Clinical Investigation of NanoFUSE® Bioactive Matrix and Autogenous Bone in Posterolateral Spinal Fusion (Nonloadbearing)
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 主要终点
- Radiographic Success
研究概览
简要总结
This study is a Post Market Follow Up Study to compare the fusion rates between the NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) and autogenous bone in posterolateral gutter spinal fusion.
详细描述
NanoFUSE® is indicated to be placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and pelvis.) These defects may be surgically created osseous defects created from traumatic injury to the bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine. This product provides a bone graft substitute that remodels into the recipient's skeletal system. Radiographic success will be the primary judgement of success. All patient's achieving fused or probably fused status will be judged as a success.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade I or II (less than 50% slip f the cephalic vertebra compared to the caudal vertebra) degenerative spondylolisthesis at one or two contiguous levels between L1 and L5
- •Lumbar spinal stenosis at the same levels of the degenerative spondylolisthesis producing radiculopathy or neurogenic claudication unresponsive to a minimum of 3 months of nonsurgical treatment, or such patients with worsening neurological condition
- •Patients who are medically suitable for surgical management and the use of NanoFUSE® Bioactive Matrix is consistent with product labeling
- •Patients who have consented for surgical treatment
- •Patients able to provide informed consent for the study and complete the questionnaires
排除标准
- •Lytic spondylolisthesis
- •Non degenerative stenosis (example: tumor, trauma, epidural, lipomatosis)
- •Segmental kyphosis at the level of the spondylolisthesis
- •Rheumatoid arthritis
- •Active infection
- •On long term disability or workers compensation claim
研究组 & 干预措施
NanoFuse® PL Gutter
NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) within one posterolateral gutter (unilateral)
干预措施: NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) (Device)
结局指标
主要结局
Radiographic Success
时间窗: 12 months
All patients achieving fused or probably fused status will be judged as successes at 12 months.
次要结局
- Overall patient success(12 months postoperatively)