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

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 …