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

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: Not yet recruiting
• Conditions: Sternotomy Closure,Open Heart Surgery
• Intervention / Treatment: Device: SC03 Plating system; Device: Stainless steel wires

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laia Rofes, PhD; Phone Number: +34935944726; Email: lrofes@neosurgery.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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"	1 month post operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper Limb functional index	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	Patients will complete the EQ-5D-5L questionnaire	Before surgery, one month and 6 months postoperatively
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.	Perioperative, 1 month and 6 months postoperatively.
Reinterventions	Incidence and cause of surgical reinterventions	1 month and 6 months postoperatively
Infections	Incidence of sternal superficial and deep wound infections (mediastinitis)	First month and six months postoperatively.
Sternal dehiscence	Incidence of sternal dehiscence (without infection)	First month and six months postoperatively
Sternotomy closure duration	Duration of sternotomy closure procedure (minutes)	Surgery
Easiness of use of the closure method	Surgeon-reported ease of use and satisfaction score (Likert Scale, from 1 to 5)	Surgery
Sternal Pain	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	Type and cumulative dose of analgesia (total morphine milligram equivalents (MME))	Day 7, 1 month and 6 months postoperatively
Post-surgery blood loss	Chest tube drainage (mL)	12 hours postoperatively
Blood loss	Haemoglobin drop (g/dL)	48 hours after surgery
Blood loss	Number of administered perioperative blood transfusions of packed red blood cells	48 hour after surgery
Intensive Care Unit stay duration	Intensive Care Unit stay duration (hours)	from surgery date to Intensive care unit discharge date (up to 150 days)]
hospitalization duration	hospitalization duration (days)	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)	7 days and 6 months postoperatively
Chest bulging	Presence of visible bulging related to the sternal closure method on the sternotomy area	1 month after surgery
Pulmonary function	Pulmonary function (FVC, FEV1 and FEV1/FVC) measured by spirometry	Baseline, day 7 and 1 month postoperatively

Collaborators and Investigators

• Sponsor: NEOS Surgery
• Collaborators: Fundacio Privada Mon Clinic Barcelona

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID 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