Actively Recruiting

Phase Not Applicable
Age: 7Years - 17Years
All Genders
NCT05131672

Cast or Operation for Medial Epicondyle Fracture Treatment in Children

Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2024-08-30

334

Participants Needed

1

Research Sites

304 weeks

Total Duration

On this page

Sponsors

A

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cast or Operation for Medial Epicondyle Fracture Treatment in Children

Who Can Participate

Age: 7Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Parent or guardian has signed informed consent and participant has signed assent if older than 12 years
  • Willingness to comply with all study procedures and availability for the full study duration
  • Male or female aged 7 to 17 years inclusive
  • Diagnosis of medial epicondyle fracture with any displacement
  • Fracture occurred within 10 days before treatment assignment
  • Ability to take oral medication and willingness to follow immobilization regimen
Not Eligible

You will not qualify if you...

  • Medial epicondyle fragment trapped inside the joint
  • Other fractures in the same elbow
  • Open fractures or fractures caused by disease (pathologic fracture)
  • Presence of metabolic or neuromuscular diagnosis
  • Inability to follow study procedures or complete follow-up due to comprehension issues or developmental delay

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Lurie Children's Hospital

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

J

Jamie Burgess, PhD

CONTACT

C

Candace Young, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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