Preliminary Review of Cold and Active Compression Therapy for Traumatic Calcaneus or Ankle Fractures
Preliminary Efficacy and Cost-effectiveness Analysis of a Cold and Active Intermittent Compression Therapy Technique for Traumatic Calcaneus or Ankle Fractures
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Florida
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Orlando, Florida, Stany Zjednoczone, 32804
- Florida Hospital
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: RICE (control)
Standard of Care procedures including ice and elevation.
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SOC ice and elevation
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Eksperymentalny: Cryocompression (experimental)
treatment using the GameReady cryotherapy system
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Cryotherapy and compression
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Time until surgery/Time until discharge (LOS)
Ramy czasowe: 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.
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Reduction in length of stay (LOS) and time of effect (pre-/post-op)
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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)
Ramy czasowe: Measured at baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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Measured at circumference of swelling point
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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
Ramy czasowe: 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
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Measured daily while inpatient (approx 2-3 days) and retroactively at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
|
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Change in Patient reported pain as measured on VAS and Knee Pain Assessment
Ramy czasowe: Reported at baseline, daily while inpatient (approx 2-3 days), and at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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As reported by VAS scale
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Reported at baseline, daily while inpatient (approx 2-3 days), and at all follow-up assessments (2, 8, 16, & 24-weeks post-op)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Quality of Life (QALY) as measured on QOL and SF-8
Ramy czasowe: At baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
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Quality of Life by QALY score
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At baseline and all follow-up assessments (2, 8, 16, & 24-weeks post-op)
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Brian Vickaryous, MD, AdventHealth
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 539147
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