A Multi-Center, Prospective, Parallel Group, Randomized, Pilot Study Evaluating Safety And Preliminary Effectiveness Of NB1 Bone Graft In Subjects With Degenerative Disc Disease Undergoing Transforaminal Lumbar Interbody Fusion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Fusion
研究概览
简要总结
The objective of this clinical study is to evaluate the safety and effectiveness of NB1 Bone Graft in subjects with degenerative disc disease undergoing transforaminal lumbar interbody fusion.
It is estimated that up to 30 participants will be enrolled in approximately 3 clinical sites. During baseline and follow-up assessments, patients will be asked to undergo x-rays and CT scans; adverse events and immunology will be collected, and; participants will be requested to complete participant questionnaires regarding quality of life, pain and function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of degenerative disc disease
- •Up to Grade I spondylolisthesis
- •Eligible to undergo a single vertebral level spine fusion (L2 to S1)
排除标准
- •Previous spinal instrumentation or previous interbody fusion procedure at the involved level
- •Grade II or greater spondylolisthesis
- •Systemic or local infection at the site of surgery
研究组 & 干预措施
Autograft
Autograft
NB1-1.5
NB1 low dose
干预措施: NB1 (Device)
NB1-2.0
NB1 high dose
干预措施: NB1 (Device)
结局指标
主要结局
Fusion
时间窗: 12 months
Defined by an independent (blinded to treatment) radiological assessment as less than five degrees angular vertebral motion, less than three millimeters of translational movement and evidence of bridging bone between the involved vertebral endplates based on x-rays at 12 months after surgery
次要结局
- Removal, revision, or supplemental fixation(12 months)