NCT04069923已完成不适用
Use of Magnesium Oxide Biomaterial as a Bone Void Filler for Bone Voids or Defects Not Intrinsic to the Stability of Bony Structure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Participants reaching one year post-op and completing all study visits
研究概览
简要总结
This trial studies the side effects of OsteoCrete in filling bone voids in participants with bone voids or defects. OsteoCrete may eliminate the need for further surgery and the removal of healthy bone.
详细描述
PRIMARY OBJECTIVES:
I. To assess the safety of the device, which for the purpose of this study is defined as the compound injected into bone.
SECONDARY OBJECTIVES:
I. To determine the rate of absorption and bone ingrowth.
OUTLINE:
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
- •Documentation of a diagnosis as evidenced by one or more clinical features consistent with one or more of the following criteria:
- •Bone void created during surgery.
- •Lucency noted on x-ray preoperatively.
- •Written informed consent (and assent when applicable) obtained from subject or subject?s legal representative and ability for subject to comply with the requirements of the study.
排除标准
- •Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- •Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
- •Creatinine greater than 1.
- •Presence of active bone infection.
结局指标
主要结局
Participants reaching one year post-op and completing all study visits
时间窗: Up to 1 year
次要结局
- Amount of reabsorption and bone ingrowth(Up to 1 year)
- Incidence of adverse events rates(Up to 1 year)
研究者
研究点 (2)
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