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

NCT06293495 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-03-05

No results posted yet for this study

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.

Conditions

  • Proximal Femoral Fractures

Interventions

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)

Sponsors & Collaborators

  • Puerta de Hierro University Hospital

    lead OTHER

Principal Investigators

  • Pedro José Torrijos Garrido, MD, PhD · Study Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-09-30
Completion
2026-04-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06293495 on ClinicalTrials.gov