Comparing treatments for children's wrist fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective randomized trial aims to compare the functional outcomes of children aged 4-10 years with dorsally displaced distal radius fractures treated with sedated reduction versus those who receive no formal reduction. The study seeks to address the lack of established guidelines for managing these common pediatric fractures by evaluating the effectiveness of immobilization alone compared to reduction. Participants will be monitored for their adherence to treatment and follow-up procedures to ensure accurate assessment of outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Phoenix Children's Hospital
  Phoenix, Arizona, United States Recruiting
• Children's Hospital of Los Angeles
  Los Angeles, California, United States Recruiting
• University of California- Los Angeles Medical Center
  Los Angeles, California, United States Recruiting
• Nemours Children's Hospital
  Wilmington, Delaware, United States Recruiting
• Niklaus Children's Hospital
  Miami, Florida, United States Recruiting
• Riley Children's Hospital
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Joseph Janicki, MD — Ann & Robert H Lurie Children's Hospital of Chicago
• Study coordinator: Jamie Burgess, PhD
• Email: jburgess@luriechildrens.org
• Phone: 312-227-6531

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.