NCT01104831终止3 期
The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cost
研究概览
简要总结
Consenting patients with proximal tibia fractures will be randomized to 10 degree or 21 degree cryotherapy sleeves. Time to discharge and complications will be monitored.
Primary outcome measure: Cost of Treatment (based on length of stay) Secondary outcome measures: Satisfaction/pain relief and narcotic requirement
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature
- •Trauma patients with single-system musculoskeletal injuries.
- •Proximal tibia fractures treated with open reduction and internal fixation.
- •Unilateral proximal tibial injuries.
排除标准
- •Previous ipsilateral knee surgery
- •Upper extremity injuries impairing mobilization
- •Pre-existing ipsilateral neurologic condition or acute ipsilateral neurologic injury
- •Associated injuries impairing mobilization
- •Suspected or confirmed compartment syndrome
- •Open fractures
- •Patients previously on narcotics
- •Patients with impaired sensorium Concurrent head injury Intoxication
研究组 & 干预措施
21 degree Cooling
Placebo Comparator
Room temperature water circulated through cryotherapy sleeve.
干预措施: Room temperature cuff (Device)
10 degree cooling
Active Comparator
Cooled water circulated through a cryotherapy sleeve.
干预措施: Cryotherapy (Device)
结局指标
主要结局
Cost
时间窗: 3 months
次要结局
- VAS Pain Score(2 weeks)
- Narcotic Requirements(2 weeks)
研究者
研究点 (1)
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