NCT07286357进行中（未招募）不适用
A Multi-Center Retrospective Data Collection Protocol to Evaluate the Real World Usage of the Orthofix AccelStim Device to Treat Fresh Metatarsal Fractures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Healing Status
研究概览
简要总结
This study examines the effect of using the AccelStim bone growth stimulator on subjects undergoing treatment for fresh metatarsal fractures.
详细描述
The objective of this investigation is to study the effect of using LIPUS treatment (via AccelStim) in subjects with fresh metatarsal fractures. The sponsor hypothesizes that use of AccelStim will result in higher rates of fusion compared to that of control. In addition to analyzing the primary endpoint, the study will collect safety information to confirm the favorable safety profile established in prior device usage.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Fresh metatarsal fracture patient that has been prescribed an Orthofix AccelStim device
- •Patient is 18 years or older at the time of treatment
排除标准
- •Patient is a prisoner
结局指标
主要结局
Healing Status
时间窗: 3, 6, and 12 month
Quantitative and qualitative assessments of clinical and radiographic healing (as available per standard of care)
次要结局
- Pain (NPRS) (0-100)(Baseline, 3, 6, and 12 month)
研究者
研究点 (3)
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