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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Reduction
Procedure/Surgeryclosed reduction under conscious sedation followed by casting
Immobilization
Procedure/Surgeryimmobilization in cast without reduction
Treatment groups
334 Participants
are divided into 2 treatment groupsGroup A: Non-sedated ImmobilizationExperimental treatment 1 intervention
Group B: Formal ReductionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
PROMIS Pediatric CAT V2.0 - Physical Function- Upper Extremity
pediatric upper extremity function PROMIS computer adaptive test (PROMIS UE CAT)
Time frame
1 year follow-upSecondary outcomes
1
PROMIS Pediatric CAT v2.0 - Physical Function- Upper Extremity
functional and patient reported outcomes
Time frame
6 weeks, 3 months, and 6 months2
Disabilities of the Arm, Shoulder and Hand (DASH) S/PA
functional and patient reported outcomes
Time frame
6 weeks, 3 months, 6 months, and 1 year3
PROMIS Pediatric V2.0 - Pain interference
functional and patient reported outcomes
Time frame
6 weeks, 3 months, and 1 year4
Wong-Baker FACES Pain score
functional and patient reported outcomes
Time frame
6 weeks and 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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