- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07342959
Technique and Preliminary Results of Medial Epicondyle Fracture Fixation Using Anchors and Review of the Literature (Epicondyle)
Medial epicondyle fractures of the humerus account for 11 to 20% of elbow fractures in children and adolescents.
The therapeutic strategy remains controversial, ranging from conservative treatment to surgical fixation depending on the degree of displacement and joint instability.
Conventional surgical management of these fractures generally involves fixation with screws or pins. However, the occurrence of certain complications, such as hardware migration, soft tissue irritation, the risk of iatrogenic comminution of small bone fragments, and the need for implant removal, has led to the exploration of alternatives, including the use of anchor fixation.
This technique involves inserting an anchor with sutures into the bone to ensure stable fixation of the fragment, while reducing the risk of comminution and avoiding the need for subsequent removal of the material.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Philippe GICQUEL, MD, PhD
- Phone Number: 33 3 88 12 82 65
- Email: Philippe.Gicquel@chru-strasbourg.fr
Study Locations
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Strasbourg, France, 67091
- Recruiting
- Service de Chirurgie Pédiatrique - CHU de Strasbourg - France
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Principal Investigator:
- Philippe GICQUEL, MD, PhD
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Contact:
- Philippe GICQUEL, MD, PhD
- Phone Number: 33 3 88 12 82 65
- Email: Philippe.Gicquel@chru-strasbourg.fr
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Principal Investigator:
- Jean-Jaurès OUATTARA, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Minor patient (under 15 years of age)
- Admitted for recent displaced fractures of the medial epicondyle of the elbow
- Treated in the pediatric surgery department at Hautepierre Hospital
- Fractures requiring surgical treatment with anchor fixation.
Exclusion Criteria:
- Non-displaced fractures
- Open fractures and associated fractures
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mayo Elbow Performance Score (MEPS)
Time Frame: Up to 12 months
|
What the Mayo Performance Status (MEPS) measures: It assigns points (out of 100) based on:
Interpretation of results:
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Up to 12 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 9814
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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