RecruitingNot ApplicableNCT05131685
Distal Radius Interventions for Fracture Treatment
Reduction and Nonreduction Treatment of Displaced Pediatric Distal Radius Fractures (Peds-DRIFT Trial - Distal Radius Interventions for Fracture Treatment)
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Enrollment
334 participants
Start Date
Apr 9, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
This protocol describes a multicenter, prospective randomized superiority trial comparing functional outcomes between children treated with sedated reduction versus no formal reduction.
Eligibility
Min Age: 4 YearsMax Age: 10 Years
Inclusion Criteria7
- Provision of signed and dated informed consent form by parent or legal guardian
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 4-10 years
- Diagnosis of 100% dorsally displaced radius metaphyseal fracture with any or no ulna involvement
- Fracture is less than 5cm from the distal radial growth plate
- Willing to adhere to the immobilization regimen
- 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 Criteria4
- Physeal involvement of fracture
- Presence of open fracture, pathologic fracture, neuromuscular disease, or metabolic disease
- Fracture cannot be treated with acute reduction due to being older than 10 days
- 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.
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Interventions
PROCEDUREReduction
closed reduction under conscious sedation followed by casting
PROCEDUREImmobilization
immobilization in cast without reduction
Locations(26)
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NCT05131685