Clinical Investigation to Evaluate the STERN FIX Device As a Sternal Fixation System in Medium Sternotomy

NEOS Surgery1 site in 1 country30 target enrollmentDecember 12, 2021

ConditionsSternotomy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sternotomy
Sponsor: NEOS Surgery
Enrollment: 30
Locations: 1
Primary Endpoint: Sternal stability according to clinical evaluation
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 12, 2021

End Date

January 25, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

NEOS Surgery

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Sternal stability according to clinical evaluation

Time Frame: 1 month post-surgery

sternal instability scale (SIS) grade: from 0 (Clinically stable sternum ) to 3 Completely separated sternum

Secondary Outcomes

sternal stability according to clinical evaluation(7 days post-surgery, 6 months)
Prevalence of patients with dehiscence (without infection)(6 months)
Prevalence and causality of adverse events(6 months)
Prevalence of device deficiencies(6 months)
Prevalence of reinterventions(6 months)
Prevalence of superficial and deep sternal wound infections(6 months)
Prevalence of patients with compromised sternal integrity(6 months)
Prevalence of artefacts associated with the product in medical images(6 months)
Time to close the sternal (minutes)(surgery)
Surgeon satisfaction score(immediately post-surgery)
Chest Pain(pre-surgery, 7 days post-surgery, 1 month, 6 months)
Upper limb functionality(pre-surgery, 7 days post-surgery, 1 month, 6 months)
Quality of life measured with EuroQol-5D-5L(pre-surgery, 7 days post-surgery, 1 month, 6 months)
Working status(pre-surgery, 6 months)
Sternal healing grade according to CT results(6 months)