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). 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.
Randomized, open and prospective clinical trial. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Open reduction an internal fixation of proximal femoral fracture with a Gamma 3 nail (single cephalic screw system)
Open reduction an internal fixation of proximal femoral fracture with a Chimaera nail (system with double cephalic screw)
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Incidence of cut-out.
Cut-out is a mechanical complication consisting of varus collapse and migration of the cephalic screw through the femoral head.
Time frame: 0-6 months
Functional Ambulatory Categories (FAC)
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.
Time frame: 0-6 months
Tip-apex distance
Distance from the tip of the screw to the apex of the femoral head in the anteroposterior and axial views.
Time frame: 3-6 months
Parker index
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.
Time frame: 3-6 months
Baumgaertner reduction quality criteria
3 groups are established according to the quality of reduction: good, acceptable and bad
Time frame: 3-6 months
Number of Surgical complications (Intraoperative)
Intraoperative complications
Time frame: 0-1 month
Number of Surgical complications (post-operative)
Postoperative complications
Time frame: 0-6 months
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