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钛表面处理技术能否降低前路腰椎间融合术中生物制剂的成本?

Can titanium surface technology reduce cost for biologics in anterior lumbar interbody fusion?

机构信息

1San Diego Spine Foundation, San Diego.

2Scripps Clinic, San Diego; and.

出版信息

J Neurosurg Spine. 2024 Aug 23;41(5):589-595. doi: 10.3171/2024.5.SPINE231323. Print 2024 Nov 1.

DOI:10.3171/2024.5.SPINE231323
PMID:39178468
Abstract

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.

摘要

目的

表面结构和技术的进步使椎间融合装置更具生物活性,有望更成功地促进融合过程。这些越来越具有生物活性的植入物的出现可能会减少对以前用于实现高融合率的昂贵生物制剂的依赖。

方法

对前瞻性收集的数据(2018 年 8 月至 2019 年 12 月)进行回顾性分析,连续进行前路腰椎椎间融合术,使用酸蚀、纳米表面调制、钛椎间融合装置,仅用皮质松质移植物和局部血液填充。最低随访时间为 1 年,纳入标准为术前和 1 年时具有可用影像学和结果指标。通过 CT 扫描和/或动力射线照相术评估融合和下沉。收集健康相关生活质量指标(Oswestry 残疾指数[ODI]、视觉模拟量表[VAS]背部/腿部)术前和术后。

结果

共有 55 例患者符合纳入标准(1 年随访、可用影像学和结果指标)。这些 55 例患者共治疗了 69 个腰椎节段。平均年龄为 67 ± 12.1 岁,女性患者占 47%。大约三分之一(35%)有以前的脊柱手术,大约十分之一(9.1%)有以前的脊柱融合。共有 20.6%的患者在多个节段接受治疗(每位患者的平均节段数为 1.2,最小 1,最大 3)。术前患者报告的结果平均值如下:ODI 39.71 ± 18.15,VAS 背部 6.49 ± 2.19,VAS 腿部 5.41 ± 2.71。术后 1 年,患者报告结果的平均改善(与术前评分相比)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)。所有水平在术后 1 年通过 CT 扫描(69/69 个水平)或动力射线照相术(69/69 个水平中的 4 个,屈伸射线照相术上的评分变化<5%)获得融合。根据 CT 分级系统,69 个水平中的 4 个被归为 3 级,这意味着在装置的两个表面上,颅侧和尾侧终板骨与植入物附着,没有明确的椎间骨连接穿过或绕过植入物。65 个中有 61 个发现有连续的椎间骨桥接,因此被归为 1 级(n = 54)或 2 级(n = 7)。低等级移植物下沉(Marchi 等级 0 或 I)发生在 9 个水平(13.0%),高等级下沉(Marchi 等级 II 或 III)发生在 4 个水平(5.8%)。没有患者需要在前路腰椎椎间融合术的水平进行再次手术,也没有观察到影像学或临床证据表明椎弓根螺钉松动或失败。

结论

纳米技术钛笼等材料科学和表面技术的进步使得仅使用同种异体移植物和局部血液即可获得腰椎椎间融合。使用低成本生物制剂/同种异体获得高融合率为降低重建脊柱护理成本提供了有吸引力的途径,并可能为医疗保健经济学带来额外的益处。

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