Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone® Bone Graft Substitute in Spinal Fusion Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Artoss Inc.
- 入组人数
- 330
- 试验地点
- 6
- 主要终点
- Radiographic Success
研究概览
简要总结
This prospective registry was designed as an observational study to ascertain how commercially available NanoBone Bone Graft is being used by surgeons performing spinal fusion as well as determining relevant patient outcomes.
详细描述
This multicenter prospective patient registry was developed with the aim of documenting how spine and neurosurgeons are utilizing the NanoBone products along with relevant patient outcomes. These outcomes include radiographic measures such as fusion outcome, 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 spine fusion surgery (as a stand-alone bone graft, or in combination with local bone only, no other BGS 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
- Cohort
- 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
- •Patient aged 18 years or older
- •Patient is diagnosed with a degenerative spine disorder requiring spinal fusion, has failed conservative treatment, and has decided to undergo surgery.
- •The surgeon has determined that a NanoBone product is or was clinically indicated, and will use or have used the product as a stand-alone bone graft substitute or in combination with local autograft only (no iliac crest harvesting, other BGS, or biologic {defined as containing growth factors, cytokines, proteins, or cells} used).
- •Patient capable of understanding the content of the Informed Consent Form
- •Patient willing and able to participate in the registry protocol including SOC follow-up visits and clinical evaluations.
- •Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the Declaration of Helsinki.
排除标准
- •Severe vascular or neurological disease
- •Uncontrolled diabetes
- •Severe degenerative disease (other than degenerative disc disease)
- •Severely impaired renal function
- •Hypercalcemia, abnormal calcium metabolism
- •Existing acute or chronic infections, especially at the site of the operation
- •Inflammatory bone disease such as osteomyelitis
- •Malignant tumors
- •Patients who are or plan to become pregnant.
- •Uncooperative patients who cannot or will not follow post-operative instruction, including individuals who abuse drugs and/or alcohol.
结局指标
主要结局
Radiographic Success
时间窗: 12-months
Evidence of bony bridging between vertebral endplates and/or transverse processes of bone grafted vertebrae or absence of motion between vertebral bodies or both.
次要结局
- Safety Evaluation(12-months)