Cast or Operation for Medial Epicondyle Fracture Treatment in Children

Recruiting now · Not applicable

Conditions studied: Fracture Elbow

In brief

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.

Key facts

Study ID

NCT05131672

Run by

Joseph Janicki

People needed

334

Starts

2022-10-28

Expected to finish

2031-07-31

Last updated by the study team

2026-07-01

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Fracture is acute (occurred within 10 days of assignment of treatment arm)
• Ability to take oral medication and be willing to adhere to the immobilization regimen

You may not qualify if…

• 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
• 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.

Where it is running

• Lurie Children's Hospital — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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