Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure (FIX IT ALL)

NEOS Surgery

Status: Not yet enrolling

Conditions: Sternotomy Closure,Open Heart Surgery

Treatments: Device: SC03 Plating system; Device: Stainless steel wires

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07366203

NEO-SC3-2025-01

Details and patient eligibility

About

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

Enrollment: 190 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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190 participants in 2 patient groups

SC03 plates

Experimental group

Description:

Adjustable carbon fiber sternal plates

Treatment:

Device: SC03 Plating system

Wires

Active Comparator group

Description:

Stainless steel sternal wires

Treatment:

Device: Stainless steel wires