NCT05131672 Cast or Operation for Medial Epicondyle Fracture Treatment in Children
| NCT ID | NCT05131672 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago |
| Condition | Fracture Elbow |
| Study Type | INTERVENTIONAL |
| Enrollment | 334 participants |
| Start Date | 2022-10-28 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 334 participants in total. It began in 2022-10-28 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: 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.
Contact & Investigator
Joseph Janicki, MD
PRINCIPAL INVESTIGATOR
Ann and Robert H. Lurie Hospital Chicago
Frequently Asked Questions
Who can join the NCT05131672 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 17 Years, studying Fracture Elbow. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05131672 currently recruiting?
Yes, NCT05131672 is actively recruiting participants. Contact the research team at jburgess@luriechildrens.org for enrollment information.
Where is the NCT05131672 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05131672 clinical trial?
NCT05131672 is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. The principal investigator is Joseph Janicki, MD at Ann and Robert H. Lurie Hospital Chicago. The trial plans to enroll 334 participants.