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

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.

Study Overview

• Status: Completed
• Conditions: Ankle Fractures
• Intervention / Treatment: Other: RICE; Device: GameReady

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32804
      • Florida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients over 18 years of age
2. Able to provide informed consent
3. Recent calcaneus or ankle fracture requiring fixation
4. Injury is determined (by physician) to be an isolated, closed, low-energy bimalleolar fracture

Exclusion Criteria:

1. Unable to provide informed consent
2. History of Dementia or mental instability
3. No recent additional fractures (within one year) at or around injury site
4. Persons with symptoms of any kind of psychosocial disorder
5. Any condition that the clinician feels would contraindicate for the postoperative test or control treatments
6. Any conditions that would contraindicate using the Game Ready
7. If the patient is prevented from transfer to the OR due to reasons other than medically necessary

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: AdventHealth
• Collaborators: Cool Systems, Inc.
• Investigators: Principal Investigator: Brian Vickaryous, MD, AdventHealth

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2015
• Primary Completion (Actual): February 9, 2017
• Study Completion (Actual): July 26, 2017

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: July 13, 2015
• First Posted (Estimate): July 15, 2015

Study Record Updates

• Last Update Posted (Actual): February 15, 2018
• Last Update Submitted That Met QC Criteria: February 13, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: 539147