Evaluating a new device for closing the sternum after heart surgery
Randomised Controlled Clinical Trial to Evaluate STERN FIX Device As a Sternal Stabilization System in Patients After Sternotomy
This study is testing a new device for closing the breastbone after heart surgery to see if it works better than traditional wire methods for patients who might be at higher risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NEOS Surgery Industry-sponsored |
| Locations | 3 sites (Freiburg im Breisgau, Baden-Württemberg and 2 other locations) |
| Trial ID | NCT05953259 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the safety and effectiveness of the STERN FIX device against traditional wire closure methods for patients undergoing median sternotomy during cardiothoracic surgery. Participants will be randomly assigned to have their sternum closed using either the STERN FIX device in combination with wires or wires alone. The primary focus is to determine if the STERN FIX provides greater sternal stability one month post-surgery in patients considered at risk due to various health factors. The study will assess outcomes related to sternal closure and overall recovery.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing median sternotomy who have at least one risk factor such as obesity, diabetes, or COPD.
Not a fit: Patients with serious osteoporosis, significant structural bone damage, or known allergies to the device materials may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could lead to improved recovery and stability for patients after heart surgery.
How similar studies have performed: While similar approaches have been explored, the specific use of the STERN FIX device represents a novel intervention in this context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Freiburg im Breisgau, Baden-Württemberg and 2 other locations
- Universitätsklinikum Freiburg — Freiburg im Breisgau, Baden-Württemberg, Germany (Recruiting)
- Complejo Hospitalario de Navarra — Pamplona, Navarra, Spain (Recruiting)
- Hospital Clínic de Barcelona — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Manel Castellà Pericás, MD/PhD — Hospital Clinic of Barcelona
- Study coordinator: Laia Rofes Salsench, PhD
- Email: lrofes@neosurgery.com
- Phone: +34 93 594 47 26
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.