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Influence of Cemented Cephalic Augmentation on the Outcome of Intramedullary Nailing in Pertrochanteric Hip Fractures

Sponsor: Diego Matías Domínguez Prado • ClinicalTrials.gov ID: NCT06634290

Registry updated: 2026-09-02

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Description

The goal of this clinical trial is to learn if small modifications in the surgical technique for the treatment of some kind of hip fractures, improve the result of the surgery. This small modification includes the addition of surgical bone cement to part of the intramedullary nail used in the surgery, to find out if it provides more stability to the construct and represents an improvement in the surgery result. The main question it aims to answer is: Does the addition of bone cement produces a decrease in complications related to mechanical failure of the implant used in the surgery and a decrease in the need for re-operation? Researchers will compare adding this bone cement to the standard surgical technique without it. Patients will: * Be randomly assigned to a group that will have surgery following standard protocol or to a group that will have surgery following standard protocol but adding bone cement to the construct. * Receive standard care for these fractures during hospitalization and posterior follow-up checkups for a year.

Interventions

intramedullary nailing augmentation (Device)
Treatment of pertrochanteric hip fractures with intramedullary nailing with cephalic augmentation with bone cement
intramedullary nailing (Device)
Treatment of pertrochanteric hip fractures with intramedullary nailing without cephalic augmentation

Eligibility criteria

Inclusion Criteria: * 75 years of age or older. * Diagnosis with a pertrochanteric fragility fracture. * Informed consent for participation in the study. Exclusion Criteria: * Not meeting the inclusion criteria described above. * Refusal of the patient or his/her legal representative to participate in the study. * Diagnosis with hip fracture of subtypes other than 31A1, 31A2, 31A3 and 31B3 of AO-OTA classification. * Bilateral hip fractures in the same episode. * Suffering from previous medical pathologies or comorbidities that contraindicate surgical intervention and indicate conservative management of the fracture. * Performing a surgical technique different from intramedullary nailing or using a surgical implant different from that used in the present study.

Conditions

Hip Fracture of Intertrochanteric Type

Locations

Hospital de Monforte de Lemos — Monforte de Lemos, Lugo, Spain
Hospital de Verin — Verín, Ourense, Spain
Complexo Hospitalario Universitario de Vigo — Vigo, Pontevedra, Spain
Hospital do Salnes — Vilagarcía de Arousa, Pontevedra, Spain
Complexo Hospitalario Universitario de Ourense — Ourense, Spain
Complexo Hospitalario Pontevedra — Pontevedra, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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