Sternotomy
Conditions
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.
Interventions
DEVICESTERN FIX (Sternal Stabilization System)
Sternotomy closure with STERN FIX and supplemented with wires
Sponsors
NEOS Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sternal stability according to clinical evaluation | 1 month post-surgery | sternal instability scale (SIS) grade: from 0 (Clinically stable sternum ) to 3 Completely separated sternum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| sternal stability according to clinical evaluation | 7 days post-surgery, 6 months | sternal instability scale (SIS) grade: from 0 (Clinically stable sternum ) to 3 Completely separated sternum |
| Surgeon satisfaction score | immediately post-surgery | Likert scale \[1-5\] |
| Chest Pain | pre-surgery, 7 days post-surgery, 1 month, 6 months | Numeric Rating Scale \[0-10\] |
| Upper limb functionality | pre-surgery, 7 days post-surgery, 1 month, 6 months | Upper Limb Functional Index (spanish version) score (0-100%) |
| Quality of life measured with EuroQol-5D-5L | pre-surgery, 7 days post-surgery, 1 month, 6 months | EuroQol-5D-5L |
| Working status | pre-surgery, 6 months | \[Fully employed/ Working with restrictions/ Unemployed/ On sick leave/ Retired\] |
| Sternal healing grade according to CT results | 6 months | Healing score, between 0: No sign of healing, nonunion and 5: complete synthesis. |
| Time to close the sternal (minutes) | surgery | — |
Countries
Spain
Outcome results
None listed