Sternal Fixation With STERN FIX After Medial Sternotomy

NCT ID: NCT05784532

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-01-01

Brief Summary

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).

Conditions

Sternotomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

STERN FIX

Patients undergoing cardiothoracic surgery through median sternotomy, once the main intervention is finished, will have their sternum closed using the sternal stabilization system STERN FIX in combination with wires according to the STERN FIX instructions for use.

STERN FIX

Intervention Type: DEVICE

Sternotomy closure with STERN FIX and supplemented with wires

Interventions

STERN FIX

Sternotomy closure with STERN FIX and supplemented with wires

Intervention Type: DEVICE

Other Intervention Names

Sternal stabilization system

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anagram-ESIC

UNKNOWN

Sponsor Role: collaborator

NEOS Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

New York-Presbyterian Hospital

Ney York, New York, United States

Countries

United States

Other Identifiers

NEO-SC1-2022-01

Identifier Type: -

Identifier Source: org_study_id