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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 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.


Sponsor: Florida Hospital

Current Primary Outcome:

  • 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)
  • 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
  • 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
  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: Florida Hospital

Dates:
Date Received: March 31, 2015
Date Started: June 2015
Date Completion: March 2016
Last Updated: July 13, 2015
Last Verified: July 2015