RCT to Evaluate STERN FIX Device As a Sternal Stabilization System in Patients After Sternotomy

Launched by NEOS SURGERY · Jul 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called STERN FIX, which is designed to help close the breastbone (sternum) after heart surgery. The goal is to see if using STERN FIX, along with traditional wires, is safer and more effective than using wires alone for patients who may be at higher risk. Researchers want to find out if patients treated with STERN FIX have a more stable sternal closure one month after their surgery compared to those who only receive the standard wire closure.

To participate in this trial, patients should be undergoing a specific type of heart surgery that requires opening the chest through the sternum and must have at least one risk factor, such as obesity, diabetes, or chronic lung disease. Eligible participants will be randomly assigned to receive either the STERN FIX system or the standard wire closure at the end of their surgery. Throughout the study, participants will be monitored for their recovery and how well the closure holds. It's important to note that certain conditions, like severe osteoporosis or active infections, may prevent someone from participating. If you or a loved one is considering this trial, it could be a valuable opportunity to contribute to research that may improve care for future heart surgery patients.

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Eligibility criteria

• 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.