STERN FIX Device as a Sternal Fixation System

Study Overview
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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.

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

Conditions
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Sternotomy

Intervention / Treatment
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* Device: STERN FIX (Sternal Stabilization System)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: STERN FIX (Sternal Stabilization System)|Sternotomy closure with STERN FIX and supplemented with wires|

What is the study measuring?
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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 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 | 
| 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 | 
| Chest Pain | Numeric Rating Scale [0-10] | pre-surgery, 7 days post-surgery, 1 month, 6 months | 
| 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 healing grade according to CT results | Healing score, between 0: No sign of healing, nonunion and 5: complete synthesis. | 6 months |