Distal Radius Interventions for Fracture Treatment

Description

This protocol describes a multicenter, prospective randomized superiority trial comparing functional outcomes between children treated with sedated reduction versus no formal reduction.

Conditions

Fracture Distal Radius

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Study Overview

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Study Details

Study overview

This protocol describes a multicenter, prospective randomized superiority trial comparing functional outcomes between children treated with sedated reduction versus no formal reduction.

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

Distal Radius Interventions for Fracture Treatment

Condition
Fracture Distal Radius
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Indianapolis

Riley Children's, Indianapolis, Indiana, United States, 46202

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Saint Paul

Gillette Children's Specialty Healthcare, Saint Paul, Minnesota, United States, 55101

Bronx

Montefiore Medical Center, Bronx, New York, United States, 10467

Chapel Hill

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Cleveland

University Hospitals Rainbow Babies & Children, Cleveland, Ohio, United States, 44106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • 1. Physeal involvement of fracture
  • 2. Presence of open fracture, pathologic fracture, neuromuscular disease, or metabolic disease
  • 3. Fracture cannot be treated with acute reduction due to being older than 10 days
  • 4. 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.

Ages Eligible for Study

4 Years to 10 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ann & Robert H Lurie Children's Hospital of Chicago,

Jospeh Janicki, MD, PRINCIPAL_INVESTIGATOR, Ann and Robert H. Lurie Children's Hospital of Chicago

Study Record Dates

2028-08-31