STERN FIX Device As a Sternal Fixation System

NEOS Surgery

Status

Completed

Conditions

Sternotomy

Treatments

Device: STERN FIX (Sternal Stabilization System)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04593732

NEO-SC1-2020-01

Details and patient eligibility

About

Pre-market clinical research, prospective, single-arm that aims to assess the sternal sealing in patients in which the sternum has been fixed with the STERN FIX system.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient over 18 years old.
Patient who must have surgery in which a medium sternotomy is indicated.
Subjects able to give their voluntary informed consent to participate in clinical research and from which written consent has been obtained.
The subject is able to meet the requirements of the protocol and is willing to do so.

Exclusion criteria

Patient with suspicious or known allergies or intolerance to implant material (PEEK - polyetheretherketone).
Patient with limitations in blood supply, insufficient bone quantity or quality, severe osteoporosis, osteomalacia or other serious bone structural damage, which, at the surgeon's discretion, may interfere with the implantation or proper functioning of the product.
Degenerative bone diseases.
Patients with a latent or active infection or inflammation in the operating area that, at the surgeon's discretion, may interfere with the implantation or proper functioning of the product.
Patients with fever or leukocytosis.
Patient with spinal abnormalities that, according to the surgeon's discretion, prevent the use of the product, such as bone tumors located in the implant region.
Patients who are pregnant or interested in becoming pregnant within 6 months of surgery.
Nursing patients.
Patients with life expectancy less than 6 months.
Patients who are participating in or participating in the previous 4 weeks in another interventional clinical study