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Median SternotomyFIXTER-2NCT05953259

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

A study testing Combination of STERN FIX and wires and Wires in people with Median Sternotomy, run by NEOS Surgery at 5 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Median Sternotomy
What is being tested?
Combination of STERN FIX and wires and Wires
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
5 sitesin 2 countries
Study dates
27 Sep 2023to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 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

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Spain4 sites

  • Hospital Clínic de Barcelona

    Barcelona, Barcelona, 08036

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

Germany1 site

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

Other trials in Germany

About this study

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

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.
Being tested
Combination of STERN FIX and wires, Wires
Keywords
sternal closure, cardiac surgery, sternotomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combination of STERN FIX and wiresDevice

    Closure of the median sternotomy using a combination of at least one STERN FIX device and wires for a total of 5 fixation points.

  • WiresDevice

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

Study groups in NCT05953259
Study groupRoleWhat they receive
STERN FIXActive comparatorCombination of at least one STERN FIX device and surgical wires to close median sternotomy (total of 5 fixation points)
Receives: Device: Combination of STERN FIX and wires
WiresActive comparatorStandard of care median sternotomy closure method with surgical wires
Receives: Device: Wires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sternal stability

    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"

    Measured: 1 month after surgery

Secondary outcomes (18)

  1. Safety SAE/AE prevalence

    All adverse events occurring during the study period will be recorded, except for frequent events after surgical interventions requiring median sternotomy.

    Measured: 6 months after surgery

  2. Safety SAE/AE causality

    All adverse events occurring during the study period will be recorded, except for frequent events after surgical interventions requiring median sternotomy.

    Measured: 6 months after surgery

  3. 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: 6 months after surgery

  4. Reinterventions - prevalence

    Prevalence of reinterventions

    Measured: 6 months after surgery

  5. Reinterventions - Causality

    Causality of reinterventions

    Measured: 6 months after surgery

  6. Prevalence of sternal wound infections

    Prevalence of sternal superficial and deep wound infections

    Measured: 1 month and 6 months after surgery

  7. Prevalence of dehiscence

    Prevalence of dehiscence (without infection)

    Measured: 1 month and 6 months after surgery

  8. Sternal closure time

    Measured time from the implantation of the first wire to the closure of the last wire (minutes)

    Measured: Surgery

  9. Easiness of use of the closure method

    The surgeon perceived difficulty of the sternal closure method will be recorded using the Likert scale (1 to 5).

    Measured: Surgery

  10. Surgeon satisfaction of the closure method

    General surgeon satisfaction with the sternotomy closure method will be recorded using the Likert scale (1 to 5).

    Measured: Surgery

  11. Chest pain

    Patients will assess their chest pain using the NRS (0 to 10) while resting and after forced cough

    Measured: Before surgery, 3 and 7 days postoperatively, during the first month and during 6 months postoperatively

  12. Blood loss

    Total blood loss volume obtained from thoracic drainage during the first 12 hours postoperatively will be recorded (mL).

    Measured: During the first 12 hours postoperatively

  13. Upper Limb functional index

    Patients will assess their upper limbs functional capacity using the Upper Limb functional index (ULFI-Sp)

    Measured: Before surgery, one month and 6 months postoperatively

  14. Quality of life - EQ5D5L

    Patients will complete the EQ-5D-5L questionnaire

    Measured: Before surgery, one month and 6 months postoperatively

  15. Sternal halves union/malunion

    Using CT scan images, the separation between the two sternal halves will be measured in mm. Later on, these measurements will be classified as:

    • Malunion: more than 3mm of separation
    • Mild malunion: between 1 and 3mm of separation
    • Union: less than 1mm of separation

    Measured: 6 months after surgery

  16. Sternal halves alignment

    Using CT scan images, the alignment between the two sternal halves will be assessed and classified as:

    • Misalignment: <50% alignment between sternal halves
    • Aligned: >50% de alignment between halves

    Measured: 6 months after surgery

  17. Sternum integrity

    Using CT scan images, the presence of bone cuts, fractures or necrosis will be assessed.

    Measured: 6 months after surgery

  18. Closure system integrity

    Using CT scan images, the sternal closure devices integrity will be assessed

    Measured: 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2023
  2. Study start27 Sep 2023
  3. Primary completion26 Jun 2025
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05953259
Sponsor's protocol ID
NEO-SC1-2023-01
Acronym
FIXTER-2
Status last verified
Sep 2025
First submitted
3 Jul 2023
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Combination of STERN FIX and wires and Wires in people with Median Sternotomy, run by NEOS Surgery at 5 sites in 2 countries.

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 12 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: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain, Germany. 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?

This study is still under way. Results are not available in the source record yet.

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: 1 month after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05953259.

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 22 Sep 2025.

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