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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STERN FIX (Sternal Stabilization System) | Experimental | Sternotomy closure with STERN FIX and supplemented with wires |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STERN FIX (Sternal Stabilization System) | Device | Sternotomy closure with STERN FIX and supplemented with wires |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClĂnic de Barcelona | Barcelona | Spain |
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| 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 measured with EuroQol-5D-5L | 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 |