Preliminary Review of Cold and Active Compression Therapy for Traumatic Calcaneus or Ankle Fractures
Primary Purpose
Ankle Fractures
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GameReady
RICE
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Fractures
Eligibility Criteria
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
Sites / Locations
- Florida Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
RICE (control)
Cryocompression (experimental)
Arm Description
Standard of Care procedures including ice and elevation.
treatment using the GameReady cryotherapy system
Outcomes
Primary Outcome Measures
Time until surgery/Time until discharge (LOS)
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)
Measured at circumference of swelling point
Total Narcotic Use as recorded on MR chart and Knee Pain Assessment
reported as yes/no and amount/type on assessment form
Change in Patient reported pain as measured on VAS and Knee Pain Assessment
As reported by VAS scale
Secondary Outcome Measures
Change in Quality of Life (QALY) as measured on QOL and SF-8
Quality of Life by QALY score
Full Information
NCT ID
NCT02498717
First Posted
March 31, 2015
Last Updated
February 13, 2018
Sponsor
AdventHealth
Collaborators
Cool Systems, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02498717
Brief Title
Preliminary Review of Cold and Active Compression Therapy for Traumatic Calcaneus or Ankle Fractures
Official Title
Preliminary Efficacy and Cost-effectiveness Analysis of a Cold and Active Intermittent Compression Therapy Technique for Traumatic Calcaneus or Ankle Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 3, 2015 (Actual)
Primary Completion Date
February 9, 2017 (Actual)
Study Completion Date
July 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth
Collaborators
Cool Systems, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RICE (control)
Arm Type
Active Comparator
Arm Description
Standard of Care procedures including ice and elevation.
Arm Title
Cryocompression (experimental)
Arm Type
Experimental
Arm Description
treatment using the GameReady cryotherapy system
Intervention Type
Device
Intervention Name(s)
GameReady
Intervention Description
Cryotherapy and compression
Intervention Type
Other
Intervention Name(s)
RICE
Intervention Description
SOC ice and elevation
Primary Outcome Measure Information:
Title
Time until surgery/Time until discharge (LOS)
Description
Reduction in length of stay (LOS) and time of effect (pre-/post-op)
Time Frame
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.
Title
Change in Swelling as measured by point of largest swollen area (tape measure)
Description
Measured at circumference of swelling point
Time Frame
Measured at baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
Title
Total Narcotic Use as recorded on MR chart and Knee Pain Assessment
Description
reported as yes/no and amount/type on assessment form
Time Frame
Measured daily while inpatient (approx 2-3 days) and retroactively at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
Title
Change in Patient reported pain as measured on VAS and Knee Pain Assessment
Description
As reported by VAS scale
Time Frame
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 Measure Information:
Title
Change in Quality of Life (QALY) as measured on QOL and SF-8
Description
Quality of Life by QALY score
Time Frame
At baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Vickaryous, MD
Organizational Affiliation
AdventHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Preliminary Review of Cold and Active Compression Therapy for Traumatic Calcaneus or Ankle Fractures
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