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Radiation Exposure Using Laser Guided Fluoroscopy in Various Orthopaedic Procedures

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ClinicalTrials.gov Identifier: NCT00972647
Recruitment Status : Withdrawn (Lack of personnel)
First Posted : September 7, 2009
Last Update Posted : October 1, 2013
Sponsor:
Information provided by (Responsible Party):
Montri D. Wongworawat, Loma Linda University

Tracking Information
First Submitted Date  ICMJE August 20, 2009
First Posted Date  ICMJE September 7, 2009
Last Update Posted Date October 1, 2013
Study Start Date  ICMJE August 2009
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2009)
Duration of radiation exposure [ Time Frame: 1 to 12 weeks after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
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
Study Arms  ICMJE
  • No Intervention: Unguided
    Fluoroscopy images taken without laser beam guidance
  • Experimental: Laser guided
    Fluoroscopy images taken with laser beam guidance
    Intervention: Procedure: Laser beam guidance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 29, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2009)
50
Estimated Study Completion Date  ICMJE June 2011
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with fractures requiring surgery with fluoroscopic assistance

Exclusion Criteria:

  • Patients with fractures treated without surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00972647
Other Study ID Numbers  ICMJE 59130
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Montri D. Wongworawat, Loma Linda University
Study Sponsor  ICMJE Loma Linda University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Montri D Wongworawat, MD Loma Linda University
PRS Account Loma Linda University
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP