STERN FIX Device As a Sternal Fixation System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-12

Study Completion Date

2023-01-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Sternotomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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STERN FIX (Sternal Stabilization System)

Sternotomy closure with STERN FIX and supplemented with wires

Group Type EXPERIMENTAL

STERN FIX (Sternal Stabilization System)

Intervention Type DEVICE

Sternotomy closure with STERN FIX and supplemented with wires

Interventions

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STERN FIX (Sternal Stabilization System)

Sternotomy closure with STERN FIX and supplemented with wires

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No