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Sternal Fixation With STERN FIX After Medial Sternotomy

NCT05784532 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-10-24

No results posted yet for this study

Summary

The goal of this single arm observational registry is to evaluate the safety and performance of the STERN FIX device in normal conditions of use, in patients treated with medial sternotomy according to the instructions for use.

The main goal of this registry is to evaluate the sternal stability in patients who had their sternum fixed with the STERN FIX system.

Participants will have their sternotomy closed with the STERN FIX device at the end of their cardiothoracic surgery and will be followed up as per standard of care. At discharge and at the 1 month FU visit the sternal stability will be assessed using the sternal instability scale (SIS).

Conditions

  • Sternotomy

Interventions

DEVICE

STERN FIX

Sternotomy closure with STERN FIX and supplemented with wires

Sponsors & Collaborators

  • Anagram-ESIC

    collaborator UNKNOWN

  • NEOS Surgery

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-01-01
Completion
2025-01-01
FDA Device
Yes

Countries

  • United States

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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 NCT05784532 on ClinicalTrials.gov