Preliminary Efficacy and Cost-effectiveness Analysis of a Cold and Active Intermittent Compression Therapy Technique for Traumatic Calcaneus or Ankle Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Time until surgery/Time until discharge (LOS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 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
排除标准
- •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
研究组 & 干预措施
Cryocompression (experimental)
treatment using the GameReady cryotherapy system
干预措施: GameReady (Device)
RICE (control)
Standard of Care procedures including ice and elevation.
干预措施: RICE (Other)
结局指标
主要结局
Time until surgery/Time until discharge (LOS)
时间窗: 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.
Reduction in length of stay (LOS) and time of effect (pre-/post-op)
Change in Swelling as measured by point of largest swollen area (tape measure)
时间窗: Measured at baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
Measured at circumference of swelling point
Total Narcotic Use as recorded on MR chart and Knee Pain Assessment
时间窗: Measured daily while inpatient (approx 2-3 days) and retroactively at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
reported as yes/no and amount/type on assessment form
Change in Patient reported pain as measured on VAS and Knee Pain Assessment
时间窗: Reported at baseline, daily while inpatient (approx 2-3 days), and at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
As reported by VAS scale
次要结局
- Change in Quality of Life (QALY) as measured on QOL and SF-8(At baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op))