Role of the Laser Pointer in Budgeting Fluoroscopy Time and Radiation Exposure

NCT ID: NCT02051582

Last Updated: 2015-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-05-31

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgeons using fluoroscopy with laser pointer

Surgeons 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.

Surgeons 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.

Surgeons using fluoroscopy with laser pointer

Intervention Type PROCEDURE

Surgeons 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.

Surgeons 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.

Surgeons using fluoroscopy without laser pointer

Surgeons will attempt to obtain a "perfect" anterior-posterior (AP) and axillary views of a cadaver wrist using a mini-fluoroscopy unit equipped without 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.

Surgeons 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.

Surgeons using fluoroscopy without laser pointer

Intervention Type PROCEDURE

Surgeons will attempt to obtain a "perfect" anterior-posterior (AP) and axillary views of a cadaver wrist using a mini-fluoroscopy unit equipped without 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.

Surgeons 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.

Interventions

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Surgeons using fluoroscopy with laser pointer

Surgeons 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.

Surgeons 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.

Intervention Type PROCEDURE

Surgeons using fluoroscopy without laser pointer

Surgeons will attempt to obtain a "perfect" anterior-posterior (AP) and axillary views of a cadaver wrist using a mini-fluoroscopy unit equipped without 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.

Surgeons 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Matthias, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF and Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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201300829

Identifier Type: -

Identifier Source: org_study_id

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