Recruiting

Observational Study

Sponsor:

Joseph Janicki

Code:

NCT05131672

Conditions

Fracture Elbow

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

open reduction and internal fixation (ORIF)

cast immobilization

Study Details

Brief summary:

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.

Conditions

Fracture Elbow

Study ID

NCT05131672

Start date

Oct 28, 2022

Status verified date

Jun, 2026

Completion date

Jul 31, 2031

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

334 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Operative reduction w/ fixation

open reduction and internal fixation (ORIF)

active comparator: Non-operative immobilization

immobilization in a cast without reduction

Interventions

open reduction and internal fixation (ORIF)

open reduction and internal fixation with pin or screw fixation

cast immobilization

immobilization in a cast without reduction

Primary outcome measure

  • pediatric upper extremity function PROMIS computer adaptive test (PROMIS UE CAT) [ Time Frame: 1 year follow-up ]

Central Contacts and Locations

Central contacts

Jamie Burgess, PhD

312-227-6531jburgess@luriechildrens.org

Michelle Adzido, MA

312-227-2492madzido@luriechildrens.org

Locations

Lurie Children's Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Jamie Burgess, PhD

jburgess@luriechildrens.org

Michelle Adzido

madzido@luriechildrens.org

Principal Investigator:

Joseph Janicki, MD

More Information

Sponsor

Joseph Janicki

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Joseph Janicki on 2026-07-01.