NCT00823251已完成1 期
IlluminOss Medical- Photodynamic Bone Stabilization System- International Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location.
研究概览
简要总结
The purpose of this study is to assess the initial safety and technical feasibility of the IlluminOss System in the treatment of fractures of bones in the hand.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature
- •Patient or his/her legal guardian understands the nature of the procedure and is willing to comply with associated follow-up evaluations, and provides written informed consent prior to the procedure
- •Female patients must be of non-child bearing potential, or have a negative pregnancy test within prior 48 hours
- •Acute fracture of metacarpal or phalangeal bone(s) that requires reduction and internal fixation
- •Fracture has occurred within past 3 weeks
- •Fracture types: transverse, short oblique, or any fracture pattern in which the comminuted segment is equal to or less than the diameter of the bone at fracture site
排除标准
- •Patient is pregnant, lactating or female patients who intend to become pregnant during the course of the study
- •Patient has experienced a crush, mangling, or burn type injury
- •Patient has probable history of infection or confirmed infection at baseline
- •Patient has previous diagnosis of a significant bone disorder that may impair bone healing
- •Patient has a life expectancy of < 26 weeks
- •Pathological fracture secondary to tumor
- •Open fracture of Gustilo-Anderson Type II or III
结局指标
主要结局
Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location.
时间窗: Immediately post-surgery
次要结局
- Bone Pin Migration(180 Day)
- Adverse Event Rate(180 day)
- Range of Motion(180 day)
- Incidence of Reintervention of Target Fracture(180 Day)
- Rate of Fracture Union(180 day)
- Rate of Anatomic Alignment(180 Day)
- Functionality Score(180 Day)
- Grip Strength(180 Day)
研究者
研究点 (1)
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