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All trials for Distal Radius Fractures All trials of Diagnostic Ultrasound All trials of X-ray imaging
-Summary
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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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Diagnostic ultrasound and radiographic imaging | | Device: Diagnostic Ultrasound; Radiation: X-ray 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. |
- Diagnostic Ultrasound (Device), also known as Sonosite Ultrasound
- X-ray imaging (Radiation)
+Outcome measures
Primary outcomes
- Presence of Fracture [Duration of office visit]: 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.
+Eligibility
Sex: All, ages: 2 Years to 15 Years
Inclusion Criteria:
* Pediatric patient with a wrist injury.
Exclusion Criteria:
* Gross deformity of the injured body part, suspected open fractures and the need for emergent surgery
+Posted results
Participant flow
| Milestone | Diagnostic Ultrasound and Radiographic Imaging |
|---|
| Started | 51 |
| Completed | 51 |
| Not completed | 0 |
Outcome results
- Presence of Fracture (Primary), Count of participants, Participants: Diagnostic Ultrasound and Radiographic Imaging 35
Adverse events
Time frame: N/A (No follow-up)
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Diagnostic Ultrasound and Radiographic Imaging | 0 | 0/51 (0.0%) | 0/51 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
|---|
| Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System | Greenville, South Carolina | United States | |
+Investigators
- Kyle Cassas, MD, Principal investigator, Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System