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NCT Number: NCT07342959

Technique and Preliminary Results of Medial Epicondyle Fracture Fixation Using Anchors and Review of the Literature

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.

Recruiting

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Key information

Age range

1 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Chirurgie Pédiatrique - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Jean-Jaurès OUATTARA, MD

PRINCIPAL_INVESTIGATOR

Philippe GICQUEL, MD, PhD

CONTACT

[email protected]

33 3 88 12 82 65

Philippe GICQUEL, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe GICQUEL, MD, PhD

CONTACT

[email protected]

33 3 88 12 82 65

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: Epicondyle

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.