Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure

N/ANot Yet RecruitingNCT07366203

NEOS Surgery190 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

190

Conditions

Sternotomy Closure,Open Heart Surgery

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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"

Time frame: 1 month post operatively

Secondary Outcomes

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.

Time frame: Perioperative, 1 month and 6 months postoperatively.

Reinterventions

Incidence and cause of surgical reinterventions

Time frame: 1 month and 6 months postoperatively

Infections

Incidence of sternal superficial and deep wound infections (mediastinitis)

Time frame: First month and six months postoperatively.

Sternal dehiscence

Incidence of sternal dehiscence (without infection)

Time frame: First month and six months postoperatively

Sternotomy closure duration

Duration of sternotomy closure procedure (minutes)

Time frame: Surgery

Easiness of use of the closure method

Surgeon-reported ease of use and satisfaction score (Likert Scale, from 1 to 5)

Time frame: Surgery

Sternal Pain

Patient-reported sternal pain at rest and during forced cough, measured by Numerical Rating Scale (0-10)

Time frame: Baseline, 7 days, 1 month and 6 months postoperatively.

Analgesia required

Type and cumulative dose of analgesia (total morphine milligram equivalents (MME))

Time frame: Day 7, 1 month and 6 months postoperatively

Post-surgery blood loss

Chest tube drainage (mL)

Time frame: 12 hours postoperatively

Blood loss

Haemoglobin drop (g/dL)

Time frame: 48 hours after surgery

Blood loss

Number of administered perioperative blood transfusions of packed red blood cells

Time frame: 48 hour after surgery

Intensive Care Unit stay duration

Intensive Care Unit stay duration (hours)

Time frame: from surgery date to Intensive care unit discharge date (up to 150 days)]

hospitalization duration

hospitalization duration (days)

Time frame: 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)

Time frame: 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)

Time frame: Before surgery, one month and 6 months postoperatively

Quality of life - EQ5D5L

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

Time frame: Before surgery, one month and 6 months postoperatively

Chest bulging

Presence of visible bulging related to the sternal closure method on the sternotomy area

Time frame: 1 month after surgery

Pulmonary function

Pulmonary function (FVC, FEV1 and FEV1/FVC) measured by spirometry

Time frame: Baseline, day 7 and 1 month postoperatively