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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
SC03 Plating system
DeviceAdjustable carbon fiber sternal plates
Stainless steel wires
DeviceNonabsorbable, sterile, surgical sutures used in sternal closure
Treatment groups
190 Participants
are divided into 2 treatment groupsGroup A: SC03 platesExperimental treatment 1 intervention
Group B: WiresActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sternal stability
Sternal stability measured by clinical assessment using the sternal instability scale (SIS), with grades 0 to 3 where 0 is "Clinically stable sternum" and 3 is "Completely separated sternum - entire length"
Time frame
1 month post operativelySecondary outcomes
1
Safety of the SC03 Plating System
Incidence of Device Deficiencies, AE and SAE with a possible, probable or causal relationship with the device or the procedure.
Time frame
Perioperative, 1 month and 6 months postoperatively.2
Reinterventions
Incidence and cause of surgical reinterventions
Time frame
1 month and 6 months postoperatively3
Infections
Incidence of sternal superficial and deep wound infections (mediastinitis)
Time frame
First month and six months postoperatively.4
Sternal dehiscence
Incidence of sternal dehiscence (without infection)
Time frame
First month and six months postoperativelyLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NEOS Surgery
Lead sponsor
Fundacio Privada Mon Clinic Barcelona
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: