Median Sternotomy
Conditions
Keywords
sternal closure, cardiac surgery, sternotomy
Brief summary
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.
Interventions
DEVICECombination of STERN FIX and wires
Closure of the median sternotomy using a combination of at least one STERN FIX device and wires for a total of 5 fixation points.
DEVICEWires
Closure of the median sternotomy using the standard of care with steel wires.
Sponsors
Hospital Clinic of Barcelona
Complejo Hospitalario de Navarra
Universitätsklinikum Freiburg
NEOS Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and primary outcome assessors will not know whether the allocated sternotomy closure system is STERN FIX or wires only.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient undergoing surgery that requires median sternotomy * Patients with at least one of the following risk criteria: obesity (BMI\>30), diabetes, COPD, non serious osteoporosis (not associated with fractures), creatinine \> 200 µmol/L and/or under dialysis treatment, scheduled Bilateral Internal Mammary Artery (BIMA) grafting * Patients willing and capable of granting informed consent to participate in clinical research and who have granted written consent * Patient willing and capable of complying with the protocol requirements
Exclusion criteria
* Patient with suspected or known allergies or intolerance to the device material (PEEK - polyether-ether-ketone and carbon fibre) * Patient with insufficient quality or quantity of bone or any other serious structural bone damage at the sternum * Patient with serious osteoporosis (associated with fractures) or a degenerative bone disease affecting the sternum * Patients with a latent or active infection or inflammation at the surgical area, that according to the surgeon criteria may interfere in the device implantation or proper function. * Patient with sternal anomalies that, according to the surgeon criteria, prevent the use of the product, such as bone tumours in the implantation area. * Pregnant patients or patients planning to become pregnant during the first 6 months after surgery. * Patients with diagnosis of dementia with a mental status score (MMSE) \< 20. * Patients with life expectancy lower than 6 months. * Patients involved in other interventionist clinical trials or that have been involved in other interventionist clinical trials during the previous 4 weeks * Parasternal sternotomy. * Patients with intraoperative conditions that, according to the surgeon's opinion, require or exclude the use of a specific sternal closure system, or that cannot be closed following the study products instructions for use. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sternal stability | 1 month after surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of dehiscence | 1 month and 6 months after surgery | Prevalence of dehiscence (without infection) |
| Sternal closure time | Surgery | Measured time from the implantation of the first wire to the closure of the last wire (minutes) |
| Easiness of use of the closure method | Surgery | The surgeon perceived difficulty of the sternal closure method will be recorded using the Likert scale (1 to 5). |
| Safety SAE/AE prevalence | 6 months after surgery | All adverse events occurring during the study period will be recorded, except for frequent events after surgical interventions requiring median sternotomy. |
| Safety SAE/AE causality | 6 months after surgery | All adverse events occurring during the study period will be recorded, except for frequent events after surgical interventions requiring median sternotomy. |
| Prevalence of device deficiencies | 6 months after surgery | 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. |
| Reinterventions - prevalence | 6 months after surgery | Prevalence of reinterventions |
| Reinterventions - Causality | 6 months after surgery | Causality of reinterventions |
| Prevalence of sternal wound infections | 1 month and 6 months after surgery | Prevalence of sternal superficial and deep wound infections |
| Chest pain | Before surgery, 3 and 7 days postoperatively, during the first month and during 6 months postoperatively | Patients will assess their chest pain using the NRS (0 to 10) while resting and after forced cough |
| Blood loss | During the first 12 hours postoperatively | Total blood loss volume obtained from thoracic drainage during the first 12 hours postoperatively will be recorded (mL). |
| Upper Limb functional index | Before surgery, one month and 6 months postoperatively | Patients will assess their upper limbs functional capacity using the Upper Limb functional index (ULFI-Sp) |
| Quality of life - EQ5D5L | Before surgery, one month and 6 months postoperatively | Patients will complete the EQ-5D-5L questionnaire |
| Sternal halves union/malunion | 6 months after surgery | Using CT scan images, the separation between the two sternal halves will be measured in mm. Later on, these measurements will be classified as: * Malunion: more than 3mm of separation * Mild malunion: between 1 and 3mm of separation * Union: less than 1mm of separation |
| Sternal halves alignment | 6 months after surgery | Using CT scan images, the alignment between the two sternal halves will be assessed and classified as: * Misalignment: \<50% alignment between sternal halves * Aligned: \>50% de alignment between halves |
| Sternum integrity | 6 months after surgery | Using CT scan images, the presence of bone cuts, fractures or necrosis will be assessed. |
| Closure system integrity | 6 months after surgery | Using CT scan images, the sternal closure devices integrity will be assessed |
| Surgeon satisfaction of the closure method | Surgery | General surgeon satisfaction with the sternotomy closure method will be recorded using the Likert scale (1 to 5). |
Countries
Germany, Spain
Outcome results
None listed