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

NCT06634290 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2024-10-09

No results posted yet for this study

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.

Conditions

  • Hip Fracture of Intertrochanteric Type

Interventions

DEVICE

intramedullary nailing augmentation

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

DEVICE

intramedullary nailing

Treatment of pertrochanteric hip fractures with intramedullary nailing without cephalic augmentation

Sponsors & Collaborators

  • Diego Matías Domínguez Prado

    lead OTHER

Principal Investigators

  • Diego Matias Dominguez Prado, MD, PhD · Complexo Hospitalario de Ourense

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2025-09-30
Completion
2026-09-30
FDA Device
Yes

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 NCT06634290 on ClinicalTrials.gov