Arnold Paul M, Sasso Rick C, Janssen Michael E, Fehlings Michael G, Smucker Joseph D, Vaccaro Alexander R, Heary Robert F, Patel Ashvin I, Goulet Benoit, Kalfas Iain H, Kopjar Branko
University of Kansas Medical Center, Kansas City, KS.
Indiana Spine Group, Carmel, IN.
Spine (Phila Pa 1976). 2016 Jul 1;41(13):1075-1083. doi: 10.1097/BRS.0000000000001466.
A prospective, randomized, controlled, parallel, single-blinded noninferiority multicenter pivotal FDA IDE trial.
The objective of this study was to investigate efficacy and safety of i-Factor Bone Graft (i-Factor) compared with local autograft in single-level anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy.
i-Factor is a composite bone substitute material consisting of the P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral and suspended in an inert biocompatible hydrogel carrier. P-15 has demonstrated bone healing efficacy in dental, orthopedic, and nonhuman applications.
Patients randomly received either autograft (N = 154) or i-Factor (N = 165) in a cortical ring allograft. Study success was defined as noninferiority in fusion, Neck Disability Index (NDI), and Neurological Success endpoints, and similar adverse events profile at 12 months.
At 12 months (follow-up rate 87%), both i-Factor and autograft subjects demonstrated a high fusion rate (88.97% and 85.82%, respectively, noninferiority P = 0.0004), significant improvements in NDI (28.75 and 27.40, respectively, noninferiority P < 0.0001), and high Neurological Success rate (93.71% and 93.01%, respectively, noninferiority P < 0.0001). There was no difference in the rate of adverse events (83.64% and 82.47% in the i-Factor and autograft groups, respectively, P = 0.8814). Overall success rate consisting of fusion, NDI, Neurological Success and Safety Success was higher in i-Factor subjects than in autograft subjects (68.75% and 56.94%, respectively, P = 0.0382). Improvements in VAS pain and SF-36v2 scores were clinically relevant and similar between the groups. A high proportion of patients reported good or excellent Odom outcomes (81.4% in both groups).
i-Factor has met all four FDA mandated noninferiority success criteria and has demonstrated safety and efficacy in single-level ACDF for cervical radiculopathy. i-Factor and autograft groups demonstrated significant postsurgical improvement and high fusion rates.
一项前瞻性、随机、对照、平行、单盲非劣效性多中心关键的美国食品药品监督管理局器械临床试验豁免研究。
本研究的目的是比较i-Factor骨移植材料（i-Factor）与自体骨移植在单节段颈椎前路椎间盘切除融合术（ACDF）治疗神经根型颈椎病中的疗效和安全性。
i-Factor是一种复合骨替代材料，由吸附在无机骨矿物质上的P-15合成胶原片段组成，并悬浮于惰性生物相容性水凝胶载体中。P-15已在牙科、骨科及非人类应用中证明具有促进骨愈合的功效。
患者被随机分配接受皮质骨环异体骨中的自体骨移植（n = 154）或i-Factor（n = 165）。研究成功定义为在融合、颈部功能障碍指数（NDI）和神经功能恢复终点方面非劣效，且在12个月时不良事件情况相似。
在12个月时（随访率87%），i-Factor组和自体骨移植组患者均显示出高融合率（分别为88.97%和85.82%，非劣效性P = 0.0004），NDI有显著改善（分别为28.75和27.40，非劣效性P < 0.0001），神经功能恢复率高（分别为93.71%和93.01%，非劣效性P < 0.0001）。不良事件发生率无差异（i-Factor组和自体骨移植组分别为83.64%和82.47%，P = 0.8814）。由融合、NDI、神经功能恢复和安全性成功组成的总体成功率，i-Factor组高于自体骨移植组（分别为68.75%和56.94%，P = 0.0382）。两组间视觉模拟评分法（VAS）疼痛评分和简明健康状况调查量表（SF-36v2）评分的改善在临床上具有相关性且相似。高比例患者报告奥多姆疗效为良好或优秀（两组均为81.4%）。
i-Factor符合美国食品药品监督管理局规定的所有四项非劣效性成功标准，并已在单节段ACDF治疗神经根型颈椎病中证明了安全性和有效性。i-Factor组和自体骨移植组术后均有显著改善且融合率高。
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