RCT to Evaluate STERN FIX Device as a Sternal Stabilization System in Patients After Sternotomy (FIXTER-2)

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

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 Overview

• Status: Recruiting
• Conditions: Median Sternotomy
• Intervention / Treatment: Device: Combination of STERN FIX and wires; Device: Wires

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laia Rofes Salsench, PhD; Phone Number: +34 93 594 47 26; Email: lrofes@neosurgery.com
• Study Contact Backup: Name: Daniel Alvarez-Berdugo, PhD; Phone Number: +34 93 594 47 26; Email: dalvarez@neosurgery.com

Study Locations

• Germany
  • Baden-Württemberg
    • Freiburg im Breisgau, Baden-Württemberg, Germany, 79106
      • Not yet recruiting
      • Universitätsklinikum Freiburg
      • Contact: Gabriele Lechner, MA; Phone Number: +49 761 270 61960; Email: gabriele.lechner@uniklinik-freiburg.de
      • Principal Investigator: Matthias Eschenhagen, MD
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona
    • Contact: Nuria Pichel; Phone Number: +34 93 227 57 33; Email: pichel@clinic.cat
    • Contact: Laia Hernández; Phone Number: +34 93 227 57 33; Email: LAHERNANDEZ@clinic.cat
    • Principal Investigator: Manel Castellà Pericás, MD/PhD
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Recruiting
      • Complejo Hospitalario de Navarra
      • Contact: Alicia Gainza Calleja; Phone Number: 23781 848423781; Email: alicia.gainza.calleja@navarra.es
      • Principal Investigator: Facundo Machado Fernández, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: STERN FIX; 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; Closure of the median sternotomy using a combination of at least one STERN FIX device and wires for a total of 5 fixation points.
Active Comparator: Wires; Standard of care median sternotomy closure method with surgical wires	Device: Wires; Closure of the median sternotomy using the standard of care with steel wires.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NEOS Surgery
• Collaborators: Hospital Clinic of Barcelona; Complejo Hospitalario de Navarra; Universitätsklinikum Freiburg
• Investigators: Principal Investigator: Manel Castellà Pericás, MD/PhD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: cardiac surgery; sternotomy; sternal closure
• Other Study ID Numbers: NEO-SC1-2023-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No