Post-Market Clinical Investigation of NanoFUSE® Bioactive Matrix
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 主要终点
- Radiographic Success that indicates patient achieving fused or probably fused status.
研究概览
简要总结
This purpose of this study is to determine fusion rates and compare clinical outcomes of the NanoFUSE® Bioactive Matrix during post-market clinical use.
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 or osseous defects created from traumatic injury to bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine and pelvis. This product provides a bone graft substitute that remodels into the recipient's skeletal system.
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
- •Skeletally mature
- •Medically suitable for surgical management and the use of NanoFUSE® Bioactive Matrix consistent with product labeling
- •Psychosocially, mentally, and physically able to fully comply with the protocol, including the post-operative regimen, requires follow-up visits, filling out required forms, and the ability to understand and give written informed consent
- •Retrospective data collection must be allowed by the IRB and all information deidentified
排除标准
- •Previous fusion surgery of the proposed site
- •Use of chronic medications known to affect the skeleton (e.g. glucocorticoid usage > 10mg/day)
- •Pregnant or female intending to become pregnant during this study period
- •Obesity (BMI >40kg/m2)
- •Systemic infection or infection at the surgical site
- •Current or past substance abuse
- •Poor general healthy or any concurrent disease process that would place the patient in excessive risk to surgery (e.g. significant circulatory or pulmonary problems, cardiac disease
- •Medical condition that would interfere with post-operative assessments and care
研究组 & 干预措施
NanoFUSE® PMCF
NanoFUSE® Bioactive Matrix will be implanted according to labeling and the intended surgical treatment plan of the surgeon.
干预措施: NanoFUSE® Bioactive Matrix (Device)
结局指标
主要结局
Radiographic Success that indicates patient achieving fused or probably fused status.
时间窗: 12 months
at 12 months
次要结局
- Overall patient success(12 months postoperatively)