Back to resultsNovel Use of an Enhanced Fluoroscopic Imaging Device to Reduce Radiation Exposure and Operative Time During Intramedullary Nailing of Hip Fractures
Primary Purpose
Radiation Exposure
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DIE
Sponsored by
About this trial
This is an interventional other trial for Radiation Exposure
Eligibility Criteria
Inclusion Criteria:
- closed hip fracture requiring intramedullary nailing
Exclusion Criteria:
- age <18 years
Sites / Locations
- Duke University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Digital Image Enhancement (DIE) Group
Control Group
Arm Description
A novel digital image enhancement technology will be used intraoperatively
Standard intraoperative imaging will be used intraoperatively
Outcomes
Primary Outcome Measures
Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Secondary Outcome Measures
Image Quality and Reproducibility of Desired Images
Measured by questionnaire related to image quality. Quality scale of 1-10, 1 being poor image quality and 10 being excellent image quality.
Operative Time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02856828
Brief Title
Novel Use of an Enhanced Fluoroscopic Imaging Device to Reduce Radiation Exposure and Operative Time During Intramedullary Nailing of Hip Fractures
Official Title
Novel Use of an Enhanced Fluoroscopic Imaging Device to Reduce Radiation Exposure and Operative Time During Intramedullary Nailing of Hip Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Closed due to slow enrollment.
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
February 6, 2018 (Actual)
Study Completion Date
February 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness of a novel digital image enhancement (DIE) technology in reducing the radiation exposure to both the patient and surgical staff during standard intramedullary nail placement for treatment of hip fractures. Secondarily, to evaluate whether the image quality and reproducibility of desired images can be improved with use of the DIE technology. Finally, to evaluate whether DIE technology reduces total operative time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Exposure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Digital Image Enhancement (DIE) Group
Arm Type
Experimental
Arm Description
A novel digital image enhancement technology will be used intraoperatively
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Standard intraoperative imaging will be used intraoperatively
Intervention Type
Device
Intervention Name(s)
DIE
Intervention Description
digital image enhancement
Primary Outcome Measure Information:
Title
Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Time Frame
intraoperatively
Title
Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Time Frame
intraoperatively
Title
Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Time Frame
intraoperatively
Secondary Outcome Measure Information:
Title
Image Quality and Reproducibility of Desired Images
Description
Measured by questionnaire related to image quality. Quality scale of 1-10, 1 being poor image quality and 10 being excellent image quality.
Time Frame
intraoperatively
Title
Operative Time
Time Frame
intraoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
closed hip fracture requiring intramedullary nailing
Exclusion Criteria:
age <18 years
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Novel Use of an Enhanced Fluoroscopic Imaging Device to Reduce Radiation Exposure and Operative Time During Intramedullary Nailing of Hip Fractures
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