方法:具有患者内部比较的多中心随机对照非劣效性试验。
目的:本研究的目的是确定具有亚微米微孔的可缓慢吸收的双相磷酸钙的非劣效性(BCP<μm,MagnetOs™颗粒)作为器械后外侧融合(PLF)中自体移植的替代品。
背景:传统上,在椎骨之间具有实心骨桥的成功脊柱融合是通过自体骨移植来实现的。然而,自体移植的缺点和不令人满意的融合率促使人们探索替代方案,包括陶瓷。然而,单独使用这些材料的临床证据有限.
方法:在五个参与中心招募了指定为仪器化PLF(一至六个级别)的成年人。双侧仪器和融合床准备后,公开了随机分配侧(左侧或右侧).每段10cc的BCP<μm颗粒(1-2mm)在一侧放置在后外侧槽中,在对侧放置10cc自体移植物。在1年的随访CT扫描中对融合进行了系统评分。该研究有能力通过每个治疗侧的融合性能评分的二项配对比较来检测>15%的劣效性。
结果:在100名患者中(57±12.9岁,62%女性),分析了91名受试者和128个片段。每节段(左侧和/或右侧)的总体后外侧融合率为83%。对于BCP<μm侧,仅融合率为79%自体移植侧为47%(差异32个百分点,95%CI=23-41)。对主要结局的分析证实了BCP<μm的非劣效性,配对比例的绝对差异为39.6%(95%CI=26.8-51.2,<0.001)。
结论:该临床试验证明了非劣性,并提出了MagnetOs™颗粒作为独立陶瓷与自体移植用于脊柱后外侧融合的几个有吸引力的特征。这些结果表明需要更大的试验和更长的随访时间。
METHODS: A multicenter randomized controlled noninferiority trial with intrapatient comparisons.
OBJECTIVE: The aim of this study was to determine noninferiority of a slowly resorbable biphasic calcium phosphate with submicron microporosity (BCP<μm, MagnetOs Granules) as an alternative for autograft in instrumented posterolateral fusion (PLF).
BACKGROUND: Successful spinal fusion with a solid bone bridge between the vertebrae is traditionally achieved by grafting with autologous iliac bone. However, the disadvantages of autografts and unsatisfactory fusion rates have prompted the exploration of alternatives, including ceramics. Nevertheless, clinical evidence for the standalone use of these materials is limited.
METHODS: Adults indicated for instrumented PLF (1 to 6 levels) were enrolled at 5 participating centers. After bilateral instrumentation and fusion-bed preparation, the randomized allocation side (left or right) was disclosed. Per segment 10 cc of BCP<μm granules (1 to 2 mm) were placed in the posterolateral gutter on one side and 10 cc autograft on the contralateral side. Fusion was systematically scored on 1-year follow-up CT scans. The study was powered to detect >15% inferiority with binomial paired comparisons of the fusion performance score per treatment side.
RESULTS: Of the 100 patients (57 ± 12.9 y, 62% female), 91 subjects and 128 segments were analyzed. The overall posterolateral fusion rate per segment (left and/or right) was 83%. For the BCP<μm side only the fusion rate was 79% versus 47% for the autograft side (difference of 32 percentage points, 95% CI, 23-41). Analysis of the primary outcome confirmed the noninferiority of BCP<μm with an absolute difference in paired proportions of 39.6% (95% CI, 26.8-51.2; p < 0.001).
CONCLUSIONS: This clinical trial demonstrates noninferiority and indicates superiority of MagnetOs Granules as a standalone ceramic when compared to autograft for posterolateral spinal fusion. These results challange the belief that autologous bone is the most optimal graft material.