Clinical trial NCT02051582: Role of the Laser Pointer in Budgeting Fluoroscopy Time and Radiation Exposure
Official title: Role of the Laser Pointer in Budgeting Fluoroscopy Time and Radiation Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 25
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty (30) orthopaedic surgeons (Attendings, Fellows, and Residents) from the Department of Orthopaedics and Rehabilitation will be recruited and enrolled in the study

Brief summary: Thirty (30) orthopaedic surgeons from the University of Florida Department of Orthopaedics and Rehabilitation will be recruited and enrolled in the study to determine whether having a laser pointed on a fluoroscopy machine can significantly decrease the amount of radiation exposure as measured while obtaining multiple views during surgery as well as decrease radiation exposure and time to accomplish the goals of surgery.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total radiation exposure with laser pointer will be measured.
timeFrame: 1 hour
measure: Total radiation exposure without laser pointer will be measured.
timeFrame: 1 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF and Shands Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: University of Florida
name: Robert Matthias, M.D.
role: PRINCIPAL_INVESTIGATOR
References: