Cho Minjoon, You Ki-Han, Yeom Jin Sup, Kim Hyoungmin, Lee Kwang Bok, Cho Jae Hwan, Yang Jae Jun, Lee Jae Hyup
Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center, Boramae-Ro 5-Gil, Dongjak-Gu, Seoul, 07061, Republic of Korea.
Department of Orthopedic Surgery, Hallym University Kangnam Sacred Heart Hospital, Seoul, Korea.
Eur Spine J. 2023 Jan;32(1):353-360. doi: 10.1007/s00586-022-07440-3. Epub 2022 Nov 17.
This study aimed to evaluate the mid-term efficacy and safety of Escherichia coli-derived bone morphogenetic protein-2 (E.BMP-2)/hydroxyapatite (HA) in lumbar posterolateral fusion (PLF).
This multicenter, evaluator-blinded, observational study utilized prospectively collected clinical data. We enrolled 74 patients who underwent lumbar PLF and had previously participated in the BA06-CP01 clinical study, which compared the short-term outcomes of E.BMP-2 with an auto-iliac bone graft (AIBG). Radiographs and CT scans were analyzed to evaluate fusion grade at 12, 24, and 36 months. Visual analog scale (VAS), Oswestry disability index (ODI), and Short Form-36 (SF-36) scores were measured preoperatively and at 36 months after surgery. All adverse events in this study were assessed for its relationship with E.BMP-2.
The fusion grade of the E.BMP-2 group (4.91 ± 0.41) was superior to that of the AIBG group (4.25 ± 1.26) in CT scans at 36 months after surgery (p = 0.007). Non-union cases were 4.3% in the E.BMP-2 and 16.7% in the AIBG. Both groups showed improvement in pain VAS, ODI, and SF-36 scores when compared to the baseline values, and there were no statistically significant differences between the two groups. No treatment-related serious adverse reactions were observed in either group. No neoplasm-related adverse events occurred in the E.BMP-2 group.
The fusion quality of E.BMP-2/HA was superior to that of AIBG. E.BMP-2/HA showed comparable mid-term outcomes to that of AIBG in terms of efficacy and safety in one-level lumbar PLF surgery.
本研究旨在评估大肠杆菌衍生的骨形态发生蛋白-2（E.BMP-2）/羟基磷灰石（HA）在腰椎后外侧融合术（PLF）中的中期疗效和安全性。
本多中心、评估者盲法观察性研究利用前瞻性收集的临床数据。我们纳入了74例行腰椎PLF且此前参与过BA06-CP01临床研究的患者，该研究比较了E.BMP-2与自体髂骨移植（AIBG）的短期疗效。通过分析X线片和CT扫描评估术后12、24和36个月时的融合等级。术前及术后36个月测量视觉模拟量表（VAS）、Oswestry功能障碍指数（ODI）和简明健康状况调查量表（SF-36）评分。评估本研究中所有不良事件与E.BMP-2的关系。
术后36个月时，CT扫描显示E.BMP-2组的融合等级（4.91±0.41）优于AIBG组（4.25±1.26）（p = 0.007）。E.BMP-2组的不愈合率为4.3%，AIBG组为16.7%。与基线值相比，两组的疼痛VAS、ODI和SF-36评分均有所改善，两组间差异无统计学意义。两组均未观察到与治疗相关的严重不良反应。E.BMP-2组未发生与肿瘤相关的不良事件。
E.BMP-2/HA的融合质量优于AIBG。在单节段腰椎PLF手术中，E.BMP-2/HA在疗效和安全性方面的中期结果与AIBG相当。
