Cast or Operation for Medial Epicondyle Fracture Treatment in Children
ConditionFracture Elbow
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-17
SponsorJoseph Janicki
About this trial
This protocol describes a multicenter, prospective randomized and patient preference cohort superiority trial of medial epicondyle fracture treatments comparing functional outcomes between children treated with operative reduction and fixation or non-operative immobilization.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form by parent or legal guardian and signed assent form if participant is older than 12 years.
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 7-17 years inclusive
Diagnosis of medial epicondyle fracture with any amount of displacement
Disqualifiers
Medial epicondyle fragment that is incarcerated within joint
Presence of other fractures about the ipsilateral elbow
Presence of pathologic fracture, open fracture
Have metabolic or neuromuscular diagnosis
Trial design
Design model
Parallel
Treatments tested in this trial
open reduction and internal fixation (ORIF)
Procedure/Surgeryopen reduction and internal fixation with pin or screw fixation
cast immobilization
Procedure/Surgeryimmobilization in a cast without reduction
Treatment groups
334 Participants
are divided into 2 treatment groupsGroup A: Operative reduction w/ fixationExperimental treatment 1 intervention
Group B: Non-operative immobilizationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
pediatric upper extremity function PROMIS computer adaptive test (PROMIS UE CAT)
functional and patient reported outcomes
Time frame
1 year follow-upSecondary outcomes
1
PROMIS UE Computerized Adaptive Test (CAT)
functional and patient reported outcomes
Time frame
6 weeks and 3, and 6 months2
Disabilities of the Arm, Shoulder and Hand (DASH) S/PA
functional and patient reported outcomes
Time frame
6 weeks and 3, and 6 months3
PROMIS Pain interference
functional and patient reported outcomes
Time frame
6 weeks, 3, 6, and 12 months4
Wong-Baker Faces Pain scores
functional and patient reported outcomes
Time frame
6 weeks, 3, 6, and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Joseph Janicki
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor institution
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov