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用于腰椎前路椎间融合的独立式钛/聚醚醚酮椎间融合器:24个月的临床和影像学结果

Standalone titanium/polyetheretherketone interbody cage for anterior lumbar interbody fusion: Clinical and radiological results at 24 months.

作者信息

Mobbs Ralph J, Amin Tajrian, Phan Kevin, Al Khawaja Darweesh, Choy Wen Jie, Parr William C H, Lovric Vedran, Walsh William R

机构信息

Faculty of Medicine, University of New South Wales (UNSW), Nepean, Sydney.

Surgical Orthopedic Research Lab (SORL), Prince of Wales Hospital, Randwick, Australia.

出版信息

J Craniovertebr Junction Spine. 2022 Jan-Mar;13(1):42-47. doi: 10.4103/jcvjs.jcvjs_133_21. Epub 2022 Mar 9.

Abstract

CONTEXT

Anterior lumbar interbody fusion (ALIF) is a common procedure for patients suffering degenerative, deformity, or posttraumatic pathologies of the lumbar spine.

AIMS

The aim of this study is to evaluate the clinical and radiological outcomes of a combination Titanium/Polyetheretherketone (Ti/PEEK) 3-screw fixation ALIF cage.

SETTINGS AND DESIGN

This was a prospective multisurgeon series of 87 patients (105 implants), with a minimum 24-month follow-up. Twelve patients (12/87) were supplemented with posterior percutaneous pedicle screw fixation for additional stability for pars defect spondylolisthesis correction. Radiological follow-up with fine-cut computed tomography (CT) scan occurred at 4-6 months, and again at 18-24 months if no fusion observed on initial CT, was performed to evaluate early and final fusion rates, and integration of the Ti/PEEK cage at the end-plate junction. Clinical follow-up included the subjective measures of pain and functional status and objective wearable device monitoring.

RESULTS

The fusion rate was 85% (97/105 implants) 6 months postoperatively, with no implant-related complications, and 95% at 24 months, based on independent radiological assessment. Patients experienced statistically significant improvement in subjective pain and functional outcomes compared to preoperative status. The objective measures revealed a daily step count with a 27% improvement, and gait velocity with a mean increase from 0.97 m/s to 1.18 m/s, at 3 months postoperatively.

CONCLUSIONS

A Ti/PEEK cage, with allograft and bone morphogenetic protein-2 (BMP-2), achieved rapid interbody progression to fusion and is an effective implant for use in anterior lumbar surgery with high early fusion rates and no peri-endplate lucency. Supercritical CO allograft provided an osteoconductive scaffold and combined well with BMP-2 to facilitate fusion.

摘要

背景

腰椎前路椎间融合术(ALIF)是治疗腰椎退行性病变、畸形或创伤后病变患者的常用手术。

目的

本研究旨在评估钛/聚醚醚酮(Ti/PEEK)三螺钉固定ALIF融合器的临床和影像学结果。

设置与设计

这是一项前瞻性多外科医生系列研究,共纳入87例患者(105枚植入物),随访至少24个月。12例患者(12/87)接受了后路经皮椎弓根螺钉固定,以增强矫正峡部裂性椎体滑脱的稳定性。术后4-6个月进行薄层计算机断层扫描(CT)的影像学随访,若初始CT未观察到融合,则在18-24个月再次进行随访,以评估早期和最终融合率以及Ti/PEEK融合器在终板交界处的融合情况。临床随访包括疼痛和功能状态的主观测量以及客观的可穿戴设备监测。

结果

术后6个月融合率为85%(97/105枚植入物),无植入物相关并发症,基于独立影像学评估,24个月时融合率为95%。与术前状态相比,患者的主观疼痛和功能结果有统计学意义的改善。客观测量显示,术后3个月每日步数增加27%,步态速度平均从0.97米/秒增加到1.18米/秒。

结论

Ti/PEEK融合器联合同种异体骨和骨形态发生蛋白-2(BMP-2)可实现椎间快速融合,是腰椎前路手术中一种有效的植入物,早期融合率高且终板周围无透亮区。超临界CO2处理的同种异体骨提供了骨传导支架,并与BMP-2良好结合以促进融合。

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