Davis Justin, Everist Brian, Hatfield Casey, Sage Katherine
Neurosurgery The University of Kansas Health System.
Radiology The University of Kansas Health System.
Orthop Rev (Pavia). 2025 Apr 29;17:133986. doi: 10.52965/001c.133986. eCollection 2025.
Spinal fusion surgeries remain a successful treatment for degenerative disc disease. While autograft is considered the gold standard bone graft, synthetic bone void fillers are increasingly used to limit donor site morbidity while giving sufficient graft volume.
This retrospective clinical study evaluates MagnetOs Easypack Putty as a standalone graft without autograft in interbody fusion. An independent radiologist blinded to the clinical status provided evaluation of computed tomography (CT) images obtained at 12 months and graded each treated level based on the Brantigan-Steffee-Fraser (BSF) Classification. Twenty subjects were enrolled in the study. A total of 36 spinal levels were treated with an average of 1.8 levels per subject (L2-L3 to L5-S1).
The primary endpoint of CT-based fusion was 94.4% (34/36 levels) based on the presence of bridging bone or locked pseudoarthrosis at 12 months. The high fusion rate was accompanied by consistent improvement in pain scores. Visual analogue scale (VAS) pain scores decreased an average of 25% from 5.3/10 pre-operatively to 2.8/10 at 12 months post-operative, and all subjects who reported pre-operative back or leg pain reported improved pain post-operatively. Although the patient population included risk factors and comorbidities, the fusion rate remained high, and no device-related adverse events (AEs) were observed.
The high fusion rate and favorable safety profile support the performance of MagnetOs Easypack Putty for standalone use without autograft in interbody fusion procedures.
脊柱融合手术仍然是治疗椎间盘退变疾病的一种成功方法。虽然自体骨移植被认为是骨移植的金标准，但合成骨缺损填充材料越来越多地被用于限制供体部位的发病率，同时提供足够的移植量。
这项回顾性临床研究评估了MagnetOs Easypack 油灰作为椎间融合中无需自体骨的独立移植材料。一位对临床状况不知情的独立放射科医生对在12个月时获得的计算机断层扫描（CT）图像进行评估，并根据布兰特igan-斯特菲-弗雷泽（BSF）分类对每个治疗节段进行分级。共有20名受试者参与了该研究。总共治疗了36个脊柱节段，每位受试者平均治疗1.8个节段（L2-L3至L5-S1）。
基于12个月时桥接骨的存在或锁定假关节，基于CT的融合的主要终点为94.4%（34/36个节段）。高融合率伴随着疼痛评分的持续改善。视觉模拟量表（VAS）疼痛评分从术前的5.3/10平均下降了25%，至术后12个月时为2.8/10，所有术前报告有背部或腿部疼痛的受试者术后疼痛均有所改善。尽管患者群体包括风险因素和合并症，但融合率仍然很高，且未观察到与器械相关的不良事件（AE）。
高融合率和良好的安全性支持MagnetOs Easypack油灰在椎间融合手术中无需自体骨独立使用的性能。
