Sternal Fixation With STERN FIX After Medial Sternotomy

NEOS Surgery

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).

Study Type

OBSERVATIONAL

Conditions

Sternotomy

Interventions

STERN FIXDEVICE

Sternotomy closure with STERN FIX and supplemented with wires

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 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.

Locations (1)

New York-Presbyterian Hospital

Ney York, New York, United States

Outcomes

Primary Outcomes

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\*)

Time frame: One month postoperatively

Secondary Outcomes

Prevalence and type of AE and SAE

All adverse events occurring during the study period related to the sternotomy must be recorded. The AE that should be recorded, include: * Any device complication (wire o STERN FIX fracture, rotation, migration, …) * Surgical complications: any injury caused by the devices or instruments. * Tissue reactions to implant materials. * Damage to the tissues surrounding the devices. * Osseous complications (fractures, sternal dehiscence, malunion, nonunion, instability, necrosis, calcification, decrease in bone density….). * Postoperative hematoma/ bleeding. * Infectious complications (superficial wound infections, mediastinitis, abscess …). * Increased fibrous tissue, keloid or seroma formation in the sternotomy area. * Any other AE that the investigator considers relevant for the registry.

Time frame: Through study completion, an average of 6 months

Prevalence of device deficiencies.

Adverse event related to the use of an investigational medical device. This includes adverse events resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction and events resulting from use error or from intentional misuse of the investigational medical device.

Time frame: Through study completion, an average of 6 months

Sternal closure time

Time elapsed from the measurement of the intercostal spaces to the closure of the last intercostal space.

Data from ClinicalTrials.gov

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