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New treatment option for Fracture Distal Radius
Official title Distal Radius Interventions for Fracture Treatment
ClinicalTrials.gov ID: NCT05131685
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 10
You may be able to join 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
You likely can't join 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...
See the full eligibility criteria
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Wilmington, Delaware, United States
- Miami, Florida, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Saint Paul, Minnesota, United States
- Jackson, Mississippi, United States
- New Brunswick, New Jersey, United States
- Albuquerque, New Mexico, United States
- New York, New York, United States
- Rochester, New York, United States
- The Bronx, New York, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 10 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; Wilmington, Delaware, United States; Miami, Florida, United States; Indianapolis, Indiana, United States; Baltimore, Maryland, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.