NuTech NuCel®: A Prospective, Efficacy Study of NuCel® in Patients Undergoing Fusion for One, Two or Three Level Degenerative Disease of the Lumbar Spine.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Spinal Fusion
研究概览
简要总结
The purpose of this study is to determine whether NuCel is effective in promoting spinal fusion in degenerative disease of the lumbar spine.
详细描述
The study is a prospective, single center clinical trial to establish the efficacy of NuCel, a minimally manipulated allograft tissue, for use in lumbar interbody and intertransverse fusion procedures. Subjects will undergo standard interbody fusion surgery as per the signed informed consent with NuCel and autograft bone. Patients will be evaluated postoperatively at 6 weeks, 3 months, 6 months, 1 year, and 2 years (if required).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be diagnosed with degenerative disease of lumbar spine
排除标准
- •Back pain due to injury
- •Back pain that is caused by infection, cancer, lesions(growths) or bone disease such as osteoporosis
- •Any terminal (will not recover from the disease) or autoimmune disease including but not limited to HIV infection, or rheumatoid arthritis
- •Any other medical condition that might affect normal healing
- •Less than 21 years of age
- •More than three levels of fusion needed
- •Recent history (within past 6 months) of any chemical or alcohol dependence
- •Morbid obesity (Body Mass Index of more than 40)
- •Currently a prisoner
- •Currently experiencing a major mental illness
- •Pregnancy at the time of enrollment
- •Previously diagnosed with diseases of the bone such as osteoporosis, osteopenia or osteomalacia (softening of the bones). Patients with any of the risk factors for osteoporosis may have DEXA scans performed prior to study entry.
研究组 & 干预措施
NuCel with Autograft
NuCel will be used with local autograft during surgical treatment of one, two or three level degenerative disease of the lumbar spine
干预措施: NuCel with Autograft (Other)
结局指标
主要结局
Spinal Fusion
时间窗: 12 months
CT scan will be used to evaluate fusion of one, two, or three levels
次要结局
- Change from baseline pain using Visual Analogue Scale (VAS)(6 weeks, 3 months, 6 months, and 12 months)
- Change from baseline Oswestry Disability Index (Ver. 2.1)(6 weeks, 3 months, 6 months, 12 months)
- X-ray to compare to baseline preoperative X-ray(6 weeks, 3 months, 6 months, 12 months)