Radiation Exposure Using Laser Guided Fluoroscopy in Various Orthopaedic Procedures
Primary Purpose
Fractures
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser beam guidance
Sponsored by
About this trial
This is an interventional diagnostic trial for Fractures focused on measuring fracture, fixation, fluoroscopy, laser, radiation
Eligibility Criteria
Inclusion Criteria:
- Patients with fractures requiring surgery with fluoroscopic assistance
Exclusion Criteria:
- Patients with fractures treated without surgery
Sites / Locations
- Loma Linda University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Unguided
Laser guided
Arm Description
Fluoroscopy images taken without laser beam guidance
Fluoroscopy images taken with laser beam guidance
Outcomes
Primary Outcome Measures
Duration of radiation exposure
Secondary Outcome Measures
Full Information
NCT ID
NCT00972647
First Posted
August 20, 2009
Last Updated
September 29, 2013
Sponsor
Loma Linda University
1. Study Identification
Unique Protocol Identification Number
NCT00972647
Brief Title
Radiation Exposure Using Laser Guided Fluoroscopy in Various Orthopaedic Procedures
Official Title
Radiation Exposure Using Laser Guided Fluoroscopy in Various Orthopaedic Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of personnel
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures
Keywords
fracture, fixation, fluoroscopy, laser, radiation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unguided
Arm Type
No Intervention
Arm Description
Fluoroscopy images taken without laser beam guidance
Arm Title
Laser guided
Arm Type
Experimental
Arm Description
Fluoroscopy images taken with laser beam guidance
Intervention Type
Procedure
Intervention Name(s)
Laser beam guidance
Intervention Description
Using the laser centralizing beam to assist in position the body part prior to fluoroscopic imaging
Primary Outcome Measure Information:
Title
Duration of radiation exposure
Time Frame
1 to 12 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with fractures requiring surgery with fluoroscopic assistance
Exclusion Criteria:
Patients with fractures treated without surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Montri D Wongworawat, MD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
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Radiation Exposure Using Laser Guided Fluoroscopy in Various Orthopaedic Procedures
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