STERN FIX Device as a Sternal Fixation System

Sternotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04593732
• Other study ID #: NEO-SC1-2020-01
• Status: Completed
• Phase: N/A
• Start date: December 12, 2021
• Est. completion date: January 25, 2023

Study information

• Verified date: July 2023
• Source: NEOS Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 25, 2023
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sternotomy

Intervention

Device:
• STERN FIX (Sternal Stabilization System)
Sternotomy closure with STERN FIX and supplemented with wires

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
NEOS Surgery

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Prevalence of patients with dehiscence (without infection)		6 months
Secondary	Prevalence and causality of adverse events		6 months
Secondary	Prevalence of device deficiencies		6 months
Secondary	Prevalence of reinterventions		6 months
Secondary	Prevalence of superficial and deep sternal wound infections		6 months
Secondary	Prevalence of patients with compromised sternal integrity		6 months
Secondary	Prevalence of artefacts associated with the product in medical images		6 months
Secondary	Time to close the sternal (minutes)		surgery
Secondary	Surgeon satisfaction score	Likert scale [1-5]	immediately post-surgery
Secondary	Chest Pain	Numeric Rating Scale [0-10]	pre-surgery, 7 days post-surgery, 1 month, 6 months
Secondary	Upper limb functionality	Upper Limb Functional Index (spanish version) score (0-100%)	pre-surgery, 7 days post-surgery, 1 month, 6 months
Secondary	Quality of life	EuroQol-5D-5L	pre-surgery, 7 days post-surgery, 1 month, 6 months
Secondary	Working status	[Fully employed/ Working with restrictions/ Unemployed/ On sick leave/ Retired]	pre-surgery, 6 months
Secondary	Sternal healing grade according to CT results	Healing score, between 0: No sign of healing, nonunion and 5: complete synthesis.	6 months