Distal Radius Interventions for Fracture Treatment
ConditionFracture Distal Radius
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-10
SponsorAnn & Robert H Lurie Children's Hospital of Chicago
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Reduction
- Immobilization
Treatment groups
334 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov