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Randomized Controlled Trial Multicenter Study
Ultrasonography or Radiography for Suspected Pediatric Distal Forearm Fractures.
- Peter J Snelling, Philip Jones, David Bade, Randy Bindra, Joshua Byrnes, Michelle Davison, Shane George, Mark Moore, Gerben Keijzers, Robert S Ware, and BUCKLED Trial Group.
- From the School of Medicine and Dentistry and Menzies Health Institute Queensland (P.J.S., P.J., R.B., M.D., S.G., G.K., R.S.W.) and the Centre for Applied Health Economics, School of Medicine and Dentistry (J.B.), Griffith University, the Departments of Emergency Medicine (P.J.S., S.G., G.K.) and Orthopaedics (R.B.) and the Children's Critical Care Unit (S.G.), Gold Coast University Hospital, and the Sonography Innovation and Research (Sonar) Group (P.J.S.), Southport, the Child Health Research Centre, University of Queensland, Brisbane (P.J.S., S.G.), the Departments of Orthopaedics (D.B.) and Emergency Medicine (M.M.), Queensland Children's Hospital, South Brisbane, the Department of Emergency Medicine, Sunshine Coast University Hospital, Birtinya (M.D.), and the Faculty of Health Sciences and Medicine, Bond University, Gold Coast (G.K.) - all in Queensland, Australia.
- N. Engl. J. Med. 2023 Jun 1; 388 (22): 204920572049-2057.
BackgroundData 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.MethodsIn 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.ResultsA 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.ConclusionsIn 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).Copyright © 2023 Massachusetts Medical Society.
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