Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
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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