RCT to Evaluate STERN FIX Device as a Sternal Stabilization System in Patients After Sternotomy

Study Overview
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Brief Summary
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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.

Official Title
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Randomised Controlled Clinical Trial to Evaluate STERN FIX Device as a Sternal Stabilization System in Patients After Sternotomy

Conditions
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Median Sternotomy

Intervention / Treatment
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* Device: Combination of STERN FIX and wires
* Device: Wires


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: STERN FIX<br>Combination of at least one STERN FIX device and surgical wires to close median sternotomy (total of 5 fixation points) | Device: Combination of STERN FIX and wires<br>* Closure of the median sternotomy using a combination of at least one STERN FIX device and wires for a total of 5 fixation points.<br>|
| Active Comparator: Wires<br>Standard of care median sternotomy closure method with surgical wires | Device: Wires<br>* Closure of the median sternotomy using the standard of care with steel wires.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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: Malunion: more than 3mm of separation Mild malunion: between 1 and 3mm of separation Union: less than 1mm of separation | 6 months after surgery | 
| Sternal halves alignment | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sternal closure, cardiac surgery, sternotomy