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The purpose of the study is to evaluate the sensitivity and specificity of using a diagnostic musculoskeletal ultrasound in pediatric distal radius fractures in an outpatient setting. Ultrasound reliability and accuracy will be tested. The result of the diagnostic ultrasound will be compared to x-ray diagnosis under routine conditions in the investigator's injury and fracture treatment evening clinic. Data will be collected and recorded during the duration of the 12 week study. Through the literature review and experience with ultrasound, the investigators anticipate that diagnostic ultrasound will provide very high sensitivity and specificity in diagnosing distal radius fractures in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic ultrasound and radiographic imaging | - The diagnostic musculoskeletal ultrasound and x-rays will both be used to image bones in perpendicular and orthogonal planes over the distal radius visualizing the physis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Ultrasound | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Fracture | Diagnostic ultrasound will be used to determine if the bones do or do not have a fracture. Fractures will be based on the presence or absence of cortical disruption or irregularity on the ultrasound. | Duration of office visit |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients with wrist injury
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Cassas, MD | Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System | Greenville | South Carolina | 29615 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic Ultrasound and Radiographic Imaging | The diagnostic musculoskeletal ultrasound and x-ray will both be used to image bones in perpendicular and orthogonal planes over the distal radius visualizing the physis. Diagnostic Ultrasound |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic Ultrasound and Radiographic Imaging | The diagnostic musculoskeletal ultrasound and x-ray will both be used to image bones in perpendicular and orthogonal planes over the distal radius visualizing the physis. |
| 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 | Presence of Fracture | Diagnostic ultrasound will be used to determine if the bones do or do not have a fracture. Fractures will be based on the presence or absence of cortical disruption or irregularity on the ultrasound. | Each of the 51 participants received both an ultrasound and a x-ray. | Posted | Count of Participants | Participants | Duration of office visit |
|
|
N/A (No follow-up)
All patients were monitored during their participation in the data collection process for adverse event occurrences.
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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 | Diagnostic Ultrasound and Radiographic Imaging | The diagnostic musculoskeletal ultrasound and x-ray will both be used to image bones in perpendicular and orthogonal planes over the distal radius visualizing the physis. Diagnostic Ultrasound |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kyle Cassas | Steadman Hawkins Clinic of the Carolinas/Greenville Health System | 864-454-7422 | kcassas@ghs.org |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D060733 | Electromagnetic Radiation |
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| X-ray imaging |
| Radiation |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 51 |
| 0 |
| 51 |
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| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |