STERN FIX Device as a Sternal Fixation System

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

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.

Study Overview

• Status: Completed
• Conditions: Sternotomy
• Intervention / Treatment: Device: STERN FIX (Sternal Stabilization System)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Clinic de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sternal stability according to clinical evaluation	sternal instability scale (SIS) grade: from 0 (Clinically stable sternum ) to 3 Completely separated sternum	1 month post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sternal healing grade according to CT results	Healing score, between 0: No sign of healing, nonunion and 5: complete synthesis.	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	Likert scale [1-5]	immediately post-surgery
Upper limb functionality	Upper Limb Functional Index (spanish version) score (0-100%)	pre-surgery, 7 days post-surgery, 1 month, 6 months
Quality of life	EuroQol-5D-5L	pre-surgery, 7 days post-surgery, 1 month, 6 months
Working status	[Fully employed/ Working with restrictions/ Unemployed/ On sick leave/ Retired]	pre-surgery, 6 months
sternal stability according to clinical evaluation	sternal instability scale (SIS) grade: from 0 (Clinically stable sternum ) to 3 Completely separated sternum	7 days post-surgery, 6 months
Chest Pain	Numeric Rating Scale [0-10]	pre-surgery, 7 days post-surgery, 1 month, 6 months

Collaborators and Investigators

• Sponsor: NEOS Surgery

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2021
• Primary Completion (Actual): September 5, 2022
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NEO-SC1-2020-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No