Preliminary Review of Cold and Active Compression Therapy for Traumatic Calcaneus or Ankle Fractures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Preliminary Efficacy and Cost-effectiveness Analysis of a Cold and Active Intermittent Compression Therapy Technique for Traumatic Calcaneus or Ankle Fractures

Conditions
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Ankle Fractures

Intervention / Treatment
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* Device: GameReady
* Other: RICE


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RICE (control)<br>Standard of Care procedures including ice and elevation. | Other: RICE<br>* SOC ice and elevation<br>|
| Experimental: Cryocompression (experimental)<br>treatment using the GameReady cryotherapy system | Device: GameReady<br>* Cryotherapy and compression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until surgery/Time until discharge (LOS) | Reduction in length of stay (LOS) and time of effect (pre-/post-op) | 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. | 
| Change in Swelling as measured by point of largest swollen area (tape measure) | Measured at circumference of swelling point | Measured at baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op) | 
| Total Narcotic Use as recorded on MR chart and Knee Pain Assessment | reported as yes/no and amount/type on assessment form | Measured daily while inpatient (approx 2-3 days) and retroactively at all follow-up assessments (2, 8, 16, & 24-weeks post-op) | 
| Change in Patient reported pain as measured on VAS and Knee Pain Assessment | As reported by VAS scale | Reported at baseline, daily while inpatient (approx 2-3 days), and at all follow-up assessments (2, 8, 16, & 24-weeks post-op) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life (QALY) as measured on QOL and SF-8 | Quality of Life by QALY score | At baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op) |