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

Ankle Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02498717
• Other study ID #: 539147
• Status: Completed
• Phase: N/A
• First received: March 31, 2015
• Last updated: February 13, 2018
• Start date: June 3, 2015
• Est. completion date: July 26, 2017

Study information

• Verified date: February 2018
• Source: Florida Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 26, 2017
• Est. primary completion date: February 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone

Intervention

Device:
• GameReady
Cryotherapy and compression

Other:
• RICE
SOC ice and elevation

Locations

Country	Name	City	State
United States	Florida Hospital	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida Hospital	Cool Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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)
Primary	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)
Primary	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	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)