Sternal Fixation With STERN FIX After Medial Sternotomy

NCT05784532 | Withdrawn FDA Device

• 1 other identifier: NEO-SC1-2022-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Rigid Fixation; Sternal Closure; STERN FIX

Outcome Measures

Primary Outcomes (1)

• Sternal stability

  The primary outcome for this registry will be the sternal stability assessed with the sternal instability scale (SIS). The SIS is a scale ranging from 0 to 3 with the following descriptors: * 0\. Clinically stable sternum (no detectable motion) - normal * 1\. Minimally separated sternum (slight increase in motion upon special testing\* - upper limbs, trunk) * 2\. Partially separated sternum - regional (moderate increase in motion upon special testing\*) * 3\. Completely separated sternum - entire length (marked increase in motion upon special testing\*)

  One month postoperatively

Secondary Outcomes (6)

• Prevalence and type of AE and SAE

  Through study completion, an average of 6 months

• Prevalence of device deficiencies.

  Through study completion, an average of 6 months

• Sternal closure time

  Surgery

• Easiness of implantation of the device (Likert)

  Immediately after surgery

• Easiness of implantation of the device (assistance)

  Immediately after surgery

Other Outcomes (2)

• Performance of the device in high-risk patients (Stability)

  One month postoperatively

• Safety of the device in high-risk patients (AE and SAE prevalence)

  Through study completion, an average of 6 months

Study Arms (1)

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.

Device: STERN FIX

Interventions

STERN FIX DEVICE

Sternotomy closure with STERN FIX and supplemented with wires

Also known as: Sternal stabilization system

STERN FIX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All those patients that have or will undergo medial sternotomy during the registry period will be considered for inclusion. They will be informed about it, and if they consent for their data to be used in the registry, their eligibility will be assessed. If a patient does not comply with all IFUs indications, they will not be included in the registry

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
• 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.

Sponsors & Collaborators

• NEOS Surgery: lead
• Anagram-ESIC: collaborator

Study Sites (1)

New York-Presbyterian Hospital

Ney York, New York, 10032, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 27, 2023
• Study Start: April 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)