Reduction and Nonreduction Treatment of Displaced Pediatric Distal Radius Fractures (Peds-DRIFT Trial - Distal Radius Interventions for Fracture Treatment)

INTRODUCTION

Distal radius fractures (DRFs) make up 20-25% of all pediatric fractures (Brudvik 2003, Cooper 2004), and are the most common fractures seen in the emergency department in children in the United States. (Naranje 2016)

The available evidence on distal radius fracture (DRF) reduction/non-reduction is based on case series, observational comparisons, and expert opinions. Displaced metaphyseal distal radius fracture (DRFs) have historically been treated with attempts at closed reduction (under conscious sedation or anesthesia). This approach was supported by retrospective studies and consensus opinion that anatomical alignment was necessary for normal function.(Rockwood 2010 text, Bae 2012 JPO) Furthermore, it is unsettling for physicians and families to see bones overlapped on a radiograph when a straightening procedure can be completed in a straightforward fashion. However, simple immobilization without attempted reduction has recently been reported for management of DRFs in children under age 10.(Crawford 2012) This approach is conceptually supported by the fracture's proximity to the distal radial physis and the remaining growth of the child, which provides significant remodeling potential and can allow for improvement of malalignment as the child grows.(Crawford 2010 JBJSAm, Price 1990 JPO) There is a paucity of literature comparing reduced to non-reduced fractures to guide management. No established or standardized guidelines exist for the optimal management of completely displaced fractures. Surveys have identified widely discrepant recommendations and high practice variation for treatments for identical DRF patterns.(Georgiadis 2019 POSNA or JPO 2020) Although these studies provide preliminary data to support clinical management, the studies lack a control population for comparison, are retrospective, lack randomization, have variable follow-up times and have no standard definitions of outcomes. In addition, the studies used radiographic or non-validated outcome measures to make conclusions, limiting their utility in identifying optimal management.

It appears that children may be undergoing unnecessary procedures, sedations, and anesthetics. The use of anesthesia and sedation has recently come into question as studies examine their effects on cognitive development. (Loepke 2013, Flick 2011) There could be a significant cost savings in terms of procedure costs, hospital costs, and lost time from work if non-procedure management is found to be a non-inferior treatment regimen. The physician investigators want to tell patients that they know why they are proposing treatments, the risks and benefits of the treatment, and use evidence to inform these recommendations and the family's decisions. The proposed trial will compare the effectiveness of alignment under sedation/anesthesia with simple immobilization for management of displaced DRFs in children, providing critical data regarding optimal management of this common fracture. Therefore, this study's primary question is: does anatomic reduction under sedation/anesthesia of DRF result in improved patient outcomes at six months compared to immobilization without attempted reduction?

Multiple reasons exist for comparing these treatment strategies for DRF, including: 1) these are the most common treatments for DRF, 2) the strategies are widely divergent (operative vs. non-operative), and 3) there is a large potential to change clinical practice.