钛表面技术能否降低腰椎间盘前路融合术中生物制剂的成本?

IF 2.9 2区 医学 Q2 CLINICAL NEUROLOGY
Journal of neurosurgery. Spine Pub Date : 2024-08-23 Print Date: 2024-11-01 DOI:10.3171/2024.5.SPINE231323
Cameron Shirazi, Mark A Ochoa, Hani Malone, Amber Price, Jay I Kumar, Behrooz A Akbarnia, Gregory M Mundis, David Sing, Robert K Eastlack
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引用次数: 0

摘要

目的:表面结构和技术的进步使椎间融合器械更具生物活性,从而有望更成功地促进融合过程。这些生物活性越来越强的植入物的出现可能会减少对更昂贵的生物制剂的依赖,而生物制剂以前一直被用来实现高融合率:对前瞻性收集的数据(2018 年 8 月至 2019 年 12 月)进行了回顾性分析,分析对象为连续进行的前路腰椎椎间融合术,在这些融合术中使用了酸蚀刻、纳米表面调制的钛椎间融合器,该器械仅填充了皮质同种异体移植物芯片和当地血液。最短随访时间为 1 年,要求在术前和 1 年时提供影像学和结果指标。通过CT扫描和/或动态X光片评估融合和下沉情况。术前和术后收集与健康相关的生活质量指标(Oswestry残疾指数[ODI]、背部/腿部视觉模拟量表[VAS]):共有 55 名患者符合纳入标准(随访 1 年、有影像学资料和结果指标)。这 55 名患者共治疗了 69 个腰椎水平。平均年龄为 67 ± 12.1 岁,女性患者占 47%。约三分之一(35%)的患者曾接受过脊柱手术,约十分之一(9.1%)的患者曾接受过脊柱融合术。共有20.6%的患者接受过多级治疗(每名患者平均接受过1.2级治疗,最少1级,最多3级)。术前患者报告的平均疗效如下:ODI 39.71 ± 18.15,VAS背部 6.49 ± 2.19,VAS腿部 5.41 ± 2.71。术后一年,患者报告结果(与术前评分相比)的平均改善情况如下:ODI -22.9 ± 13.08(P < 0.001),VAS 背部 -3.75 ± 2.03(P < 0.001),VAS 腿部 -3.73 ± 2.32(P < 0.001)。根据 CT 扫描(65/69 个椎间孔水平)或动态影像学检查(4/69 个椎间孔水平,屈伸影像学检查评分变化小于 5%),所有椎间孔水平在术后 1 年都实现了融合。根据基于CT的分级系统,65个水平中的4个被归为3级,即头颅和尾椎板骨与植入物两面贴合,植入物通过或围绕植入物没有明显的椎间骨连接。65例中有61例发现有连续的椎间骨桥,因此被划分为1级(54例)或2级(7例)。低级别移植物下沉(Marchi 0 级或 I 级)发生在 9 个层面(13.0%),高级别下沉(Marchi II 级或 III 级)发生在 4 个层面(5.8%)。没有患者需要在前路腰椎椎间融合术水平上再次手术,也没有观察到椎弓根螺钉松动或失效的影像学或临床证据:结论:材料科学和表面技术的进步与纳米技术钛笼的结合,使得仅使用同种异体芯片和局部血液就能实现腰椎椎间融合。利用低成本生物制剂/同种异体移植物实现高融合率为降低脊柱重建护理成本提供了一条极具吸引力的途径,并为医疗保健经济学带来了潜在的增量收益。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Can titanium surface technology reduce cost for biologics in anterior lumbar interbody fusion?

Objective: Advances in surface architecture and technology have made interbody fusion devices more bioactive, with the hope of facilitating the fusion process more successfully. The advent of these increasingly bioactive implants may reduce reliance on more expensive biologics that have previously been used to achieve high fusion rates.

Methods: A retrospective review of prospectively collected data (August 2018-December 2019) was conducted of consecutively performed anterior lumbar interbody fusions in which an acid-etched, nanosurface-modulated, titanium interbody device packed only with corticocancellous allograft chips and local blood was used. Minimum follow-up was 1 year, and inclusion required available imaging and outcome metrics preoperatively and at 1 year. Fusion and subsidence were assessed via CT scans and/or dynamic radiographs. Health-related quality-of-life measures (Oswestry Disability Index [ODI], visual analog scale [VAS] back/leg) were collected pre- and postoperatively.

Results: In total, 55 patients met inclusion criteria (1 year of follow-up, available imaging, and outcome metrics). A total of 69 lumbar levels were treated in these 55 patients. The mean age was 67 ± 12.1 years, with 47% female patients. Roughly one-third (35%) had previous spine surgery, and approximately one-tenth (9.1%) had prior spinal fusion. A total of 20.6% were treated at multiple levels (mean levels per patient 1.2, minimum 1, maximum 3). The mean preoperative patient-reported outcomes were as follows: ODI 39.71 ± 18.15, VAS back 6.49 ± 2.19, and VAS leg 5.41 ± 2.71. One year after surgery, the mean improvements in patient-reported outcomes (vs preoperative scores) were as follows: ODI -22.9 ± 13.08 (p < 0.001), VAS back -3.75 ± 2.03 (p < 0.001), VAS leg -3.73 ± 2.32 (p < 0.001). All levels achieved fusion at 1 year postoperatively based on CT scans (65/69 levels) or dynamic radiographs (4/69 levels, change in score < 5% on flexion-extension radiographs). Four of the 65 levels were assigned to the grade 3 category according to a CT-based grading system, meaning cranial and caudal endplate bone apposition to the implant on both surfaces with no clear intervertebral bone connection through or around the implant. Sixty-one of 65 were found to have contiguous intervertebral bone bridging and thus were assigned to grade 1 (n = 54) or grade 2 (n = 7). Low-grade graft subsidence (Marchi grade 0 or I) occurred in 9 levels (13.0%) and high-grade subsidence (Marchi grade II or III) in 4 levels (5.8%). No patients required reoperation at the level of anterior lumbar interbody fusion and no radiographic or clinical evidence of pedicle screw loosening or failure was observed.

Conclusions: The combination of advances in materials science and surface technology as demonstrated with a nanotechnology titanium cage resulted in the ability to obtain lumbar interbody fusion with allograft chips and local blood alone. Achieving high fusion rates with low-cost biologics/allograft provides for an attractive pathway toward reducing the cost of reconstructive spine care, and a potential incremental benefit for healthcare economics.

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来源期刊
Journal of neurosurgery. Spine
Journal of neurosurgery. Spine 医学-临床神经学
CiteScore
5.10
自引率
10.70%
发文量
396
审稿时长
6 months
期刊介绍: Primarily publish original works in neurosurgery but also include studies in clinical neurophysiology, organic neurology, ophthalmology, radiology, pathology, and molecular biology.
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