NCT06293495

Incidence of Cut-out Using Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures

Comparison of the Incidence of Cut-out Between Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures: a Prospective Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Puerta de Hierro University Hospital · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Proximal Femoral Fractures

Interventions

Type	Name	Description
DEVICE	Gamma 3 Nail (Stryker)	Open reduction an internal fixation of proximal femoral fracture with a Gamma 3 nail (single cephalic screw system)
DEVICE	Chimaera Nail (Orthofix)	Open reduction an internal fixation of proximal femoral fracture with a Chimaera nail (system with double cephalic screw)

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-09-30
• Completion: 2026-04-01
• First posted: 2024-03-05
• Last updated: 2024-03-05

Locations

1 site across 1 country: Spain