Cast vs. Surgery for Medial Epicondyle Fractures in Children
Exploring the Best Way to Treat Elbow Fractures in Kids
There are different ways to treat medial epicondyle fractures (break in the part of the upper arm bone closest to the elbow) but doctors do not know which treatment is better. This research study is being done to compare two common treatments that are used by orthopedic surgeons today to see which one treats the broken bone better.Ìý
Study Location | Status
ÎÚÑ»ÊÓƵ Children’s Health, Delaware | Enrolling
Ìý
ParticipantÌýEligibility
Clinical trials have inclusion and exclusion requirements that determine eligibility. Key requirements are listed below. Please note there may be additional qualifications.
Participants must be/have:
- Ages seven to 17 years old.Ìý
- An acute fracture of the medial epicondyle (bone in theÌýinner elbow) within the last 10 days.
Ìý
About the Study
Formal Study Name:ÌýCast or Operation for Medial Epicondyle Treatment in Children (COMET)
Study Type: InterventionalÌý(researchers intervene and assign treatments)
Study ID:ÌýNCHRS-IRB #00299
Sponsor/Coordinating Site:ÌýAnn & Robert H Lurie Children's Hospital of Chicago
Start Date:ÌýJune 2022
Completion Date (Estimated):ÌýAugust 2028
Ìý
What’s Involved
Participants are randomly assigned to one of two study groups. The two common treatments to be compared in this study are:
- Surgical:ÌýParticipants randomized to the surgery group, will be scheduled for surgery and then be taken to the operating room for surgery. The displaced bone will be restored to its original location and hardware (pins or screws) will be used to stabilize it. The arm will be casted.
- Non-surgical:ÌýParticipants randomized to the non-surgery group, the arm will be splinted or casted. They may be given pain medicine or sedated if in the emergency room.Ìý
Participants will be treated the same way in follow-up for their fracture no matter which study treatment they receive and whether or not they participate in the study.Ìý
Children in both study treatment groups as well as those who chose not to participate in the study will be seen regularly to monitor healing of the fracture. All children will follow-up in the orthopedic surgeon’s office according to the surgeon’s standard of care.Ìý
Participants/families will be sent surveys by email or text at 3 months, 6 months, 1, 2, and 3 years after the injury.
Note:ÌýÎÚÑ»ÊÓƵ is a participating site but not the lead sponsor of this trial.
Orthopedic Center, Delaware Valley
CLINICAL CARE
Pediatric orthopedic care including neuromuscular, spine, and limb conditions at ÎÚÑ»ÊÓƵ Children’s Hospital, Delaware and throughout Greater Philadelphia.
Orthopedics Clinical Trials
CLINICAL RESEARCH
We are conducting clinical trials to enhance diagnosis, treatment, and quality of life for children with various orthopedic conditions.
Orthopedics Research
RESEARCH AREA
Our teams study bone, joint, and muscle development to improve care for children with orthopedic conditions through innovation and collaboration.
More About Clinical Trials
Learn what to expect from a clinical trialÌý—Ìýhow they work, why they matter, and what to consider when deciding if one is right for your child.
Learn About Broken Bones from ÎÚÑ»ÊÓƵ KidsHealth®
Broken bones are a common part of growing up, and most heal well with the right treatment. Learn how fractures are diagnosed, what happens when a cast or surgery is needed, and what to expect during healing from the experts at ÎÚÑ»ÊÓƵ.