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

NCT05953259 | Active Not Recruiting

• 1 other identifier: NEO-SC1-2023-01
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 5

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.

Conditions

Median Sternotomy

Keywords

sternal closure; cardiac surgery; sternotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Safety SAE/AE prevalence

  6 months after surgery

• Safety SAE/AE causality

  6 months after surgery

• Prevalence of device deficiencies

  6 months after surgery

• Reinterventions - prevalence

  6 months after surgery

• Reinterventions - Causality

  6 months after surgery

Study Arms (2)

STERN FIX

ACTIVE COMPARATOR

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

Wires

ACTIVE COMPARATOR

Standard of care median sternotomy closure method with surgical wires

Device: Wires

Interventions

Combination of STERN FIX and wires DEVICE

Closure of the median sternotomy using a combination of at least one STERN FIX device and wires for a total of 5 fixation points.

STERN FIX

Wires DEVICE

Closure of the median sternotomy using the standard of care with steel wires.

Wires

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NEOS Surgery: lead
• Hospital Clinic of Barcelona: collaborator
• Complejo Hospitalario de Navarra: collaborator
• Universitätsklinikum Freiburg: collaborator

Study Sites (5)

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

MeSH Terms

Interventions

Bone Wires

Intervention Hierarchy (Ancestors)

Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• Manel Castellà Pericás, MD/PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and primary outcome assessors will not know whether the allocated sternotomy closure system is STERN FIX or wires only.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 20, 2023
• Study Start: September 27, 2023
• Primary Completion: June 26, 2025
• Study Completion: December 31, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

DE (1); ES (4)