Sternal Fixation With STERN FIX After Medial Sternotomy

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Sternotomy

Clinical Trial Details

NCT number	NCT05784532
Study type	Observational [Patient Registry]
Source	NEOS Surgery
Contact	Laia Rofes Salsench, PhD
Phone	+34 93 594 47 26
Email	lrofes@neosurgery.com
Status	Recruiting
Phase
Start date	April 1, 2023
Completion date	November 30, 2024

View Details

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