Mechanical performance of lumbar intervertebral body fusion devices: An analysis of data submitted to the Food and Drug Administration

Lumbar intervertebral body fusion devices (L-IBFDs) are intended to provide stability to promote fusion in patients with a variety of lumbar pathologies. Different L-IBFD designs have been developed to accommodate various surgical approaches for lumbar interbody fusion procedures including anterior, lateral, posterior, and transforaminal lumbar interbody fusions (ALIF, LLIF, PLIF, and TLIF, respectively). Due to design differences, there is a potential for mechanical performance differences between ALIF, LLIF, PLIF, and TLIF devices. To evaluate this, mechanical performance and device dimension data were collected from 124 Traditional 510(k) submissions to the FDA for L-IBFDs cleared for marketing from 2007 through 2016. From these submissions, mechanical test results were aggregated for seven commonly performed tests: static and dynamic axial compression, compression-shear, and torsion testing per ASTM F2077, and subsidence testing per ASTM F2267. The Kruskal-Wallis test and Wilcoxon signed-rank test were used to determine if device type (ALIF, LLIF, PLIF, TLIF) had a significant effect on mechanical performance parameters (static testing: stiffness and yield strength; dynamic testing: runout load; subsidence testing: stiffness [Kp]). Generally, ALIFs and LLIFs were found to be stiffer, stronger, and had higher subsidence resistance than PLIF and TLIF designs. These results are likely due to the larger footprints of the ALIF and LLIF devices. The relative mechanical performance and subsidence resistance can be considered when determining the appropriate surgical approach and implant for a given patient. Overall, the mechanical performance data presented here can be utilized for future L-IBFD development and design verification.     

老年腰椎间盘突出症患者术后下肢深静脉血栓形成的影响因素及术前D-D、TM、Leptin联合应用的预测价值

摘要 目的：分析老年腰椎间盘突出症（LDH）患者术后下肢深静脉血栓形成（LDVT）的影响因素并探讨术前D-二聚体（D-D）、血栓调节蛋白（TM）、瘦素（Leptin）联合应用的预测价值。方法：选取2020年1月～2021年12月广州医科大学附属第三医院收治的412例接受腰椎椎间融合术（LIF）老年LDH患者,根据术后是否发生LDVT将其分为LDVT组和非LDVT组。收集老年LDH患者临床资料,采用酶联免疫吸附法检测术前血清D-D、TM、Leptin水平。采用多因素Logistic回归分析老年LDH患者LIF术后LDVT的影响因素,采用受试者工作特征（ROC）曲线分析术前血清D-D、TM、Leptin水平对老年LDH患者LIF术后LDVT的预测价值。结果：412例老年LDH患者LIF术后LDVT发生率为21.12%（87/412）。多因素Logistic回归分析显示,年龄增加、体质指数≥24 kg/m²、卧床时间≥7 d、D-D升高、TM升高、Leptin升高为老年LDH患者LIF术后LDVT的独立危险因素（P＜0.05）。ROC曲线分析显示,术前血清D-D、TM、Leptin水平单独与联合预测老年LDH患者LIF术后LDVT的曲线下面积分别为0.766、0.760、0.767、0.894,联合预测的曲线下面积大于D-D、TM、Leptin单独预测。结论：老年LDH患者LIF术后LDVT发生与年龄、体质指数、卧床时间和D-D、TM、Leptin有关,术前血清D-D、TM、Leptin水平联合预测老年LDH患者LIF术后LDVT的价值较高。     

温热中频治疗仪联合热敏灸对腰椎间盘突出症患者腰椎功能、血液流变学及血清PGE2和5-HT水平的影响

摘要 目的：探讨温热中频治疗仪联合热敏灸对腰椎间盘突出症（LDH）患者腰椎功能、血液流变学及血清前列腺素E₂（PGE₂）和5-羟色胺（5-HT）水平的影响。方法：采用随机数字表法,将湖南中医药大学第一附属医院2020年4月~2022年6月期间收治的128例LDH患者分为研究组（n=64,热敏灸联合温热中频治疗仪治疗）和对照组（n=64,热敏灸治疗）。对比两组疗效、腰椎功能、血液流变学及血清PGE₂、5-HT水平,同时观察两组不良反应发生情况。结果：研究组的临床总有效率（93.75%）明显高于对照组（79.69%）（P<0.05）。治疗4周后,与对照组相比,研究组全血高切黏度、血浆粘度、全血低切黏度、红细胞压积、视觉模拟疼痛（VAS）评分和血清PGE₂、5-HT水平更低,日本骨科协会（JOA）评分更高（P<0.05）。治疗过程中两组患者均未出现不良反应。结论：温热中频治疗仪联合热敏灸治疗LDH患者,可有效改善患者的腰椎功能、血液流变学及血清PGE₂和5-HT水平。     

腰椎间盘突出症的CT及MRI诊断

目的：总结分析１９１例腰椎间盘突出症的ＣＴ及ＭＲＩ影像特征。方法：ＣＴ组１０４例,ＭＲＩ组８７例,同时行ＣＴ及ＭＲ检查４４例。结果：ＣＴ组中,椎间盘同位于Ｌ３－４者１２例,Ｌ４－５者３２例,Ｌ５－Ｓ１者６０例。骨质增生３１例,髓核钙化１１例,后纵韧带钙化９例。ＭＲ组中,椎间盘突出位于Ｌ３－４者１３例,Ｌ４－５者３９例,Ｌ５－Ｓ１者３５例,椎间盘突变性４１例。     

Sarcomere length organization as a design for cooperative function amongst all lumbar spine muscles

The functional design of spine muscles in part dictates their role in moving, loading, and stabilizing the lumbar spine. There have been numerous studies that have examined the isolated properties of these individual muscles. Understanding how these muscles interact and work together, necessary for the prediction of muscle function, spine loading, and stability, is lacking. The objective of this study was to measure sarcomere lengths of lumbar muscles in a neutral cadaveric position and predict the sarcomere operating ranges of these muscles throughout full ranges of spine movements. Sarcomere lengths of seven lumbar muscles in each of seven cadaveric donors were measured using laser diffraction. Using published anatomical coordinate data, superior muscle attachment sites were rotated about each intervertebral joint and the total change in muscle length was used to predict sarcomere length operating ranges. The extensor muscles had short sarcomere lengths in a neutral spine posture and there were no statistically significant differences between extensor muscles. The quadratus lumborum was the only muscle with sarcomere lengths that were optimal for force production in a neutral spine position, and the psoas muscles had the longest lengths in this position. During modeled flexion the extensor, quadratus lumborum, and intertransversarii muscles lengthened so that all muscles operated in the approximate same location on the descending limb of the force-length relationship. The intrinsic properties of lumbar muscles are designed to complement each other. The extensor muscles are all designed to produce maximum force in a mid-flexed posture, and all muscles are designed to operate at similar locations of the force-length relationship at full spine flexion.     

腰椎间盘突出合并脊柱滑脱患者的手术治疗观察

目的:研究手术治疗腰椎间盘突出合并脊柱滑脱的临床疗效。方法:将腰椎间盘突出合并脊柱滑脱的120例患者随机分为两组,其中对照组54例采取保守(非手术)治疗;观察组66例采取手术治疗,对所有接受治疗的患者进行6至9个月不等(平均8个月)的随访,采用视觉模拟评分(VAS)以及腰椎功能障碍指数评分(ODI)两组结果,比较保守和手术治疗的效果。结果:根据VAS和ODI评价结果,手术治疗组疗效明显优于保守治疗组,两治疗组的比较差异具有统计学意义(P0.05)。结论:手术治疗腰椎间盘突出合并脊柱滑脱效果优于保守治疗,是一种安全、有效的方法,能显著改善临床症状,疗效显著。     

罗哌卡因腰麻联合硬膜外麻醉在剖宫产手术中的应用效果

目的:探讨罗哌卡因腰麻联合硬膜外麻醉在剖宫产手术中的应用效果及安全性,为妇科手术麻醉提供可借鉴的方法。方法:对我院于2012年2月至2013年2月期间收治的100例行剖宫产术患者,均于腰硬联合麻醉方式下进行手术,按照随机数字表法,分为观察组50例与对照组50例,分别使用甲磺酸罗哌卡因与盐酸布比卡因进行麻醉,观察与对比两组患者的麻醉效果与不良反应。结果:观察组患者的运动阻滞起效时间、运动阻滞维持时间均显著低于对照组患者,差异存在统计学意义(P0.05);观察组患者与对照组患者在不良反应方面比较,差异不存在统计学意义(P0.05)。结论:罗哌卡因腰麻联合硬膜外麻醉在剖宫产手术中,产生的麻醉效果快速,且安全可靠性有保障,具备临床推广应用的价值。