Study Stopped
Closed due to slow enrollment.
Novel Use of an Enhanced Fluoroscopic Imaging Device to Reduce Radiation Exposure and Operative Time During Intramedullary Nailing of Hip Fractures
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2016
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2018
CompletedResults Posted
Study results publicly available
October 1, 2019
CompletedOctober 15, 2019
October 1, 2019
11 months
July 28, 2016
September 12, 2019
October 4, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
intraoperatively
Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
intraoperatively
Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
intraoperatively
Secondary Outcomes (2)
Image Quality and Reproducibility of Desired Images
intraoperatively
Operative Time
intraoperatively
Study Arms (2)
Digital Image Enhancement (DIE) Group
EXPERIMENTALA novel digital image enhancement technology will be used intraoperatively
Control Group
NO INTERVENTIONStandard intraoperative imaging will be used intraoperatively
Interventions
Eligibility Criteria
You may qualify if:
- closed hip fracture requiring intramedullary nailing
You may not qualify if:
- age \<18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University
Durham, North Carolina, 27710, United States
Limitations and Caveats
Only two radiation dosimeters were purchased. Therefore, there is no radiation exposure data for the secondary surgeon.
Results Point of Contact
- Title
- Dr. Rachel Reilly
- Organization
- Duke University Health Systems
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2016
First Posted
August 5, 2016
Study Start
March 1, 2017
Primary Completion
February 6, 2018
Study Completion
February 6, 2018
Last Updated
October 15, 2019
Results First Posted
October 1, 2019
Record last verified: 2019-10