N/A N=51

Pediatric Distal Radius US Study

Distal Radius Fractures

Bottom Line

View on ClinicalTrials.gov: NCT01937624 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcome: Primary: Presence of Fracture — 35; 16; 34; 17 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Diagnostic Ultrasound (Device); X-ray imaging (Radiation)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: The Hawkins Foundation
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Presence of Fracture	35; 16; 34; 17	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01937624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.