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| Name | Class |
|---|---|
| Hospital Clinic of Barcelona | OTHER |
| Complejo Hospitalario de Navarra | OTHER |
| Universitätsklinikum Freiburg | UNKNOWN |
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The goal of this clinical trial is to compare the safety and performance of the sternal stabilization system STERN FIX with the standard of care (sternal closure with wires only) in normal conditions of use, in patients of risk undergoing median sternotomy during cardiothoracic surgery. The main question it aims to answer is:
• whether STERN FIX is a safe and efficient device to close the sternum after a sternotomy in patients of risk, achieving higher sternal stability than wires one month after surgery Participants will have their median sternotomy closed using STERN FIX in combination with wires or wires only at the end of their cardiothoracic surgery, according to the allocated treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STERN FIX | Active Comparator | Combination of at least one STERN FIX device and surgical wires to close median sternotomy (total of 5 fixation points) |
|
| Wires | Active Comparator | Standard of care median sternotomy closure method with surgical wires |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of STERN FIX and wires | Device | Closure of the median sternotomy using a combination of at least one STERN FIX device and wires for a total of 5 fixation points. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sternal stability | The primary outcome of this study will evaluate the sternal stability through clinical assessment using the sternal instability scale (SIS) with grades 0 to 3 where 0 is "Clinically stable sternum" and 3 is "Completely separated sternum - entire length" | 1 month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Safety SAE/AE prevalence | All adverse events occurring during the study period will be recorded, except for frequent events after surgical interventions requiring median sternotomy. | 6 months after surgery |
| Safety SAE/AE causality |
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Inclusion Criteria:
Exclusion Criteria:
IMPORTANT: When the allocated closure method is wires only, the surgeon must assess whether the patient could have also had STERN FIX implanted in order to decide if the patient can continue in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Manel Castellà Pericás, MD/PhD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany | ||
| Hospital ClÃnic de Barcelona |
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| ID | Term |
|---|---|
| D001864 | Bone Wires |
| ID | Term |
|---|---|
| D016268 | Internal Fixators |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D009984 | Orthopedic Fixation Devices |
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Participants and primary outcome assessors will not know whether the allocated sternotomy closure system is STERN FIX or wires only.
| Wires | Device | Closure of the median sternotomy using the standard of care with steel wires. |
|
All adverse events occurring during the study period will be recorded, except for frequent events after surgical interventions requiring median sternotomy.
| 6 months after surgery |
| 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. | 6 months after surgery |
| Reinterventions - prevalence | Prevalence of reinterventions | 6 months after surgery |
| Reinterventions - Causality | Causality of reinterventions | 6 months after surgery |
| Prevalence of sternal wound infections | Prevalence of sternal superficial and deep wound infections | 1 month and 6 months after surgery |
| Prevalence of dehiscence | Prevalence of dehiscence (without infection) | 1 month and 6 months after surgery |
| Sternal closure time | Measured time from the implantation of the first wire to the closure of the last wire (minutes) | Surgery |
| Easiness of use of the closure method | The surgeon perceived difficulty of the sternal closure method will be recorded using the Likert scale (1 to 5). | Surgery |
| Surgeon satisfaction of the closure method | General surgeon satisfaction with the sternotomy closure method will be recorded using the Likert scale (1 to 5). | Surgery |
| Chest pain | Patients will assess their chest pain using the NRS (0 to 10) while resting and after forced cough | Before surgery, 3 and 7 days postoperatively, during the first month and during 6 months postoperatively |
| Blood loss | Total blood loss volume obtained from thoracic drainage during the first 12 hours postoperatively will be recorded (mL). | During the first 12 hours postoperatively |
| Upper Limb functional index | Patients will assess their upper limbs functional capacity using the Upper Limb functional index (ULFI-Sp) | Before surgery, one month and 6 months postoperatively |
| Quality of life - EQ5D5L | Patients will complete the EQ-5D-5L questionnaire | Before surgery, one month and 6 months postoperatively |
| Sternal halves union/malunion | Using CT scan images, the separation between the two sternal halves will be measured in mm. Later on, these measurements will be classified as:
| 6 months after surgery |
| Sternal halves alignment | Using CT scan images, the alignment between the two sternal halves will be assessed and classified as:
| 6 months after surgery |
| Sternum integrity | Using CT scan images, the presence of bone cuts, fractures or necrosis will be assessed. | 6 months after surgery |
| Closure system integrity | Using CT scan images, the sternal closure devices integrity will be assessed | 6 months after surgery |
| Barcelona |
| Barcelona |
| 08036 |
| Spain |
| Complejo Hospitalario de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |