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

AdventHealth

Status: Completed

Conditions: Ankle Fractures

Treatments: Other: RICE; Device: GameReady

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02498717

539147

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

RICE (control)

Active Comparator group

Description:

Standard of Care procedures including ice and elevation.

Treatment:

Other: RICE

Cryocompression (experimental)

Experimental group

Description:

treatment using the GameReady cryotherapy system

Treatment:

Device: GameReady