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

NEOS Surgery5 sites in 2 countries90 target enrollmentSeptember 27, 2023

ConditionsMedian Sternotomy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Median Sternotomy
Sponsor: NEOS Surgery
Enrollment: 90
Locations: 5
Primary Endpoint: Sternal stability
Status: Active, not recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 27, 2023

End Date

December 31, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NEOS Surgery

Responsible Party

Sponsor

Eligibility Criteria

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) \<
•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.

Outcomes

Primary Outcomes

Sternal stability

Time Frame: 1 month after surgery

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"

Secondary Outcomes

Safety SAE/AE causality(6 months after surgery)
Prevalence of sternal wound infections(1 month and 6 months after surgery)
Prevalence of device deficiencies(6 months after surgery)
Reinterventions - prevalence(6 months after surgery)
Sternum integrity(6 months after surgery)
Safety SAE/AE prevalence(6 months after surgery)
Reinterventions - Causality(6 months after surgery)
Prevalence of dehiscence(1 month and 6 months after surgery)
Surgeon satisfaction of the closure method(Surgery)
Chest pain(Before surgery, 3 and 7 days postoperatively, during the first month and during 6 months postoperatively)
Sternal closure time(Surgery)
Easiness of use of the closure method(Surgery)
Quality of life - EQ5D5L(Before surgery, one month and 6 months postoperatively)
Sternal halves alignment(6 months after surgery)
Closure system integrity(6 months after surgery)
Blood loss(During the first 12 hours postoperatively)
Upper Limb functional index(Before surgery, one month and 6 months postoperatively)
Sternal halves union/malunion(6 months after surgery)