Distal Radius Fractures
Conditions
Keywords
Diagnostic ultrasound
Brief 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.
Interventions
DEVICEDiagnostic Ultrasound
RADIATIONX-ray imaging
Sponsors
The Hawkins Foundation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | Diagnostic Ultrasound and Radiographic Imaging |
|---|---|
| Age, Categorical <=18 years | 51 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
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.
Time frame: Duration of office visit
Population: Each of the 51 participants received both an ultrasound and a x-ray.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Diagnostic Ultrasound and Radiographic Imaging | Presence of Fracture | Ultrasound | Fracture YES | 35 Participants |
| Diagnostic Ultrasound and Radiographic Imaging | Presence of Fracture | Ultrasound | Fracture No | 16 Participants |
| Diagnostic Ultrasound and Radiographic Imaging | Presence of Fracture | X Ray | Fracture YES | 34 Participants |
| Diagnostic Ultrasound and Radiographic Imaging | Presence of Fracture | X Ray | Fracture No | 17 Participants |