Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-31 @ 2:59 AM
Study NCT ID:
NCT06293495
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Cut-out Using Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092526', 'term': 'Proximal Femoral Fractures'}, {'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005265', 'term': 'Femoral Neck Fractures'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, prospective trial with a CE-marked medical devices'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2024-02-20', 'studyFirstSubmitQcDate': '2024-02-27', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of cut-out.', 'timeFrame': '0-6 months', 'description': 'Cut-out is a mechanical complication consisting of varus collapse and migration of the cephalic screw through the femoral head.'}], 'secondaryOutcomes': [{'measure': 'Functional Ambulatory Categories (FAC)', 'timeFrame': '0-6 months', 'description': 'Classifies patients into 6 categories based on their ability and need for assistance with ambulation. Classifies patients into 6 categories based on their ability and need for help with ambulation, where 0 is equivalent to a patient with the impossibility of ambulation and 5 is a patient completely independent for ambulation.'}, {'measure': 'Tip-apex distance', 'timeFrame': '3-6 months', 'description': 'Distance from the tip of the screw to the apex of the femoral head in the anteroposterior and axial views.'}, {'measure': 'Parker index', 'timeFrame': '3-6 months', 'description': 'Indicates the distance of the screw from the inferior edge of the femoral neck in anteroposterior view or from the posterior edge of the femoral neck in lateral view.'}, {'measure': 'Baumgaertner reduction quality criteria', 'timeFrame': '3-6 months', 'description': '3 groups are established according to the quality of reduction: good, acceptable and bad'}, {'measure': 'Number of Surgical complications (Intraoperative)', 'timeFrame': '0-1 month', 'description': 'Intraoperative complications'}, {'measure': 'Number of Surgical complications (post-operative)', 'timeFrame': '0-6 months', 'description': 'Postoperative complications'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Proximal femoral fracture', 'Hip fracture', 'Cut-out'], 'conditions': ['Proximal Femoral Fractures']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare outcomes in the treatment of proximal femur fractures. The main question it aims to answer is whether the use of a double cephalic screw prevents nail failure (cut-out).\n\nParticipants will be treated using open reduction and internal fixation with a proximal femoral nail. Researchers will compare intramedullary nailing with a single cephalic screw (Gamma nail) and with a double cephalic screw (Chimaera nail) to see the cut-out rate.', 'detailedDescription': 'Randomized, open and prospective clinical trial.\n\nFollowing the surgical indication for open reduction and internal fixation as treatment for proximal femoral fractures, patients will be randomly assigned (ratio 1:1) to one of the following treatments:\n\nControl group: a Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture.\n\nExperimental group: a Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture.\n\nPatient (or their legal guardian) must provide/sign the informed consent prior to inclusion in the study.\n\nAfter the surgery, patients will be followed-up at 6 weeks, 3 and 6 months. At those times, data related to the radiological examination, the appearance of complications and the walking ability evaluation scale (FAC) will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with proximal femur fracture (OTA/AO 31-A1, A2 and A3) requiring surgical treatment.\n* Signing of written informed consent according to current legislation before collecting any information, either by the patient or by the legal representative or by people linked by family ties.\n\nExclusion Criteria:\n\n* Presence of other fractures in the ipsilateral femur that condition the surgical treatment of the pertrochanteric femur fracture.\n* Subcapital fracture of the proximal femur.\n* Subtrochanteric fracture of the proximal femur.\n* Pathological fracture.'}, 'identificationModule': {'nctId': 'NCT06293495', 'briefTitle': 'Incidence of Cut-out Using Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Puerta de Hierro University Hospital'}, 'officialTitle': 'Comparison of the Incidence of Cut-out Between Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures: a Prospective Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CUT-OUT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single Cephalic Screw System', 'description': 'A Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture.', 'interventionNames': ['Device: Gamma 3 Nail (Stryker)']}, {'type': 'EXPERIMENTAL', 'label': 'Double Cephalic Screw System', 'description': 'A Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture.', 'interventionNames': ['Device: Chimaera Nail (Orthofix)']}], 'interventions': [{'name': 'Gamma 3 Nail (Stryker)', 'type': 'DEVICE', 'description': 'Open reduction an internal fixation of proximal femoral fracture with a Gamma 3 nail (single cephalic screw system)', 'armGroupLabels': ['Single Cephalic Screw System']}, {'name': 'Chimaera Nail (Orthofix)', 'type': 'DEVICE', 'description': 'Open reduction an internal fixation of proximal femoral fracture with a Chimaera nail (system with double cephalic screw)', 'armGroupLabels': ['Double Cephalic Screw System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro Majadahonda', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}], 'centralContacts': [{'name': 'Pedro Jose Torrijos Garrido, MD, PhD', 'role': 'CONTACT', 'email': 'pedrojose.torrijos@salud.madrid.org', 'phone': '+34 91 191 74 85'}], 'overallOfficials': [{'name': 'Pedro José Torrijos Garrido, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Puerta de Hierro University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pedro-José Torrijos-Garrido', 'investigatorAffiliation': 'Puerta de Hierro University Hospital'}}}}