Comparing treatments for children's wrist fractures
Reduction and Nonreduction Treatment of Displaced Pediatric Distal Radius Fractures (Peds-DRIFT Trial - Distal Radius Interventions for Fracture Treatment)
This study is testing whether treating children's wrist fractures with a special procedure works better than just putting them in a cast to see which method helps them heal and function better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 334 (estimated) |
| Ages | 4 Years to 10 Years |
| Sex | All |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Locations | 26 sites (Phoenix, Arizona and 25 other locations) |
| Trial ID | NCT05131685 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-10 years with a specific type of acute distal radius fracture that is less than 5cm from the growth plate.
Not a fit: Patients with physeal involvement, open fractures, or those unable to adhere to study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence-based guidance on the optimal treatment for distal radius fractures in children, potentially reducing unnecessary procedures.
How similar studies have performed: While there is limited literature directly comparing reduced to non-reduced fractures, recent studies suggest that non-reduction may be a viable option, indicating that this approach is novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion 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. 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.
Where this trial is running
Phoenix, Arizona and 25 other locations
- 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)
- Riley Children's — Indianapolis, Indiana, United States (Recruiting)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- TRIA Health Partners — Minneapolis, Minnesota, United States (Recruiting)
- Gillette Children's Specialty Healthcare — Saint Paul, Minnesota, United States (Recruiting)
- University of Mississippi Medical Center — Jackson, Mississippi, United States (Recruiting)
- University Hospital- Rutgers — New Brunswick, New Jersey, United States (Recruiting)
- University of New Mexico - Carrie Tingley — Albuquerque, New Mexico, United States (Recruiting)
- New York University-Langone Health — New York, New York, United States (Recruiting)
- Hospital of Special Surgery — New York, New York, United States (Recruiting)
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Cincinnati's Children's Hospital — Cincinnati, Ohio, United States (Recruiting)
- University Hospitals Rainbow Babies & Children — Cleveland, Ohio, United States (Recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Texas Scottish Rite Hospital for Children — Dallas, Texas, United States (Recruiting)
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
- The Hospital for Sick Children — Toronto, Canada, Canada (Recruiting)
Study contacts
- Principal investigator: Jospeh Janicki, MD — Ann & Robert H Lurie Children's Hospital of Chicago
- Study coordinator: Jamie Burgess, PhD
- Email: jburgess@luriechildrens.org
- Phone: 312-227-6531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.