A Retrospective Study to Assess the Efficacy of PEMF Treatment in Ankle Fusion
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 16
- 主要终点
- Radiographic fusion rate at 6 months post treatment
研究概览
简要总结
This study examines the effect of using the PhysioStim bone growth stimulator on subjects undergoing treatment for ankle and hindfoot fusion surgery.
详细描述
The objective of this investigation is to study the effect of using adjunctive PEMF treatment (via PhysioStim) in subjects undergoing ankle fusion, and also as nonoperative treatment for failed ankle fusion. The sponsor hypothesizes that use of PhysioStim 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
- 23 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Condition requiring ankle fusion surgery or nonoperative treatment for failed ankle fusion
- •Age 23 years or older
- •Subjects must have a minimum of 6 months follow-up data or evidence of fusion, whichever occurs first
排除标准
- •Subject is a prisoner
结局指标
主要结局
Radiographic fusion rate at 6 months post treatment
时间窗: 6 months from the start of treatment
Fusion rate (# subjects fused / # total evaluable subjects) based on radiographic assessment.
次要结局
未报告次要终点