SternotomyNCT05784532
Sternal Fixation With STERN FIX After Medial Sternotomy
An observational study of Sternotomy, run by NEOS Surgery at 1 site in United States.
Trial summary
The goal of this single arm observational registry is to evaluate the safety and performance of the STERN FIX device in normal conditions of use, in patients treated with medial sternotomy according to the instructions for use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sternotomy
- What is being tested?
- STERN FIX
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 1 Jan 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All those patients that have or will undergo medial sternotomy during the registry period will be considered for inclusion. They will be informed about it, and if they consent for their data to be used in the registry, their eligibility will be assessed. If a patient does not comply with all IFUs indications, they will not be included in the registry
Who may be able to join
- Older than 18 years old patient
- Patient undergoing surgery requiring medial sternotomy
- Patient able and willing to provide informed consent to participate in the registry and/or who have provided written consent to have their clinical data added to the registry
Who cannot join
- Patients that are still growing.
- Patients with Sternal anomalies preventing the use of the STERN FIX Sternal Stabilization System, such as bone tumors located in the implant region.
- Patient with conditions previous to surgery that may impact healing, including bone blood supply limitations, insufficient quantity or quality of bone, or other severe structural bone damage.
- Patients with suspected or known allergies or intolerances to the implant material.
- Patients with severe osteoporosis or other degenerative bone diseases.
- Any patient unwilling to, or incapable of, following postoperative care instructions.
Show all 16Show fewer
- Patients with any other medical or surgical process that may compromise or limit the adequate functionality of the implant.
- Pregnant patients or planning to become pregnant during the 2 months following surgery.
- Patients with life expectancy lower than 2 months.
- Patients who are or have been participating in an interventionist trial during the last 4 weeks
- Intraoperative exclusion criteria
- Latent or active infection, or inflammation in the operating area.
- Signs of infection on the surgical site.
- Parasternal sternotomy.
- When the STERN FIX Sternal Stabilization System cannot ensure sufficient fixation.
- When a STERN FIX Sternal Stabilization System device cannot be placed properly in any intercostal space.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York-Presbyterian Hospital
Ney York, New York, 10032
About this study
The goal of this single arm observational registry is to evaluate the safety and performance of the STERN FIX device in normal conditions of use, in patients treated with medial sternotomy according to the instructions for use.
The main goal of this registry is to evaluate the sternal stability in patients who had their sternum fixed with the STERN FIX system.
Participants will have their sternotomy closed with the STERN FIX device at the end of their cardiothoracic surgery and will be followed up as per standard of care. At discharge and at the 1 month FU visit the sternal stability will be assessed using the sternal instability scale (SIS).
- Conditions
- Sternotomy
- Being tested
- STERN FIX
- Keywords
- Rigid Fixation, Sternal Closure, STERN FIX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STERN FIXDevice
Also called Sternal stabilization system
Sternotomy closure with STERN FIX and supplemented with wires
| Study group | Role | What they receive |
|---|---|---|
| STERN FIX | Patients undergoing cardiothoracic surgery through median sternotomy, once the main intervention is finished, will have their sternum closed using the sternal stabilization system STERN FIX in combination with wires according to the STERN FIX instructions for use. Receives: Device: STERN FIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sternal stability
The primary outcome for this registry will be the sternal stability assessed with the sternal instability scale (SIS). The SIS is a scale ranging from 0 to 3 with the following descriptors:
- 0. Clinically stable sternum (no detectable motion) - normal
- 1. Minimally separated sternum (slight increase in motion upon special testing* - upper limbs, trunk)
- 2. Partially separated sternum - regional (moderate increase in motion upon special testing*)
- 3. Completely separated sternum - entire length (marked increase in motion upon special testing*)
Measured: One month postoperatively
Secondary outcomes (6)
Prevalence and type of AE and SAE
All adverse events occurring during the study period related to the sternotomy must be recorded. The AE that should be recorded, include:
- Any device complication (wire o STERN FIX fracture, rotation, migration, …)
- Surgical complications: any injury caused by the devices or instruments.
- Tissue reactions to implant materials.
- Damage to the tissues surrounding the devices.
- Osseous complications (fractures, sternal dehiscence, malunion, nonunion, instability, necrosis, calcification, decrease in bone density….).
- Postoperative hematoma/ bleeding.
- Infectious complications (superficial wound infections, mediastinitis, abscess …).
- Increased fibrous tissue, keloid or seroma formation in the sternotomy area.
- Any other AE that the investigator considers relevant for the registry.
Measured: Through study completion, an average of 6 months
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.
Measured: Through study completion, an average of 6 months
Sternal closure time
Time elapsed from the measurement of the intercostal spaces to the closure of the last intercostal space.
Measured: Surgery
Easiness of implantation of the device (Likert)
The easiness score assessed by the surgeon about the usage of the medical device will be registered according to the Likert scale (1-5) with the following descriptors:
- 5. Very easy
- 4. Easy
- 3. Neither easy or difficult
- 2. Difficult
- 1. Very difficult
Measured: Immediately after surgery
Easiness of implantation of the device (assistance)
The surgeon will indicate whether they requested external assistance during the implantation of the device
Measured: Immediately after surgery
Surgeon satisfaction for the use of the device
The surgeon general satisfaction with the sternotomy closure using STERN FIX will be assessed in comparison with the usual wire closure using the Likert scale (1-5) with the following descriptors:
- 5. Very satisfied
- 4. Satisfied
- 3. Neither satisfied or dissatisfied
- 2. Dissatisfied
- 1. Very dissatisfied
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Apr 2023
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Why it stopped: Participating sites could not perform recruitment due to administrative obstacles that could not be addressed. Sponsor decided in agreement with sites to withdraw the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SternotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- NEOS Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Anagram-ESIC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784532
- Sponsor's protocol ID
- NEO-SC1-2022-01
- Status last verified
- Oct 2025
- First submitted
- 20 Feb 2023
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sternal Fixation With STERN FIX After Medial Sternotomy
- ClinicalTrials.gov ID
- NCT05784532
- Acronym / sponsor ID
- NEO-SC1-2022-01
- Conditions
- Sternotomy
- Keywords
- Rigid Fixation, Sternal Closure, STERN FIX
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Participating sites could not perform recruitment due to administrative obstacles that could not be addressed. Sponsor decided in agreement with sites to withdraw the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NEOS SurgeryIndustry (pharma, biotech, devices)
- Collaborators
- Anagram-ESIC
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this single arm observational registry is to evaluate the safety and performance of the STERN FIX device in normal conditions of use, in patients treated with medial sternotomy according to the instructions for use.
The main goal of this registry is to evaluate the sternal stability in patients who had their sternum fixed with the STERN FIX system.
Participants will have their sternotomy closed with the STERN FIX device at the end of their cardiothoracic surgery and will be followed up as per standard of care. At discharge and at the 1 month FU visit the sternal stability will be assessed using the sternal instability scale (SIS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STERN FIX | – | Device: STERN FIXPatients undergoing cardiothoracic surgery through median sternotomy, once the main intervention is finished, will have their sternum closed using the sternal stabilization system STERN FIX in combination with wires according to the STERN FIX instructions for use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All those patients that have or will undergo medial sternotomy during the registry period will be considered for inclusion. They will be informed about it, and if they consent for their data to be used in the registry, their eligibility will be assessed. If a patient does not comply with all IFUs indications, they will not be included in the registry
Key inclusion criteria (3 listed)
- Older than 18 years old patient
- Patient undergoing surgery requiring medial sternotomy
- Patient able and willing to provide informed consent to participate in the registry and/or who have provided written consent to have their clinical data added to the registry
Key exclusion criteria (16 listed)
- Patients that are still growing.
- Patients with Sternal anomalies preventing the use of the STERN FIX Sternal Stabilization System, such as bone tumors located in the implant region.
- Patient with conditions previous to surgery that may impact healing, including bone blood supply limitations, insufficient quantity or quality of bone, or other severe structural bone damage.
- Patients with suspected or known allergies or intolerances to the implant material.
- Patients with severe osteoporosis or other degenerative bone diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STERN FIXAlso: Sternal stabilization systemSternotomy closure with STERN FIX and supplemented with wires | Device | STERN FIX |
Primary outcome
Sternal stability
Time frame: One month postoperatively
The primary outcome for this registry will be the sternal stability assessed with the sternal instability scale (SIS). The SIS is a scale ranging from 0 to 3 with the following descriptors: * 0. Clinically stable sternum (no detectable motion) - normal * 1. Minimally separated sternum (slight increase in motion upon special testing* - upper limbs, trunk) * 2. Partially separated sternum - regional (moderate increase in motion upon special testing*) * 3. Completely separated sternum - entire length (marked increase in motion upon special testing*)
6 secondary outcomes
Prevalence and type of AE and SAE
Time frame: Through study completion, an average of 6 months
Prevalence of device deficiencies.
Time frame: Through study completion, an average of 6 months
Sternal closure time
Time frame: Surgery
Easiness of implantation of the device (Likert)
Time frame: Immediately after surgery
Easiness of implantation of the device (assistance)
Time frame: Immediately after surgery
Surgeon satisfaction for the use of the device
Time frame: Immediately after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sternotomy, run by NEOS Surgery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sternal stability (time frame: One month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.