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

13. februar 2018 opdateret af: AdventHealth

Preliminary Efficacy and Cost-effectiveness Analysis of a Cold and Active Intermittent Compression Therapy Technique 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

55

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Florida
      • Orlando, Florida, Forenede Stater, 32804
        • Florida Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: RICE (control)
Standard of Care procedures including ice and elevation.
Andet: RICE
SOC ice and elevation
Eksperimentel: Cryocompression (experimental)
treatment using the GameReady cryotherapy system
Enhed: GameReady
Cryotherapy and compression

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time until surgery/Time until discharge (LOS)
Tidsramme: 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)
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)
Tidsramme: Measured at baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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
Tidsramme: 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
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
Tidsramme: 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
Reported at baseline, daily while inpatient (approx 2-3 days), and at all follow-up assessments (2, 8, 16, & 24-weeks post-op)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Quality of Life (QALY) as measured on QOL and SF-8
Tidsramme: At baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
Quality of Life by QALY score
At baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AdventHealth

Samarbejdspartnere

Cool Systems, Inc.

Efterforskere

  • Ledende efterforsker: Brian Vickaryous, MD, Adventhealth

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. juni 2015

Primær færdiggørelse (Faktiske)

9. februar 2017

Studieafslutning (Faktiske)

26. juli 2017

Datoer for studieregistrering

Først indsendt

31. marts 2015

Først indsendt, der opfyldte QC-kriterier

13. juli 2015

Først opslået (Skøn)

15. juli 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. februar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. februar 2018

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 539147

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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