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Cast or Operation for Medial Epicondyle Fracture Treatment in Children

NCT05131672 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2026-07-01

No results posted yet for this study

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

Interventions

PROCEDURE

cast immobilization

immobilization in a cast without reduction

PROCEDURE

open reduction and internal fixation (ORIF)

open reduction and internal fixation with pin or screw fixation

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Joseph Janicki

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-28
Primary Completion
2030-12-31
Completion
2031-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05131672 on ClinicalTrials.gov