Morgan Jeremy P, Miller Ashley L, Thompson Paul A, Asfora Wilson T
S D Med. 2016 Apr;69(4):157-65, 167.
Low back pain and degeneration of the intervertebral disc are an integrated malady that affects millions of Americans. Cage devices used in association with posterior lumbar interbody fusion (PLIF) have been shown to be an effective approach in the treatment of a number of lower spine disorders attributed to degenerative disc disease (DDD).
This study was undertaken as part of a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study and compares the effectiveness of the Asfora Bullet Cage System (ABCS) to successfully fuse vertebra at one or two levels between L2 and S1 in patients with DDD to an FDA approved comparison device, the Medtronic-Sofamor Danek Inter Fix Threaded Fusion Device (MSDIFD).
A total of 257 randomized participants were implanted with either the ABCS device (n = 132) or the MSDIFD device (n = 125) through an open posterior approach using autogenous local bone graft without the use of pedicle screws. Patients were evaluated prior to surgery and at the 24 month (24-M) visit for fusion status, deep tendon reflex status, sensory function, motor function, straight leg raise status, pain, disability, and device safety. Radiological evaluation and statistical analysis were performed by independent professionals.
Evaluation of device success was performed at 24-M visit. From the original group of 257 patients, 59 were lost to follow-up. Primary measures of success at the 24-M visit involved pain and function, fusion, neurological status, and device-related adverse events measures. Pain and function improved in both (MSDIFD: 75.7 percent; ABCS: 82.6 percent). Fusion success with all radiographic points at 24-M visits was 79.4 percent MSDIFD and 88.2 percent ABCS. Neurological improvement was seen in both (MSDIFD: 77.0 percent; ABCS: 87.8 percent). One device-related grade 1 adverse event was reported in the MSDIFD group. Disc height preservation was equivalent for single level fusions (MSDIFD: 16.1 percent; ABCS: 20.0 percent) and second level fusions (MSDIFD: 10.7 percent; ABCS: 14.3 percent). General health and well-being improvement was the same (MSDIFD: 37.0 percent; ABCS: 40.0 percent). Subsequent fusion, up to 10 years, was equivalent (MSDIFD: 83.8 percent; ABCS: 91.2). Results for both devices were considered to be satisfactory, with a slight non-significant superiority for the ABCS.
From the ABCS device FDA IDE sanctioned study and the review of the literature, we concluded that the Asfora Bullet Cage System is safe, effective and comparable to other interbody fusion devices which are used stand-alone or in conjunction with pedicle screws, rhBMP-2, or autogenous bone harvested from the iliac crest inserted through anterior, lateral or posterior approaches.
腰痛和椎间盘退变是一种综合病症，影响着数百万美国人。与后路腰椎椎间融合术（PLIF）联合使用的椎间融合器已被证明是治疗多种因椎间盘退变疾病（DDD）导致的下脊柱疾病的有效方法。
本研究作为美国食品药品监督管理局（FDA）研究性器械豁免（IDE）研究的一部分，比较了阿斯福拉子弹型椎间融合器系统（ABCS）与FDA批准的对照器械美敦力-索法玛·丹尼克Inter Fix螺纹融合器（MSDIFD）在DDD患者中成功融合L2至S1节段一个或两个椎体的有效性。
总共257名随机参与者通过开放后路入路，使用自体局部骨移植且不使用椎弓根螺钉，植入ABCS器械（n = 132）或MSDIFD器械（n = 125）。在手术前及术后24个月（24-M）随访时对患者进行融合状态、深部腱反射状态、感觉功能、运动功能、直腿抬高状态、疼痛、残疾和器械安全性评估。由独立专业人员进行放射学评估和统计分析。
在24-M随访时对器械成功率进行评估。在最初的257名患者中，59名失访。24-M随访时成功的主要指标包括疼痛和功能、融合、神经状态以及与器械相关的不良事件指标。两组患者的疼痛和功能均有改善（MSDIFD组：75.7%；ABCS组：82.6%）。在24-M随访时所有影像学指标显示融合成功率MSDIFD组为79.4%，ABCS组为88.2%。两组患者神经功能均有改善（MSDIFD组：77.0%；ABCS组：87.8%）。MSDIFD组报告了1例与器械相关的1级不良事件。单节段融合（MSDIFD组：16.1%；ABCS组：20.0%）和双节段融合（MSDIFD组：10.7%；ABCS组：14.3%）时椎间盘高度保留情况相当。总体健康和幸福感改善情况相同（MSDIFD组：37.0%；ABCS组：40.0%）。后续长达10年的融合情况相当（MSDIFD组：83.8%；ABCS组：91.2%）。两种器械的结果均被认为令人满意，ABCS组有轻微的非显著性优势。
从ABCS器械的FDA IDE批准研究及文献回顾来看，我们得出结论，阿斯福拉子弹型椎间融合器系统安全、有效，且与其他单独使用或与椎弓根螺钉、重组人骨形态发生蛋白-2（rhBMP-2）或通过前路、侧路或后路入路取自髂嵴的自体骨联合使用的椎间融合器相当。
