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Closed due to slow enrollment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Image Enhancement (DIE) Group | Experimental | A novel digital image enhancement technology will be used intraoperatively |
|
| Control Group | No Intervention | Standard intraoperative imaging will be used intraoperatively |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIE | Device | digital image enhancement |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | intraoperatively |
| Operative Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Digital Image Enhancement (DIE) Group | A novel digital image enhancement technology will be used intraoperatively DIE: digital image enhancement |
| FG001 | Control Group | Standard intraoperative imaging will be used intraoperatively |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Hip fracture patients only, not surgeons
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| ID | Title | Description |
|---|---|---|
| BG000 | Digital Image Enhancement (DIE) Group | A novel digital image enhancement technology will be used intraoperatively DIE: digital image enhancement |
| BG001 | Control Group | Standard intraoperative imaging will be used intraoperatively |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Posted | Number | mGy | intraoperatively |
|
|
During surgery and post-operative time of hospital admission, approximately 2 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Digital Image Enhancement (DIE) Group | A novel digital image enhancement technology will be used intraoperatively DIE: digital image enhancement |
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Only two radiation dosimeters were purchased. Therefore, there is no radiation exposure data for the secondary surgeon.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rachel Reilly | Duke University Health Systems | 919-668-0291 | rachel.reilly@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2016 | Sep 12, 2019 | Prot_SAP_000.pdf |
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| intraoperatively |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
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| Primary | Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Posted | Number | mrem | intraoperatively |
|
|
|
| Primary | Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge | Posted | Number | mrem | intraoperatively |
|
|
|
| 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. | Posted | Number | Quality Scale of 1-10, 10 being the best | intraoperatively |
|
|
|
| Secondary | Operative Time | Posted | Number | minutes | intraoperatively |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Control Group | Standard intraoperative imaging will be used intraoperatively | 0 | 3 | 0 | 3 | 0 | 3 |
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| Primary Surgeon 3 |
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| Primary Surgeon 4 |
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| Primary Surgeon 5 |
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| Surgical Technician 3 |
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| Surgical Technician 4 |
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| Surgical Technician 5 |
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| Participant 3 Image |
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| Participant 4 Image |
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| Participant 5 Image |
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| Participant 3 |
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| Participant 4 |
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| Participant 5 |
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