A Randomized Study Evaluating ViBone®, Demineralized Bone Matrix, and Bone Morphogenetic Protein in 3-Level Oblique Lateral Lumbar Interbody Fusion
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Graft Mineralization/Fusion
研究概览
简要总结
The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo three-level oblique lateral lumbar interbody fusion (OLIF) using ViBone, demineralized bone matrix (DBM), and bone morphogenetic protein (BMP). One product will be used on each level. Subjects will be followed for 12 months following surgery to assess degree of mineralization via computed tomography (CT) scan at 6 and 12 months, mean time to fusion, and maturation of fusion mass postoperatively via x-ray radiograph.
详细描述
Up to 120 patients undergoing three-level OLIF using ViBone, DBM, and BMP each on separate levels will be enrolled.
Implantation of ViBone, DBM, and BMP will be randomized between the three levels.
Subjects will be followed for a total of 12 months. Data and x-ray radiographs will be collected according to standard of care, including baseline, 3, 6, and 12 months post-surgery. Additionally, a CT scan will be required at 6 and 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Graft Mineralization/Fusion
时间窗: 6 months
Degree of graft mineralization/fusion for each product via CT scan
次要结局
- Fusion Rates(3, 6, and 12 months)
- Time to Fusion(3, 6, and 12 months)