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

N/AActive Not RecruitingNCT05953259

NEOS Surgery90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Median Sternotomy

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Outcomes

Primary Outcomes

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"

Time frame: 1 month after surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months after surgery

Reinterventions - prevalence

Prevalence of reinterventions

Time frame: 6 months after surgery

Reinterventions - Causality

Causality of reinterventions

Time frame: 6 months after surgery

Prevalence of sternal wound infections

Prevalence of sternal superficial and deep wound infections

Time frame: 1 month and 6 months after surgery

Prevalence of dehiscence

Prevalence of dehiscence (without infection)

Time frame: 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)

Time frame: 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).

Time frame: 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).

Time frame: Surgery

Chest pain

Patients will assess their chest pain using the NRS (0 to 10) while resting and after forced cough

Time frame: 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).

Time frame: 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)

Time frame: Before surgery, one month and 6 months postoperatively

Quality of life - EQ5D5L

Patients will complete the EQ-5D-5L questionnaire

Time frame: 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

Time frame: 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

Time frame: 6 months after surgery

Sternum integrity

Using CT scan images, the presence of bone cuts, fractures or necrosis will be assessed.

Time frame: 6 months after surgery

Closure system integrity

Using CT scan images, the sternal closure devices integrity will be assessed

Time frame: 6 months after surgery