Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT06357312
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Static Distal Locking of a Short Proximal Femoral Nail
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blinding of the patient included in the study and the investigator evaluating the results'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, comparative, randomized and double-blind study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of functional status using the Barthel index', 'timeFrame': '12 months', 'description': 'Evaluation of functional status 12 months after hip surgery'}], 'secondaryOutcomes': [{'measure': 'Postoperative mechanical complications', 'timeFrame': '12 months', 'description': 'Complication rate with nail, cephalic screw, or distal screw'}, {'measure': 'Parker mobility scale', 'timeFrame': '12 months', 'description': "Assessment of the patient's mobility capacity before and 12 months after hip surgery"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hip', 'fracture', 'intertrochanteric', 'elderly', 'screw'], 'conditions': ['Hip Fracture']}, 'descriptionModule': {'briefSummary': 'Prospective, comparative, randomized, double-blind study to evaluate the outcomes of trochanteric nailing in unstable hip fractures with and without a distal interlocking screw.', 'detailedDescription': 'Due to the lack of first-level evidence, this study aims to evaluate the effectiveness and safety of surgical treatment for unstable hip fractures, with or without the inclusion of a distal interlocking screw in the hip nail.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 50 years old\n* With unstable intertrochanteric hip fracture\n* Operated in the first 48 hours after hospital admission\n\nExclusion Criteria:\n\n* Simultaneous associated fractures\n* Fractures with subtrochanteric line\n* Non-acute fractures'}, 'identificationModule': {'nctId': 'NCT06357312', 'briefTitle': 'Influence of Static Distal Locking of a Short Proximal Femoral Nail', 'organization': {'class': 'OTHER', 'fullName': 'Elda University Hospital'}, 'officialTitle': 'Influence of Static Distal Locking on Outcomes of Unstable Intertrochanteric Fracture Treated With a Short Proximal Femoral Nail', 'orgStudyIdInfo': {'id': '2023/11P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group with distal screw', 'description': 'Patients who have been randomly selected for this procedure are included.', 'interventionNames': ['Device: hip trochanteric nail']}, {'type': 'EXPERIMENTAL', 'label': 'Group without distal screw', 'description': 'Patients who have been randomly selected for this procedure are included.', 'interventionNames': ['Device: hip trochanteric nail']}], 'interventions': [{'name': 'hip trochanteric nail', 'type': 'DEVICE', 'description': 'hip trochanteric nail with and without distal interlocking screw', 'armGroupLabels': ['Group with distal screw', 'Group without distal screw']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03600', 'city': 'Elda', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'FRANCISCO ANTONIO MIRALLES MUÑOZ', 'role': 'CONTACT', 'email': 'fr_miralles@hotmail.com', 'phone': '651552115'}], 'facility': 'Elda University Hospital', 'geoPoint': {'lat': 38.47783, 'lon': -0.79157}}], 'centralContacts': [{'name': 'FRANCISCO ANTONIO MIRALLES MUÑOZ', 'role': 'CONTACT', 'email': 'fr_miralles@hotmail.com', 'phone': '651552115'}], 'overallOfficials': [{'name': 'Carlos De la Pinta Zazo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elda University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elda University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Orthopedic Surgery', 'investigatorFullName': 'Francisco Antonio Miralles-Muñoz', 'investigatorAffiliation': 'Elda University Hospital'}}}}