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

Median Sternotomy Clinical Trial

— FIXTER-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05953259
• Other study ID #: NEO-SC1-2023-01
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: October 2023
• Source: NEOS Surgery
• Contact: Laia Rofes Salsench, PhD
• Phone: +34 93 594 47 26
• Email: lrofes[@]neosurgery.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 31, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Median Sternotomy

Intervention

Device:
• Combination 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.
• Wires
Closure of the median sternotomy using the standard of care with steel wires.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Freiburg	Freiburg im Breisgau	Baden-Württemberg
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra

Sponsors (4)

Lead Sponsor	Collaborator
NEOS Surgery	Complejo Hospitalario de Navarra, Hospital Clinic of Barcelona, Universitätsklinikum Freiburg

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Reinterventions - prevalence	Prevalence of reinterventions	6 months after surgery
Secondary	Reinterventions - Causality	Causality of reinterventions	6 months after surgery
Secondary	Prevalence of sternal wound infections	Prevalence of sternal superficial and deep wound infections	1 month and 6 months after surgery
Secondary	Prevalence of dehiscence	Prevalence of dehiscence (without infection)	1 month and 6 months after surgery
Secondary	Sternal closure time	Measured time from the implantation of the first wire to the closure of the last wire (minutes)	Surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Quality of life - EQ5D5L	Patients will complete the EQ-5D-5L questionnaire	Before surgery, one month and 6 months postoperatively
Secondary	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
Secondary	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
Secondary	Sternum integrity	Using CT scan images, the presence of bone cuts, fractures or necrosis will be assessed.	6 months after surgery
Secondary	Closure system integrity	Using CT scan images, the sternal closure devices integrity will be assessed	6 months after surgery