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

NCT02498717 | Completed

• 1 other identifier: 539147
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Fractures

Outcome Measures

Primary Outcomes (4)

• 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.

• 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)

• 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)

• 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 Outcomes (1)

• Change in Quality of Life (QALY) as measured on QOL and SF-8

  At baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)

Study Arms (2)

RICE (control)

ACTIVE COMPARATOR

Standard of Care procedures including ice and elevation.

Other: RICE

Cryocompression (experimental)

EXPERIMENTAL

treatment using the GameReady cryotherapy system

Device: GameReady

Interventions

GameReady DEVICE

Cryotherapy and compression

Cryocompression (experimental)

RICE OTHER

SOC ice and elevation

RICE (control)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age
• Able to provide informed consent
• Recent calcaneus or ankle fracture requiring fixation
• Injury is determined (by physician) to be an isolated, closed, low-energy bimalleolar fracture

You may not qualify if:

• Unable to provide informed consent
• History of Dementia or mental instability
• No recent additional fractures (within one year) at or around injury site
• Persons with symptoms of any kind of psychosocial disorder
• Any condition that the clinician feels would contraindicate for the postoperative test or control treatments
• Any conditions that would contraindicate using the Game Ready
• If the patient is prevented from transfer to the OR due to reasons other than medically necessary

Sponsors & Collaborators

• AdventHealth: lead
• Cool Systems, Inc.: collaborator

Study Sites (1)

Florida Hospital

Orlando, Florida, 32804, United States

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Officials

• Brian Vickaryous, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: July 15, 2015
• Study Start: June 3, 2015
• Primary Completion: February 9, 2017
• Study Completion: July 26, 2017
• Last Updated: February 15, 2018

Record last verified: 2018-02

Locations

US (1)