RCT to Evaluate STERN FIX Device As a Sternal Stabilization System in Patients After Sternotomy (FIXTER-2)

NEOS Surgery

Status: Enrolling

Conditions: Median Sternotomy

Treatments: Device: Wires; Device: Combination of STERN FIX and wires

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05953259

NEO-SC1-2023-01

Details and patient eligibility

About

The goal of this clinical trial is to compare the safety and performance of the sternal stabilization system STERN FIX with the standard of care (sternal closure with wires only) in normal conditions of use, in patients of risk undergoing median sternotomy during cardiothoracic surgery. The main question it aims to answer is:

• whether STERN FIX is a safe and efficient device to close the sternum after a sternotomy in patients of risk, achieving higher sternal stability than wires one month after surgery Participants will have their median sternotomy closed using STERN FIX in combination with wires or wires only at the end of their cardiothoracic surgery, according to the allocated treatment.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient undergoing surgery that requires median sternotomy
• Patients with at least one of the following risk criteria: obesity (BMI>30), diabetes, COPD, non serious osteoporosis (not associated with fractures), creatinine > 200 µmol/L and/or under dialysis treatment, scheduled Bilateral Internal Mammary Artery (BIMA) grafting
• Patients willing and capable of granting informed consent to participate in clinical research and who have granted written consent
• Patient willing and capable of complying with the protocol requirements

Exclusion criteria

• Patient with suspected or known allergies or intolerance to the device material (PEEK - polyether-ether-ketone and carbon fibre)
• Patient with insufficient quality or quantity of bone or any other serious structural bone damage at the sternum
• Patient with serious osteoporosis (associated with fractures) or a degenerative bone disease affecting the sternum
• Patients with a latent or active infection or inflammation at the surgical area, that according to the surgeon criteria may interfere in the device implantation or proper function.
• Patient with sternal anomalies that, according to the surgeon criteria, prevent the use of the product, such as bone tumours in the implantation area.
• Pregnant patients or patients planning to become pregnant during the first 6 months after surgery.
• Patients with diagnosis of dementia with a mental status score (MMSE) < 20.
• Patients with life expectancy lower than 6 months.
• Patients involved in other interventionist clinical trials or that have been involved in other interventionist clinical trials during the previous 4 weeks
• Parasternal sternotomy.
• Patients with intraoperative conditions that, according to the surgeon's opinion, require or exclude the use of a specific sternal closure system, or that cannot be closed following the study products instructions for use.

IMPORTANT: When the allocated closure method is wires only, the surgeon must assess whether the patient could have also had STERN FIX implanted in order to decide if the patient can continue in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

STERN FIX

Active Comparator group

Description:

Combination of at least one STERN FIX device and surgical wires to close median sternotomy (total of 5 fixation points)

Treatment:

Device: Combination of STERN FIX and wires

Wires

Active Comparator group

Description:

Standard of care median sternotomy closure method with surgical wires

Treatment:

Device: Wires