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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

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Participants: 334 · Started: Apr 9, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05131685

Locations in the U.S.

ArizonaPhoenix Children's Hospital, Phoenix
CaliforniaChildren's Hospital of Los Angeles, Los Angeles
University of California- Los Angeles Medical Center, Los Angeles
DelawareNemours Children's Hospital, Wilmington
FloridaNiklaus Children's Hospital, Miami
IndianaRiley Children's, Indianapolis
Riley Children's Hospital, Indianapolis
MarylandJohns Hopkins Hospital, Baltimore
MassachusettsBoston Children's Hospital, Boston
MinnesotaTRIA Health Partners, Minneapolis
Gillette Children's Specialty Healthcare, Saint Paul
MississippiUniversity of Mississippi Medical Center, Jackson
New JerseyUniversity Hospital- Rutgers, New Brunswick
New MexicoUniversity of New Mexico - Carrie Tingley, Albuquerque
New YorkHospital of Special Surgery, New York
University of Rochester Medical Center, Rochester
Montefiore Medical Center, The Bronx
North CarolinaUniversity of North Carolina at Chapel Hill, Chapel Hill
OhioCincinnati's Children's Hospital, Cincinnati
University Hospitals Rainbow Babies & Children, Cleveland
OregonOregon Health and Science University, Portland
PennsylvaniaChildren's Hospital of Philadelphia, Philadelphia
TexasTexas Scottish Rite Hospital for Children, Dallas
Texas Children's Hospital, Houston

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.