Sternotomy Closure,Open Heart SurgeryFIX IT ALLNCT07366203
Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure
A study testing SC03 Plating system and Stainless steel wires in people with Sternotomy Closure,Open Heart Surgery, run by NEOS Surgery.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sternotomy Closure,Open Heart Surgery
- What is being tested?
- SC03 Plating system and Stainless steel wires
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Dec 2027
- 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 ≥ 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
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Conditions
- Sternotomy Closure,Open Heart Surgery
- Being tested
- SC03 Plating system, Stainless steel wires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC03 Plating systemDevice
Adjustable carbon fiber sternal plates
Stainless steel wiresDevice
Nonabsorbable, sterile, surgical sutures used in sternal closure
| Study group | Role | What they receive |
|---|---|---|
| SC03 plates | Experimental | Adjustable carbon fiber sternal plates Receives: Device: SC03 Plating system |
| Wires | Active comparator | Stainless steel sternal wires Receives: Device: Stainless steel wires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sternal stability
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"
Measured: 1 month post operatively
Secondary outcomes (18)
Safety of the SC03 Plating System
Incidence of Device Deficiencies, AE and SAE with a possible, probable or causal relationship with the device or the procedure.
Measured: Perioperative, 1 month and 6 months postoperatively.
Reinterventions
Incidence and cause of surgical reinterventions
Measured: 1 month and 6 months postoperatively
Infections
Incidence of sternal superficial and deep wound infections (mediastinitis)
Measured: First month and six months postoperatively.
Sternal dehiscence
Incidence of sternal dehiscence (without infection)
Measured: First month and six months postoperatively
Sternotomy closure duration
Duration of sternotomy closure procedure (minutes)
Measured: Surgery
Easiness of use of the closure method
Surgeon-reported ease of use and satisfaction score (Likert Scale, from 1 to 5)
Measured: Surgery
Sternal Pain
Patient-reported sternal pain at rest and during forced cough, measured by Numerical Rating Scale (0-10)
Measured: Baseline, 7 days, 1 month and 6 months postoperatively.
Analgesia required
Type and cumulative dose of analgesia (total morphine milligram equivalents (MME))
Measured: Day 7, 1 month and 6 months postoperatively
Post-surgery blood loss
Chest tube drainage (mL)
Measured: 12 hours postoperatively
Blood loss
Haemoglobin drop (g/dL)
Measured: 48 hours after surgery
Blood loss
Number of administered perioperative blood transfusions of packed red blood cells
Measured: 48 hour after surgery
Intensive Care Unit stay duration
Intensive Care Unit stay duration (hours)
Measured: from surgery date to Intensive care unit discharge date (up to 150 days)]
hospitalization duration
hospitalization duration (days)
Measured: from surgery date to hospital discharge date (up to 150 days)
sternal stability
Sternal stability clinically assessed with the sternal instability scale (from 0 to 3)
Measured: 7 days and 6 months postoperatively
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
Quality of life - EQ5D5L
Patients will complete the EQ-5D-5L questionnaire
Measured: Before surgery, one month and 6 months postoperatively
Chest bulging
Presence of visible bulging related to the sternal closure method on the sternotomy area
Measured: 1 month after surgery
Pulmonary function
Pulmonary function (FVC, FEV1 and FEV1/FVC) measured by spirometry
Measured: Baseline, day 7 and 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sternotomy Closure,Open Heart SurgeryStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NEOS Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundacio Privada Mon Clinic Barcelona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366203
- Sponsor's protocol ID
- NEO-SC3-2025-01
- Acronym
- FIX IT ALL
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Evaluate the Use of Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure
- ClinicalTrials.gov ID
- NCT07366203
- Acronym / sponsor ID
- FIX IT ALL / NEO-SC3-2025-01
- Conditions
- Sternotomy Closure,Open Heart Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- NEOS SurgeryIndustry (pharma, biotech, devices)
- Collaborators
- Fundacio Privada Mon Clinic Barcelona
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Jan 2026 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SC03 plates | Experimental | Device: SC03 Plating systemAdjustable carbon fiber sternal plates |
| Wires | Active comparator | Device: Stainless steel wiresStainless steel sternal 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 ≥ 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
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| SC03 Plating systemAdjustable carbon fiber sternal plates | Device | SC03 plates |
| Stainless steel wiresNonabsorbable, sterile, surgical sutures used in sternal closure | Device | Wires |
Primary outcome
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"
18 secondary outcomes
Safety of the SC03 Plating System
Time frame: Perioperative, 1 month and 6 months postoperatively.
Reinterventions
Time frame: 1 month and 6 months postoperatively
Infections
Time frame: First month and six months postoperatively.
Sternal dehiscence
Time frame: First month and six months postoperatively
Sternotomy closure duration
Time frame: Surgery
Easiness of use of the closure method
Time frame: Surgery
Sternal Pain
Time frame: Baseline, 7 days, 1 month and 6 months postoperatively.
Analgesia required
Time frame: Day 7, 1 month and 6 months postoperatively
Post-surgery blood loss
Time frame: 12 hours postoperatively
Blood loss
Time frame: 48 hours after surgery
Blood loss
Time frame: 48 hour after surgery
Intensive Care Unit stay duration
Time frame: 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)
sternal stability
Time frame: 7 days and 6 months postoperatively
Upper Limb functional index
Time frame: Before surgery, one month and 6 months postoperatively
Quality of life - EQ5D5L
Time frame: Before surgery, one month and 6 months postoperatively
Chest bulging
Time frame: 1 month after surgery
Pulmonary function
Time frame: Baseline, day 7 and 1 month postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing SC03 Plating system and Stainless steel wires in people with Sternotomy Closure,Open Heart Surgery, run by NEOS Surgery.
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 15 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: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Laia Rofes, PhD (+34935944726, lrofes@neosurgery.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sternal stability (time frame: 1 month post operatively). 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 26 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.