Radiation Exposure
Conditions
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.
Interventions
DEVICEDIE
digital image enhancement
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* closed hip fracture requiring intramedullary nailing
Exclusion criteria
* age \<18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Image Quality and Reproducibility of Desired Images | intraoperatively | 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 | intraoperatively | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Digital Image Enhancement (DIE) Group A novel digital image enhancement technology will be used intraoperatively
DIE: digital image enhancement | 2 |
| Control Group Standard intraoperative imaging will be used intraoperatively | 3 |
| Total | 5 |
Baseline characteristics
| Characteristic | Control Group | Total | Digital Image Enhancement (DIE) Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 3 participants | 5 participants | 2 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 0 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Time frame: intraoperatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Digital Image Enhancement (DIE) Group | Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Participant 2 | NA mGy |
| Digital Image Enhancement (DIE) Group | Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Participant 4 | NA mGy |
| Digital Image Enhancement (DIE) Group | Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Participant 3 | 9.79 mGy |
| Digital Image Enhancement (DIE) Group | Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Participant 5 | NA mGy |
| Digital Image Enhancement (DIE) Group | Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Participant 1 | 5.12 mGy |
| Control Group | Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Participant 5 | 15.41 mGy |
| Control Group | Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Participant 1 | NA mGy |
| Control Group | Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Participant 2 | 12.9 mGy |
| Control Group | Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Participant 3 | NA mGy |
| Control Group | Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Participant 4 | 7.93 mGy |
Primary
Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Time frame: intraoperatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Digital Image Enhancement (DIE) 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 |
| Digital Image Enhancement (DIE) 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 |
| Digital Image Enhancement (DIE) Group | 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 |
| Digital Image Enhancement (DIE) 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 |
| Digital Image Enhancement (DIE) Group | Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Surgical Technician 5 | NA mrem |
| Control Group | Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Surgical Technician 5 | 0.1 mrem |
| Control Group | Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Surgical Technician 1 | NA mrem |
| Control Group | Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Surgical Technician 4 | 0.9 mrem |
| Control Group | Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Surgical Technician 2 | 1.1 mrem |
| Control Group | Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Surgical Technician 3 | NA mrem |
Primary
Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Time frame: intraoperatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Digital Image Enhancement (DIE) Group | Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Primary Surgeon 2 | NA mrem |
| Digital Image Enhancement (DIE) Group | Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Primary Surgeon 4 | NA mrem |
| Digital Image Enhancement (DIE) Group | Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Primary Surgeon 5 | NA mrem |
| Digital Image Enhancement (DIE) Group | Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Primary Surgeon 3 | 1.6 mrem |
| Digital Image Enhancement (DIE) 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 |
| Control Group | Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Primary Surgeon 4 | 1.2 mrem |
| Control Group | Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Primary Surgeon 1 | NA mrem |
| Control Group | Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Primary Surgeon 2 | 1.9 mrem |
| Control Group | Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Primary Surgeon 3 | NA mrem |
| Control Group | Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Primary Surgeon 5 | 3.1 mrem |
Secondary
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.
Time frame: intraoperatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Digital Image Enhancement (DIE) Group | Image Quality and Reproducibility of Desired Images | Participant 2 Image | NA Quality Scale of 1-10, 10 being the best |
| Digital Image Enhancement (DIE) Group | Image Quality and Reproducibility of Desired Images | Participant 4 Image | NA Quality Scale of 1-10, 10 being the best |
| Digital Image Enhancement (DIE) Group | Image Quality and Reproducibility of Desired Images | Participant 3 Image | 8 Quality Scale of 1-10, 10 being the best |
| Digital Image Enhancement (DIE) Group | Image Quality and Reproducibility of Desired Images | Participant 5 Image | NA Quality Scale of 1-10, 10 being the best |
| Digital Image Enhancement (DIE) Group | Image Quality and Reproducibility of Desired Images | Participant 1 Image | 9 Quality Scale of 1-10, 10 being the best |
| Control Group | Image Quality and Reproducibility of Desired Images | Participant 5 Image | 9 Quality Scale of 1-10, 10 being the best |
| Control Group | Image Quality and Reproducibility of Desired Images | Participant 1 Image | NA Quality Scale of 1-10, 10 being the best |
| Control Group | Image Quality and Reproducibility of Desired Images | Participant 2 Image | 8 Quality Scale of 1-10, 10 being the best |
| Control Group | Image Quality and Reproducibility of Desired Images | Participant 3 Image | NA Quality Scale of 1-10, 10 being the best |
| Control Group | Image Quality and Reproducibility of Desired Images | Participant 4 Image | 7 Quality Scale of 1-10, 10 being the best |
Secondary
Operative Time
Time frame: intraoperatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Digital Image Enhancement (DIE) Group | Operative Time | Participant 1 | 51 minutes |
| Digital Image Enhancement (DIE) Group | Operative Time | Participant 2 | NA minutes |
| Digital Image Enhancement (DIE) Group | Operative Time | Participant 3 | 79 minutes |
| Digital Image Enhancement (DIE) Group | Operative Time | Participant 4 | NA minutes |
| Digital Image Enhancement (DIE) Group | Operative Time | Participant 5 | NA minutes |
| Control Group | Operative Time | Participant 5 | 125 minutes |
| Control Group | Operative Time | Participant 4 | 80 minutes |
| Control Group | Operative Time | Participant 2 | 103 minutes |
| Control Group | Operative Time | Participant 1 | NA minutes |
| Control Group | Operative Time | Participant 3 | NA minutes |