Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure (FIX IT ALL)

January 16, 2026 updated by: NEOS Surgery

Clinical Investigation to Evaluate the Use of Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure

The goal of this clinical trial is to learn if a new medical device (SC03 plates) to close the sternum after a sternotomy in patients that have been operated of a cardiac surgery, is safe and effective. The main question it aims to answer is:

Do patients that have the sternum closed with the SC03 plates present a stable sternum one month after surgery?

Researchers will compare the SC03 plates with stainless steel wires (current standard of care to close the sternum).

Participants will:

  • be implanted with the SC03 or stainless steel wires.
  • visit the clinic one month and six months after surgery
  • Keep a diary of their symptoms and analgesia use

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient ≥ 18 years old.
  • Patient who must undergo surgery in which a median or an upper partial sternotomy is indicated.
  • Patients capable of giving their voluntary informed consent to participate in the clinical investigation and from whom written consent has been obtained.
  • Patient able and willing to meet the protocol requirements and to follow postoperative care instructions

Exclusion Criteria:

  • Patient with sternal anomalies, such as bone tumours located in the sternum.
  • Patient with limited sternum bone blood supply.
  • Patient with suspected or known allergies or intolerances to the implants materials: PEEK, carbon fibre, titanium, stainless steel.
  • Patient with severe osteoporosis or other degenerative bone diseases that affect the sternum.
  • Pregnant or breastfeeding patient or patient planning to become pregnant during the first 6 months after surgery.
  • Patient who is currently using opioid analgesics (e.g., morphine, oxycodone, hydrocodone, fentanyl, tramadol) for the management of chronic or acute pain.
  • Patient with diagnosis of dementia with a mental status score (MMSE) < 20.
  • Patient with life expectancy lower than 6 months.
  • Patient with any other medical process that may compromise or limit the adequate functionality of the implants.
  • Patient involved in other interventionist clinical trial or that have been involved in other interventionist clinical trial during the previous 4 weeks.
  • Patient with signs of latent or active infection or inflammation on the surgical site.
  • Patient with insufficient quantity or quality of sternum bone, or other severe structural bone damage.
  • Patient for whom the closure technique cannot ensure sufficient sternal fixation.
  • Parasternal sternotomy.
  • Patient with intraoperative conditions that may compromise or limit the adequate functionality of the implants or that may prevent the surgeon to use the sternal closure system or that cannot be closed following the product instructions for use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SC03 plates
Adjustable carbon fiber sternal plates
Device: SC03 Plating system
Adjustable carbon fiber sternal plates
Active Comparator: Wires
Stainless steel sternal wires
Device: Stainless steel wires
Nonabsorbable, sterile, surgical sutures used in sternal closure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sternal stability
Time Frame: 1 month post operatively
Sternal stability measured by 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 post operatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Upper Limb functional index
Time Frame: Before surgery, one month and 6 months postoperatively
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
Time Frame: Before surgery, one month and 6 months postoperatively
Patients will complete the EQ-5D-5L questionnaire
Before surgery, one month and 6 months postoperatively
Safety of the SC03 Plating System
Time Frame: Perioperative, 1 month and 6 months postoperatively.
Incidence of Device Deficiencies, AE and SAE with a possible, probable or causal relationship with the device or the procedure.
Perioperative, 1 month and 6 months postoperatively.
Reinterventions
Time Frame: 1 month and 6 months postoperatively
Incidence and cause of surgical reinterventions
1 month and 6 months postoperatively
Infections
Time Frame: First month and six months postoperatively.
Incidence of sternal superficial and deep wound infections (mediastinitis)
First month and six months postoperatively.
Sternal dehiscence
Time Frame: First month and six months postoperatively
Incidence of sternal dehiscence (without infection)
First month and six months postoperatively
Sternotomy closure duration
Time Frame: Surgery
Duration of sternotomy closure procedure (minutes)
Surgery
Easiness of use of the closure method
Time Frame: Surgery
Surgeon-reported ease of use and satisfaction score (Likert Scale, from 1 to 5)
Surgery
Sternal Pain
Time Frame: Baseline, 7 days, 1 month and 6 months postoperatively.
Patient-reported sternal pain at rest and during forced cough, measured by Numerical Rating Scale (0-10)
Baseline, 7 days, 1 month and 6 months postoperatively.
Analgesia required
Time Frame: Day 7, 1 month and 6 months postoperatively
Type and cumulative dose of analgesia (total morphine milligram equivalents (MME))
Day 7, 1 month and 6 months postoperatively
Post-surgery blood loss
Time Frame: 12 hours postoperatively
Chest tube drainage (mL)
12 hours postoperatively
Blood loss
Time Frame: 48 hours after surgery
Haemoglobin drop (g/dL)
48 hours after surgery
Blood loss
Time Frame: 48 hour after surgery
Number of administered perioperative blood transfusions of packed red blood cells
48 hour after surgery
Intensive Care Unit stay duration
Time Frame: from surgery date to Intensive care unit discharge date (up to 150 days)]
Intensive Care Unit stay duration (hours)
from surgery date to Intensive care unit discharge date (up to 150 days)]
hospitalization duration
Time Frame: from surgery date to hospital discharge date (up to 150 days)
hospitalization duration (days)
from surgery date to hospital discharge date (up to 150 days)
sternal stability
Time Frame: 7 days and 6 months postoperatively
Sternal stability clinically assessed with the sternal instability scale (from 0 to 3)
7 days and 6 months postoperatively
Chest bulging
Time Frame: 1 month after surgery
Presence of visible bulging related to the sternal closure method on the sternotomy area
1 month after surgery
Pulmonary function
Time Frame: Baseline, day 7 and 1 month postoperatively
Pulmonary function (FVC, FEV1 and FEV1/FVC) measured by spirometry
Baseline, day 7 and 1 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NEOS Surgery

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundacio Privada Mon Clinic Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEO-SC3-2025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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