Clinical trial NCT05953259: RCT to Evaluate STERN FIX Device As a Sternal Stabilization System in Patients After Sternotomy
Official title: Randomised Controlled Clinical Trial to Evaluate STERN FIX Device As a Sternal Stabilization System in Patients After Sternotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Median Sternotomy
Keywords: sternal closure
cardiac surgery
sternotomy
Lead sponsor: NEOS Surgery
Sponsor class: INDUSTRY
Collaborators: name: Hospital Clinic of Barcelona
name: Complejo Hospitalario de Navarra
name: Universitätsklinikum Freiburg
First posted: 2023-07-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the safety and performance of the sternal stabilization system STERN FIX with the standard of care (sternal closure with wires only) in normal conditions of use, in patients of risk undergoing median sternotomy during cardiothoracic surgery. The main question it aims to answer is:

• whether STERN FIX is a safe and efficient device to close the sternum after a sternotomy in patients of risk, achieving higher sternal stability than wires one month after surgery Participants will have their median sternotomy closed using STERN FIX in combination with wires or wires only at the end of their cardiothoracic surgery, according to the allocated treatment.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing surgery that requires median sternotomy
* Patients with at least one of the following risk criteria: obesity (BMI\>30), diabetes, COPD, non serious osteoporosis (not associated with fractures), creatinine \> 200 µmol/L and/or under dialysis treatment, scheduled Bilateral Internal Mammary Artery (BIMA) grafting
* Patients willing and capable of granting informed consent to participate in clinical research and who have granted written consent
* Patient willing and capable of complying with the protocol requirements

Exclusion Criteria:

* Patient with suspected or known allergies or intolerance to the device material (PEEK - polyether-ether-ketone and carbon fibre)
* Patient with insufficient quality or quantity of bone or any other serious structural bone damage at the sternum
* Patient with serious osteoporosis (associated with fractures) or a degenerative bone disease affecting the sternum
* Patients with a latent or active infection or inflammation at the surgical area, that according to the surgeon criteria may interfere in the device implantation or proper function.
* Patient with sternal anomalies that, according to the surgeon criteria, prevent the use of the product, such as bone tumours in the implantation area.
* Pregnant patients or patients planning to become pregnant during the first 6 months after surgery.
* Patients with diagnosis of dementia with a mental status score (MMSE) \< 20.
* Patients with life expectancy lower than 6 months.
* Patients involved in other interventionist clinical trials or that have been involved in other interventionist clinical trials during the previous 4 weeks
* Parasternal sternotomy.
* Patients with intraoperative conditions that, according to the surgeon's opinion, require or exclude the use of a specific sternal closure system, or that cannot be closed following the study products instructions for use.

IMPORTANT: When the allocated closure method is wires only, the surgeon must assess whether the patient could have also had STERN FIX implanted in order to decide if the patient can continue in the study.

Primary outcomes:
measure: Sternal stability
timeFrame: 1 month after surgery
Secondary outcomes:
measure: Safety SAE/AE prevalence
timeFrame: 6 months after surgery
measure: Safety SAE/AE causality
timeFrame: 6 months after surgery
measure: Prevalence of device deficiencies
timeFrame: 6 months after surgery
measure: Reinterventions - prevalence
timeFrame: 6 months after surgery
measure: Reinterventions - Causality
timeFrame: 6 months after surgery
measure: Prevalence of sternal wound infections
timeFrame: 1 month and 6 months after surgery
measure: Prevalence of dehiscence
timeFrame: 1 month and 6 months after surgery
measure: Sternal closure time
timeFrame: Surgery
measure: Easiness of use of the closure method
timeFrame: Surgery
measure: Surgeon satisfaction of the closure method
timeFrame: Surgery
measure: Chest pain
timeFrame: Before surgery, 3 and 7 days postoperatively, during the first month and during 6 months postoperatively
measure: Blood loss
timeFrame: During the first 12 hours postoperatively
measure: Upper Limb functional index
timeFrame: Before surgery, one month and 6 months postoperatively
measure: Quality of life - EQ5D5L
timeFrame: Before surgery, one month and 6 months postoperatively
measure: Sternal halves union/malunion
timeFrame: 6 months after surgery
measure: Sternal halves alignment
timeFrame: 6 months after surgery
measure: Sternum integrity
timeFrame: 6 months after surgery
measure: Closure system integrity
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Freiburg im Breisgau
country: Germany
facility: Universitätsklinikum Freiburg
state: Baden-Württemberg
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Manel Castellà Pericás, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: