An interventional study of DIE in Radiation Exposure, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-15.
Sponsored by Duke University · Not applicable, Interventional, and Other
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.
822 studies on the registry are indexed under Hip Fractures; 160 are open to participants now.
This study's enrollment of 5 is below the median of 90 across 529 interventional studies indexed under Hip Fractures.
Browse Hip Fractures studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A novel digital image enhancement technology will be used intraoperatively
Device: DIE
Standard intraoperative imaging will be used intraoperatively
digital image enhancement
Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Time frame: intraoperatively
Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Time frame: intraoperatively
Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
Time frame: intraoperatively
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
Operative Time
Time frame: intraoperatively
| Milestone | Digital Image Enhancement (DIE) Group | Control Group |
|---|---|---|
| Started | 2 | 3 |
| Completed | 2 | 3 |
| Not completed | 0 | 0 |
| mGy | Digital Image Enhancement (DIE) Group | Control Group |
|---|---|---|
| Participant 1 | 5.12 | NA |
| Participant 2 | NA | 12.9 |
| Participant 3 | 9.79 | NA |
| Participant 4 | NA | 7.93 |
| Participant 5 | NA | 15.41 |
| mrem | Digital Image Enhancement (DIE) Group | Control Group |
|---|---|---|
| Primary Surgeon 1 | 0.7 | NA |
| Primary Surgeon 2 | NA | 1.9 |
| Primary Surgeon 3 | 1.6 | NA |
| Primary Surgeon 4 | NA | 1.2 |
| Primary Surgeon 5 | NA | 3.1 |
| mrem | Digital Image Enhancement (DIE) Group | Control Group |
|---|---|---|
| Surgical Technician 1 | 0.5 | NA |
| Surgical Technician 2 | NA | 1.1 |
| Surgical Technician 3 | 0.9 | NA |
| Surgical Technician 4 | NA | 0.9 |
| Surgical Technician 5 | NA | 0.1 |
Measured by questionnaire related to image quality. Quality scale of 1-10, 1 being poor image quality and 10 being excellent image quality.
| Quality Scale of 1-10, 10 being the best | Image Quality of the Digital Image Enhancement (DIE) Group | Image Quality of the Control Group |
|---|---|---|
| Participant 1 Image | 9 | NA |
| Participant 2 Image | NA | 8 |
| Participant 3 Image | 8 | NA |
| Participant 4 Image | NA | 7 |
| Participant 5 Image | NA | 9 |
| minutes | Digital Image Enhancement (DIE) Group | Control Group |
|---|---|---|
| Participant 1 | 51 | NA |
| Participant 2 | NA | 103 |
| Participant 3 | 79 | NA |
| Participant 4 | NA | 80 |
| Participant 5 | NA | 125 |
Collected over During surgery and post-operative time of hospital admission, approximately 2 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Digital Image Enhancement (DIE) Group | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Control Group | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
Hip fracture patients only, not surgeons
| Age, Categorical(Participants) | Digital Image Enhancement (DIE) Group | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 1 | 1 |
| >=65 years | 2 | 2 | 4 |
| Sex: Female, Male(Participants) | Digital Image Enhancement (DIE) Group | Control Group | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 0 | 1 | 1 |
| Race and Ethnicity Not Collected(Participants) | Digital Image Enhancement (DIE) Group | Control Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Digital Image Enhancement (DIE) Group | Control Group | Total |
|---|---|---|---|
| United States | 2 | 3 | 5 |
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This study is terminated, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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