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

Not Applicable

Completed

• Conditions: Ankle Fractures
• Interventions: Other: RICE; Device: GameReady

• Registration Number: NCT02498717
• Lead Sponsor: AdventHealth

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.

Study Timeline

• Study First Submitted: 2015-03-31
• Study Start: 2015-06-03
• Study First Submitted QC: 2015-07-13
• Study First Posted: 2015-07-15
• Primary Completion: 2017-02-09
• Study Completion: 2017-07-26
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RICE (control)	RICE	Standard of Care procedures including ice and elevation.
Cryocompression (experimental)	GameReady	treatment using the GameReady cryotherapy system

Primary Outcome Measures

Name	Time	Method
Time until surgery/Time until discharge (LOS)	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)	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	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	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

Secondary Outcome Measures

Name	Time	Method
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)	Quality of Life by QALY score

Trial Locations

Locations (1)

Florida Hospital; 🇺🇸 Orlando, Florida, United States