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NCT02856828

Novel Use of an Enhanced Fluoroscopic Imaging Device to Reduce Radiation Exposure and Operative Time During Intramedullary Nailing of Hip Fractures

Terminated NA Results posted Last updated 15 October 2019
What this trial tests

NA trial testing DIE in Radiation Exposure in 5 participants. Terminated before completion.

Timeline
1 March 2017
Primary endpoint
6 February 2018
6 February 2018

Quick facts

Lead sponsorDuke University
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeother
Enrollment5
Start date1 March 2017
Primary completion6 February 2018
Estimated completion6 February 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Duke University

Who can join

18 and older, any sex, with Radiation Exposure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge Primary · intraoperatively
Participant 1
GroupValue95% CI
Digital Image Enhancement (DIE) Group5.12
Control GroupNA
Participant 2
GroupValue95% CI
Digital Image Enhancement (DIE) GroupNA
Control Group12.9
Participant 3
GroupValue95% CI
Digital Image Enhancement (DIE) Group9.79
Control GroupNA
Participant 4
GroupValue95% CI
Digital Image Enhancement (DIE) GroupNA
Control Group7.93
Participant 5
GroupValue95% CI
Digital Image Enhancement (DIE) GroupNA
Control Group15.41
Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge Primary · intraoperatively
Primary Surgeon 1
GroupValue95% CI
Digital Image Enhancement (DIE) Group0.7
Control GroupNA
Primary Surgeon 2
GroupValue95% CI
Digital Image Enhancement (DIE) GroupNA
Control Group1.9
Primary Surgeon 3
GroupValue95% CI
Digital Image Enhancement (DIE) Group1.6
Control GroupNA
Primary Surgeon 4
GroupValue95% CI
Digital Image Enhancement (DIE) GroupNA
Control Group1.2
Primary Surgeon 5
GroupValue95% CI
Digital Image Enhancement (DIE) GroupNA
Control Group3.1
Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge Primary · intraoperatively
Surgical Technician 1
GroupValue95% CI
Digital Image Enhancement (DIE) Group0.5
Control GroupNA
Surgical Technician 2
GroupValue95% CI
Digital Image Enhancement (DIE) GroupNA
Control Group1.1
Surgical Technician 3
GroupValue95% CI
Digital Image Enhancement (DIE) Group0.9
Control GroupNA
Surgical Technician 4
GroupValue95% CI
Digital Image Enhancement (DIE) GroupNA
Control Group0.9
Surgical Technician 5
GroupValue95% CI
Digital Image Enhancement (DIE) GroupNA
Control Group0.1
Image Quality and Reproducibility of Desired Images Secondary · intraoperatively

Measured by questionnaire related to image quality. Quality scale of 1-10, 1 being poor image quality and 10 being excellent image quality.

Participant 1 Image
GroupValue95% CI
Image Quality of the Digital Image Enhancement (DIE) Group9
Image Quality of the Control GroupNA
Participant 2 Image
GroupValue95% CI
Image Quality of the Digital Image Enhancement (DIE) GroupNA
Image Quality of the Control Group8
Participant 3 Image
GroupValue95% CI
Image Quality of the Digital Image Enhancement (DIE) Group8
Image Quality of the Control GroupNA
Participant 4 Image
GroupValue95% CI
Image Quality of the Digital Image Enhancement (DIE) GroupNA
Image Quality of the Control Group7
Participant 5 Image
GroupValue95% CI
Image Quality of the Digital Image Enhancement (DIE) GroupNA
Image Quality of the Control Group9
Operative Time Secondary · intraoperatively
Participant 1
GroupValue95% CI
Digital Image Enhancement (DIE) Group51
Control GroupNA
Participant 2
GroupValue95% CI
Digital Image Enhancement (DIE) GroupNA
Control Group103
Participant 3
GroupValue95% CI
Digital Image Enhancement (DIE) Group79
Control GroupNA
Participant 4
GroupValue95% CI
Digital Image Enhancement (DIE) GroupNA
Control Group80
Participant 5
GroupValue95% CI
Digital Image Enhancement (DIE) GroupNA
Control Group125

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Radiation Exposure

Currently open trials in the same condition.

Other Duke University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02856828.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing