Sternal Fixation With STERN FIX After Medial Sternotomy

Description

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

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Study Overview

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Study Details

Study overview

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).

Sternal Fixation With STERN FIX After Medial Sternotomy

Sternal Fixation With STERN FIX After Medial Sternotomy

Condition
Sternotomy
Intervention / Treatment

-

Contacts and Locations

New York

New York-Presbyterian Hospital, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NEOS Surgery,

Study Record Dates

2024-11-30