BUCKLED
Trial question
Is ultrasonography noninferior to radiography as initial diagnostic imaging method in children and adolescents with distal forearm injury?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
47.0% female
53.0% male
N = 270
270 patients (126 female, 144 male).
Inclusion criteria: patients 5-15 years of age who presented to the emergency department with an isolated distal forearm injury, without a clinically visible deformity, in whom further evaluation with imaging was indicated.
Key exclusion criteria: injury sustained for > 48 hours at time of emergency department presentation; known metabolic bone disease; suspicion of non-accidental injury; congenital bone malformation; compound fracture.
Interventions
N=135 ultrasonography (point-of-care ultrasonography performed by emergency department healthcare practitioner).
N=135 radiography (biplanar imaging performed by a radiographer and later reported by a radiologist).
Primary outcome
Pediatric Upper Extremity Short Patient-Reported Outcomes Measurement Information System score at 4 weeks
36.4 points
36.3 points
36.4 points
27.3 points
18.2 points
9.1 points
0.0 points
Ultrasonography
Radiography
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in PROMIS System score at 4 weeks (36.4 points vs. 36.3 points; MD 0.1, 95% CI -1.3 to 1.4).
Secondary outcomes
No significant difference in PROMIS System score at 1 week (28.4 points vs. 27.7 points; MD 0.7, 95% CI -1.4 to 2.8).
No significant difference in PROMIS System score at 8 weeks (39.2 points vs. 39.1 points; MD 0.1, 95% CI -0.5 to 0.7).
No significant difference in patient-reported satisfaction at week 4 (1.57 vs. 1.72; MD -0.15, 95% CI -0.36 to 0.06).
Safety outcomes
No significant difference in adverse events or unplanned returns to the emergency department.
Conclusion
In patients 5-15 years of age who presented to the emergency department with an isolated distal forearm injury, without a clinically visible deformity, in whom further evaluation with imaging was indicated, ultrasonography was noninferior to radiography with respect to PROMIS System score at 4 weeks.
Reference
Peter J Snelling, Philip Jones, David Bade et al. Ultrasonography or Radiography for Suspected Pediatric Distal Forearm Fractures. N Engl J Med. 2023 Jun 1;388(22):2049-2057.
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