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Cast or Operation for Medial Epicondyle Fracture Treatment in Children
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
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
open reduction and internal fixation (ORIF)
open reduction and internal fixation with pin or screw fixation
cast immobilization
immobilization in a cast without reduction
Locations (1)
Lurie Children's Hospital
Chicago, Illinois, United States