背景:椎间融合术是一种广泛使用和接受的治疗晚期衰弱性腰椎间盘退变性疾病(DDD)的方法。越来越多,外科医生正在寻找能够达到稳定性和移植目的的大型体间装置,但可以用侵入性较小的技术插入。为了实现这些相反的目标,一部小说,适形网状椎间融合器被设计成通过一个小门放置在椎间盘间隙中,并在原位填充大尺寸的骨移植物。这种设计可以减少对周围结构的创伤的风险,同时创建一个大的移植足迹,密切轮廓的病人自己的解剖。这项研究装置豁免(IDE)试验的目的是评估这种新型的可整合网状椎间融合装置的围手术期和长期结果。
方法:这项调查是前瞻性的,多中心,单臂,食品和药物管理局和机构审查委员会批准的IDE,绩效目标试验。共有102名在L2和S1之间的单一水平出现DDD且对6个月的保守治疗无反应的成年人进行了腰椎椎间融合术。经过验证的评估工具包括100毫米疼痛视觉模拟量表,Oswestry功能残疾指数(ODI),患者满意度单一问题调查,和计算机断层扫描(CT)进行融合。在10个地理分布的地点招募患者。疼痛/ODI调查,身体评估,和成像连续进行24个月。具体来说,CT在12岁和12岁时进行,如果没有融合,24个月.独立的放射科医生评估CT的融合。一个独立委员会裁定不良事件。在24个月时具有完整数据的患者被包括在分析中。
结果:96例(96,94%随访率)患者(57.0±12.0年,50.0%女性,身体质量指数30.6±4.9)报告的下腰痛平均从基线下降,6周时为45.0±26.6,24个月时为51.4±26.2。右腿/左腿疼痛在6周时减少28.9±36.7/37.8±32.4,在24个月时减少30.5±33.0/40.334.6。平均ODI从基线到6周改善了17.1±18.7,到24个月时改善了32.0±18.5。24个月时,91.7%的患者将其程序评为优秀/良好。12个月时融合率为97.9%(94/96),99%(95/96)在24个月。平均手术时间,估计失血量,住院时间为2.6±0.9小时,137±217毫升,和2.3±1.2天,分别。没有发生与设备相关的严重不良事件。
结论:疼痛的临床显著结果,函数,聚变,在这一人群中证明了装置的安全性。在术后6周出现实质性临床改善,并持续改善至24个月。在该试验中观察到的成功结果支持将这种新型设备用于腰椎椎间融合术。
方法:3.
结论:本报告证实了本研究早期发表的1年初步发现,融合率和报告的患者改善持续了2年。
BACKGROUND: Interbody fusion is a widely utilized and accepted procedure to treat advanced debilitating lumbar degenerative disc disease (DDD). Increasingly, surgeons are seeking interbody devices that are large for stability and grafting purposes but can be inserted with less invasive techniques. To achieve these contrary objectives a novel, conformable mesh interbody fusion device was designed to be placed in the disc space through a small portal and filled with bone graft in situ to a large size. This design can reduce the risk of trauma to surrounding structures while creating a large graft footprint that intimately contours to the patient\'s own anatomy. The purpose of this Investigational Device Exempt (IDE) trial was to evaluate the perioperative and long-term results of this novel conformable mesh interbody fusion device.
METHODS: This investigation is a prospective, multicenter, single-arm, Food and Drug Administration and Institutional Review Board-approved IDE, performance goal trial. A total of 102 adults presenting with DDD at a single level between L2 and S1 and unresponsive to 6 months conservative care had instrumented lumbar interbody fusion. Validated assessment tools include 100 mm visual analog scale for pain, Oswestry Disability Index (ODI) for function, single question survey for patient satisfaction, and computed tomography (CT) scan for fusion. Patients were enrolled across 10 geographically distributed sites. Pain/ODI surveys, physical evaluations, and imaging were performed serially through 24 months. Specifically, CT was performed at 12 and, if not fused, 24 months. Independent radiologists assessed CTs for fusion. An independent committee adjudicated adverse events. Patients with complete data at 24 months were included in the analysis.
RESULTS: Ninety-six (96, 94% follow-up rate) patients (57.0 ± 12.0 years, 50.0% female, Body Mass Index 30.6 ± 4.9) reported average decreased low back pain from baseline of 45.0 ± 26.6 at 6 weeks and 51.4 ± 26.2 at 24 months. Right/left leg pain reduced by 28.9 ± 36.7/37.8±32.4 at 6 weeks and 30.5±33.0/40.3 34.6 at 24 months. Mean ODI improved 17.1 ± 18.7 from baseline to 6 weeks and 32.0 ± 18.5 by 24 months. At 24 months, 91.7% of patients rated their procedure as excellent/good. Fusion rates were 97.9% (94/96) at 12 months, and 99% (95/96) at 24 months. Mean operative time, estimated blood loss, and length of stay were 2.6 ± 0.9 hours, 137 ± 217 mL, and 2.3 ± 1.2 days, respectively. No device-related serious adverse events have occurred.
CONCLUSIONS: Clinically significant outcomes for pain, function, fusion, and device safety were demonstrated in this population. Substantial clinical improvements occur by 6 weeks postoperative and continue to improve to 24 months. The successful outcomes observed in this trial support use of this novel device in an instrumented lumbar interbody fusion.
METHODS: 3.
CONCLUSIONS: This reports substantiates that the preliminary 1-year findings published earlier for this investigation are confirmed and the fusion rates and that patient improvements reported are sustained through 2 years.