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New treatment option for Fracture Elbow
Official title Cast or Operation for Medial Epicondyle Fracture Treatment in Children
ClinicalTrials.gov ID: NCT05131672
What this study is testing
- What it's testing
- This protocol describes a multicenter, prospective randomized and patient preference cohort superiority trial of medial epicondyle fracture treatments comparing functional outcomes between children treated with operative reduction and fixation or non-operative immobilization.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 17
You may be able to join if
- Provision of signed and dated informed consent form by parent or legal guardian and signed assent form if participant is older than 12 years.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 7-17 years inclusive
- Diagnosis of medial epicondyle fracture with any amount of displacement
- Fracture is acute (occurred within 10 days of assignment of treatment arm)
You likely can't join if
- Medial epicondyle fragment that is incarcerated within joint
- Presence of other fractures about the ipsilateral elbow
- Presence of pathologic fracture, open fracture
- Have metabolic or neuromuscular diagnosis
- Patient and parents are unable to adhere to procedures or complete follow-up due to insufficient comprehension of consent form or surveys or...
See the full eligibility criteria
- Provision of signed and dated informed consent form by parent or legal guardian and signed assent form if participant is older than 12 years.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 7-17 years inclusive
- Diagnosis of medial epicondyle fracture with any amount of displacement
- 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
- Medial epicondyle fragment that is incarcerated within joint
- Presence of other fractures about the ipsilateral elbow
- Presence of pathologic fracture, open fracture
- Have metabolic or neuromuscular diagnosis
- Patient and parents are unable to adhere to procedures or complete follow-up due to insufficient comprehension of consent form or surveys or developmental delay.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.