Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Orlando, Florida 32804


Purpose:

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 summary:

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.


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


NCT ID:

NCT02498717


Primary Contact:

Principal Investigator
Brian Vickaryous, MD
Florida Hospital


Backup Contact:

N/A


Location Contact:

Orlando, Florida 32804
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.