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Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure
Sponsor: NEOS Surgery
Summary
The goal of this clinical trial is to learn if a new medical device (SC03 plates) to close the sternum after a sternotomy in patients that have been operated of a cardiac surgery, is safe and effective. The main question it aims to answer is: Do patients that have the sternum closed with the SC03 plates present a stable sternum one month after surgery? Researchers will compare the SC03 plates with stainless steel wires (current standard of care to close the sternum). Participants will: * be implanted with the SC03 or stainless steel wires. * visit the clinic one month and six months after surgery * Keep a diary of their symptoms and analgesia use
Official title: Clinical Investigation to Evaluate the Use of Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
190
Start Date
2026-02
Completion Date
2027-12
Last Updated
2026-01-26
Healthy Volunteers
No
Conditions
Interventions
SC03 Plating system
Adjustable carbon fiber sternal plates
Stainless steel wires
Nonabsorbable, sterile, surgical sutures used in sternal closure