Radiation Exposure Using Laser Guided Fluoroscopy in Various Orthopaedic Procedures

This study has been withdrawn prior to enrollment.
(Lack of personnel)
Sponsor:
Information provided by (Responsible Party):
Montri D. Wongworawat, Loma Linda University
ClinicalTrials.gov Identifier:
NCT00972647
First received: August 20, 2009
Last updated: September 29, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Fractures
Procedure: Laser beam guidance

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Radiation Exposure Using Laser Guided Fluoroscopy in Various Orthopaedic Procedures

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Duration of radiation exposure [ Time Frame: 1 to 12 weeks after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: August 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Unguided
Fluoroscopy images taken without laser beam guidance
Experimental: Laser guided
Fluoroscopy images taken with laser beam guidance
Procedure: Laser beam guidance
Using the laser centralizing beam to assist in position the body part prior to fluoroscopic imaging

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with fractures requiring surgery with fluoroscopic assistance

Exclusion Criteria:

  • Patients with fractures treated without surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972647

Locations
United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Montri D Wongworawat, MD Loma Linda University
  More Information

No publications provided

Responsible Party: Montri D. Wongworawat, Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT00972647     History of Changes
Other Study ID Numbers: 59130
Study First Received: August 20, 2009
Last Updated: September 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
fracture
fixation
fluoroscopy
laser
radiation

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on July 29, 2014