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

NCT ID: NCT02498717

Last Updated: 2018-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-03
• Study Completion Date: 2017-07-26

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.

Conditions

Ankle Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RICE (control)

Standard of Care procedures including ice and elevation.

Group Type: ACTIVE_COMPARATOR

RICE

Intervention Type: OTHER

SOC ice and elevation

Cryocompression (experimental)

treatment using the GameReady cryotherapy system

Group Type: EXPERIMENTAL

GameReady

Intervention Type: DEVICE

Cryotherapy and compression

Interventions

GameReady

Cryotherapy and compression

Intervention Type: DEVICE

RICE

SOC ice and elevation

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cool Systems, Inc.

INDUSTRY

Sponsor Role: collaborator

AdventHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Vickaryous, MD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Locations

Florida Hospital

Orlando, Florida, United States

Countries

United States

Other Identifiers

539147

Identifier Type: -

Identifier Source: org_study_id