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โ† Trials
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Distal Radius Interventions for Fracture Treatment

RecruitingNAAges 4 Years - 10 YearsAllAnn & Robert H Lurie Children's Hospital of Chicaโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Reduction
  • Immobilization
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Where

24 sites
Phoenix Children's Hospital
Phoenix, United States
Children's Hospital of Los Angeles
Los Angeles, United States
University of California- Los Angeles Medical Center
Los Angeles, United States
Nemours Children's Hospital
Wilmington, United States
Niklaus Children's Hospital
Miami, United States
Riley Children's Hospital
Indianapolis, United States
Riley Children's
Indianapolis, United States
Johns Hopkins Hospital
Baltimore, United States

โ€ฆand 16 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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