Farrokhi Majid R, Nikoo Zahra, Gholami Mehrnaz, Hosseini Khadijeh
Neurosurgery Department, Shiraz Neuroscience Research Center, Chamran Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.
Clin Spine Surg. 2017 Feb;30(1):38-46. doi: 10.1097/BSD.0000000000000251.
Prospective, single-blind randomized-controlled clinical study.
To compare polyetheretherketone (PEEK) cage with a novel Acrylic cage to find out which fusion cage yielded better clinical outcomes following single-level anterior cervical discectomy and fusion (ACDF).
ACDF is considered a standard neurosurgical treatment for degenerative diseases of cervical intervertebral disks. There are many options, including bone grafts, bone cement, and spacers made of titanium, carbon fiber, and synthetic materials, used to restore physiological disk height and enhance spinal fusion, but the ideal device, which would provide immediate structural support and subsequent osteointegration and stability, has not been identified yet. To overcome this, we designed a new, inexpensive Acrylic cage.
A total of 64 patients were eligible to participate and were randomly allocated to undergo ACDF either with Acrylic interbody fusion cage filled with bone substitute (n=32) or PEEK cage (n=32). Nurick's grading was used for quantifying the neurological deficit. Clinical and radiologic outcome was assessed preoperatively, immediately after surgery, and subsequently at 2, 6, and 12 months of follow-up using Odom's criteria and dynamic radiographs (flexion-extension) and computed tomography scans, respectively.
There was a statistically significant improvement in the clinical outcomes of the Acrylic cage group compared with the PEEK cage group (mean difference: -0.438; 95% confidence interval, -0.807 to -0.068; P=0.016). There was a statistically significant difference in disk space height increase between the 2 groups at the 6- and 12-month follow-up. The Acrylic cage achieved higher fusion rate (good fusion) than the PEEK cage (96.9% vs. 93.8%). Intervertebral angle demonstrated a significant difference among the 2 treated groups throughout the follow-up period.
This study suggests that the use of Acrylic cage is associated with good clinical and radiologic outcomes and it can be therefore a good substitute for bone graft and other cages in ACDF.
前瞻性、单盲随机对照临床研究。
比较聚醚醚酮（PEEK）椎间融合器与新型丙烯酸椎间融合器，以确定在单节段颈椎前路椎间盘切除融合术（ACDF）后哪种融合器能产生更好的临床效果。
ACDF被认为是治疗颈椎间盘退行性疾病的标准神经外科手术。有多种选择，包括骨移植、骨水泥以及由钛、碳纤维和合成材料制成的椎间融合器，用于恢复生理椎间盘高度并增强脊柱融合，但尚未确定能提供即时结构支撑、随后实现骨整合和稳定性的理想装置。为克服这一问题，我们设计了一种新型、廉价的丙烯酸椎间融合器。
共有64例患者符合参与条件，被随机分配接受ACDF手术，其中32例使用填充骨替代物的丙烯酸椎间融合器，32例使用PEEK椎间融合器。采用Nurick分级来量化神经功能缺损。术前、术后即刻以及随后在随访的2、6和12个月时，分别使用奥多姆标准、动态X线片（屈伸位）和计算机断层扫描评估临床和影像学结果。
与PEEK椎间融合器组相比，丙烯酸椎间融合器组的临床效果有统计学意义的改善（平均差异：-0.438；95%置信区间，-0.807至-0.068；P = 0.016）。在6个月和12个月随访时，两组间椎间盘间隙高度增加有统计学意义的差异。丙烯酸椎间融合器的融合率（良好融合）高于PEEK椎间融合器（96.9%对93.8%）。在整个随访期间，两个治疗组的椎间角度存在显著差异。
本研究表明，使用丙烯酸椎间融合器具有良好的临床和影像学效果，因此在ACDF中它可以很好地替代骨移植和其他椎间融合器。
