Calvert Graham C, VanBuren Huffmon George, Rambo William M, Smith Micah W, McEntire Bryan J, Bal B Sonny
Mississippi Sports Medicine & Orthopedic Center, Jackson, MS, USA.
Atlantic Neurosurgical and Spine Specialists, Wilmington, NC, USA.
J Spine Surg. 2020 Mar;6(1):33-48. doi: 10.21037/jss.2019.12.11.
In lumbar fusion surgery, intervertebral spacer cages made of silicon nitride (SiN) ceramic are an available option among other biomaterials. While the surface chemistry of SiN is known to favor bone fusion, large-scale clinical studies attesting to its efficacy are lacking. This multicenter retrospective study compared lumbar fusion outcomes for SiN cages to previously reported data for other cage materials.
Pre-operative patient demographics, comorbidities, changes in visual analog scale (ΔVAS) pain scores, complications, adverse events, and secondary surgical interventions (SSI) were compiled from the records of 450 patients who underwent SiN lumbar spinal fusion at four separate U.S. surgical centers. For comparison, MEDLINE/PubMed and Google Scholar searches identified studies reporting similar outcomes for other biomaterials. A total of 1,025 patients from 26 cohorts reported in 14 publications met inclusion criteria for this control group.
Overall, the mean last-follow-up for all patients was 341±293 days (11.4±9.8 months), with the longest follow-up being 6.4 years. Patients with SiN implants were similar in gender and age distribution to the control group but had higher BMI values (30.9±6.1 . 25.8±4.1, P<0.01) and lower tobacco use (15.8% 30.0%, P<0.01). Both the SiN and control groups showed significant improvements in VAS pain scores from preoperative to last follow-up. For the SiN group, ΔVAS was 36.8±35.4 points compared to 37.6±22.5 points (P=0.63) for the metadata group. Complications and reoperations for the SiN and the control groups were similar (i.e., 9.8% and 3.1% versus 12.4% and 2.9%, P=0.16 and P=0.84, respectively).
Lumbar fusion with SiN spacers compared favorably with the improvements reported with other commonly used biomaterial cages.
在腰椎融合手术中，由氮化硅（SiN）陶瓷制成的椎间融合器是其他生物材料中的一种可用选择。虽然已知SiN的表面化学性质有利于骨融合，但缺乏证明其疗效的大规模临床研究。这项多中心回顾性研究将SiN融合器的腰椎融合结果与先前报道的其他融合器材料的数据进行了比较。
从美国四个不同外科中心接受SiN腰椎融合术的450例患者的记录中收集术前患者的人口统计学、合并症、视觉模拟量表（ΔVAS）疼痛评分变化、并发症、不良事件和二次手术干预（SSI）。为了进行比较，通过MEDLINE/PubMed和谷歌学术搜索确定了报告其他生物材料类似结果的研究。14篇出版物中报道的26个队列的1025例患者符合该对照组的纳入标准。
总体而言，所有患者的平均末次随访时间为341±293天（11.4±9.8个月），最长随访时间为6.4年。植入SiN的患者在性别和年龄分布上与对照组相似，但BMI值较高（30.9±6.1对25.8±4.1，P<0.01），吸烟率较低（15.8%对30.0%，P<0.01）。SiN组和对照组从术前到末次随访的VAS疼痛评分均有显著改善。SiN组的ΔVAS为36.8±35.4分，而元数据组为37.6±22.5分（P=0.63）。SiN组和对照组的并发症和再次手术情况相似（即分别为9.8%和3.1%对12.4%和2.9%，P分别为0.16和0.84）。
与其他常用生物材料融合器所报告的改善情况相比，SiN融合器进行的腰椎融合效果良好。
