NCT05953259

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

Randomised Controlled Clinical Trial to Evaluate STERN FIX Device as a Sternal Stabilization System in Patients After Sternotomy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: NEOS Surgery · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-09-27
• Primary completion: 2025-06-26
• Completion: 2025-12-31
• First posted: 2023-07-20
• Last updated: 2025-09-22

Locations

5 sites across 2 countries: Germany, Spain