STERN FIX Device As a Sternal Fixation System
Not Applicable
Completed
- Conditions
- Sternotomy
- Registration Number
- NCT04593732
- Lead Sponsor
- NEOS Surgery
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Sternal stability according to clinical evaluation 1 month post-surgery sternal instability scale (SIS) grade: from 0 (Clinically stable sternum ) to 3 Completely separated sternum
- Secondary Outcome Measures
Name Time Method sternal stability according to clinical evaluation 7 days post-surgery, 6 months sternal instability scale (SIS) grade: from 0 (Clinically stable sternum ) to 3 Completely separated sternum
Prevalence of patients with dehiscence (without infection) 6 months Prevalence and causality of adverse events 6 months Prevalence of device deficiencies 6 months Prevalence of reinterventions 6 months Prevalence of superficial and deep sternal wound infections 6 months Prevalence of patients with compromised sternal integrity 6 months Prevalence of artefacts associated with the product in medical images 6 months Time to close the sternal (minutes) surgery Surgeon satisfaction score immediately post-surgery Likert scale \[1-5\]
Chest Pain pre-surgery, 7 days post-surgery, 1 month, 6 months Numeric Rating Scale \[0-10\]
Upper limb functionality pre-surgery, 7 days post-surgery, 1 month, 6 months Upper Limb Functional Index (spanish version) score (0-100%)
Quality of life measured with EuroQol-5D-5L pre-surgery, 7 days post-surgery, 1 month, 6 months EuroQol-5D-5L
Working status pre-surgery, 6 months \[Fully employed/ Working with restrictions/ Unemployed/ On sick leave/ Retired\]
Sternal healing grade according to CT results 6 months Healing score, between 0: No sign of healing, nonunion and 5: complete synthesis.
Trial Locations
- Locations (1)
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain