Clinical trial NCT04593732: STERN FIX Device As a Sternal Fixation System
Official title: Clinical Investigation to Evaluate the STERN FIX Device As a Sternal Fixation System in Medium Sternotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sternotomy
Lead sponsor: NEOS Surgery
Sponsor class: INDUSTRY
First posted: 2020-10-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sternal stability according to clinical evaluation
timeFrame: 1 month post-surgery
Secondary outcomes:
measure: sternal stability according to clinical evaluation
timeFrame: 7 days post-surgery, 6 months
measure: Prevalence of patients with dehiscence (without infection)
timeFrame: 6 months
measure: Prevalence and causality of adverse events
timeFrame: 6 months
measure: Prevalence of device deficiencies
timeFrame: 6 months
measure: Prevalence of reinterventions
timeFrame: 6 months
measure: Prevalence of superficial and deep sternal wound infections
timeFrame: 6 months
measure: Prevalence of patients with compromised sternal integrity
timeFrame: 6 months
measure: Prevalence of artefacts associated with the product in medical images
timeFrame: 6 months
measure: Time to close the sternal (minutes)
timeFrame: surgery
measure: Surgeon satisfaction score
timeFrame: immediately post-surgery
measure: Chest Pain
timeFrame: pre-surgery, 7 days post-surgery, 1 month, 6 months
measure: Upper limb functionality
timeFrame: pre-surgery, 7 days post-surgery, 1 month, 6 months
measure: Quality of life measured with EuroQol-5D-5L
timeFrame: pre-surgery, 7 days post-surgery, 1 month, 6 months
measure: Working status
timeFrame: pre-surgery, 6 months
measure: Sternal healing grade according to CT results
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
References: