- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02051582
Role of the Laser Pointer in Budgeting Fluoroscopy Time and Radiation Exposure
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Florida
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Gainesville, Florida, Estados Unidos, 32611
- UF and Shands Orthopaedics and Sports Medicine Institute
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Total radiation exposure with laser pointer will be measured.
Prazo: 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.
|
1 hour
|
|
Total radiation exposure without laser pointer will be measured.
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Robert Matthias, M.D., University of Florida
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 201300829
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