Trial Outcomes & Findings for Novel Use of an Enhanced Fluoroscopic Imaging Device to Reduce Radiation Exposure and Operative Time During Intramedullary Nailing of Hip Fractures (NCT NCT02856828)
NCT ID: NCT02856828
Last Updated: 2019-10-15
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
intraoperatively
Results posted on
2019-10-15
Participant Flow
Participant milestones
| Measure |
Digital Image Enhancement (DIE) Group
A novel digital image enhancement technology will be used intraoperatively
DIE: digital image enhancement
|
Control Group
Standard intraoperative imaging will be used intraoperatively
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Digital Image Enhancement (DIE) Group
n=2 Participants
A novel digital image enhancement technology will be used intraoperatively
DIE: digital image enhancement
|
Control Group
n=3 Participants
Standard intraoperative imaging will be used intraoperatively
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=5 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
2 participants
n=2 Participants
|
3 participants
n=3 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: intraoperativelyOutcome measures
| Measure |
Digital Image Enhancement (DIE) Group
n=2 Participants
The radiation exposure to the patient in the digital image enhancement group.
|
Control Group
n=3 Participants
The radiation exposure to the patient in the standard intraoperative imaging group.
|
|---|---|---|
|
Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Participant 1
|
5.12 mGy
|
NA mGy
Participant was in the DIE Group.
|
|
Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Participant 2
|
NA mGy
Participant was in the Control Group.
|
12.9 mGy
|
|
Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Participant 3
|
9.79 mGy
|
NA mGy
Participant was in the DIE Group.
|
|
Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Participant 4
|
NA mGy
Participant was in the Control Group.
|
7.93 mGy
|
|
Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Participant 5
|
NA mGy
Participant was in the Control Group.
|
15.41 mGy
|
PRIMARY outcome
Timeframe: intraoperativelyOutcome measures
| Measure |
Digital Image Enhancement (DIE) Group
n=2 Participants
The radiation exposure to the patient in the digital image enhancement group.
|
Control Group
n=3 Participants
The radiation exposure to the patient in the standard intraoperative imaging group.
|
|---|---|---|
|
Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Primary Surgeon 1
|
0.7 mrem
|
NA mrem
This participant was not in the control group.
|
|
Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Primary Surgeon 2
|
NA mrem
This participant was not in the Digital Image Enhancement group.
|
1.9 mrem
|
|
Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Primary Surgeon 3
|
1.6 mrem
|
NA mrem
This participant was not in the control group.
|
|
Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Primary Surgeon 4
|
NA mrem
This participant was not in the Digital Image Enhancement group.
|
1.2 mrem
|
|
Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Primary Surgeon 5
|
NA mrem
This participant was not in the Digital Image Enhancement group.
|
3.1 mrem
|
PRIMARY outcome
Timeframe: intraoperativelyOutcome measures
| Measure |
Digital Image Enhancement (DIE) Group
n=2 Participants
The radiation exposure to the patient in the digital image enhancement group.
|
Control Group
n=3 Participants
The radiation exposure to the patient in the standard intraoperative imaging group.
|
|---|---|---|
|
Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Surgical Technician 1
|
0.5 mrem
|
NA mrem
This participant was not in the Control group.
|
|
Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Surgical Technician 2
|
NA mrem
This participant was not in the Digital Image Enhancement group.
|
1.1 mrem
|
|
Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Surgical Technician 3
|
0.9 mrem
|
NA mrem
This participant was not in the Control group.
|
|
Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Surgical Technician 4
|
NA mrem
This participant was not in the Digital Image Enhancement group.
|
0.9 mrem
|
|
Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Surgical Technician 5
|
NA mrem
This participant was not in the Digital Image Enhancement group.
|
0.1 mrem
|
SECONDARY outcome
Timeframe: intraoperativelyMeasured by questionnaire related to image quality. Quality scale of 1-10, 1 being poor image quality and 10 being excellent image quality.
Outcome measures
| Measure |
Digital Image Enhancement (DIE) Group
n=2 Participants
The radiation exposure to the patient in the digital image enhancement group.
|
Control Group
n=3 Participants
The radiation exposure to the patient in the standard intraoperative imaging group.
|
|---|---|---|
|
Image Quality and Reproducibility of Desired Images
Participant 1 Image
|
9 Quality Scale of 1-10, 10 being the best
|
NA Quality Scale of 1-10, 10 being the best
This participant was not in the Control group.
|
|
Image Quality and Reproducibility of Desired Images
Participant 2 Image
|
NA Quality Scale of 1-10, 10 being the best
This participant was not in the Digital Image Enhancement group.
|
8 Quality Scale of 1-10, 10 being the best
|
|
Image Quality and Reproducibility of Desired Images
Participant 3 Image
|
8 Quality Scale of 1-10, 10 being the best
|
NA Quality Scale of 1-10, 10 being the best
This participant was not in the Control group.
|
|
Image Quality and Reproducibility of Desired Images
Participant 4 Image
|
NA Quality Scale of 1-10, 10 being the best
This participant was not in the Digital Image Enhancement group.
|
7 Quality Scale of 1-10, 10 being the best
|
|
Image Quality and Reproducibility of Desired Images
Participant 5 Image
|
NA Quality Scale of 1-10, 10 being the best
This participant was not in the Digital Image Enhancement group.
|
9 Quality Scale of 1-10, 10 being the best
|
SECONDARY outcome
Timeframe: intraoperativelyOutcome measures
| Measure |
Digital Image Enhancement (DIE) Group
n=2 Participants
The radiation exposure to the patient in the digital image enhancement group.
|
Control Group
n=3 Participants
The radiation exposure to the patient in the standard intraoperative imaging group.
|
|---|---|---|
|
Operative Time
Participant 1
|
51 minutes
|
NA minutes
This participant was not in the Control group.
|
|
Operative Time
Participant 2
|
NA minutes
This participant was not in the Digital Image Enhancement group.
|
103 minutes
|
|
Operative Time
Participant 5
|
NA minutes
This participant was not in the Digital Image Enhancement group.
|
125 minutes
|
|
Operative Time
Participant 3
|
79 minutes
|
NA minutes
This participant was not in the Control group.
|
|
Operative Time
Participant 4
|
NA minutes
This participant was not in the Digital Image Enhancement group.
|
80 minutes
|
Adverse Events
Digital Image Enhancement (DIE) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place