STERN FIX Device As a Sternal Fixation System

NCT04593732 | Completed

• 1 other identifier: NEO-SC1-2020-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sternotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

Study Arms (1)

STERN FIX (Sternal Stabilization System)

EXPERIMENTAL

Sternotomy closure with STERN FIX and supplemented with wires

Device: STERN FIX (Sternal Stabilization System)

Interventions

STERN FIX (Sternal Stabilization System) DEVICE

Sternotomy closure with STERN FIX and supplemented with wires

STERN FIX (Sternal Stabilization System)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NEOS Surgery: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 20, 2020
• Study Start: December 12, 2021
• Primary Completion: September 5, 2022
• Study Completion: January 25, 2023
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)