Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 501
- 试验地点
- 16
- 主要终点
- Time (Days) to Radiographic Healing of Tibial Fractures
研究概览
简要总结
The purpose of this study is to determine the effect of low-intensity, pulsed ultrasound on tibial fractures treated with intramedullary nailing.
详细描述
A randomized, placebo controlled, clinical trial to evaluate the safety and efficacy of low-intensity, pulsed ultrasound, applied to tibial fractures treated with intramedullary nailing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Males and females age 18 years or older
- •Have an open or closed tibial fracture amenable to intramedullary nail fixation
排除标准
- •Tibial fracture associated with a vascular injury requiring repair
- •Pilon fractures
- •Tibial fractures that extend into the joint and require reduction
- •Pathologic fractures • Bilateral tibial fractures
研究组 & 干预措施
Exogen 4000+
Single arm, Exogen 4000+
干预措施: Exogen 4000+ (Device)
Sham
Single arm, sham (identical device with the exception of administration of ultrasound).
干预措施: Sham (Device)
结局指标
主要结局
Time (Days) to Radiographic Healing of Tibial Fractures
时间窗: over 365 days
Days from randomization to day of x-ray assessed healed or, if not healed, day of premature withdrawal/study termination or day 365 (end of study visit)/ Kaplan-Meier
Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36)
时间窗: Over 365 days
Assessments at baseline and 6 post baseline time points/ mixed effects repeated measure single point estimate. Range= -100 worst, 0 best
次要结局
未报告次要终点