Reduction and Nonreduction Treatment of Displaced Pediatric Distal Radius Fractures (Peds-DRIFT Trial - Distal Radius Interventions for Fracture Treatment)
Ann & Robert H Lurie Children's Hospital of Chicago
Summary
This protocol describes a multicenter, prospective randomized superiority trial comparing functional outcomes between children treated with sedated reduction versus no formal reduction.
Description
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…
Eligibility
- Age range
- 4–10 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form by parent or legal guardian 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 4-10 years 4. Diagnosis of 100% dorsally displaced radius metaphyseal fracture with any or no ulna involvement 5. Fracture is less than 5cm from the distal radial growth plate 6. Willing to adhere to the immobilization regimen 7. Fracture is acute (occurred less than 10 days prior to consent and assignment of treatment arm AND with ability to be taken to operating…
Interventions
- ProcedureReduction
closed reduction under conscious sedation followed by casting
- ProcedureImmobilization
immobilization in cast without reduction
Locations (26)
- Phoenix Children's HospitalPhoenix, Arizona
- Children's Hospital of Los AngelesLos Angeles, California
- University of California- Los Angeles Medical CenterLos Angeles, California
- Nemours Children's HospitalWilmington, Delaware
- Niklaus Children's HospitalMiami, Florida
- Riley Children's HospitalIndianapolis, Indiana