Le Huec Jean Charles, Cloche Thibault, Thompson Wendy, Edorh Grégoire, Boue Lisa, Bourret Stéphnae
VERTEBRA Institute, Polyclinic Bordeaux North Aquitaine, Bordeaux, France.
BIOBank, Lieusaint, France.
Eur Spine J. 2025 Jun 4. doi: 10.1007/s00586-025-08851-8.
Prospective, single-center study OBJECTIVE: To assess the efficacy, tolerance, and safety of BIOBank supercritical CO-treated bone paste for cervical interbody arthrodesis using grafts and plates.
This was a prospective, single-center, observational clinical study of 49 individuals (72 grafted levels) undergoing anterior cervical discectomy and fusion (ACDF) with interbody cages and grafting with a novel bone paste (BIOBank Synergy, France) with fixation plates. The clinical and radiographic outcomes were evaluated at 3, 12, and 24 months.
The mean (SD) NDI improved significantly from 41.3 (17.0) preoperatively to 22.2 (19.7) at 24 months (p < 0.001). Median (IQR) neck pain significantly improved from 6.0 (3.0) preoperatively to 0 (4.0) at 24 months (p < 0.001), and median arm pain significantly improved from 3.25 (2.5) preoperatively to 0.0 (0.0) at 24 months (p < 0.001). In terms of quality of life, the mean physical score significantly improved from 37.8 (8.6) preoperatively to 45.1 (11.0) (p < 0.001) at 24 months. The cumulative fusion rate at 24 months post-operatively was 96.7%. Surgical ease of handling was excellent (9.9 ± 0.5 points/10 maximum). There were no graft-related serious adverse events.
This first clinical study of BIOBank bone paste shows that the material is acceptable to surgeons and results in good functional, radiological, and outcomes for patients requiring anterior cervical arthrodesis combined with interbody grafting with a fixation plate.
前瞻性单中心研究
评估生物银行超临界二氧化碳处理的骨糊剂用于颈椎椎间融合术（采用植骨和钢板）的疗效、耐受性及安全性。
这是一项前瞻性、单中心、观察性临床研究，纳入49例（72个植骨节段）接受前路颈椎间盘切除融合术（ACDF）的患者，使用椎间融合器并植入一种新型骨糊剂（法国生物银行协同型）及固定钢板。在术后3个月、12个月和24个月对临床及影像学结果进行评估。
平均（标准差）颈部残疾指数（NDI）从术前的41.3（17.0）显著改善至24个月时的22.2（19.7）（p<0.001）。中位（四分位间距）颈部疼痛从术前的6.0（3.0）显著改善至24个月时的0（4.0）（p<0.001），中位手臂疼痛从术前的3.25（2.5）显著改善至24个月时的0.0（0.0）（p<0.001）。在生活质量方面，平均身体评分从术前的37.8（8.6）显著改善至24个月时的45.1（11.0）（p<0.001）。术后24个月的累积融合率为96.7%。手术操作简便性极佳（9.9±0.5分/满分10分）。未发生与植骨相关的严重不良事件。
这项关于生物银行骨糊剂的首次临床研究表明，该材料为外科医生所接受，对于需要前路颈椎融合术并结合椎间植骨及固定钢板的患者，能带来良好的功能、影像学及治疗效果。
