RECRUITING

Cast or Operation for Medial Epicondyle Fracture Treatment in Children

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Conditions

Fracture Elbow

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-10-28
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05131672

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.

Ages Eligible for Study:7 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. 3. Male or female, aged 7-17 years inclusive
  4. 4. Diagnosis of medial epicondyle fracture with any amount of displacement
  5. 5. Fracture is acute (occurred within 10 days of assignment of treatment arm)
  6. 6. Ability to take oral medication and be willing to adhere to the immobilization regimen
  1. 1. Medial epicondyle fragment that is incarcerated within joint
  2. 2. Presence of other fractures about the ipsilateral elbow
  3. 3. Presence of pathologic fracture, open fracture
  4. 4. Have metabolic or neuromuscular diagnosis
  5. 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.

Contacts and Locations

Study Contact

Jamie Burgess, PhD
CONTACT
312-227-6531
jburgess@luriechildrens.org
Candace Young, BS
CONTACT
312-227-6427
cayoung@luriechildrens.org

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-28
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2022-10-28
Study Completion Date2028-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Fracture Elbow