Sternal Fixation With STERN FIX After Medial Sternotomy

Sternotomy Clinical Trial

Official title:

Sternal Fixation With STERN FIX After Medial Sternotomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05784532
• Other study ID #: NEO-SC1-2022-01
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: January 2024
• Source: NEOS Surgery
• Contact: Laia Rofes Salsench, PhD
• Phone: +34 93 594 47 26
• Email: lrofes[@]neosurgery.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sternotomy

Intervention

Device:
• STERN FIX
Sternotomy closure with STERN FIX and supplemented with wires

Locations

Country	Name	City	State
United States	New York-Presbyterian Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NEOS Surgery	Anagram-ESIC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Performance of the device in high-risk patients (Stability)	The performance of the device (stability) in high-risk patients will be assessed in a sub-analysis.; Patients considered of high-risk should comply at least one of the following criteria: Pre-operative criteria: diabetes mellitus, COPD, obesity (BMI =30kg/m2), renal failure, chronic usage of steroids, immunosuppression, previous sternotomy, osteoporosis.; Intra-operative criteria: BIMA, cardiopulmonary bypass lasting more than 2 hours.; The sternal stability assessed with the sternal instability scale (SIS). The SIS is a scale ranging from 0 to 3 with the following descriptors: 0 Clinically stable sternum (no detectable motion) - normal; 1 Minimally separated sternum (slight increase in motion upon special testing* - upper limbs, trunk); 2 Partially separated sternum - regional (moderate increase in motion upon special testing*); 3 Completely separated sternum - entire length (marked increase in motion upon special testing*)	One month postoperatively
Other	Safety of the device in high-risk patients (AE and SAE prevalence)	The safety of the device (prevalence and type of AE and SAE) in high-risk patients will be assessed in a sub-analysis.; All adverse events occurring during the study period related to the sternotomy must be recorded. The AE that should be recorded, include: Any device complication (wire o STERN FIX fracture, rotation, migration, …); Surgical complications: any injury caused by the devices or instruments.; Tissue reactions to implant materials.; Damage to the tissues surrounding the devices.; Osseous complications (fractures, sternal dehiscence, malunion, nonunion, instability, necrosis, calcification, decrease in bone density….).; Postoperative hematoma/ bleeding.; Infectious complications (superficial wound infections, mediastinitis, abscess …).; Increased fibrous tissue, keloid or seroma formation in the sternotomy area.; Any other AE that the investigator considers relevant for the registry.	Through study completion, an average of 6 months
Primary	Sternal stability	The primary outcome for this registry will be the sternal stability assessed with the sternal instability scale (SIS). The SIS is a scale ranging from 0 to 3 with the following descriptors: 0. Clinically stable sternum (no detectable motion) - normal; 1. Minimally separated sternum (slight increase in motion upon special testing* - upper limbs, trunk); 2. Partially separated sternum - regional (moderate increase in motion upon special testing*); 3. Completely separated sternum - entire length (marked increase in motion upon special testing*)	One month postoperatively
Secondary	Prevalence and type of AE and SAE	All adverse events occurring during the study period related to the sternotomy must be recorded. The AE that should be recorded, include: Any device complication (wire o STERN FIX fracture, rotation, migration, …); Surgical complications: any injury caused by the devices or instruments.; Tissue reactions to implant materials.; Damage to the tissues surrounding the devices.; Osseous complications (fractures, sternal dehiscence, malunion, nonunion, instability, necrosis, calcification, decrease in bone density….).; Postoperative hematoma/ bleeding.; Infectious complications (superficial wound infections, mediastinitis, abscess …).; Increased fibrous tissue, keloid or seroma formation in the sternotomy area.; Any other AE that the investigator considers relevant for the registry.	Through study completion, an average of 6 months
Secondary	Prevalence of device deficiencies.	Adverse event related to the use of an investigational medical device. This includes adverse events resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction and events resulting from use error or from intentional misuse of the investigational medical device.	Through study completion, an average of 6 months
Secondary	Sternal closure time	Time elapsed from the measurement of the intercostal spaces to the closure of the last intercostal space.	Surgery
Secondary	Easiness of implantation of the device (Likert)	The easiness score assessed by the surgeon about the usage of the medical device will be registered according to the Likert scale (1-5) with the following descriptors: 5. Very easy; 4. Easy; 3. Neither easy or difficult; 2. Difficult; 1. Very difficult	Immediately after surgery
Secondary	Easiness of implantation of the device (assistance)	The surgeon will indicate whether they requested external assistance during the implantation of the device	Immediately after surgery
Secondary	Surgeon satisfaction for the use of the device	The surgeon general satisfaction with the sternotomy closure using STERN FIX will be assessed in comparison with the usual wire closure using the Likert scale (1-5) with the following descriptors: 5. Very satisfied; 4. Satisfied; 3. Neither satisfied or dissatisfied; 2. Dissatisfied; 1. Very dissatisfied	Immediately after surgery