Evaluating STERN FIX for Sternal Closure After Heart Surgery
Sternal Fixation With STERN FIX After Medial Sternotomy
This study is testing a new device called STERN FIX to see if it safely and effectively closes the breastbone after heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NEOS Surgery Industry-sponsored |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05784532 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to assess the safety and effectiveness of the STERN FIX device used for closing the sternum after medial sternotomy in patients undergoing cardiothoracic surgery. Participants will have their sternum closed with the STERN FIX system and will be monitored for sternal stability at discharge and one month post-surgery using the sternal instability scale (SIS). The study focuses on real-world conditions to gather data on the performance of the device.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for surgery requiring medial sternotomy.
Not a fit: Patients with sternal anomalies, severe osteoporosis, or other conditions affecting healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve sternal stability and recovery outcomes for patients undergoing heart surgery.
How similar studies have performed: While this approach is being evaluated in this registry, similar studies on sternal fixation devices have shown promising results in enhancing post-surgical recovery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Older than 18 years old patient * Patient undergoing surgery requiring medial sternotomy * Patient able and willing to provide informed consent to participate in the registry and/or who have provided written consent to have their clinical data added to the registry Exclusion Criteria: * Patients that are still growing. * Patients with Sternal anomalies preventing the use of the STERN FIX Sternal Stabilization System, such as bone tumors located in the implant region. * Patient with conditions previous to surgery that may impact healing, including bone blood supply limitations, insufficient quantity or quality of bone, or other severe structural bone damage. * Patients with suspected or known allergies or intolerances to the implant material. * Patients with severe osteoporosis or other degenerative bone diseases. * Any patient unwilling to, or incapable of, following postoperative care instructions. * Patients with any other medical or surgical process that may compromise or limit the adequate functionality of the implant. * Pregnant patients or planning to become pregnant during the 2 months following surgery. * Patients with life expectancy lower than 2 months. * Patients who are or have been participating in an interventionist trial during the last 4 weeks Intraoperative exclusion criteria * Latent or active infection, or inflammation in the operating area. * Signs of infection on the surgical site. * Parasternal sternotomy. * When the STERN FIX Sternal Stabilization System cannot ensure sufficient fixation. * When a STERN FIX Sternal Stabilization System device cannot be placed properly in any intercostal space.
Where this trial is running
New York, New York
- New York-Presbyterian Hospital — New York, New York, United States (Recruiting)
Study contacts
- 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.