Clinical Trial

Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure

Study acronym: FIX IT ALL
Not Yet Recruiting
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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
Trial Details
NCT Number NCT07366203
Lead Sponsor NEOS Surgery
Collaborators: Fundacio Privada Mon Clinic Barcelona
Conditions Sternotomy Closure,Open Heart Surgery
Enrollment 190 participants
Start Date 2026-02
Primary Completion 2027-06 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-26