Jang Gi-Wuk, Kim Kyung-Hyun, Shin Dong-Ah, Jang Hyun-Joon, Lee Chang-Kyu, Chin Dong-Kyu, Park Jeong-Yoon, Koo Seong-Wook, Moon Bong-Ju
Department of Neurosurgery, Spine and Spinal Cord Institute, Gangnam Severance Spine Hospital, Seoul, Republic of Korea.
Department of Neurosurgery, Yonsei University College of Medicine, Seoul, Republic of Korea.
J Biomed Mater Res B Appl Biomater. 2025 Jan;113(1):e35521. doi: 10.1002/jbm.b.35521.
The bioactive glass-ceramic spacer (BGS)-7, a biosynthetic intervertebral fusion material introduced in 2014, has not been the subject of comparative clinical studies on anterior cervical discectomy and fusion (ACDF) surgery. This study, for the first time, aims to compare the radiological and clinical outcomes of the renewed BGS-7, released in 2019, with those of an allograft spacer. The comparison includes a finite element analysis of the biomechanical properties of each implant, adding a novel dimension to the research. We prospectively followed up on 29 patients who underwent ACDF using BGS-7 as the experimental group. To select a control group for comparison, 253 patients with level 1 ACDF with an allograft spacer between 2012 and 2022 were selected from our hospital. Using propensity score matching, 27 and 54 patients in the BGS-7 and allograft groups, respectively, were selected. The average subsidence length was 1.02 ± 1.44 mm per level in the BGS-7 group and 2.27 ± 2.25 mm per level in the allograft group. Subsidence was observed in 14 of 54 patients (25.9%) in the allograft group and one of 27 patients (3.7%) in the BGS-7 group (p = 0.016). In the allograft group, 16 of the 54 patients (29.6%) monitored for 6 months achieved satisfactory fusion outcomes with grades 4 and 5. Thirty-eight of 54 patients (70.4%) followed up for > 1 year in the allograft group achieved adequate fusion outcomes with grades 4 and 5. In the BGS-7 group, 17 of the 27 patients (63.0%) monitored for 6 months achieved satisfactory fusion results with grades 4 and 5. Twenty-three of the 27 patients (85.2%) followed up for > 1 year obtained adequate fusion outcomes with grades 4 and 5. There was a significant difference in the fusion rates between the two groups at 6 months (p = 0.008). BGS-7 is a reliable instrument for ACDF with no instances of instrumental failure. The BGS-7 group had positive clinical outcomes after surgery without any untoward events, and an early fusion rate with the creation of a bone bridge was noted during the 6-month follow-up period. Our findings not only indicate the safety of BGS-7 but also its practicality as a substitute for allografts in ACDF, instilling confidence in its application.
生物活性玻璃陶瓷间隔器（BGS）-7是2014年推出的一种生物合成椎间融合材料，尚未成为颈椎前路椎间盘切除融合术（ACDF）的比较临床研究对象。本研究首次旨在比较2019年推出的新型BGS-7与同种异体移植间隔器的放射学和临床结果。该比较包括对每个植入物生物力学特性的有限元分析，为研究增添了新的维度。我们前瞻性地随访了29例接受以BGS-7为实验组的ACDF手术的患者。为选择对照组进行比较，从我院选取了2012年至2022年间接受1级ACDF并使用同种异体移植间隔器的253例患者。采用倾向得分匹配法，分别从BGS-7组和同种异体移植组中选取了27例和54例患者。BGS-7组平均每节段下沉长度为1.02±1.44mm，同种异体移植组为2.27±2.25mm。同种异体移植组54例患者中有14例（25.9%）出现下沉，BGS-7组27例患者中有1例（3.7%）出现下沉（p = 0.016）。在同种异体移植组中，54例接受6个月监测的患者中有16例（29.6%）获得了4级和5级的满意融合结果。同种异体移植组54例随访超过1年的患者中有38例（70.4%）获得了4级和5级的充分融合结果。BGS-7组27例接受6个月监测的患者中有17例（63.0%）获得了4级和5级的满意融合结果。BGS-7组27例随访超过1年的患者中有23例（85.2%）获得了4级和5级的充分融合结果。两组在6个月时的融合率有显著差异（p = 0.008）。BGS-7是ACDF的可靠器械，无器械失败病例。BGS-7组术后临床结果良好，无任何不良事件，且在6个月随访期间观察到有骨桥形成的早期融合率。我们的研究结果不仅表明了BGS-7的安全性，还表明了其在ACDF中作为同种异体移植替代物的实用性，增强了对其应用的信心。
