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| Name | Class |
|---|---|
| North Carolina Translational and Clinical Sciences Institute | OTHER |
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Trauma to the extremities such wrist, ankle, limb is very common and affects all population groups. It constitutes a significant public health issue. Standard radiography remains the basic imaging tool. However, as a 2-dimensional (2D) imaging modality it lacks sensitivity and specificity. Misdiagnosis rates are known to be high, especially for non-displaced fractures of the scaphoid and talus as well as erosions due to rheumatoid arthritis. Misdiagnosis leads to over treatment and unnecessary loss of productivity and quality of life including 6-12 weeks in a cast. Missed fractures can result in a chronic, non-healing fracture that may require surgical fixation and early arthritis of the joint. From a physician perspective, a missed diagnosis can result in a lawsuit and an expensive settlement/penalty.
Computed tomography (CT) offers high resolution and excellent visualization of bone and joint morphology, and Magnetic Resonance Imaging (MRI) delivers soft tissue and cartilage visibility. However, cost, space and workflow related issues make them prohibitive for small orthopedic clinics. Although the radiation dose of a CT scan has been reduced considerably in recent years, it is still significantly higher than a regular radiograph. The whole-body scanners also have difficulties in imaging patients in portable and weight-bearing conditions. Dedicated extremity CT scanners have been commercialized recently in an attempt to address the current deficiency. They still suffer from higher cost and at such have a limited installation base.
The aim of this one-year study is to demonstrate Tomo-E's clinical utility for diagnosis of wrist fractures. Tomo-E is a compact and stationary device that utilizes a distributed carbon nanotube (CNT) x-ray source array that will be specially designed for extremity imaging to collect all the projection views without any mechanical motion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Experimental | Participants that have undergone standard of care, conventional 2D radiographic imaging of wrist for presumed or known scaphoid, wrist or distal radius fractures will receive the Tomo-E scans within two weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tomo-E scan | Device | High-resolution limited-angle tomography positioning and examination will vary depending on injury. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | The sensitivity of Tomo-E is defined as the ability of readers (radiologists) to detect wrist fractures in patients. Diagnostic accuracy will be defined by the presence of a fracture as clinically determined by the attending orthopedic surgeon. All Tomo-E scans will be reviewed in a standardized reader study at the conclusion of all study imaging to determine the overall sensitivity of the device. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity | The specificity of Tomo-E is defined as the ability to distinguish between individuals that do not have a wrist fracture. Diagnostic accuracy will be defined by the presence of a fracture as defined clinically by the attending orthopedic surgeon. All Tomo-E scans will be reviewed in a standardized reader study at the conclusion of all study imaging to determine the overall specificity of the device. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Nissman, MD, MPH | UNC Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
Identified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
9 to 36 months following publication
The investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants that have undergone standard of care, conventional 2D radiographic imaging of wrist for presumed or known scaphoid, wrist or distal radius fractures will receive the Tomo-E scans within two weeks. Tomo-E scan: High-resolution limited-angle tomography positioning and examination will vary depending on injury. Radiograph: Standard of Care radiographic imaging of wrist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants that have undergone standard of care, conventional 2D radiographic imaging of wrist for presumed or known scaphoid, wrist or distal radius fractures will receive the Tomo-E scans within two weeks. Tomo-E scan: High-resolution limited-angle tomography positioning and examination will vary depending on injury. Radiograph: Standard of Care radiographic imaging of wrist. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Sensitivity | The sensitivity of Tomo-E is defined as the ability of readers (radiologists) to detect wrist fractures in patients. Diagnostic accuracy will be defined by the presence of a fracture as clinically determined by the attending orthopedic surgeon. All Tomo-E scans will be reviewed in a standardized reader study at the conclusion of all study imaging to determine the overall sensitivity of the device. | Posted | Number | percent of scans with a fracture | 8 months |
|
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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 | All Participants | Participants that have undergone standard of care, conventional 2D radiographic imaging of wrist for presumed or known scaphoid, wrist or distal radius fractures will receive the Tomo-E scans within two weeks. Tomo-E scan: High-resolution limited-angle tomography positioning and examination will vary depending on injury. Radiograph: Standard of Care radiographic imaging of wrist. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Operations, Department of Radiology | University of North Carolina at Chapel Hill | 919-966-4997 | rad_research@med.unc.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 | Nov 18, 2020 | Apr 26, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 26, 2021 | Feb 1, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
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| ID | Term |
|---|---|
| D008327 | Mammography |
| D003952 | Diagnostic Imaging |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Radiograph | Device | Standard of Care radiographic imaging of wrist. |
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| 8 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Specificity | The specificity of Tomo-E is defined as the ability to distinguish between individuals that do not have a wrist fracture. Diagnostic accuracy will be defined by the presence of a fracture as defined clinically by the attending orthopedic surgeon. All Tomo-E scans will be reviewed in a standardized reader study at the conclusion of all study imaging to determine the overall specificity of the device. | Posted | Number | percentage of scans without a fracture | 8 months |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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