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Participating sites could not perform recruitment due to administrative obstacles that could not be addressed. Sponsor decided in agreement with sites to withdraw the study.
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| Name | Class |
|---|---|
| Anagram-ESIC | UNKNOWN |
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The goal of this single arm observational registry is to evaluate the safety and performance of the STERN FIX device in normal conditions of use, in patients treated with medial sternotomy according to the instructions for use.
The main goal of this registry is to evaluate the sternal stability in patients who had their sternum fixed with the STERN FIX system.
Participants will have their sternotomy closed with the STERN FIX device at the end of their cardiothoracic surgery and will be followed up as per standard of care. At discharge and at the 1 month FU visit the sternal stability will be assessed using the sternal instability scale (SIS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STERN FIX | Patients undergoing cardiothoracic surgery through median sternotomy, once the main intervention is finished, will have their sternum closed using the sternal stabilization system STERN FIX in combination with wires according to the STERN FIX instructions for use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STERN FIX | Device | Sternotomy closure with STERN FIX and supplemented with wires |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sternal stability | The primary outcome for this registry will be the sternal stability assessed with the sternal instability scale (SIS). The SIS is a scale ranging from 0 to 3 with the following descriptors:
| One month postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence and type of AE and SAE | All adverse events occurring during the study period related to the sternotomy must be recorded. The AE that should be recorded, include:
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance of the device in high-risk patients (Stability) | The performance of the device (stability) in high-risk patients will be assessed in a sub-analysis. Patients considered of high-risk should comply at least one of the following criteria:
The sternal stability assessed with the sternal instability scale (SIS). The SIS is a scale ranging from 0 to 3 with the following descriptors:
|
Inclusion Criteria:
Exclusion Criteria:
Intraoperative exclusion criteria
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All those patients that have or will undergo medial sternotomy during the registry period will be considered for inclusion. They will be informed about it, and if they consent for their data to be used in the registry, their eligibility will be assessed. If a patient does not comply with all IFUs indications, they will not be included in the registry
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York-Presbyterian Hospital | Ney York | New York | 10032 | United States |
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| Through study completion, an average of 6 months |
| Prevalence of device deficiencies. | Adverse event related to the use of an investigational medical device. This includes adverse events resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction and events resulting from use error or from intentional misuse of the investigational medical device. | Through study completion, an average of 6 months |
| Sternal closure time | Time elapsed from the measurement of the intercostal spaces to the closure of the last intercostal space. | Surgery |
| Easiness of implantation of the device (Likert) | The easiness score assessed by the surgeon about the usage of the medical device will be registered according to the Likert scale (1-5) with the following descriptors:
| Immediately after surgery |
| Easiness of implantation of the device (assistance) | The surgeon will indicate whether they requested external assistance during the implantation of the device | Immediately after surgery |
| Surgeon satisfaction for the use of the device | The surgeon general satisfaction with the sternotomy closure using STERN FIX will be assessed in comparison with the usual wire closure using the Likert scale (1-5) with the following descriptors:
| Immediately after surgery |
| One month postoperatively |
| Safety of the device in high-risk patients (AE and SAE prevalence) | The safety of the device (prevalence and type of AE and SAE) in high-risk patients will be assessed in a sub-analysis. All adverse events occurring during the study period related to the sternotomy must be recorded. The AE that should be recorded, include:
| Through study completion, an average of 6 months |