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Surgery vs Casting for Children's Elbow Fractures (COMET Trial)

N/A
Recruiting
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fracture is acute (occurred within 10 days of assignment of treatment arm)
Ability to take oral medication and be willing to adhere to the immobilization regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 year
Awards & highlights

COMET Trial Summary

This trial compares outcomes of surgery and immobilization for kids' elbow fracture repair.

Who is the study for?
This trial is for children aged 7-17 with a recent elbow fracture called medial epicondyle fracture. They must be able to take oral medication and follow the treatment plan. Kids with other bone or muscle conditions, additional fractures around the same elbow, or who can't understand the study rules are not eligible.Check my eligibility
What is being tested?
The study compares two ways to treat elbow fractures in kids: surgery (ORIF) versus wearing a cast (non-operative immobilization). It's designed to see which method leads to better arm function after healing.See study design
What are the potential side effects?
Surgery may lead to risks like infection, pain at the site of operation, and possible damage to nearby nerves or blood vessels. Wearing a cast might cause skin irritation, stiffness in the joint once removed, and discomfort.

COMET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My fracture happened less than 10 days ago.
Select...
I can take pills and follow a strict treatment schedule.
Select...
I am between 7 and 17 years old.
Select...
I have a diagnosed fracture in my elbow.

COMET Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
pediatric upper extremity function PROMIS computer adaptive test (PROMIS UE CAT)
Secondary outcome measures
Disabilities of the Arm, Shoulder and Hand (DASH) S/PA
Estimated unit cost data for hospital and patient charges and costs
Follow-up Disabilities of the Arm, Shoulder and Hand (DASH) S/PA
+8 more

COMET Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Operative reduction w/ fixationExperimental Treatment1 Intervention
open reduction and internal fixation (ORIF)
Group II: Non-operative immobilizationActive Control1 Intervention
immobilization in a cast without reduction

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
484 Previous Clinical Trials
1,086,673 Total Patients Enrolled
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
258 Previous Clinical Trials
5,188,796 Total Patients Enrolled

Media Library

open reduction and internal fixation (ORIF) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05131672 — N/A
Elbow Fractures Research Study Groups: Operative reduction w/ fixation, Non-operative immobilization
Elbow Fractures Clinical Trial 2023: open reduction and internal fixation (ORIF) Highlights & Side Effects. Trial Name: NCT05131672 — N/A
open reduction and internal fixation (ORIF) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05131672 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study accept participants who are 25 years or older?

"The age range for patient participation in this trial is from 7 to 17 years old, as specified by the study's eligibility criteria."

Answered by AI

Is the opportunity still available to join this medical experiment?

"Indeed, the data on clinicaltrials.gov corroborates that this trial is actively searching for participants. The project was originally posted in October 28th 2022 and was recently modified by April 7th 2023; it requires 334 patients to be recruited from a single site."

Answered by AI

Who would be the ideal participants for this trial?

"This clinical trial is seeking 334 young candidates, aged between 7 and 17 years old, with elbow fractures."

Answered by AI

How many participants is this experiment recruiting?

"Affirmative. According to the clinicaltrials.gov website, this trial is actively recruiting participants, having first been posted on October 28th 2022 and recently updated on April 7th 2023. The research team intends to enroll 334 patients from a single location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cast or Operation for Medial Epicondyle Fracture Treatment in Children
2022. "Cast or Operation for Medial Epicondyle Fracture Treatment in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05131672.
~176 spots leftby Jan 2026
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