Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 7:49 PM
Study NCT ID:
NCT07342959
Status:
RECRUITING
Last Update Posted:
2026-01-15
First Post:
2026-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Technique and Preliminary Results of Medial Epicondyle Fracture Fixation Using Anchors and Review of the Literature
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-06', 'studyFirstSubmitDate': '2026-01-06', 'studyFirstSubmitQcDate': '2026-01-06', 'lastUpdatePostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mayo Elbow Performance Score (MEPS)', 'timeFrame': 'Up to 12 months', 'description': 'What the Mayo Performance Status (MEPS) measures:\n\nIt assigns points (out of 100) based on:\n\n* Pain\n* Elbow mobility\n* Stability\n* Ability to perform everyday activities\n\nInterpretation of results:\n\n* 90-100 points: Excellent\n* 75-89 points: Good\n* 60-74 points: Average\n* \\<60 points: Poor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medial Epicondyle Fractures of the Elbow', 'Anchor Fixation', 'Fractures of the humerus'], 'conditions': ['Medial Epicondyle Fractures of the Elbow']}, 'descriptionModule': {'briefSummary': 'Medial epicondyle fractures of the humerus account for 11 to 20% of elbow fractures in children and adolescents.\n\nThe therapeutic strategy remains controversial, ranging from conservative treatment to surgical fixation depending on the degree of displacement and joint instability.\n\nConventional 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Minor patient (under 15 years of age) admitted for recent displaced fractures of the medial epicondyle of the elbow', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minor patient (under 15 years of age)\n* Admitted for recent displaced fractures of the medial epicondyle of the elbow\n* Treated in the pediatric surgery department at Hautepierre Hospital\n* Fractures requiring surgical treatment with anchor fixation.\n\nExclusion Criteria:\n\n* Non-displaced fractures\n* Open fractures and associated fractures'}, 'identificationModule': {'nctId': 'NCT07342959', 'acronym': 'Epicondyle', 'briefTitle': 'Technique and Preliminary Results of Medial Epicondyle Fracture Fixation Using Anchors and Review of the Literature', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Technique and Preliminary Results of Medial Epicondyle Fracture Fixation Using Anchors and Review of the Literature', 'orgStudyIdInfo': {'id': '9814'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe GICQUEL, MD, PhD', 'role': 'CONTACT', 'email': 'Philippe.Gicquel@chru-strasbourg.fr', 'phone': '33 3 88 12 82 65'}, {'name': 'Philippe GICQUEL, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jean-Jaurès OUATTARA, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de Chirurgie Pédiatrique - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Philippe GICQUEL, MD, PhD', 'role': 'CONTACT', 'email': 'Philippe.Gicquel@chru-strasbourg.fr', 'phone': '33 3 88 12 82 65'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}