Tobler William D, Melgar Miguel A, Raley Thomas J, Anand Neel, Miller Larry E, Nasca Richard J
Department of Neurosurgery, University of Cincinnati College of Medicine, Mayfield Clinic, and The Christ Hospital, Cincinnati, OH, USA.
Med Devices (Auckl). 2013 Sep 18;6:155-61. doi: 10.2147/MDER.S48442. eCollection 2013.
Previous studies have confirmed the benefits and limitations of the presacral retroperitoneal approach for L5-S1 interbody fusion. The purpose of this study was to determine the safety and effectiveness of the minimally invasive axial lumbar interbody approach (AxiaLIF) for L4-S1 fusion.
In this retrospective series, 52 patients from four clinical sites underwent L4-S1 interbody fusion with the AxiaLIF two-level system with minimum 2-year clinical and radiographic follow-up (range: 24-51 months). Outcomes included back pain severity (on a 10-point scale), the Oswestry Disability Index (ODI), and Odom's criteria. Flexion and extension radiographs, as well as computed tomography scans, were evaluated to determine fusion status. Longitudinal outcomes were assessed with repeated measures analysis of variance.
Mean subject age was 52 ± 11 years and the male:female ratio was 1:1. Patients sustained no intraoperative bowel or vascular injury, deep infection, or neurologic complication. Median procedural blood loss was 220 cc and median length of hospital stay was 3 days. At 2-year follow-up, mean back pain had improved 56%, from 7.7 ± 1.6 at baseline to 3.4 ± 2.7 (P < 0.001). Back pain clinical success (ie, ≥30% improvement from baseline) was achieved in 39 (75%) patients at 2 years. Mean ODI scores improved 42%, from 60% ± 16% at baseline to 35% ± 27% at 2 years (P < 0.001). ODI clinical success (ie, ≥30% improvement from baseline) was achieved in 26 (50%) patients. At final follow-up, 45 (87%) patients were rated as good or excellent, five as fair, and two as poor by Odom's criteria. Interbody fusion observed on imaging was achieved in 97 (93%) of 104 treated interspaces. During follow-up, five patients underwent reoperation on the lumbar spine, including facet screw removal (two), laminectomy (two), and transforaminal lumbar interbody fusion (one).
The AxiaLIF two-level device is a safe, effective treatment adjunct for patients with L4-S1 disc pathology resistant to conservative treatments.
先前的研究已证实骶前腹膜后入路用于L5-S1椎间融合的益处和局限性。本研究的目的是确定微创轴向腰椎椎间入路（AxiaLIF）用于L4-S1融合的安全性和有效性。
在这个回顾性系列研究中，来自四个临床地点的52例患者接受了使用AxiaLIF两级系统的L4-S1椎间融合术，并进行了至少2年的临床和影像学随访（范围：24 - 51个月）。结果包括背痛严重程度（采用10分制）、奥斯维斯特残疾指数（ODI）和奥多姆标准。对屈伸位X线片以及计算机断层扫描进行评估以确定融合状态。采用重复测量方差分析评估纵向结果。
患者平均年龄为52±11岁，男女比例为1:1。患者术中未发生肠或血管损伤、深部感染或神经并发症。术中平均失血量为220 cc，平均住院时间为3天。在2年随访时，平均背痛改善了56%，从基线时的7.7±1.6降至3.4±2.7（P < 0.001）。2年时，39例（75%）患者背痛临床成功（即较基线改善≥30%）。平均ODI评分改善了42%，从基线时的60%±16%降至2年时的35%±27%（P < 0.001）。26例（50%）患者ODI临床成功（即较基线改善≥30%）。在末次随访时，根据奥多姆标准，45例（87%）患者被评为良好或优秀，5例为中等，2例为差。在104个治疗节段中，97个（93%）在影像学上观察到椎间融合。随访期间，5例患者接受了腰椎再次手术，包括取出小关节螺钉（2例）、椎板切除术（2例）和经椎间孔腰椎椎间融合术（1例）。
AxiaLIF两级装置对于L4-S1椎间盘病变经保守治疗无效的患者是一种安全、有效的治疗辅助手段。
