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

NCT05953259 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

  • Median Sternotomy

Interventions

DEVICE

Combination of STERN FIX and wires

Closure of the median sternotomy using a combination of at least one STERN FIX device and wires for a total of 5 fixation points.

DEVICE

Wires

Closure of the median sternotomy using the standard of care with steel wires.

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    collaborator OTHER

  • Complejo Hospitalario de Navarra

    collaborator OTHER

  • Universitätsklinikum Freiburg

    collaborator UNKNOWN

  • NEOS Surgery

    lead INDUSTRY

Principal Investigators

  • Manel Castellà Pericás, MD/PhD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-27
Primary Completion
2025-06-26
Completion
2025-12-31

Countries

  • Germany
  • 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 NCT05953259 on ClinicalTrials.gov