Cast or Operation for Medial Epicondyle Fracture Treatment in Children

Description

This protocol describes a multicenter, prospective randomized superiority trial of medial epicondyle fracture treatments comparing functional outcomes between children treated with operative reduction and fixation or non-operative immobilization.

Conditions

Fracture Elbow

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Study Overview

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Study Details

Study overview

This protocol describes a multicenter, prospective randomized superiority trial of medial epicondyle fracture treatments comparing functional outcomes between children treated with operative reduction and fixation or non-operative immobilization.

Operative Versus Nonoperative Treatment of Pediatric Medial Epicondyle Fractures (COMET Trial - Cast or Operation for Medial Epicondyle Fracture Treatment in Children)

Cast or Operation for Medial Epicondyle Fracture Treatment in Children

Condition
Fracture Elbow
Intervention / Treatment

-

Contacts and Locations

Chicago

Lurie Children's Hospital, Chicago, Illinois, United States, 60611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Provision of signed and dated informed consent form by parent or legal guardian and signed assent form if participant is older than 12 years.
  • 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  • 3. Male or female, aged 7-17 years inclusive
  • 4. Diagnosis of medial epicondyle fracture with any amount of displacement
  • 5. Fracture is acute (occurred within 10 days of assignment of treatment arm)
  • 6. Ability to take oral medication and be willing to adhere to the immobilization regimen
  • 1. Medial epicondyle fragment that is incarcerated within joint
  • 2. Presence of other fractures about the ipsilateral elbow
  • 3. Presence of pathologic fracture, open fracture
  • 4. Have metabolic or neuromuscular diagnosis
  • 5. 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.

Ages Eligible for Study

7 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ann & Robert H Lurie Children's Hospital of Chicago,

Joseph Janicki, MD, PRINCIPAL_INVESTIGATOR, Ann and Robert H. Lurie Hospital Chicago

Study Record Dates

2028-08-31