Clinical Trial

RCT to Evaluate STERN FIX Device as a Sternal Stabilization System in Patients After Sternotomy

Study acronym: FIXTER-2
Active, Not Recruiting
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Summary
The goal of this clinical trial is to compare the safety and performance of the sternal stabilization system STERN FIX with the standard of care (sternal closure with wires only) in normal conditions of use, in patients of risk undergoing median sternotomy during cardiothoracic surgery. The main question it aims to answer is: • whether STERN FIX is a safe and efficient device to close the sternum after a sternotomy in patients of risk, achieving higher sternal stability than wires one month after surgery Participants will have their median sternotomy closed using STERN FIX in combination with wires or wires only at the end of their cardiothoracic surgery, according to the allocated treatment.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-07-11; most recent amendment 2025-09-17.
Status change: Recruiting → Active, Not Recruiting 2025-09-17
Status change: Not Yet Recruiting → Recruiting 2023-10-17
Trial Details
NCT Number NCT05953259
Lead Sponsor NEOS Surgery
Collaborators: Hospital Clinic of Barcelona, Complejo Hospitalario de Navarra, Universitätsklinikum Freiburg
Conditions Median Sternotomy
Enrollment 90 participants
Start Date 2023-09-27
Primary Completion 2025-06-26 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-22