Clinical trial NCT02498717: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Fractures
Lead sponsor: AdventHealth
Sponsor class: OTHER
Collaborators: name: Cool Systems, Inc.
First posted: 2015-07-15
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time until surgery/Time until discharge (LOS)
timeFrame: 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.
measure: Change in Swelling as measured by point of largest swollen area (tape measure)
timeFrame: Measured at baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
measure: Total Narcotic Use as recorded on MR chart and Knee Pain Assessment
timeFrame: Measured daily while inpatient (approx 2-3 days) and retroactively at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
measure: Change in Patient reported pain as measured on VAS and Knee Pain Assessment
timeFrame: Reported at baseline, daily while inpatient (approx 2-3 days), and at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
Secondary outcomes:
measure: Change in Quality of Life (QALY) as measured on QOL and SF-8
timeFrame: At baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
Study officials:
affiliation: AdventHealth
name: Brian Vickaryous, MD
role: PRINCIPAL_INVESTIGATOR
References: