Beaumont Hospital, PO Box 1297, Beaumont Road, Dublin 9, Republic of Ireland.
Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL, 60015, USA.
Eur Spine J. 2019 Jul;28(7):1733-1742. doi: 10.1007/s00586-019-05926-1. Epub 2019 Mar 5.
Silicate-substituted calcium phosphate-enhanced porosity (SiCaP EP, Inductigraft™, Altapore) is a synthetic bone graft material with enhanced strut porosity of 31-47%. SiCaP EP remains to be fully clinically evaluated in patients undergoing instrumented posterolateral fusion (PLF) surgery. We conducted a prospective, open-label, non-randomised, multicentre clinical study to evaluate efficacy of SiCaP EP as bone grafting material in PLF surgery with instrumentation for treatment of spinal disorders.
Patients with degenerative disc disease, spondylolisthesis or spinal stenosis underwent PLF surgery with SiCaP EP. The primary endpoint was evaluated in the per protocol population (N = 102) as solid fusion at postoperative month 12 assessed using computed tomography scans, with motion assessed using flexion-extension radiographs. Clinical outcomes included the Oswestry Disability Index, 36-item short-form health survey for quality-of-life, visual analog scale for pain scores and neurological assessments. Adverse events were recorded.
Successful fusion was achieved in 59/89 (66.3%) patients at month 6, 88/102 patients (86.3%) at month 12 (primary endpoint) and 87/96 (90.6%) patients at month 24. Disability and pain reduced following surgery. Quality-of-life improved and neurological function was maintained postoperatively. Forty-three (33.3%) of the 129 patients who underwent surgery experienced adverse events; back pain was most frequent (n = 10); nine and 14 patients experienced serious adverse events judged related to device and procedure, respectively.
Enhanced strut porosity SiCaP EP provided high (month 12: 86.3%) spinal fusion success rates in PLF surgery. Fusion success was associated with improved clinical outcomes in patients within 12 months, relative to baseline. CLINICALTRIALS.
NCT01452022 These slides can be retrieved under Electronic Supplementary Material.
硅取代的磷酸钙增强多孔性（SiCaP EP，InductigraftTM，Altapore）是一种具有 31-47%增强支撑多孔性的合成骨移植物材料。SiCaP EP 在接受器械辅助后路融合（PLF）手术的患者中仍有待全面临床评估。我们进行了一项前瞻性、开放标签、非随机、多中心临床研究，以评估 SiCaP EP 作为骨移植物材料在 PLF 手术中的疗效，该手术采用器械治疗脊柱疾病。
患有退行性椎间盘疾病、脊椎滑脱或脊柱狭窄的患者接受 SiCaP EP 的 PLF 手术。主要终点在符合方案人群（N=102）中评估为术后 12 个月时的骨融合，通过计算机断层扫描评估，通过屈伸位 X 线片评估运动。临床结果包括 Oswestry 残疾指数、36 项简短健康调查的生活质量、疼痛评分的视觉模拟量表和神经评估。记录不良事件。
6 个月时 59/89（66.3%）患者、12 个月时 88/102（66.3%）（主要终点）和 24 个月时 87/96（90.6%）患者成功融合。术后残疾和疼痛减轻，生活质量提高，神经功能保持。129 例手术患者中有 43 例（33.3%）经历了不良事件；最常见的是背痛（n=10）；9 例和 14 例患者分别经历了与设备和手术相关的严重不良事件。
增强的支撑多孔性 SiCaP EP 在 PLF 手术中提供了高（12 个月：86.3%）的脊柱融合成功率。与基线相比，融合成功与 12 个月内患者的临床结果改善相关。临床试验.gov 标识符：NCT01452022这些幻灯片可以在电子补充材料中检索。
