- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02051582
Role of the Laser Pointer in Budgeting Fluoroscopy Time and Radiation Exposure
Przegląd badań
Status
Warunki
Szczegółowy opis
The subject be asked to participate in one test session at the UF Psychomotor and Surgical Skills Lab located in the UF Orthopaedics & Sports Medicine Institute. During this test session the patient will be asked to wear a 0.5mm thick lead wrap-around apron and thyroid shield for maximal protection from radiation. The patient will also be asked to wear three dosimeter badges: one on the collar, one on the waist, and a ring badge under a pair of regular sterile surgical gloves.
The patient will attempt to obtain a "perfect" anterior-posterior (AP) and axillary views of a cadaver wrist using a mini-fluoroscopy unit equipped with a laser pointer.
A "perfect" view is considered the ability to obtain perfect circle views through a cannulated mini acutrak screw that will have been placed into the cadaver prior to data collection.
The patient will attempt to achieve the perfect views using the fluoroscopy unit with and without the laser pointer. The use of the laser pointer will be randomized by a randomization table that is prepared prior to testing. The patient's total fluoroscopy time and the number of shots you take for each task recorded. The investigators will also record the number of years training the patient has as an orthopaedic surgeon.
Female Participants: Because the radiation exposure from the fluoroscopy machine in this study might affect an unborn baby, the patient will not be allowed to participate in the study if they are pregnant. All women of childbearing potential must take a pregnancy test prior to participating in this study.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Florida
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Gainesville, Florida, Stany Zjednoczone, 32611
- UF and Shands Orthopaedics and Sports Medicine Institute
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
orthopaedic surgeons (Attendings, Fellows, and Residents) from the Department of Orthopaedics and Rehabilitation
Exclusion Criteria:
non-orthopaedic surgeons (Attendings, Fellows, and Residents) from the Department of Orthopaedics and Rehabilitation
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: Kohorta
- Perspektywy czasowe: Spodziewany
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
---|---|
Surgeons using fluoroscopy with laser pointer
Surgeons will attempt to obtain a "perfect" anterior-posterior (AP) and axillary views of a cadaver wrist using a mini-fluoroscopy unit equipped with a laser pointer. A "perfect" view is considered the ability to obtain perfect circle views through a cannulated mini acutrak screw that will have been placed into the cadaver prior to data collection. Surgeons will also be asked to wear three dosimeter badges: one on the collar, one on the waist, and a ring badge under a pair of regular sterile surgical gloves. |
Surgeons will attempt to obtain a "perfect" anterior-posterior (AP) and axillary views of a cadaver wrist using a mini-fluoroscopy unit equipped with a laser pointer. A "perfect" view is considered the ability to obtain perfect circle views through a cannulated mini acutrak screw that will have been placed into the cadaver prior to data collection. Surgeons will also be asked to wear three dosimeter badges: one on the collar, one on the waist, and a ring badge under a pair of regular sterile surgical gloves. |
Surgeons using fluoroscopy without laser pointer
Surgeons will attempt to obtain a "perfect" anterior-posterior (AP) and axillary views of a cadaver wrist using a mini-fluoroscopy unit equipped without a laser pointer. A "perfect" view is considered the ability to obtain perfect circle views through a cannulated mini acutrak screw that will have been placed into the cadaver prior to data collection. Surgeons will also be asked to wear three dosimeter badges: one on the collar, one on the waist, and a ring badge under a pair of regular sterile surgical gloves. |
Surgeons will attempt to obtain a "perfect" anterior-posterior (AP) and axillary views of a cadaver wrist using a mini-fluoroscopy unit equipped without a laser pointer. A "perfect" view is considered the ability to obtain perfect circle views through a cannulated mini acutrak screw that will have been placed into the cadaver prior to data collection. Surgeons will also be asked to wear three dosimeter badges: one on the collar, one on the waist, and a ring badge under a pair of regular sterile surgical gloves. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Total radiation exposure with laser pointer will be measured.
Ramy czasowe: 1 hour
|
All dosimeters will be read for total radiation exposure.
Data analysis will include simple statistics to compare the total radiation exposure and number of shots taken per task using each of the fluoroscopy machines with laser pointer.
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1 hour
|
Total radiation exposure without laser pointer will be measured.
Ramy czasowe: 1 hours
|
All dosimeters will be read for total radiation exposure.
Data analysis will include simple statistics to compare the total radiation exposure and number of shots taken per task using each of the fluoroscopy machines without laser pointer.
|
1 hours
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Robert Matthias, M.D., University of Florida
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
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 (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 201300829
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