Distal Radius Interventions for Fracture Treatment
United States334 participantsStarted 2023-04-09
Plain-language summary
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.
Who can participate
Age range
4 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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)
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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