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Distal Radius Interventions for Fracture Treatment
Recruiting
Reduction and Nonreduction Treatment of Displaced Pediatric Distal Radius Fractures (Peds-DRIFT Trial - Distal Radius Interventions for Fracture Treatment)
Who can join
Ages 4 to 10 · All sexes
Full eligibility criteria
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 room (OR) or reduced in the emergency department (ED) Exclusion Criteria: 1. Physeal involvement of fracture 2. Presence of open fracture, pathologic fracture, neuromuscular disease, or metabolic disease 3. Fractures other than the ulna near the same level in the ipsilateral arm 4. Fracture cannot be treated with acute reduction due to being older than 10 days 5. Patient and parents are unable to adhere to procedures or complete follow-up due to insufficient comprehension of consent form or surveys or developmental delay
About the study
This protocol describes a multicenter, prospective randomized superiority trial with a patient preference cohort comparing functional outcomes between children treated with sedated reduction versus no formal reduction.
What is being tested
- Reduction (procedure)
- Immobilization (procedure)
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Participants: 334 · Started: Apr 9, 2023
Contact the study team
- Jamie Burgess, PhD · Phone: 312-227-6531
- Michelle Adzido, MA · Phone: 312-227-2492
Official record on ClinicalTrials.gov — NCT05131685
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.