Mo Fred F, Felix Brox A, Babak Kalantar S

机构信息

Hospital for Special Surgery, New York, NY, USA

MedStar Georgetown University Hospital, Washington, DC, USA.

出版信息

Int J Spine Surg. 2024 May 6;18(2):122-129. doi: 10.14444/8585.

Abstract

BACKGROUND

This is a multicenter observational registry analysis of 1-year radiographic and clinical outcomes following anterior cervical discectomy and fusion (ACDF) using hydroxyapatite (HA)-infused polyetheretherketone (PEEK) intervertebral cages.

METHODS

Radiographic and clinical outcome data were collected preoperatively and at 6 weeks, 3 months, 6 months, and 12 months postoperatively. To assess fusion, dynamic flexion-extension radiographs were independently evaluated with a validated method. Clinical outcomes were assessed using the following disease-specific measures: Neck Disability Index (NDI) and visual analog scale (VAS) for neck, left arm, and right arm pain. Patient satisfaction was also evaluated.

RESULTS

A total of 789 ACDF patients (men: 51.5%/women: 48.5%; mean body mass index: 29.9 kg/m) were included at the time of analysis, and 1565 segments have been operated. Successful fusion was confirmed in 91.3% of all operated levels after 6 months and 92.2% after 12 months. Mean NDI scores improved significantly ( < 0.01) preoperatively (46.3, = 771) to postoperatively (12 months: 25.2, = 281). Consistently, mean VAS neck (preoperative: 64.2, = 770; 12 months: 28.6, = 278), VAS right arm (preoperative: 42.6, = 766; 12 months: 20.4, = 277), and VAS left arm (preoperative: 41.1, = 768; 12 months: 20.8, = 277) decreased significantly ( < 0.01). Patients reported high satisfaction rates after surgery with no significant changes in postoperative patient satisfaction between 6 weeks and 12 months (95.1%, = 273).

CONCLUSIONS

ACDF with HA-infused PEEK cages demonstrates promising radiographic and clinical outcomes, supporting the potential benefits of incorporating HA into PEEK cages to enhance fusion rates and improve patient outcomes.

CLINICAL RELEVANCE

This study demonstrates a >90% fusion rate by level with reliable improvements in patient reported outcomes, along with a high rate of patient satisfaction, in a large patient cohort undergoing ACDF with HA-infused PEEK cages.

LEVEL OF EVIDENCE

2 .

摘要

背景

这是一项多中心观察性注册研究分析,旨在评估使用注入羟基磷灰石(HA)的聚醚醚酮(PEEK)椎间融合器进行颈椎前路椎间盘切除融合术(ACDF)后1年的影像学和临床结果。

方法

在术前以及术后6周、3个月、6个月和12个月收集影像学和临床结果数据。为评估融合情况,采用一种经过验证的方法对动态屈伸位X线片进行独立评估。使用以下特定疾病指标评估临床结果:颈部功能障碍指数(NDI)以及颈部、左臂和右臂疼痛的视觉模拟量表(VAS)。还对患者满意度进行了评估。

结果

分析时共纳入789例ACDF患者(男性:51.5%/女性:48.5%;平均体重指数:29.9kg/m²),共手术1565个节段。6个月后,所有手术节段中有91.3%确认成功融合,12个月后为92.2%。平均NDI评分从术前(46.3,n = 771)显著改善(P < 0.01)至术后(12个月:25.2,n = 281)。同样,平均VAS颈部评分(术前:64.2,n = 770;12个月:28.6,n = 278)、VAS右臂评分(术前:42.6,n = 766;12个月:20.4,n = 277)和VAS左臂评分(术前:41.1,n = 768;12个月:20.8,n = 277)均显著降低(P < 0.01)。患者术后报告的满意度较高,术后6周和12个月之间患者满意度无显著变化(95.1%,n = 273)。

结论

使用注入HA的PEEK融合器进行ACDF显示出良好的影像学和临床结果,支持将HA纳入PEEK融合器以提高融合率并改善患者结局的潜在益处。

临床意义

本研究表明,在接受使用注入HA的PEEK融合器进行ACDF的大型患者队列中,每个节段的融合率>90%,患者报告的结局有可靠改善,且患者满意度较高。

证据级别

2级

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本文引用的文献

1
Surface Treatments of PEEK for Osseointegration to Bone.PEEK 表面处理与骨整合。
Biomolecules. 2023 Mar 2;13(3):464. doi: 10.3390/biom13030464.

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