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 BadgePrimary· intraoperatively
Participant 1
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
5.12
Control Group
NA
Participant 2
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
NA
Control Group
12.9
Participant 3
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
9.79
Control Group
NA
Participant 4
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
NA
Control Group
7.93
Participant 5
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
NA
Control Group
15.41
Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter BadgePrimary· intraoperatively
Primary Surgeon 1
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
0.7
Control Group
NA
Primary Surgeon 2
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
NA
Control Group
1.9
Primary Surgeon 3
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
1.6
Control Group
NA
Primary Surgeon 4
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
NA
Control Group
1.2
Primary Surgeon 5
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
NA
Control Group
3.1
Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter BadgePrimary· intraoperatively
Surgical Technician 1
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
0.5
Control Group
NA
Surgical Technician 2
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
NA
Control Group
1.1
Surgical Technician 3
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
0.9
Control Group
NA
Surgical Technician 4
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
NA
Control Group
0.9
Surgical Technician 5
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
NA
Control Group
0.1
Image Quality and Reproducibility of Desired ImagesSecondary· 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
Group
Value
95% CI
Image Quality of the Digital Image Enhancement (DIE) Group
9
Image Quality of the Control Group
NA
Participant 2 Image
Group
Value
95% CI
Image Quality of the Digital Image Enhancement (DIE) Group
NA
Image Quality of the Control Group
8
Participant 3 Image
Group
Value
95% CI
Image Quality of the Digital Image Enhancement (DIE) Group
8
Image Quality of the Control Group
NA
Participant 4 Image
Group
Value
95% CI
Image Quality of the Digital Image Enhancement (DIE) Group
NA
Image Quality of the Control Group
7
Participant 5 Image
Group
Value
95% CI
Image Quality of the Digital Image Enhancement (DIE) Group
NA
Image Quality of the Control Group
9
Operative TimeSecondary· intraoperatively
Participant 1
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
51
Control Group
NA
Participant 2
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
NA
Control Group
103
Participant 3
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
79
Control Group
NA
Participant 4
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
NA
Control Group
80
Participant 5
Group
Value
95% CI
Digital Image Enhancement (DIE) Group
NA
Control Group
125
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.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 15 October 2019
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.