A Prospective Post-Market Historically Controlled Open-Label Study to Assess the Efficacy of Virtuos in Lumbar Fusion
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 9
- 主要终点
- Fusion
研究概览
简要总结
A post-market open label study to assess the efficacy of a cellular based allograft bone graft in lumbar spinal fusion at one or two levels
详细描述
Single arm prospectively enrolled observational study of subjects who undergo lumbar spinal fusion at one or two levels with an anterior or lateral surgical approach using a cellular based allograft (Virtuos) as the bone graft There is no experimental intervention for this study. Subjects will be treated per standard of care by their attending physician/surgeon. The primary endpoint in this study is fusion success at 12 months. as determined by the attending physician/surgeon using CT as the imaging modality. The fusion rates observed at 12-months will be compared to an historical group of patients that underwent a one or two level lumbar fusion procedure with an anterior or lateral approach using a cellular based allograft (Trinity Elite).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be 18 years of age (≥ 18 years) or older at the time of consent.
- •Subject must undergo lumbar interbody fusion study at 1-2 contiguous levels.
- •Virtuos must be the primary bone graft (≥ 50% of the total graft volume) and may be augmented with autograft or cortical or cancellous bone chips.
- •Subject must be willing and able to sign an informed consent document.
- •Subject must be willing and able to return for all follow-up visits, agree to participate in postoperative clinical and radiographic evaluations, and comply with the required study protocol.-
排除标准
- •Subject is under 18 years of age (<18) at the time of consent.
- •Subject has had prior lumbar spine fusion surgery at any level.
- •Subject has greater than grade 1 spondylolisthesis of the lumbar spine. Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy in the past 5 years (benign skin cancer is permitted)
- •Subject has an active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection
结局指标
主要结局
Fusion
时间窗: 12-months
Fusion of the spinal motion segments
次要结局
- Disability (ODI)(12 months)
- Pain (NPRS)(12 months)