Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure

Official title

Clinical Investigation to Evaluate the Use of Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure

Overview

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

Interventions

• Device SC03 Plating system
  Adjustable carbon fiber sternal plates
• Device Stainless steel wires
  Nonabsorbable, sterile, surgical sutures used in sternal closure

Primary outcome measures

• Sternal stability [Time frame: 1 month post operatively]

Secondary outcome measures (12)

• Safety of the SC03 Plating System [Time frame: Perioperative, 1 month and 6 months postoperatively.]
• Reinterventions [Time frame: 1 month and 6 months postoperatively]
• Infections [Time frame: First month and six months postoperatively.]
• Sternal dehiscence [Time frame: First month and six months postoperatively]
• Sternotomy closure duration [Time frame: Surgery]
• Easiness of use of the closure method [Time frame: Surgery]
• Sternal Pain [Time frame: Baseline, 7 days, 1 month and 6 months postoperatively.]
• Analgesia required [Time frame: Day 7, 1 month and 6 months postoperatively]
• Post-surgery blood loss [Time frame: 12 hours postoperatively]
• Blood loss [Time frame: 48 hours after surgery]
• Blood loss [Time frame: 48 hour after surgery]
• Intensive Care Unit stay duration [Time frame: from surgery date to Intensive care unit discharge date (up to 150 days)]]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.
• Pregnant or breastfeeding patient or patient planning to become pregnant during the first 6 months after surgery.
• Patient who is currently using opioid analgesics (e.g., morphine, oxycodone, hydrocodone, fentanyl, tramadol) for the management of chronic or acute pain.
• Patient with diagnosis of dementia with a mental status score (MMSE) < 20.
• Patient with life expectancy lower than 6 months.
• Patient with any other medical process that may compromise or limit the adequate functionality of the implants.
• Patient involved in other interventionist clinical trial or that have been involved in other interventionist clinical trial during the previous 4 weeks.
• Patient with signs of latent or active infection or inflammation on the surgical site.
• Patient with insufficient quantity or quality of sternum bone, or other severe structural bone damage.
• Patient for whom the closure technique cannot ensure sufficient sternal fixation.
• Parasternal sternotomy.
• Patient with intraoperative conditions that may compromise or limit the adequate functionality of the implants or that may prevent the surgeon to use the sternal closure system or that cannot be closed following the product instructions for use

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07366203 · NEO-SC3-2025-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗