NCT00950183终止4 期
Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures: An Evaluation of Narcotic Consumption, Pain, Wound Healing, and Patient Satisfaction
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS) Pain Scores
研究概览
简要总结
This study will compares differences in pain level, narcotic consumption, wound healing, patient satisfaction in patients randomized to the Iceman® cold pack therapy system (djOrtho, Inc) versus those who use ice. This will be assessed postoperatively following the foot and ankle procedures primary first metatarsal osteotomy (PMO) or lateral ankle ligament reconstruction (LAR).
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are scheduled to have either lateral ankle ligament reconstruction (LAR) surgery or primary first metatarsal osteotomy surgery
- •Patients who agree to be compliant and to keep a patient diary daily for 2 weeks and to return to the clinic for a 2 week postoperative follow- up appointment
排除标准
- •Patients with Diabetes Mellitus, peripheral vascular disease, Reynauds Syndrome, hypersensitivity to cold
- •Patients allergic to hydrocodone or oxycodone
- •Patients who are unwilling to complete the patient diary and/or follow their specific cold therapy instructions
结局指标
主要结局
Visual Analog Scale (VAS) Pain Scores
时间窗: postop day 1 up to postop day 14
次要结局
- Narcotic Pain Medication Usage(postop day 1 up to postop day 14)
- Patient Satisfaction(first postoperative visit (between postop day 10 and 14))
- Surgical Complications(Day of Surgery)
- Postoperative Complications(postop day 1 up to postop day 14)
研究者
研究点 (2)
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