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

Qualifiers

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

Treatments tested in this trial

open reduction and internal fixation (ORIF)
cast immobilization

Treatment groups

334 Participants

are divided into 2 treatment groups

Sponsors and collaborators

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