Spine Institute of San Diego, 6719 Alvarado Road Suite 308, San Diego, CA, 92120, USA.
Connecticut Neck and Back Specialists, 39 Hospital Ave, Danbury, CT, 06810, USA.
J Orthop Surg Res. 2023 Mar 25;18(1):239. doi: 10.1186/s13018-023-03686-9.
To investigate the clinical safety and efficacy of ViBone Viable Bone Matrix (VBM), a next generation cellular bone matrix allograft that comprises all three essential bone-forming components: osteogenic, osteoinductive, and osteoconductive factors, and is optimized to enhance cell viability and bone formation.
This was a multi-center, prospective, post-market study evaluating the safety and efficacy of ViBone VBM in patients undergoing 1-3 level anterior cervical discectomy and fusion or lumbar interbody fusion surgery. Patients were evaluated at baseline, 6-month, and 12-month follow-up clinically and radiographically. Clinical assessment included Visual Analog Scale for pain (VAS-pain), the Neck Disability Index (NDI) for patients with cervical pathologies, and the Oswestry Disability Index (ODI) for patients with lumbar pathologies. Fusion success defined by an independent radiologist was determined radiographically by plain films.
Clinical outcomes evaluated with VAS-pain, NDI, and ODI scales were improved significantly at 6 and 12 months compared to baseline. All patients reached clinically significant improvements at 12 months. There were no adverse events or infections attributed to ViBone VBM. At 12 months, the fusion rate per patient was 88.1% in cervical and 97.6% in lumbar patients, while per-level fusion was 98.5% for cervical and 100% for lumbar segments.
Patients undergoing cervical and lumbar spinal fusion implanted with ViBone VBM demonstrated favorable outcomes at 6 months and 12 months as measured by subjective clinical measures and radiographic fusion rates. Trial registration This study was registered as NCT03425682 on 1/29/2018.
为了研究 ViBone 活性骨基质（VBM）的临床安全性和疗效，这是一种下一代细胞骨基质同种异体移植物，包含所有三个基本的成骨成分：成骨、骨诱导和骨传导因子，并优化以提高细胞活力和骨形成。
这是一项多中心、前瞻性、上市后研究，评估 ViBone VBM 在接受 1-3 级前路颈椎间盘切除术和融合或腰椎椎间融合术的患者中的安全性和疗效。患者在基线、6 个月和 12 个月时进行临床和影像学评估。临床评估包括疼痛视觉模拟量表（VAS-pain）、颈椎病变患者的颈部残疾指数（NDI）和腰椎病变患者的 Oswestry 残疾指数（ODI）。独立放射科医生通过 X 线片确定融合成功。
与基线相比，6 个月和 12 个月时 VAS-pain、NDI 和 ODI 评分的临床结果显著改善。所有患者在 12 个月时均达到临床显著改善。没有与 ViBone VBM 相关的不良事件或感染。在 12 个月时，颈椎患者的每个患者融合率为 88.1%，腰椎患者为 97.6%，而颈椎每级融合率为 98.5%，腰椎为 100%。
接受颈椎和腰椎脊柱融合术的患者在 6 个月和 12 个月时，通过主观临床测量和影像学融合率显示出良好的结果。
试验注册 本研究于 2018 年 1 月 29 日在 NCT03425682 上注册。
