Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNEOS Surgery
About this trial
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
Eligibility criteria
Qualifiers
Patient ≥ 18 years old.
Patient who must undergo surgery in which a median or an upper partial sternotomy is indicated.
Patients capable of giving their voluntary informed consent to participate in the clinical investigation and from whom written consent has been obtained.
Patient able and willing to meet the protocol requirements and to follow postoperative care instructions
Disqualifiers
Patient with sternal anomalies, such as bone tumours located in the sternum.
Patient with limited sternum bone blood supply.
Patient with suspected or known allergies or intolerances to the implants materials: PEEK, carbon fibre, titanium, stainless steel.
Patient with severe osteoporosis or other degenerative bone diseases that affect the sternum.
Trial design
Treatments tested in this trial
- SC03 Plating system
- Stainless steel wires
Treatment groups
190 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
NEOS Surgery
Lead sponsor
Fundacio Privada Mon Clinic Barcelona
Collaborator
Source ClinicalTrials.gov