Carle Spine Institute, Urbana, Illinois, USA.
Department of Orthopaedics, Thomas Jefferson University Hospital and Rothman Institute, Philadelphia, Pennsylvania, USA.
Neurosurgery. 2023 Apr 1;92(4):725-733. doi: 10.1227/neu.0000000000002290. Epub 2022 Dec 23.
Previous analyses of the US Food and Drug Administration (FDA) Investigational Device Exemption study demonstrated the superiority of i-FACTOR compared with local autograft bone in single-level anterior cervical discectomy and fusion (ACDF) at 12 and 24 months postoperatively in a composite end point of overall success.
To report the final, 6-year clinical and radiological outcomes of the FDA postapproval study.
Of the original 319 subjects enrolled in the Investigational Device Exemption study, 220 participated in the postapproval study (106 i-FACTOR and 114 control).
The study met statistical noninferiority success for all 4 coprimary end points. Radiographic fusion was achieved in 99% (103/104) and 98.2% (109/111) in i-FACTOR and local autograft subjects, mean Neck Disability Index improvement from baseline was 28.6 (24.8, 32.3) in the i-FACTOR and 29.2 (25.6, 32.9) in the control group, respectively (noninferiority P < .0001). The neurological success rate at 6 years was 95.9% (70/73) in i-FACTOR subjects and 93.7% (70/75) in local autograft subjects (noninferiority P < .0001). Safety outcomes were similar between the 2 groups. Secondary surgery on the same or different cervical levels occurred in 20/106 (18.9%) i-FACTOR subjects and 23/114 (20.2%) local autograft subjects ( P = .866). Secondary outcomes (pain, SF-36 physical component score and mental component score) in i-FACTOR subjects were similar to those in local autograft subjects.
i-FACTOR met all 4 FDA-mandated noninferiority success criteria and demonstrated safety and efficacy in single-level anterior cervical discectomy and fusion for cervical radiculopathy through 6 years postoperatively. Safety outcomes are acceptable, and the clinical and functional outcomes observed at 12 and 24 months remained at 72 months.
美国食品和药物管理局（FDA）的一项研究显示，在单节段前路颈椎间盘切除融合术（ACDF）中，i-FACTOR 组在术后 12 个月和 24 个月的复合终点（总体成功率）上优于自体骨移植。
报告 FDA 批准后研究的最终 6 年临床和影像学结果。
在参加 i-FACTOR 研究的 319 名受试者中，有 220 名参加了批准后研究（i-FACTOR 组 106 例，对照组 114 例）。
研究在所有 4 个主要次要终点均达到了统计学上的非劣效性成功。在 i-FACTOR 组和自体骨移植组中，影像学融合率分别达到 99%（103/104）和 98.2%（109/111），i-FACTOR 组的颈痛残疾指数（NDI）从基线的改善值为 28.6（24.8，32.3），对照组为 29.2（25.6，32.9）（非劣效性 P<0.0001）。6 年时 i-FACTOR 组的神经功能成功率为 95.9%（70/73），对照组为 93.7%（70/75）（非劣效性 P<0.0001）。两组的安全性结果相似。在 i-FACTOR 组中有 20/106（18.9%）的患者和对照组中有 23/114（20.2%）的患者进行了同一或不同颈椎水平的二次手术（P=0.866）。i-FACTOR 组的次要手术结果（疼痛、SF-36 生理成分评分和心理成分评分）与自体骨移植组相似。
i-FACTOR 满足了 FDA 规定的所有 4 项非劣效性成功标准，并在单节段前路颈椎间盘切除融合术治疗颈椎神经根病方面显示了安全性和有效性，术后 6 年仍可观察到。安全性结果是可以接受的，在 12 个月和 24 个月观察到的临床和功能结果在 72 个月时仍然存在。
