Radiation Exposure Using Laser Guided Fluoroscopy in Various Orthopaedic Procedures
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| First Received Date ICMJE | August 20, 2009 | ||||
| Last Updated Date | June 20, 2011 | ||||
| Start Date ICMJE | August 2009 | ||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Duration of radiation exposure [ Time Frame: 1 to 12 weeks after surgery ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00972647 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Radiation Exposure Using Laser Guided Fluoroscopy in Various Orthopaedic Procedures | ||||
| Official Title ICMJE | Radiation Exposure Using Laser Guided Fluoroscopy in Various Orthopaedic Procedures | ||||
| Brief Summary | Introduction: The orthopaedic surgeon is frequently exposed to ionizing radiation, especially during intraoperative fluoroscopy. It is expected that using a laser guided fluoroscopy technique, which should improve accuracy of radiography, should also reduce the amount of time of exposure to radiation. Finally, the literature appears controversial in this matter with no clear conclusions that could be drawn from such. Hypothesis: The test hypothesis is that the use of the laser-aiming device for fluoroscopy in several orthopaedic procedures will reduce the exposure of the patient and the surgeon to the damaging effects of radiation. The null hypothesis then states that there will be no difference in exposure to radiation between the group using the laser device and the group not using the apparatus. Methods: A prospective randomized controlled trial will be performed in which patients undergoing fluoroscopy will be randomly allocated to two groups. One group will undergo imaging with use of the device throughout the procedure and the other group will undergo radiation without the laser guided device. Number and time of exposure will be recorded for each procedure. It is of the utmost importance that the complexity of the procedures remains relatively similar. It is believed that a good measure of complexity is the surgical time. Therefore, any procedures that are statistically similar from a set mean (p > 0.05) would be included into the study. It is also important that one or two surgeons with similar expertise and years of experience perform the surgeries to avoid confounding factors. It is expected that throughout the duration of the study (8 weeks) 50-100 cases would be reported which would produce statistically significant results. The results will be analyzed by calculating confidence intervals and differences between means of continuous data and significance levels by the Student's t test. Statistical significance will be set to P < 0.05. Risks and Benefits: This study involves minimal risk. The use of the laser guide will not increase or introduce any risks other than the associated inherent surgical risks. The risks usually associated with this type of studies concern breach of confidentiality. To reduce this risk, research numbers will be assigned to subjects' data collected during the procedure, whose personal information will be found in another password-protected database. This study will help the investigators to investigate a technique that may help reduce the amount of time that a patient is exposed to radiation. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Diagnostic |
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| Condition ICMJE | Fractures | ||||
| Intervention ICMJE | Procedure: Laser beam guidance
Using the laser centralizing beam to assist in position the body part prior to fluoroscopic imaging |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | June 2011 | ||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 89 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00972647 | ||||
| Other Study ID Numbers ICMJE | 59130 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Montri D. Wongworawat, Associate Professor, Loma Linda University Department of Orthopaedic Surgery | ||||
| Study Sponsor ICMJE | Loma Linda University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Loma Linda University | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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