Clinical Trials Logo

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).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05784532
Study type Observational [Patient Registry]
Source NEOS Surgery
Contact Laia Rofes Salsench, PhD
Phone +34 93 594 47 26
Email lrofes@neosurgery.com
Status Recruiting
Phase
Start date April 1, 2023
Completion date November 30, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05054179 - Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain Phase 2/Phase 3
Completed NCT00976313 - Does Thoracic Epidural Analgesia Influence Urinary Micturition by Patients Undergoing Thoracic Surgery? N/A
Completed NCT00161733 - Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery Phase 3
Completed NCT06153550 - The Benefit of Preparation in Respiratory Physiotherapy Before a Sternotomy in the Context of Cardiac Surgery
Completed NCT04626180 - EFFECT OF PRE EXTUBATION MANUAL HYPERINFLATION TECHNIQUE VS REGULAR EXTUBATION AFTER STERNOTOMY N/A
Completed NCT02457572 - Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition N/A
Completed NCT04591119 - Transversus Thoracis Muscle Plane Block for Postoperative Pain in Adult Cardiac Surgery N/A
Recruiting NCT04585867 - Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy Phase 1
Recruiting NCT06115759 - RCT on T-REX Twente Regimen Effects on Quality of Life and Mobilisation for Cardiac Surgery Patients After Sternotomy N/A
Completed NCT05676814 - Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients Phase 4
Recruiting NCT06418100 - Recto-intercostal Block for Coronary Artery Bypass Grafting N/A
Completed NCT01870063 - Comparision of FIBTEM and Blood-loss N/A
Recruiting NCT04985500 - ESP/PIF for Sternotomy Early Phase 1
Completed NCT04743895 - Study Comparing Steel Wire to a Flat, Braided Suture to Close the Breastbone N/A
Completed NCT05356715 - Erector Spinae Plane Block in Post-operative Recovery in Cardiac Surgery With Median Sternotomy. N/A
Completed NCT02031016 - Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain Phase 4
Not yet recruiting NCT00822419 - Percutaneous Ketamine Versus Lidocaine for Mid-Sternotomy Phase 4
Completed NCT04593732 - STERN FIX Device as a Sternal Fixation System N/A
Completed NCT01828788 - Postoperative Rehabilitation After Cardiac Surgery in Patients at Risk of Respiratory Complications. Effects of a Continuous Bi-laterosternal Infusion of Ropivacaine Through Multihole Catheters Phase 2
Recruiting NCT05357963 - Incidence of Chronic Pain After Sternotomy