Medial Epicondyle Fractures of the ElbowEpicondyleNCT07342959
Technique and Preliminary Results of Medial Epicondyle Fracture Fixation Using Anchors and Review of the Literature
An observational study of Medial Epicondyle Fractures of the Elbow, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Medial Epicondyle Fractures of the Elbow
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2025to 15 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Minor patient (under 15 years of age) admitted for recent displaced fractures of the medial epicondyle of the elbow
Who may be able to join
- 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.
Who cannot join
- Non-displaced fractures
- Open fractures and associated fractures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Pédiatrique - CHU de Strasbourg - France
Strasbourg, 67091
Philippe GICQUEL, MD, PhD, 33 3 88 12 82 65, Philippe.Gicquel@chru-strasbourg.fr
Philippe GICQUEL, MD, PhD
About this study
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.
Read more
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.
- Conditions
- Medial Epicondyle Fractures of the Elbow
- Keywords
- Medial Epicondyle Fractures of the Elbow, Anchor Fixation, Fractures of the humerus
What is being measured
The primary outcome is the main question the study is designed to answer.
Mayo Elbow Performance Score (MEPS)
What the Mayo Performance Status (MEPS) measures:
It assigns points (out of 100) based on:
- Pain
- Elbow mobility
- Stability
- Ability to perform everyday activities
Interpretation of results:
- 90-100 points: Excellent
- 75-89 points: Good
- 60-74 points: Average
- <60 points: Poor
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start15 Jul 2025
- Primary completionJul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medial Epicondyle Fractures of the ElbowStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342959
- Sponsor's protocol ID
- 9814
- Acronym
- Epicondyle
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technique and Preliminary Results of Medial Epicondyle Fracture Fixation Using Anchors and Review of the Literature
- ClinicalTrials.gov ID
- NCT07342959
- Acronym / sponsor ID
- Epicondyle / 9814
- Conditions
- Medial Epicondyle Fractures of the Elbow
- Keywords
- Medial Epicondyle Fractures of the Elbow, Anchor Fixation, Fractures of the humerus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Minor patient (under 15 years of age) admitted for recent displaced fractures of the medial epicondyle of the elbow
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Non-displaced fractures
- Open fractures and associated fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: * Pain * Elbow mobility * Stability * Ability to perform everyday activities Interpretation of results: * 90-100 points: Excellent * 75-89 points: Good * 60-74 points: Average * <60 points: Poor
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medial Epicondyle Fractures of the Elbow, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe GICQUEL, MD, PhD (33 3 88 12 82 65, Philippe.Gicquel@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mayo Elbow Performance Score (MEPS) (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.