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.     

MIS-TLIF与TLIF治疗单节段腰椎退行性疾病近期疗效的对比分析

摘要 目的：对比分析微创经椎间孔入路腰椎椎间融合术（MIS-TLIF）与传统经椎间孔腰椎椎体间融合术（TLIF）治疗单节段腰椎退行性疾病近期疗效。方法：回顾性选取我院2018年4月-2020年12月收治的72例单节段腰椎退行性疾病患者的临床资料,根据手术方式分为A组（n=36,给予TLIF治疗）,B组（n=36,给予MIS-TLIF治疗）。对比两组患者手术指标（手术时间、术中出血量、切口长度）;对比两组患者手术前和手术后1个月、手术后6个月疼痛程度和腰椎功能;对比两组患者椎间融合率。结果：相比于A组,B组手术时间更长,切口长度更短,术中出血量更少（P＜0.05）;相比于A组,B组手术后1个月、手术后6个月视觉模拟评分法（VAS）评分均更低（P＜0.05）;相比于A组,B组手术后1个月、手术后6个月日本骨科协会（JOA）评分均更高（P＜0.05）。B组椎间融合率为97.22%（35/36）与A组的88.89%（32/36）比较差异无统计学意义（P＞0.05）。结论：与TLIF治疗相比,采用MIS-TLIF治疗单节段腰椎退行性疾病患者,手术时间更长,但对于患者疼痛的缓解和腰椎功能的改善更为明显。     

经椎间孔腰椎融合术在腰椎翻修手术中应用的临床疗效

目的:探讨经椎间孔腰椎融合术(TLIF)在腰椎翻修手术中应用的临床疗效和安全性。方法:回顾性分析2008年10月至2012年5月38例腰椎术后需要翻修的患者接受TLIF手术治疗后的临床资料。结果:38例患者随访(22.6±4.4)个月;术前下肢疼痛和背部疼痛VAS评分分别为(8.2±1.6)分、(7.2±1.4)分,术后18个月下肢疼痛和背部疼痛VAS评分为(1.8±0.8)分,(1.5±0.7)分,术前和术后18个月相比较有统计学差异(P0.05)。功能障碍指数为24.3±8.2,较术前明显下降(P0.05),JOA评分为(25.5±7.6)分,较术前显著上升(P0.05);术后改善率和优良率均为86.8%;术前椎间高度和椎间移动幅度分别为(7.5±1.2)mm,(8.7±2.1)°,经TLIF技术治疗后相应指标依次为(10.6±1.9)mm,(1.8±0.7)°,差异显著(P0.05);骨融合率100%。结论:经椎间孔腰椎融合术(TLIF)治疗翻修的腰椎手术患者的临床疗效可靠,并发症少,值得推广。