NCT05190159已完成不适用
Monster Screw System Post-Market Clinical Follow-Up Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Paragon 28
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Incidence of secondary procedures
研究概览
简要总结
Post-market clinical follow-up study on the Monster Screw System
详细描述
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Monster Screw System.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has undergone a foot and/or ankle procedure using the Monster Screw System and completed by one of the investigators.
- •The subject has adequate radiographic and medical records
- •For the Prospective Data Collection:
- •The subject is willing to provide written informed consent
排除标准
- 未提供
结局指标
主要结局
Incidence of secondary procedures
时间窗: Up to 9 months
Safety will be assessed by recording the incidence of secondary procedures related to the index procedure
Incidence of adverse events
时间窗: Up to 9 months
Safety will be assessed by recording the incidence of adverse events
次要结局
- Rate of Nonunion(Up to 9 months)
- Patient satisfaction(Up to 54 months)
- Rate of Index Device Failure(Up to 9 months)
- Rate of Maintenance of Correction(Up to 9 months)
- Foot and Ankle Mobility Measure(Up to 54 months)
- Visual Analog Scale(Up to 54 months)
研究者
研究点 (1)
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