Woodward Josha, Malone Hani, Witiw Christopher D, Kolcun John Paul G, Koro Lacin, Keegan Kevin C, Ahmad Shahjehan, Kerolus Mena G, David Brian T, Fessler R David, Fessler Richard G
J Neurosurg Spine. 2021 Jun 4;35(2):170-176. doi: 10.3171/2020.11.SPINE201139. Print 2021 Aug 1.
The goal of this study was to evaluate the clinical and radiographic outcomes of a novel multidirectional in situ expandable minimally invasive surgery (MIS) transforaminal lumbar interbody fusion (TLIF) cage.
A retrospective analysis of 69 consecutive patients undergoing a 1- or 2-level MIS TLIF using an expandable cage was performed over a 2-year period. Standard MIS techniques with pedicle screw fixation were used in all cases. Upright lateral dynamic flexion/extension radiographs were reviewed prior to and at 1 year after surgery. Clinical metrics included numeric rating scale for back and leg pain, Oswestry Disability Index, and the SF-12 and VR-12 physical and mental health surveys. Radiographic parameters included anterior and posterior disc height, neuroforaminal height, spondylolisthesis, segmental lordosis, lumbar lordosis, and fusion rate.
A total of 69 patients representing 75 operative levels met study inclusion criteria. The mean patient age at surgery was 63.4 ± 1.2 years, with a female predominance of 51%. The average radiographic and clinical follow-ups were 372 and 368 days, respectively. A total of 63 patients (91%) underwent 1-level surgery and 6 patients (9%) underwent 2-level surgery. Significant reductions of numeric rating scale scores for back and leg pain were observed-from 6.1 ± 0.7 to 2.5 ± 0.3 (p < 0.0001) and 4.9 ± 0.6 to 1.9 ± 0.2 (p < 0.0001), respectively. A similar reduction in Oswestry Disability Index from 38.0 ± 4.6 to 20.0 ± 2.3 (p < 0.0001) was noted. Likewise, SF-12 and VR-12 scores all showed statistically significant improvement from baseline (p < 0.001). The mean anterior and posterior disc heights improved from 8.7 ± 1.0 mm to 13.4 ± 1.5 mm (p = 0.0001) and 6.5 ± 0.8 mm to 9.6 ± 1.1 mm (p = 0.0001), respectively. Neuroforaminal height improved from 17.6 ± 2.0 mm to 21.9 ± 2.5 mm (p = 0.0001). When present, spondylolisthesis was, on average, reduced from 4.3 ± 0.5 mm to 1.9 ± 0.2 mm (p = 0.0001). Lumbar lordosis improved from 47.8° ± 5.5° to 58.5° ± 6.8° (p = 0.2687), and no significant change in segmental lordosis was observed. The overall rate of radiographic fusion was 93.3% at 1 year. No perioperative complications requiring operative revision were encountered.
In this series of MIS TLIFs, use of this novel interbody cage was shown to be safe and effective. Significant improvements in pain and disability were observed. Effective and durable restoration of disc height and neuroforaminal height and reduction of spondylolisthesis were obtained, with concurrent gains in lumbar lordosis. Taken together, this device offers excellent clinical and radiographic outcomes via an MIS approach.
本研究的目的是评估一种新型多向原位可扩张微创手术（MIS）经椎间孔腰椎椎间融合（TLIF）椎间融合器的临床和影像学结果。
对连续69例在2年期间接受单节段或双节段使用可扩张椎间融合器的MIS TLIF手术的患者进行回顾性分析。所有病例均采用标准的MIS技术加椎弓根螺钉固定。在手术前和术后1年复查站立位侧位动态屈伸X线片。临床指标包括背部和腿部疼痛数字评分量表、Oswestry功能障碍指数以及SF-12和VR-12身心健康调查问卷。影像学参数包括椎间盘前后高度、神经孔高度、椎体滑脱、节段性前凸、腰椎前凸和融合率。
共有69例患者（代表75个手术节段）符合研究纳入标准。手术时患者的平均年龄为63.4±1.2岁，女性占51%。影像学和临床的平均随访时间分别为372天和368天。共有63例患者（91%）接受了单节段手术，6例患者（9%）接受了双节段手术。观察到背部和腿部疼痛数字评分量表得分显著降低，分别从6.1±0.7降至2.5±0.3（p<0.0001）和从4.9±0.6降至1.9±0.2（p<0.0001）。Oswestry功能障碍指数也有类似降低，从38.0±4.6降至20.0±2.3（p<0.0001）。同样，SF-12和VR-12评分与基线相比均有统计学显著改善（p<0.001）。椎间盘平均前后高度分别从8.7±1.0毫米提高到13.4±1.5毫米（p = 0.0001）和从6.5±0.8毫米提高到9.6±1.1毫米（p = 0.0001）。神经孔高度从17.6±2.0毫米提高到21.9±2.5毫米（p = 0.0001）。存在椎体滑脱时，平均从4.3±0.5毫米降至1.9±0.2毫米（p = 0.0001）。腰椎前凸从47.8°±5.5°提高到58.5°±6.8°（p = 0.2687），节段性前凸未观察到显著变化。1年时影像学融合的总体发生率为93.3%。未遇到需要手术翻修的围手术期并发症。
在这一系列MIS TLIF手术中，使用这种新型椎间融合器显示出安全有效。观察到疼痛和功能障碍有显著改善。实现了椎间盘高度和神经孔高度的有效且持久恢复以及椎体滑脱的减轻，同时腰椎前凸增加。总体而言，该装置通过MIS方法提供了出色的临床和影像学结果。
