Sternal Fixation With STERN FIX After Medial Sternotomy

Withdrawn before enrolling

Conditions studied: Sternotomy

In brief

The goal of this single arm observational registry is to evaluate the safety and performance of the STERN FIX device in normal conditions of use, in patients treated with medial sternotomy according to the instructions for use. The main goal of this registry is to evaluate the sternal stability in patients who had their sternum fixed with the STERN FIX system. Participants will have their sternotomy closed with the STERN FIX device at the end of their cardiothoracic surgery and will be followed up as per standard of care. At discharge and at the 1 month FU visit the sternal stability will be assessed using the sternal instability scale (SIS).

Key facts

Study ID

NCT05784532

Run by

NEOS Surgery

People needed

0

Starts

2023-04-01

Expected to finish

2025-01-01

Last updated by the study team

2025-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• New York-Presbyterian Hospital — Ney York, New York, United States

Full record on ClinicalTrials.gov

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