RecruitingNot ApplicableNCT06634290

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

Influence of Cemented Cephalic Augmentation on the Outcome of Osteosynthesis Using Intramedullary Nailing in the Surgical Treatment of Pertrochanteric Hip Fractures in the Elderly


Sponsor

Diego Matías Domínguez Prado

Enrollment

314 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 75 Years

Inclusion Criteria8

  • years of age or older.
  • Diagnosis with a pertrochanteric fragility fracture.
  • Informed consent for participation in the study.
  • 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.

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Interventions

DEVICEintramedullary nailing augmentation

Treatment of pertrochanteric hip fractures with intramedullary nailing with cephalic augmentation with bone cement

DEVICEintramedullary nailing

Treatment of pertrochanteric hip fractures with intramedullary nailing without cephalic augmentation


Locations(6)

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

View Full Details on ClinicalTrials.gov

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NCT06634290