Incidence of Cut-out Using Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures
NCT ID: NCT06293495
Last Updated: 2024-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2024-03-01
2026-04-01
Brief Summary
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Participants 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.
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Detailed Description
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Following 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:
Control group: a Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture.
Experimental group: a Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture.
Patient (or their legal guardian) must provide/sign the informed consent prior to inclusion in the study.
After 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Single Cephalic Screw System
A Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture.
Gamma 3 Nail (Stryker)
Open reduction an internal fixation of proximal femoral fracture with a Gamma 3 nail (single cephalic screw system)
Double Cephalic Screw System
A Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture.
Chimaera Nail (Orthofix)
Open reduction an internal fixation of proximal femoral fracture with a Chimaera nail (system with double cephalic screw)
Interventions
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Gamma 3 Nail (Stryker)
Open reduction an internal fixation of proximal femoral fracture with a Gamma 3 nail (single cephalic screw system)
Chimaera Nail (Orthofix)
Open reduction an internal fixation of proximal femoral fracture with a Chimaera nail (system with double cephalic screw)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Subcapital fracture of the proximal femur.
* Subtrochanteric fracture of the proximal femur.
* Pathological fracture.
70 Years
ALL
No
Sponsors
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Puerta de Hierro University Hospital
OTHER
Responsible Party
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Pedro-José Torrijos-Garrido
Principal Investigator
Principal Investigators
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Pedro José Torrijos Garrido, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Study Principal Investigator
Locations
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Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Countries
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Central Contacts
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Other Identifiers
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CUT-OUT
Identifier Type: -
Identifier Source: org_study_id
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