NEJM Trial Shows Point-of-Care Ultrasound Is Non-Inferior to Radiography for Paediatric Forearm Fractures
The BUCKLED multicentre RCT randomised 270 children with suspected distal forearm fractures to point-of-care ultrasonography or radiography. Arm function at 4 weeks was non-inferior with ultrasound (mean PROMIS score difference 0.1 points), no clinically important fractures were missed, and adverse event rates were equivalent. The results support ultrasound as a radiation-free first-line imaging option in paediatric emergency departments.
The original study
Ultrasonography or Radiography for Suspected Pediatric Distal Forearm Fractures.
- Authors
- Snelling PJ, Jones P, Bade D, Bindra R, Byrnes J, Davison M, et al.
- Journal
- The New England journal of medicine
- Type
- Equivalence Trial, Journal Article, Multicenter Study, Randomized Controlled Trial
- PMID
- 37256975
Original abstract
BACKGROUND: Data on whether ultrasonography for the initial diagnostic imaging of forearm fractures in children and adolescents is noninferior to radiography for subsequent physical function of the arm are limited. METHODS: In this open-label, multicenter, noninferiority, randomized trial in Australia, we recruited participants 5 to 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. Participants were randomly assigned to initially undergo point-of-care ultrasonography or radiography, and were then followed for 8 weeks. The primary outcome was physical function of the affected arm at 4 weeks as assessed with the use of the validated Pediatric Upper Extremity Short Patient-Reported Outcomes Measurement Information System (PROMIS) score (range, 8 to 40, with higher scores indicating better function); the noninferiority margin was 5 points. RESULTS: A total of 270 participants were enrolled, with outcomes for 262 participants (97%) available at 4 weeks (with a window of ±3 days) as prespecified. PROMIS scores at 4 weeks in the ultrasonography group were noninferior to those in the radiography group (mean, 36.4 and 36.3 points, respectively; mean difference, 0.1 point; 95% confidence interval [CI], -1.3 to 1.4). Intention-to-treat analyses (in 266 participants with primary outcome data recorded at any time) produced similar results (mean difference, 0.1 point; 95% CI, -1.3 to 1.4). No clinically important fractures were missed, and there were no between-group differences in the occurrence of adverse events. CONCLUSIONS: In children and adolescents with a distal forearm injury, the use of ultrasonography as the initial diagnostic imaging method was noninferior to radiography with regard to the outcome of physical function of the arm at 4 weeks. (Funded by the Emergency Medicine Foundation and others; BUCKLED Australian New Zealand Clinical Trials Registry number, ACTRN12620000637943).