Preliminary Review of Cold and Active Compression Therapy for Traumatic Calcaneus or Ankle Fractures
Preliminary Efficacy and Cost-effectiveness Analysis of a Cold and Active Intermittent Compression Therapy Technique for Traumatic Calcaneus or Ankle Fractures
研究概览
详细说明
Initial research has shown that cryocompression therapy applied post-operatively has been effective in reducing recovery time and improving health and pain factors related to patient recovery. However, there has been limited research into how this translates into positive economic outcomes for both the hospital and the patient. In addition, it can be reasonably hypothesized that the use of the cryocompression therapy system before surgery will lead to an increased rate of reduction in swelling necessary to allow proper operative procedures to take place when compared to the standard ice and elevation (RICE) therapy techniques and cryocompression therapy applied only post-operatively. This should lead to decreased hospital costs and possible improved patient outcomes related to recovery.
Study Objectives This study will examine the initial efficacy and cost-effectiveness of using the cryocompression therapy model both pre-operatively and post-operatively in patients that have recently suffered a traumatic calcaneus or ankle fracture compared to the standard pre-operative RICE therapy procedures.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Florida
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Orlando、Florida、美国、32804
- Florida Hospital
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients over 18 years of age
- Able to provide informed consent
- Recent calcaneus or ankle fracture requiring fixation
- Injury is determined (by physician) to be an isolated, closed, low-energy bimalleolar fracture
Exclusion Criteria:
- Unable to provide informed consent
- History of Dementia or mental instability
- No recent additional fractures (within one year) at or around injury site
- Persons with symptoms of any kind of psychosocial disorder
- Any condition that the clinician feels would contraindicate for the postoperative test or control treatments
- Any conditions that would contraindicate using the Game Ready
- If the patient is prevented from transfer to the OR due to reasons other than medically necessary
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：RICE (control)
Standard of Care procedures including ice and elevation.
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SOC ice and elevation
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实验性的：Cryocompression (experimental)
treatment using the GameReady cryotherapy system
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Cryotherapy and compression
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time until surgery/Time until discharge (LOS)
大体时间：Measured from intake to time of surgery (days) and upon discharge from hospital (days). Estimated period of time to be up to 10 days until surgery and up to 7 days after surgery until discharge.
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Reduction in length of stay (LOS) and time of effect (pre-/post-op)
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Measured from intake to time of surgery (days) and upon discharge from hospital (days). Estimated period of time to be up to 10 days until surgery and up to 7 days after surgery until discharge.
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Change in Swelling as measured by point of largest swollen area (tape measure)
大体时间：Measured at baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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Measured at circumference of swelling point
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Measured at baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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Total Narcotic Use as recorded on MR chart and Knee Pain Assessment
大体时间：Measured daily while inpatient (approx 2-3 days) and retroactively at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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reported as yes/no and amount/type on assessment form
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Measured daily while inpatient (approx 2-3 days) and retroactively at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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Change in Patient reported pain as measured on VAS and Knee Pain Assessment
大体时间：Reported at baseline, daily while inpatient (approx 2-3 days), and at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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As reported by VAS scale
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Reported at baseline, daily while inpatient (approx 2-3 days), and at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Quality of Life (QALY) as measured on QOL and SF-8
大体时间：At baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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Quality of Life by QALY score
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At baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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RICE的临床试验
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