Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone® Bone Graft Substitute in Acute Trauma Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Artoss Inc.
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Radiographic evidence of fracture healing
研究概览
简要总结
This multicenter prospective patient registry was developed with the aim of documenting how orthopedic surgeons are utilizing the NanoBone products in acute trauma cases along with relevant patient outcomes. These outcomes include radiographic measures such as fracture healing, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.
详细描述
This multicenter prospective patient registry was developed with the aim of documenting how orthopedic surgeons are utilizing the NanoBone products in acute trauma cases along with relevant patient outcomes. These outcomes include radiographic measures such as fracture healing, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.
The primary objective of this study is to document and analyze the use of NanoBone products in acute trauma cases (as a stand-alone bone graft, or in combination with local bone only, no other bone graft substitute or biologic product used) and determine both radiographic success and clinical outcomes. All product related adverse events will be documented, tabulated, and summarized.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects at least 18 years old at the time of injury
- •Acute fractures, resulting from blunt or penetrating trauma
- •In the extremities or pelvis
- •Requiring surgery
- •Treated emergently, delayed or staged up to 4 weeks from the date of injury
- •Where bone grafting is clinically indicated
排除标准
- •Certain fracture locations (these apply to non-unions as well)
- •Hand - metacarpals, phalanges
- •Forefoot - metatarsals, phalanges
- •Fractures requiring definitive fracture stabilization beyond the initial 4 weeks from the date of injury
- •Pathologic fractures secondary to malignancy
- •Subjects unable to follow recommended post-operative plan and complete follow ups
- •Subjects unable to complete patient reported outcome measures
结局指标
主要结局
Radiographic evidence of fracture healing
时间窗: 2 weeks, 6 weeks, 3 months, 6 months
AP and lateral x-rays
次要结局
- Pain relief(2 weeks, 6 weeks, 3 months, 6 months)