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骨质量对一体化固定笼螺钉性能的影响。

Impact of bone quality on the performance of integrated fixation cage screws.

机构信息

Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Applied Mechanics, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA.

Department of Orthopaedics, Walter Reed National Military Medical Center, 4494 North Palmer Rd, Bethesda, MD 20889, USA.

出版信息

Spine J. 2018 Feb;18(2):321-329. doi: 10.1016/j.spinee.2017.08.239. Epub 2017 Aug 17.

Abstract

BACKGROUND CONTEXT

Commercially available lumbar integrated fixation cages (IFCs) have variable designs. For example, screw-based designs have up to four screws inserted at different locations across the vertebral end plate as well as at different angles in the sagittal and transverse planes. This is important as end plate and trabecular bone quality may vary across the vertebra and may affect the screw's fixation ability, particularly if bone purchase at the bone-screw interface is poor.

PURPOSE

This study aimed to evaluate whether variations in local bone quality surrounding IFC screws inserted at different locations in the vertebrae would affect their mechanical performance.

STUDY DESIGN

This study is an in vitro human cadaveric biomechanical analysis.

MATERIALS AND METHODS

Fourteen lumbar (L3 and L4) vertebrae from 10 cadavers (age: 76±10 years, bone mineral density: 0.89±0.17 g/cm) were used for this study. Pilot holes (3.5-mm diameter×15-mm length) representing three different IFC screw orientations (lateral to medial [LM], midsagittal [MS], and medial to lateral [ML]) were created in vertebrae using an IFC guide and bone awl. The screw locations and trajectories chosen are representative of commercially available IFC designs. These pilot holes were then imaged with high-resolution microcomputed tomography to obtain a three-dimensional structure of the bone surrounding the pilot hole. Local bone morphology was then quantified by evaluating a 3-mm-thick circumferential volume surrounding the pilot hole. Integrated fixation screws were implanted into pilot holes while recording maximum screw insertional torques. Screws were toggled in the cranial direction from 10 to 50 N for first 10,000 cycles, and the maximum load was increased by 25 N for every 5,000 cycles for a total of 25,000 cycles.

RESULTS

Total bone volume (BV) and trabecular bone volume fraction surrounding ML screws were significantly greater (p<.03) compared with those around MS screws and LM screws. The maximum insertional torque for ML screws were greater (p=.06) than LM and significantly greater (p<.02) than MS screws. The number of cycles to failure for the ML screw was significantly greater (p<.04) than that for the LM and the MS screws. Total BV (R≤46.2%, p<.03) and the maximum insertional torque (R≤59.6%, p<.03) provided better correlations to screw loosening compared with all the other bone quality parameters.

CONCLUSIONS

Our findings indicate that bone quality in the vertebral body varied spatially depending on the orientation and the insertion location of the IFC screw. These alterations in local bone quality significantly affected the screw's ability to fixate to bone. These variations in bone quality may be assessed intraoperatively using screw insertional torque measurements. By understanding available bone purchase at the bone-implant interface, the appropriate implant design can be selected to maximize the fixation strength.

摘要

背景

市售的腰椎一体化固定笼(IFC)具有不同的设计。例如,基于螺钉的设计在椎体终板的不同位置以及矢状面和横断面上的不同角度插入多达四个螺钉。这很重要,因为终板和小梁骨的质量可能在椎体之间有所不同,并且可能会影响螺钉的固定能力,特别是如果骨-螺钉界面的骨质获取较差。

目的

本研究旨在评估在椎体的不同位置插入的 IFC 螺钉周围局部骨质量的变化是否会影响其力学性能。

研究设计

这是一项体外人体尸体生物力学分析研究。

材料和方法

本研究使用了来自 10 具尸体(年龄:76±10 岁,骨密度:0.89±0.17g/cm)的 14 个腰椎(L3 和 L4)椎体。使用 IFC 导向器和骨钻在椎体中创建了三个不同的 IFC 螺钉方向(外侧到内侧[LM]、正中矢状位[MS]和内侧到外侧[ML])的导孔(直径 3.5mm×15mm 长)。选择的螺钉位置和轨迹代表市售的 IFC 设计。然后使用高分辨率微计算机断层扫描对导孔周围的骨进行三维成像。通过评估导孔周围 3mm 厚的环形体积来量化局部骨形态。在记录最大螺钉插入扭矩的同时,将集成固定螺钉植入导孔中。螺钉在颅侧方向从 10 到 50N 摆动 10,000 次循环,每 5,000 次循环增加 25N 的最大负载,总共进行 25,000 次循环。

结果

ML 螺钉周围的总骨体积(BV)和小梁骨体积分数明显大于 MS(p<.03)和 LM(p<.03)螺钉周围的骨体积。ML 螺钉的最大插入扭矩(p=.06)大于 LM,明显大于 MS(p<.02)螺钉。ML 螺钉的失效循环数明显大于 LM(p<.04)和 MS(p<.04)螺钉。总 BV(R≤46.2%,p<.03)和最大插入扭矩(R≤59.6%,p<.03)与螺钉松动的相关性优于所有其他骨质量参数。

结论

我们的发现表明,椎体的骨质量在空间上取决于 IFC 螺钉的方向和插入位置。这些局部骨质量的变化显著影响了螺钉固定在骨上的能力。这些骨质量的变化可以通过螺钉插入扭矩测量在术中进行评估。通过了解骨-植入物界面上的可用骨质获取情况,可以选择适当的植入物设计,以最大程度地提高固定强度。

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