Distal Radius Interventions for Fracture Treatment

Recruiting now · Not applicable

Conditions studied: Fracture Distal Radius

In brief

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.

Key facts

Study ID

NCT05131685

Run by

Ann & Robert H Lurie Children's Hospital of Chicago

People needed

334

Starts

2023-04-09

Expected to finish

2031-07-31

Last updated by the study team

2026-07-01

Who can join

Age: 4 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Physeal involvement of fracture
• Presence of open fracture, pathologic fracture, neuromuscular disease, or metabolic disease
• Fractures other than the ulna near the same level in the ipsilateral arm
• 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

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States (enrolling)
• Children's Hospital of Los Angeles — Los Angeles, California, United States (enrolling)
• University of California- Los Angeles Medical Center — Los Angeles, California, United States (enrolling)
• Nemours Children's Hospital — Wilmington, Delaware, United States (enrolling)
• Niklaus Children's Hospital — Miami, Florida, United States (enrolling)
• Riley Children's Hospital — Indianapolis, Indiana, United States (enrolling)
• Riley Children's — Indianapolis, Indiana, United States (enrolling)
• Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• TRIA Health Partners — Minneapolis, Minnesota, United States (enrolling)
• Gillette Children's Specialty Healthcare — Saint Paul, Minnesota, United States (enrolling)
• University of Mississippi Medical Center — Jackson, Mississippi, United States (enrolling)
• University Hospital- Rutgers — New Brunswick, New Jersey, United States (enrolling)
• University of New Mexico - Carrie Tingley — Albuquerque, New Mexico, United States (enrolling)
• Hospital of Special Surgery — New York, New York, United States (enrolling)
• University of Rochester Medical Center — Rochester, New York, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Cincinnati's Children's Hospital — Cincinnati, Ohio, United States (enrolling)
• University Hospitals Rainbow Babies & Children — Cleveland, Ohio, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Texas Scottish Rite Hospital for Children — Dallas, Texas, United States (enrolling)
• Texas Children's Hospital — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.