New device aims to improve healing after heart surgery
NCT ID NCT05953259
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a device called STERN FIX, used with wires to close the breastbone after heart surgery. The goal is to see if it provides better stability than standard wires alone, especially in patients at higher risk for complications. About 90 participants will be randomly assigned to receive either STERN FIX plus wires or wires only, and their recovery will be monitored for one month.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- STERN FIX device (used with wires to close the breastbone after surgery)
- What this could lead to
- If it works, STERN FIX could provide a safer, more stable closure of the breastbone after heart surgery, reducing complications in high-risk patients.
- What could go wrong
- This is a small, early-stage trial with only 90 participants, so results may not apply to everyone. The device is compared to standard wires, and any new device carries risks like infection or device failure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Dec 2025
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008, Spain
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Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036, Spain
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Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
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Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
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Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
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