SternotomyNCT04593732
STERN FIX Device As a Sternal Fixation System
A study testing STERN FIX (Sternal Stabilization System) in people with Sternotomy, run by NEOS Surgery at 1 site in Spain.
Trial summary
Pre-market clinical research, prospective, single-arm that aims to assess the sternal sealing in patients in which the sternum has been fixed with the STERN FIX system. 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 (Sternal Stabilization System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 12 Dec 2021to 25 Jan 2023
- Phase
- Interventional
- 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
Who may be able to join
- Patient over 18 years old.
- Patient who must have surgery in which a medium sternotomy is indicated.
- Subjects able to give their voluntary informed consent to participate in clinical research and from which written consent has been obtained.
- The subject is able to meet the requirements of the protocol and is willing to do so.
Who cannot join
- Patient with suspicious or known allergies or intolerance to implant material (PEEK - polyetheretherketone).
- Patient with limitations in blood supply, insufficient bone quantity or quality, severe osteoporosis, osteomalacia or other serious bone structural damage, which, at the surgeon's discretion, may interfere with the implantation or proper functioning of the product.
- Degenerative bone diseases.
- Patients with a latent or active infection or inflammation in the operating area that, at the surgeon's discretion, may interfere with the implantation or proper functioning of the product.
- Patients with fever or leukocytosis.
- Patient with spinal abnormalities that, according to the surgeon's discretion, prevent the use of the product, such as bone tumors located in the implant region.
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- Patients who are pregnant or interested in becoming pregnant within 6 months of surgery.
- Nursing patients.
- Patients with life expectancy less than 6 months.
- Patients who are participating in or participating in the previous 4 weeks in another interventional clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation to Evaluate the STERN FIX Device As a Sternal Fixation System in Medium Sternotomy
Pre-market clinical research, prospective, single-arm that aims to assess the sternal sealing in patients in which the sternum has been fixed with the STERN FIX system.
- Conditions
- Sternotomy
- Being tested
- STERN FIX (Sternal Stabilization System)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STERN FIX (Sternal Stabilization System)Device
Sternotomy closure with STERN FIX and supplemented with wires
| Study group | Role | What they receive |
|---|---|---|
| STERN FIX (Sternal Stabilization System) | Experimental | Sternotomy closure with STERN FIX and supplemented with wires Receives: Device: STERN FIX (Sternal Stabilization System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sternal stability according to clinical evaluation
sternal instability scale (SIS) grade: from 0 (Clinically stable sternum ) to 3 Completely separated sternum
Measured: 1 month post-surgery
Secondary outcomes (15)
sternal stability according to clinical evaluation
sternal instability scale (SIS) grade: from 0 (Clinically stable sternum ) to 3 Completely separated sternum
Measured: 7 days post-surgery, 6 months
Prevalence of patients with dehiscence (without infection)
Measured: 6 months
Prevalence and causality of adverse events
Measured: 6 months
Prevalence of device deficiencies
Measured: 6 months
Prevalence of reinterventions
Measured: 6 months
Prevalence of superficial and deep sternal wound infections
Measured: 6 months
Prevalence of patients with compromised sternal integrity
Measured: 6 months
Prevalence of artefacts associated with the product in medical images
Measured: 6 months
Time to close the sternal (minutes)
Measured: surgery
Surgeon satisfaction score
Likert scale [1-5]
Measured: immediately post-surgery
Chest Pain
Numeric Rating Scale [0-10]
Measured: pre-surgery, 7 days post-surgery, 1 month, 6 months
Upper limb functionality
Upper Limb Functional Index (spanish version) score (0-100%)
Measured: pre-surgery, 7 days post-surgery, 1 month, 6 months
Quality of life measured with EuroQol-5D-5L
EuroQol-5D-5L
Measured: pre-surgery, 7 days post-surgery, 1 month, 6 months
Working status
[Fully employed/ Working with restrictions/ Unemployed/ On sick leave/ Retired]
Measured: pre-surgery, 6 months
Sternal healing grade according to CT results
Healing score, between 0: No sign of healing, nonunion and 5: complete synthesis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start12 Dec 2021
- Primary completion5 Sep 2022
- Study completion25 Jan 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NEOS Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593732
- Sponsor's protocol ID
- NEO-SC1-2020-01
- Status last verified
- Jan 2025
- First submitted
- 5 Oct 2020
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Evaluate the STERN FIX Device As a Sternal Fixation System in Medium Sternotomy
- ClinicalTrials.gov ID
- NCT04593732
- Acronym / sponsor ID
- NEO-SC1-2020-01
- Conditions
- Sternotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NEOS SurgeryIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2021 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 20 Oct 2020 (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.
Pre-market clinical research, prospective, single-arm that aims to assess the sternal sealing in patients in which the sternum has been fixed with the STERN FIX system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STERN FIX (Sternal Stabilization System) | Experimental | Device: STERN FIX (Sternal Stabilization System)Sternotomy closure with STERN FIX and supplemented with wires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over 18 years old.
- Patient who must have surgery in which a medium sternotomy is indicated.
- Subjects able to give their voluntary informed consent to participate in clinical research and from which written consent has been obtained.
- The subject is able to meet the requirements of the protocol and is willing to do so.
Key exclusion criteria (10 listed)
- Patient with suspicious or known allergies or intolerance to implant material (PEEK - polyetheretherketone).
- Patient with limitations in blood supply, insufficient bone quantity or quality, severe osteoporosis, osteomalacia or other serious bone structural damage, which, at the surgeon's discretion, may interfere with the implantation or proper functioning of the product.
- Degenerative bone diseases.
- Patients with a latent or active infection or inflammation in the operating area that, at the surgeon's discretion, may interfere with the implantation or proper functioning of the product.
- Patients with fever or leukocytosis.
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 FIX (Sternal Stabilization System)Sternotomy closure with STERN FIX and supplemented with wires | Device | STERN FIX (Sternal Stabilization System) |
Primary outcome
Sternal stability according to clinical evaluation
Time frame: 1 month post-surgery
sternal instability scale (SIS) grade: from 0 (Clinically stable sternum ) to 3 Completely separated sternum
15 secondary outcomes
sternal stability according to clinical evaluation
Time frame: 7 days post-surgery, 6 months
Prevalence of patients with dehiscence (without infection)
Time frame: 6 months
Prevalence and causality of adverse events
Time frame: 6 months
Prevalence of device deficiencies
Time frame: 6 months
Prevalence of reinterventions
Time frame: 6 months
Prevalence of superficial and deep sternal wound infections
Time frame: 6 months
Prevalence of patients with compromised sternal integrity
Time frame: 6 months
Prevalence of artefacts associated with the product in medical images
Time frame: 6 months
Time to close the sternal (minutes)
Time frame: surgery
Surgeon satisfaction score
Time frame: immediately post-surgery
Chest Pain
Time frame: pre-surgery, 7 days post-surgery, 1 month, 6 months
Upper limb functionality
Time frame: pre-surgery, 7 days post-surgery, 1 month, 6 months
Quality of life measured with EuroQol-5D-5L
Time frame: pre-surgery, 7 days post-surgery, 1 month, 6 months
Working status
Time frame: pre-surgery, 6 months
Sternal healing grade according to CT results
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 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?
A study testing STERN FIX (Sternal Stabilization System) in people with Sternotomy, run by NEOS Surgery at 1 site in Spain.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 9 Jan 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 Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 according to clinical evaluation (time frame: 1 month post-surgery). 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 9 Jan 2025.