WITHDRAWN

Sternal Fixation With STERN FIX After Medial Sternotomy

Conditions

Sternotomy Rigid Fixation Sternal Closure STERN FIX

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

Sternal Fixation With STERN FIX After Medial Sternotomy

Quick Facts

Study Start:2023-04-01

Study Completion:2025-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:WITHDRAWN

Study ID

NCT05784532

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Locations (Sites)

New York-Presbyterian Hospital

Ney York, New York, 10032

United States

Collaborators and Investigators

Sponsor: NEOS Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-01

Study Completion Date2025-01-01

Study Record Updates

Study Start Date2023-04-01

Study Completion Date2025-01-01

Terms related to this study

Keywords Provided by Researchers

Rigid Fixation
Sternal Closure
STERN FIX

Additional Relevant MeSH Terms

Sternotomy