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Completed

NCT Number: NCT02498717

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida Hospital

Orlando, Florida, 32804, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

GameReady

Device

Cryotherapy and compression

Rice

Other

SOC ice and elevation

Primary outcomes

  1. Time until surgery/Time until discharge (LOS)

    Time frame: 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.

    Reduction in length of stay (LOS) and time of effect (pre-/post-op)

  2. Change in Swelling as measured by point of largest swollen area (tape measure)

    Time frame: Measured at baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)

    Measured at circumference of swelling point

  3. Total Narcotic Use as recorded on MR chart and Knee Pain Assessment

    Time frame: Measured daily while inpatient (approx 2-3 days) and retroactively at all follow-up assessments (2, 8, 16, & 24-weeks post-op)

    reported as yes/no and amount/type on assessment form

  4. Change in Patient reported pain as measured on VAS and Knee Pain Assessment

    Time frame: Reported at baseline, daily while inpatient (approx 2-3 days), and at all follow-up assessments (2, 8, 16, & 24-weeks post-op)

    As reported by VAS scale

Secondary outcomes

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

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

    Quality of Life by QALY score

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Collaborators

  • Cool Systems, Inc.

Registry information

Official study title

Preliminary Efficacy and Cost-effectiveness Analysis of a Cold and Active Intermittent Compression Therapy Technique for Traumatic Calcaneus or Ankle Fractures

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 15, 2015
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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