Distal Radius Interventions for Fracture Treatment (DRIFT) trial: study protocol for a multicentre randomised clinical trial of completely translated distal radius fractures at paediatric hospitals in North America

作者：Lauren C. Balmert, Joseph A. Janicki, Andrew G. Georgiadis, Walter H. Truong, Dorothy H. Beauvais, Mohan V. Belthur, Erika Daley, Jeanne M. Franzone, Andrew Howard, Collin May, Frank W. Rockhold, Jacob F. Schulz, Mary Bailey, Karen Chiswell, Jesse DeLaRosa, Jaysson T. Brooks, Anthony A Cantanzano, Andrea Chan, Alice Chu, Emily R. Dodwell, Ron El‐Hawary, Henry Ellis, Ryan Fitzgerald, Steven L. Frick, Theodore J. Ganley, Dominic Gargiulo, Luke Gauthier, Corey S. Gill, Rachel Y. Goldstein, Matthew F. Halsey, Christina K. Hardesty, Christine A. Ho, Neil Kaushal, J. Todd R. Lawrence, R. Jay Lee, Khristinn Kellie Leitch, Karim Masrouha, Stuart L. Mitchell, Natasha O’Malley, Monica Lizano, Daniel C. Perry, Wendy Ramalingam, Jason Rhodes, Julia S. Sanders, Apurva S. Shah, Melinda S. Sharkey, Mauricio Silva, Selina Silva, R.C. Thompson, John S. Vorhies, James G. Wright, Candace Young, Jamie Burgess · 发表于：BMJ Open · 年份：2025 · DOI：10.1136/bmjopen-2024-088273 · 被引用次数：3 · 研究领域：Orthopedic Surgery and Rehabilitation、Foot and Ankle Surgery、Elbow and Forearm Trauma Treatment

INTRODUCTION: Distal radius fractures are the most common fractures seen in the emergency department in children in the USA. However, no established or standardised guidelines exist for the optimal management of completely displaced fractures in younger children. The proposed multicentre randomised trial will compare functional outcomes between children treated with fracture reduction under sedation versus children treated with simple immobilisation. METHODS AND ANALYSIS: Participants aged 4-10 years presenting to the emergency department with 100% dorsally translated metaphyseal fractures of the radius less than 5 cm from the distal radial physis will be recruited for the study. Those patients with open fractures, other ipsilateral arm fractures (excluding ulna), pathologic fractures, bone diseases, or neuromuscular or metabolic conditions will be excluded. Participants who agree to enrol in the trial will be randomly assigned via a minimal sufficient balance algorithm to either sedated reduction or in situ immobilisation. A sample size of 167 participants per arm will provide at least 90% power to detect a difference in the primary outcome of Patient-Reported Outcomes Measurement Information System Upper Extremity computer adaptive test scores of 4 points at 1 year from treatment. Primary analyses will employ a linear mixed model to estimate the treatment effect at 1 year. Secondary outcomes include additional measures of perceived pain, complications, radiographic angulati...