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RECRUITING
NCT05131672
NA

Cast or Operation for Medial Epicondyle Fracture Treatment in Children

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

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

7 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

334

Start Date

2022-10-28

Completion Date

2028-08-31

Last Updated

2024-08-30

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

open reduction and internal fixation (ORIF)

open reduction and internal fixation with pin or screw fixation

PROCEDURE

cast immobilization

immobilization in a cast without reduction

Locations (1)

Lurie Children's Hospital

Chicago, Illinois, United States