Hospital for Special Surgery, Department of Orthopedic Surgery, New York, NY, USA; Orthopedic Soft Tissue Research Program, Hospital for Special Surgery, 535 East 70th St., New York, NY, USA; Department of Orthopedic Surgery, Hofstra University North Shore-LIJ Medical School.
Department of Biomechanics, Hospital for Special Surgery, New York, NY, USA.
Spine J. 2021 Apr;21(4):698-707. doi: 10.1016/j.spinee.2020.10.030. Epub 2020 Nov 3.
Annular repair devices offer a solution to recurrent disc herniations by closing an annular defect and lowering the risk of reherniation. Given the significant risk of neurologic injury from device failure it is imperative that a reliable preclinical model exists to demonstrate a high load to failure for the disc repair devices.
To establish a preclinical model for disc herniation and demonstrate how changes in species, intervertebral disc height and Pfirrmann classification impacts failure load on an injured disc. We hypothesized that: (1) The force required for disc herniation would be variable across disc morphologies and species, and (2) for human discs the force to herniation would inversely correlate with the degree of disc degeneration.
Animal and human cadaveric biomechanical model of disc herniation.
We tested calf lumbar spines, bovine tail segments and human lumbar spines. We first divided individual lumbar or tail segments to include the vertebral bodies and disc. We then hydrated the specimens by placing them in a saline bath overnight. A magnetic resonance images were acquired from human specimens and a Pfirrmann classification was made. A stab incision measuring 25% of the diameter of the disc was then done to each specimen along the posterior intervertebral disc space. Each specimen was placed in custom test fixtures on a servo-hydraulic test frame (MTS, Eden Prarie, MN) such that the superior body was attached to a 10,000 lb load cell and the inferior body was supported on the piston. A compressive ramping load was placed on the specimen in load control at 4 MPa/sec stopping at 75% of the disc height. Load was recorded throughout the test and failure load calculated. Once the test was completed each specimen was sliced through the center of the disc and photos were taken of the cut surface.
Fifteen each of calf, human, and bovine tail segments were tested. The failure load varied significantly between specimens (p<.001) with human specimens having the highest average failure load (8154±2049 N). Disc height was higher for lumbar/bovine tail segments as compared to calf specimens (p<.001) with bovine tails having the highest disc height (7.1±1.7 mm). Similarly, human lumbar discs had a cross sectional area that was greater than both bovine tail/calf lumbar spines (p<.001). There was no correlation between disc height and failure load within each individual species (p>.05). Cross sectional area and failure load did not correlate with failure load for human lumbar spine and bovine tails (p>.05) but did correlate with calf spine (r=0.53, p=.04). There was a statistically significant inverse correlation between disc height and Pfirrmann classification for human lumbar spines (r=-0.84, p<.001). There was also a statistically significant inverse relationship between Pfirrmann classification and failure load (r=-0.58, p=.02).
We have established a model for disc herniation and have shown how results of this model vary between species, disc morphology, and Pfirrmann classification. Both hypotheses were accepted: The force required for disc herniation was variable across species, and the force to herniation for human spines was inversely correlated with the degree of disc degeneration. We recommend that models using human intervertebral discs should include data on Pfirrmann classification, while biomechanical models using calf spines should report cross sectional area. Failure loads do not vary based on dimensions for bovine tails.
Our analysis of models for disc herniation will allow for quicker, reliable comparisons of failure forces required to induce a disc herniation. Future work with these models may facilitate rapid testing of devices to repair a torn/ruptured annulus.
环形修复装置通过封闭环形缺陷并降低再次突出的风险,为复发性椎间盘突出提供了一种解决方案。鉴于器械故障导致神经损伤的风险很大,因此必须存在可靠的临床前模型,以证明椎间盘修复器械具有较高的失效负荷。
建立椎间盘突出的临床前模型,并展示物种、椎间盘高度和 Pfirrmann 分类的变化如何影响受损椎间盘的失效负荷。我们假设:(1)椎间盘突出所需的力在不同的椎间盘形态和物种之间是可变的;(2)对于人类椎间盘,突出的力与椎间盘退变的程度成反比。
椎间盘突出的动物和人体尸体生物力学模型。
我们测试了小牛腰椎、牛尾段和人腰椎。我们首先将单个腰椎或尾段分为包含椎体和椎间盘的部分。然后,我们将标本浸泡在盐水中过夜进行水合。从人标本中获取磁共振图像,并进行 Pfirrmann 分类。然后,在每个标本的后椎间盘间隙处做一个直径为 25%的刺切。每个标本都放在定制的测试夹具上,放在伺服液压测试框架(MTS,Eden Prairie,MN)上,使上体连接到 10000 磅的负载单元,下体支撑在活塞上。以 4 MPa/sec 的速度在负荷控制下对标本施加压缩斜坡负荷,停止在椎间盘高度的 75%处。在整个测试过程中记录负载,并计算失效负载。一旦测试完成,每个标本都沿着椎间盘的中心切开,并拍摄切口表面的照片。
测试了 15 个小牛、人、牛尾段。标本之间的失效负载差异显著(p<.001),人标本的平均失效负载最高(8154±2049 N)。与小牛标本相比,腰椎/牛尾段的椎间盘高度更高(p<.001),牛尾的椎间盘高度最高(7.1±1.7 mm)。同样,人腰椎间盘的横截面积大于牛尾/小牛腰椎的横截面积(p<.001)。在每个单独的物种中,椎间盘高度与失效负载之间没有相关性(p>.05)。人腰椎和牛尾的横截面积和失效负载与失效负载不相关(p>.05),但与小牛腰椎相关(r=0.53,p=.04)。人腰椎间盘的椎间盘高度与 Pfirrmann 分类之间存在显著的负相关(r=-0.84,p<.001)。Pfirrmann 分类与失效负载之间也存在显著的负相关(r=-0.58,p=.02)。
我们已经建立了椎间盘突出模型,并展示了该模型在物种、椎间盘形态和 Pfirrmann 分类之间的结果如何变化。两个假设都被接受:椎间盘突出所需的力在物种之间是可变的,而人类脊柱的突出力与椎间盘退变的程度成反比。我们建议,使用人椎间盘的模型应包括 Pfirrmann 分类的数据,而使用小牛脊柱的生物力学模型应报告横截面积。牛尾的失效负载不随尺寸变化而变化。
我们对椎间盘突出模型的分析将允许更快、更可靠地比较导致椎间盘突出所需的失效力。未来使用这些模型的工作可能会促进对撕裂/破裂的环形修复装置的快速测试。