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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-27

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

STEELEX® Sternum Set + BONE WAX® + STEELEX® Electrode Set in Patients Undergoing Cardiac Surgery

NCT06065800

Sternum Closure

COMPLETED

Comparative Study Between Sternal Closure With Sternalock® Blue Versus Steel Wire Submitted To Bilateral Anterior Transsternal Thoracotomy (Clamshell) For Bilateral Lung Transplant

NCT05055739

Lung Lung Transplant

UNKNOWN NA

Study Comparing Steel Wire to a Flat, Braided Suture to Close the Breastbone

NCT04743895

Sternotomy

COMPLETED NA

Risk of Pneumothorax With and Without Chest Tube Clamping in Patients With Pleural Pathology

NCT05243316

Pneumothorax Chest Tube Pleural Diseases

COMPLETED NA

Thoracostomy Tube Irrigation: a Multi-Center Trial

NCT05935267

Thoracic Trauma

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Median Sternotomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants and primary outcome assessors will not know whether the allocated sternotomy closure system is STERN FIX or wires only.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

STERN FIX

Combination of at least one STERN FIX device and surgical wires to close median sternotomy (total of 5 fixation points)

Group Type ACTIVE_COMPARATOR

Combination of STERN FIX and wires

Intervention Type 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.

Wires

Standard of care median sternotomy closure method with surgical wires

Group Type ACTIVE_COMPARATOR

Wires

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Wires

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No