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| Name | Class |
|---|---|
| Cool Systems, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RICE (control) | Active Comparator | Standard of Care procedures including ice and elevation. |
|
| Cryocompression (experimental) | Experimental | treatment using the GameReady cryotherapy system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GameReady | Device | Cryotherapy and compression |
| |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Vickaryous, MD | AdventHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital | Orlando | Florida | 32804 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 6, 2021 | |
| Reset | May 27, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 6, 2021 | May 27, 2021 |
| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| RICE |
| Other |
SOC ice and elevation |
|