Clinical trial NCT05784532: Sternal Fixation With STERN FIX After Medial Sternotomy
Official title: Sternal Fixation With STERN FIX After Medial Sternotomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sternotomy
Keywords: Rigid Fixation
Sternal Closure
STERN FIX
Lead sponsor: NEOS Surgery
Sponsor class: INDUSTRY
Collaborators: name: Anagram-ESIC
First posted: 2023-03-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All those patients that have or will undergo medial sternotomy during the registry period will be considered for inclusion. They will be informed about it, and if they consent for their data to be used in the registry, their eligibility will be assessed. If a patient does not comply with all IFUs indications, they will not be included in the registry

Brief summary: The goal of this single arm observational registry is to evaluate the safety and performance of the STERN FIX device in normal conditions of use, in patients treated with medial sternotomy according to the instructions for use.

The main goal of this registry is to evaluate the sternal stability in patients who had their sternum fixed with the STERN FIX system.

Participants will have their sternotomy closed with the STERN FIX device at the end of their cardiothoracic surgery and will be followed up as per standard of care. At discharge and at the 1 month FU visit the sternal stability will be assessed using the sternal instability scale (SIS).


Eligibility criteria: Inclusion Criteria:

* Older than 18 years old patient
* Patient undergoing surgery requiring medial sternotomy
* Patient able and willing to provide informed consent to participate in the registry and/or who have provided written consent to have their clinical data added to the registry

Exclusion Criteria:

* Patients that are still growing.
* Patients with Sternal anomalies preventing the use of the STERN FIX Sternal Stabilization System, such as bone tumors located in the implant region.
* Patient with conditions previous to surgery that may impact healing, including bone blood supply limitations, insufficient quantity or quality of bone, or other severe structural bone damage.
* Patients with suspected or known allergies or intolerances to the implant material.
* Patients with severe osteoporosis or other degenerative bone diseases.
* Any patient unwilling to, or incapable of, following postoperative care instructions.
* Patients with any other medical or surgical process that may compromise or limit the adequate functionality of the implant.
* Pregnant patients or planning to become pregnant during the 2 months following surgery.
* Patients with life expectancy lower than 2 months.
* Patients who are or have been participating in an interventionist trial during the last 4 weeks

Intraoperative exclusion criteria

* Latent or active infection, or inflammation in the operating area.
* Signs of infection on the surgical site.
* Parasternal sternotomy.
* When the STERN FIX Sternal Stabilization System cannot ensure sufficient fixation.
* When a STERN FIX Sternal Stabilization System device cannot be placed properly in any intercostal space.

Primary outcomes:
measure: Sternal stability
timeFrame: One month postoperatively
Secondary outcomes:
measure: Prevalence and type of AE and SAE
timeFrame: Through study completion, an average of 6 months
measure: Prevalence of device deficiencies.
timeFrame: Through study completion, an average of 6 months
measure: Sternal closure time
timeFrame: Surgery
measure: Easiness of implantation of the device (Likert)
timeFrame: Immediately after surgery
measure: Easiness of implantation of the device (assistance)
timeFrame: Immediately after surgery
measure: Surgeon satisfaction for the use of the device
timeFrame: Immediately after surgery
Other outcomes:
measure: Performance of the device in high-risk patients (Stability)
timeFrame: One month postoperatively
measure: Safety of the device in high-risk patients (AE and SAE prevalence)
timeFrame: Through study completion, an average of 6 months
Locations:
city: New York
country: United States
facility: New York-Presbyterian Hospital
state: New York
Study officials:
References: