Cento

This research aims to assess the safety and performance of Teknimed arthroplasty products, including the CEMFIX and GENTAFIX bone cement families and the CEMSTOP cement restrictor, which have been used for more than 20 years in joint replacement surgeries. The study focuses on real-life long-term data to confirm previous findings on these products safety and effectiveness in patients undergoing joint replacement due to osteoarthritis, osteonecrosis, trauma, or revision surgeries. The study is a global, multicenter, observational trial that collects both retrospective and prospective data from patients receiving primary or revision joint replacements involving Teknimed bone cements and cement restrictors. Different groups include patients undergoing knee, hip, or shoulder surgeries with various cement types. Patients receive treatment as part of their standard medical care, without additional interventions mandated by the study. Participants will be monitored according to local medical practices, with data collected on outcomes such as implant survival, infection rates, pain levels, patient satisfaction, function restoration, complications, and adverse events. The primary outcomes cover up to 15 years, focusing on device lifetime and postoperative infections, while secondary outcomes evaluate patient-reported and clinical measures over five years. This long-term follow-up aims to provide comprehensive safety and performance information for these arthroplasty products.

Researchers are evaluating the clinical characteristics and procedural outcomes of patients receiving permanent cardiac pacing to treat various heart rhythm disorders. This observational study compares the effectiveness and safety of different device implantation methods used in routine clinical practice, including the contribution of advanced non-fluoroscopic anatomical and electrophysiological mapping systems. The study focuses on patients over 18 years old who require a pacemaker or intracardiac defibrillator implant following European Society of Cardiology guidelines. The study includes several types of cardiac pacing approaches conventional right ventricular pacing, conduction system pacing such as His bundle or left bundle branch area pacing, cardiac resynchronization therapy CRT with biventricular or left ventricular pacing, epicardial pacing often done during cardiac surgery, and leadless pacing via a percutaneous femoral vein approach. Each method involves implantation of a device connected to cardiac leads positioned in specific heart locations, with vascular access through veins like the cephalic, axillary, or subclavian. Electrical parameters such as pacing threshold and sensing are measured to ensure device stability before final placement. Participants will be followed for up to 120 months with clinical and procedural data collected, including assessments of device efficacy and safety at 30 days, 6 months, and 12 months. Outcome measures include stable electrical device performance, absence of cardiovascular hospitalizations or death, and monitoring for heart failure or arrhythmia events. The study also tracks procedural times, radiation exposure, and complications such as infections or lead dislocations. This long-term observation aims to understand the benefits and risks of various pacing strategies in real-world settings.